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Th e Jou r n a l of C li n i ca l a n d A ppl i ed R esea rc h a n d E ducati o n Volume 43 | Supplement 1

January 2020

www.diabetes.org/diabetescare January 2020

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in diabetes—2020
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American Diabetes Association
Standards of

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© 2019 by the American Diabetes Association. Readers may use this work as long as the work is properly
cited, the use is educational and not for profit, and the work is not altered. Readers may link to the version of
record of this work on https://care.diabetesjournals.org, but ADA permission is required to post this work on
any third-party website or platform. Requests to reuse or repurpose; adapt or modify; or post, display, or
distribute this work may be sent to permissions@diabetes.org.
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January 2020 Volume 43, Supplement 1

[T]he simple word Care may suffice to express [the journal’s] philosophical
mission. The new journal is designed to promote better patient care by
serving the expanded needs of all health professionals committed to the care
of patients with diabetes. As such, the American Diabetes Association views

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Diabetes Care as a reaffirmation of Francis Weld Peabody’s contention that

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“the secret of the care of the patient is in caring for the patient.”
—Norbert Freinkel, Diabetes Care, January-February 1978

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EDITOR IN CHIEF

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Matthew C. Riddle, MD

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ASSOCIATE EDITORS EDITORIAL BOARD

George Bakris, MD Andrew J. Ahmann, MD M. Sue Kirkman, MD

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Lawrence Blonde, MD, FACP Linda A. Barbour, MD, MSPH John J.V. McMurray, MD, FRCP, FESC,
Andrew J.M. Boulton, MD Ananda Basu, MD, FRCP FACC, FAHA, FRSE, FMedSci
David D’Alessio, MD Roy W. Beck, MD, PhD Maureen Monaghan, PhD, CDE

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Linda A. DiMeglio, MA, MD, MPH Gianni Bellomo, MD Kristen J. Nadeau, MD, MS

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Linda Gonder-Frederick, PhD Geremia Bolli, MD Gregory A. Nichols, PhD, MBA
Korey K. Hood, PhD Sonia Caprio, MD Bruce A. Perkins, MD, MPH
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Frank B. Hu, MD, MPH, PhD Jessica R. Castle, MD Ravi Retnakaran, MD, MSc, FRCPC
Steven E. Kahn, MB, ChB J. Hans DeVries, MD, PhD Elizabeth Seaquist, MD
Sanjay Kaul, MD, FACC, FAHA Kathleen M. Dungan, MD, MPH Jonathan Shaw, MD, FRCP, FRACP,
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Lawrence A. Leiter, MD, FRCPC, FACP, Thomas W. Gardner, MD, MS FAAHMS


FACE, FACC, FAHA Jennifer Green, MD Jay M. Sosenko, MD, MS
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Robert G. Moses, MD Petr Heneberg, RNDr, PhD Kristina M. Utzschneider, MD


Stephen Rich, PhD Norbert Hermanns, PhD, MSc Daniel H. van Raalte, MD, PhD
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Julio Rosenstock, MD Reinhard W. Holl, MD, PhD Ram Weiss, MD, PhD
Judith Wylie-Rosett, EdD, RD Philip Home, DM, DPhil Deborah Wexler, MD, MSc
Byron J. Hoogwerf, MD, FACP, FACE Vincent C. Woo, MD, FRCPC
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George S. Jeha, MD Bernard Zinman, CM, MD, FRCPC,


Lee M. Kaplan, MD, PhD FACP
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AMERICAN DIABETES ASSOCIATION OFFICERS


CHAIR OF THE BOARD PRESIDENT-ELECT, MEDICINE & SCIENCE
David J. Herrick, MBA Robert H. Eckel, MD
PRESIDENT, MEDICINE & SCIENCE
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Louis H. Philipson, MD, PhD, FACP PRESIDENT-ELECT, HEALTH CARE &


EDUCATION
PRESIDENT, HEALTH CARE & Mary de Groot, PhD
EDUCATION
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Gretchen Youssef, MS, RD, CDE


SECRETARY/TREASURER-ELECT
SECRETARY/TREASURER Martha Parry Clark, MBA
©

Brian Bertha, JD, MBA


CHAIR OF THE BOARD-ELECT CHIEF EXECUTIVE OFFICER
Umesh Verma Tracey D. Brown, MBA, BChE

The mission of the American Diabetes Association


is to prevent and cure diabetes and to improve
the lives of all people affected by diabetes.
Diabetes Care is a journal for the health care practitioner that is intended to
increase knowledge, stimulate research, and promote better management of people
with diabetes. To achieve these goals, the journal publishes original research on
human studies in the following categories: Clinical Care/Education/Nutrition/

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Psychosocial Research, Epidemiology/Health Services Research, Emerging
Technologies and Therapeutics, Pathophysiology/Complications, and Cardiovascular

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and Metabolic Risk. The journal also publishes ADA statements, consensus reports,
clinically relevant review articles, letters to the editor, and health/medical news or points

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of view. Topics covered are of interest to clinically oriented physicians, researchers,
epidemiologists, psychologists, diabetes educators, and other health professionals.

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More information about the journal can be found online at care.diabetesjournals.org.

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Copyright © 2019 by the American Diabetes Association, Inc. All rights reserved. Printed in
the USA. Requests for permission to reuse content should be sent to Copyright Clearance
Center at www.copyright.com or 222 Rosewood Dr., Danvers, MA 01923; phone: (978)

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750-8400; fax: (978) 646-8600. Requests for permission to translate should be sent to
Permissions Editor, American Diabetes Association, at permissions@diabetes.org.
The American Diabetes Association reserves the right to reject any advertisement for
any reason, which need not be disclosed to the party submitting the advertisement.

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Commercial reprint orders should be directed to Sheridan Content Services,
(800) 635-7181, ext. 8065.

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Single issues of Diabetes Care can be ordered by calling toll-free (800) 232-3472, 8:30 A.M.
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to 5:00 P.M. EST, Monday through Friday. Outside the United States, call (703) 549-1500.
Rates: $75 in the United States, $95 in Canada and Mexico, and $125 for all other countries.
Diabetes Care is available online at care.diabetesjournals.org. Please call the
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numbers listed above, e-mail membership@diabetes.org, or visit the online journal for
more information about submitting manuscripts, publication charges, ordering reprints,
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AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS


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ASSOCIATE PUBLISHER, EDITORIAL MANAGER ADVERTISING REPRESENTATIVES


SCHOLARLY JOURNALS Donna J. Reynolds
Christian S. Kohler American Diabetes Association
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TECHNICAL EDITOR Associate Publisher, Advertising &
EDITORIAL OFFICE DIRECTOR
Theresa M. Cooper Sponsorships
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PRODUCTION COORDINATOR
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Keang Hok (703) 299-5511 (609) 882-8887, ext. 112
January 2020 Volume 43, Supplement 1

Standards of Medical Care in Diabetes—2020


S1 Introduction S89 8. Obesity Management for the Treatment of Type
2 Diabetes

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S3 Professional Practice Committee
Assessment
Summary of Revisions: Standards of Medical Care in

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S4 Diet, Physical Activity, and Behavioral Therapy
Diabetes—2020 Pharmacotherapy
Medical Devices for Weight Loss

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S7 1. Improving Care and Promoting Health in Metabolic Surgery
Populations 9. Pharmacologic Approaches to Glycemic

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S98
Diabetes and Population Health Treatment
Tailoring Treatment for Social Context

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Pharmacologic Therapy for Type 1 Diabetes
Surgical Treatment for Type 1 Diabetes
S14 2. Classification and Diagnosis of Diabetes Pharmacologic Therapy for Type 2 Diabetes

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Classification
S111 10. Cardiovascular Disease and Risk
Diagnostic Tests for Diabetes
Management
A1C
Type 1 Diabetes The Risk Calculator
Prediabetes and Type 2 Diabetes Hypertension/Blood Pressure Control

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Cystic Fibrosis–Related Diabetes Lipid Management
Posttransplantation Diabetes Mellitus Statin Changes

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Monogenic Diabetes Syndromes Antiplatelet Agents
Pancreatic Diabetes/Diabetes in the Cardiovascular Disease
Cardiac Testing
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Context of the Exocrine Pancreas
Gestational Diabetes Mellitus Screening Asymptomatic Patients
Lifestyle and Pharmacologic Interventions
Glucose-Lowering Therapies and Cardiovascular Outcomes
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S32 3. Prevention or Delay of Type 2 Diabetes


Lifestyle Interventions S135 11. Microvascular Complications and Foot Care
Chronic Kidney Disease
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Pharmacologic Interventions
Prevention of Cardiovascular Disease Diabetic Retinopathy
Diabetes Self-management Education and Support Neuropathy
Foot Care
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S37 4. Comprehensive Medical Evaluation and S152 12. Older Adults


Assessment of Comorbidities Neurocognitive Function
Patient-Centered Collaborative Care
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Hypoglycemia
Comprehensive Medical Evaluation Treatment Goals
Assessment of Comorbidities Lifestyle Management
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Pharmacologic Therapy
S48 5. Facilitating Behavior Change and Well-being to Special Considerations for Type 1 Diabetes
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Improve Health Outcomes Treatment in Skilled Nursing Facilities


and Nursing Homes
Diabetes Self-management Education and Support End-of-Life Care
Medical Nutrition Therapy
Physical Activity S163 13. Children and Adolescents
Smoking Cessation: Tobacco and e-Cigarettes Type 1 Diabetes
Psychosocial Issues
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Type 2 Diabetes
Transition From Pediatric to Adult Care
S66 6. Glycemic Targets
S183 14. Management of Diabetes in Pregnancy
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Assessment of Glycemic Control


A1C Goals Diabetes in Pregnancy
Hypoglycemia Preconception Counseling
Intercurrent Illness Glycemic Targets
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Management of Gestational Diabetes Mellitus


Management of Preexisting Type 1 Diabetes
S77 7. Diabetes Technology and Type 2 Diabetes
Self-monitoring of Blood Glucose Preeclampsia and Aspirin
Continuous Glucose Monitors Pregnancy and Drug Considerations
Insulin Delivery Postpartum Care
This issue is freely accessible online at care.diabetesjournals.org/content/43/Supplement_1.
Keep up with the latest information for Diabetes Care and other ADA titles via Facebook (/ADAJournals) and Twitter (@ADA_Journals).

S193 15. Diabetes Care in the Hospital Transition From the Hospital to the Ambulatory Setting
Hospital Care Delivery Standards Preventing Admissions and Readmissions
Glycemic Targets in Hospitalized Patients
Bedside Blood Glucose Monitoring S203 16. Diabetes Advocacy
Glucose-Lowering Agents in Hospitalized Patients Advocacy Statements
Hypoglycemia
Medical Nutrition Therapy in the Hospital S205 Disclosures
Self-management in the Hospital
Standards for Special Situations S207 Index

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Diabetes Care Volume 43, Supplement 1, January 2020 S1

Introduction: Standards of Medical


Care in Diabetesd2020

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Diabetes Care 2020;43(Suppl. 1):S1–S2 | https://doi.org/10.2337/dc20-SINT

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Diabetes is a complex, chronic illness re- The ADA strives to improve and update immediate inclusion. More information on
the “living Standards” can be found on the

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quiring continuous medical care with the Standards of Care to ensure that
multifactorial risk-reduction strategies clinicians, health plans, and policy mak- ADA’s professional website DiabetesPro at
beyond glycemic control. Ongoing dia- ers can continue to rely on it as the professional.diabetes.org/content-page/
betes self-management education and most authoritative source for current living-standards. The Standards of Care

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support are critical to preventing acute guidelines for diabetes care. supersedes all previous ADA position

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complications and reducing the risk of long- statementsdand the recommendations
ADA STANDARDS, STATEMENTS,

INTRODUCTION
term complications. Significant evidence thereindon clinical topics within the
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REPORTS, and REVIEWS purview of the Standards of Care; ADA
exists that supports a range of interven-
tions to improve diabetes outcomes. The ADA has been actively involved in position statements, while still contain-
The American Diabetes Association the development and dissemination of ing valuable analysis, should not be con-
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(ADA) “Standards of Medical Care in Di- diabetes care clinical practice recom- sidered the ADA’s current position. The
abetes,” referred to as the Standards of mendations and related documents for Standards of Care receives annual review
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30 years. The ADA’s Standards of Medical and approval by the ADA Board of Directors.
Care, is intended to provide clinicians,
Care is viewed as an important resource
patients, researchers, payers, and other ADA Statement
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for health care professionals who care for


interested individuals with the compo- An ADA statement is an official
people with diabetes.
nents of diabetes care, general treatment ADA point of view or belief that
goals, and tools to evaluate the quality of
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Standards of Care does not contain clinical practice


care. The Standards of Care recommen- The annual Standards of Care recommendations and may be issued
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dations are not intended to preclude supplement to Diabetes Care contains on advocacy, policy, economic, or
clinical judgment and must be applied official ADA position, is authored by medical issues related to diabetes.
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in the context of excellent clinical care, the ADA, and provides all of the ADA statements undergo a formal re-
with adjustments for individual prefer- ADA’s current clinical practice view process, including a review by the
ences, comorbidities, and other patient recommendations. appropriate ADA national committee,
factors. For more detailed information To update the Standards of Care, the ADA science and medicine staff, and
about the management of diabetes, please
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ADA’s Professional Practice Committee the ADA Board of Directors.


refer to Medical Management of Type 1 (PPC) performs an extensive clinical di-
Diabetes (1) and Medical Management of abetes literature search, supplemented Consensus Report
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Type 2 Diabetes (2). with input from ADA staff and the med- A consensus report of a particular
The recommendations in the Stand- ical community at large. The PPC updates topic contains a comprehensive
ards of Care include screening, diagnos- the Standards of Care annually. However, examination and is authored by an
©

tic, and therapeutic actions that are known the Standards of Care is a “living” docu- expert panel (i.e., consensus panel)
or believed to favorably affect health out- ment, where important updates are pub- and represents the panel’s collective
comes of patients with diabetes. Many lished online should the PPC determine analysis, evaluation, and opinion.
of these interventions have also been that new evidence or regulatory changes The need for a consensus report arises
shown to be cost-effective (3). (e.g., drug approvals, label changes) merit when clinicians, scientists, regulators,

The “Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: December 2019.
© 2019 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
S2 Introduction Diabetes Care Volume 43, Supplement 1, January 2020

Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes” the evidence in support of the recom-
Level of
mendation. Expert opinion E is a separate
evidence Description category for recommendations in which
there is no evidence from clinical trials,
A Clear evidence from well-conducted, generalizable randomized controlled trials that
are adequately powered, including
clinical trials may be impractical, or there
c Evidence from a well-conducted multicenter trial is conflicting evidence. Recommendations
c Evidence from a meta-analysis that incorporated quality ratings in the analysis with A level evidence are based on large
Compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre well-designed clinical trials or well-done

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for Evidence-Based Medicine at the University of Oxford meta-analyses. Generally, these recom-
Supportive evidence from well-conducted randomized controlled trials that are mendations have the best chance of im-

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adequately powered, including
proving outcomes when applied to the
c Evidence from a well-conducted trial at one or more institutions
c Evidence from a meta-analysis that incorporated quality ratings in the analysis
population for which they are appropriate.

a
B Supportive evidence from well-conducted cohort studies
Recommendations with lower levels of

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c Evidence from a well-conducted prospective cohort study or registry evidence may be equally important
c Evidence from a well-conducted meta-analysis of cohort studies but are not as well supported.

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Supportive evidence from a well-conducted case-control study Of course, evidence is only one com-
C Supportive evidence from poorly controlled or uncontrolled studies ponent of clinical decision-making. Clini-
c Evidence from randomized clinical trials with one or more major or three or more cians care for patients, not populations;

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minor methodological flaws that could invalidate the results guidelines must always be interpreted
c Evidence from observational studies with high potential for bias (such as case
with the individual patient in mind. In-
series with comparison with historical controls)
c Evidence from case series or case reports
dividual circumstances, such as comorbid

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Conflicting evidence with the weight of evidence supporting the recommendation and coexisting diseases, age, education,
E disability, and, above all, patients’ values

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Expert consensus or clinical experience
and preferences, must be considered and
may lead to different treatment targets
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and/or policy makers desire guidance Standards of Care. The category may also and strategies. Furthermore, conven-
and/or clarity on a medical or scientific include task force and expert committee tional evidence hierarchies, such as the
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issue related to diabetes for which the reports. one adapted by the ADA, may miss
evidence is contradictory, emerging, or nuances important in diabetes care.
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incomplete. Consensus reports may also GRADING OF SCIENTIFIC EVIDENCE For example, although there is excellent
highlight gaps in evidence and propose Since the ADA first began publishing evidence from clinical trials supporting
areas of future research to address clinical practice guidelines, there has the importance of achieving multiple risk
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these gaps. A consensus report is not been considerable evolution in the eval- factor control, the optimal way to achieve
an ADA position but represents expert uation of scientific evidence and in the this result is less clear. It is difficult to
assess each component of such a complex
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opinion only and is produced under the development of evidence-based guide-


auspices of the ADA by invited experts. lines. In 2002, the ADA developed a intervention.
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A consensus report may be developed af- classification system to grade the quality
ter an ADA Clinical Conference or Re- of scientific evidence supporting ADA rec- References
1. American Diabetes Association. Medical
Am

search Symposium. ommendations. A 2015 analysis of the


Management of Type 1 Diabetes. 7th ed. Wang
evidence cited in the Standards of Care
Scientific Review CC, Shah AC, Eds. Alexandria, VA, American Di-
found steady improvement in quality abetes Association, 2017
A scientific review is a balanced review over the previous 10 years, with the 2. American Diabetes Association. Medical Man-
and analysis of the literature on a 2014 Standards of Care for the first time agement of Type 2 Diabetes. 7th ed. Burant CF,
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scientific or medical topic related having the majority of bulleted recom- Young LA, Eds. Alexandria, VA, American Diabetes
Association, 2012
to diabetes. mendations supported by A level or 3. Li R, Zhang P, Barker LE, Chowdhury FM, Zhang
A scientific review is not an ADA position B level evidence (4). A grading system
20

X. Cost-effectiveness of interventions to prevent


and does not contain clinical practice (Table 1) developed by the ADA and and control diabetes mellitus: a systematic
recommendations but is produced un- modeled after existing methods was used to review. Diabetes Care 2010;33:1872–1894
4. Grant RW, Kirkman MS. Trends in the evi-
©

der the auspices of the ADA by invited clarify and codify the evidence that forms
dence level for the American Diabetes Associa-
experts. The scientific review may pro- the basis for the recommendations. ADA tion’s “Standards of Medical Care in Diabetes”
vide a scientific rationale for clini- recommendations are assigned ratings of from 2005 to 2014. Diabetes Care 2015;38:
cal practice recommendations in the A, B, or C, depending on the quality of 6–8
Diabetes Care Volume 43, Supplement 1, January 2020 S3

Professional Practice Committee:


Standards of Medical Care in
Diabetesd2020

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Diabetes Care 2020;43(Suppl. 1):S3| https://doi.org/10.2337/dc20-SPPC

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The Professional Practice Committee (PPC) and published since 15 October 2018. Hsu, MD; Sally C. Hughes, BA; Scott
of the American Diabetes Association (ADA) Due to limitations associated with pro- Kahan, MD, MPH; Ka Hei Karen Lau,
is responsible for the “Standards of Medical duction timelines, evidence published in MS, RD, LDN, CDE; Jose Leon, MD; Ingrid

As
Care in Diabetes,” referred to as the Stand- late 2019 was not incorporated into the Libman, MD, PhD; Sarah K. Lyons, MD;

IMPROVING CARE AND PROMOTING HEALTH


ards of Care. The PPC is a multidisciplinary initial 2020 Standards of Care release (e.g., Medha Munshi, MD; Henry Rodriguez,
expert committee comprised of physicians, Dapagliflozin in Patients with Heart Failure MD; Amy Shah, MD; Connor K. Smith,

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diabetes educators, and others who have and Reduced Ejection Fraction [DAPA-HF], BS; Andrea Steck, MD; William S. Yancy,

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expertise in a range of areas, including, but Cardiovascular Outcome Study of Linaglip- MD, MHS; and Ann Zmuda, DPM.
not limited to, adult and pediatric endocri- tin Versus Glimepiride in Patients With Members of the PPC
nology, epidemiology, public health, cardio- Type 2 Diabetes [CAROLINA], etc.), but
be
Joshua J. Neumiller, PharmD, CDE, FASCP
vascular risk management, microvascular salient new data will be incorporated in (Chair)
complications, preconception and preg- a living Standards update in early 2020 George Bakris, MD
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nancy care, weight management and di- (professional.diabetes.org/content-page/ William T. Cefalu, MD


abetes prevention, and use of technology in living-standards). Recommendations were Jill Crandall, MD
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diabetes management. Appointment to the revised based on new evidence or, in some David D’Alessio, MD
PPCisbasedonexcellenceinclinicalpractice cases, to clarify the prior recommendation Jennifer Green, MD
and research. Although the primary role of or match the strength of the wording to the
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Elbert Huang, MD, MPH, FACP


the PPC members is to review and update strength of the evidence. A table linking Kathryn Evans Kreider, DNP, APRN, FNP-BC,
the Standards of Care, they may also be the changes in recommendations to new BC-ADM
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involved in ADA statements, reports, and evidence can be reviewed online at profes- Christine G. Lee, MD, MS
reviews. sional.diabetes.org/SOC. The Standards Nisa Maruthur, MD, MHS
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The ADA adheres to the National Acad- of Care is approved by the ADA’s Board Anne Peters, MD
emy of Medicine Standards for Developing of Directors, which includes health care Maria Jose Redondo, MD, PhD, MPH
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Trustworthy Clinical Practice Guidelines. All professionals, scientists, and lay people. Jane Reusch, MD
members of the PPC arerequired to disclose Feedback from the larger clinical com- Emily Weatherup, MS, RDN, CDE
potential conflicts of interest with industry munity was invaluable for the annual Jennifer Wyckoff, MD
and other relevant organizations. These 2019 revision of the Standards of Care. Deborah Young-Hyman, PhD, CDE
disclosures are discussed at the onset of Readers who wish to comment on the
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each Standards of Care revision meeting. 2020 Standards of Care are invited to do so American College of
Members of the committee, their employ- at professional.diabetes.org/SOC. CardiologydDesignated
ers, and their disclosed conflicts of interest The PPC thanks the following indi- Representatives (Section 10)
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are listed in “Disclosures: Standards of viduals who provided their expertise Sandeep Das, MD, MPH, FACC
Medical Care in Diabetesd2020” (https:// in reviewing and/or consulting with Mikhail Kosiborod, MD, FACC
©

doi.org/10.2337/dc20-SPPC). The ADA funds the committee: Nidhi Bansal, MD; Linda ADA Staff
development of the Standards of Care A. Barbour, MD, MSPH, FACP; Florence Mindy Saraco, MHA (corresponding author:
out of its general revenues and does not Brown, MD; Thomas Buchanan, MD; Linda msaraco@diabetes.org)
use industry support for this purpose. A. DiMeglio, MD; Alison B. Evert, MS, Malaika I. Hill, MA
For the current revision, PPC members RD, CDE; Hermes Flores, MD, PhD; Matthew P. Petersen
systematically searched MEDLINE for Thomas W. Gardner, MD, MS; Rose Shamera Robinson, MPH, RDN
human studies related to each section Gubitosi-Klug, MD, PhD; William C. Kenneth P. Moritsugu, MD, MPH, FACPM

© 2019 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
S4 Diabetes Care Volume 43, Supplement 1, January 2020

Summary of Revisions: Standards


of Medical Care in Diabetesd2020

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Diabetes Care 2020;43(Suppl. 1):S4–S6 | https://doi.org/10.2337/dc20-SREV

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GENERAL CHANGES autoimmune diabetes in adults is now Centers for Disease Control (CDC) Diabetes
The field of diabetes care is rapidly chang- acknowledged. Prevention Impact Tool Kit. More infor-

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ing as new research, technology, and A new recommendation (2.8) was added mation was added on the risk reduction
treatments that can improve the health regarding testing for prediabetes and/or certain groups experienced with metformin

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and well-being of people with diabetes type 2 diabetes for women with over- use, based on 15-year follow-up data
continue to emerge. With annual up- weight or obesity and/or who have one from the Diabetes Prevention Program
dates since 1989, the American Diabetes or more additional risk factors for dia- Outcomes Study.
Association (ADA) has long been a leader betes who are planning a pregnancy.

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Additional considerations were added Section 4. Comprehensive Medical
in producing guidelines that capture the
SUMMARY OF REVISIONS

to the section “Cystic Fibrosis–Related Evaluation and Assessment of

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most current state of the field.
Diabetes” (CFRD) regarding the use of Comorbidities
Although levels of evidence for several
(https://doi.org/10.2337/dc20-S004)
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recommendations have been updated, A1C tests to detect CFRD.
The 2020 Standards of Care includes The autoimmune diseases recommen-
these changes are not outlined below
a new section on “Pancreatic Diabetes or dation (4.12) was modified, and a new
where the clinical recommendation has
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Diabetes in the Context of Disease of recommendation was added (4.13) with


remained the same. That is, changes in
autoimmune thyroid disease and celiac
evidence level from, for example, E to C the Exocrine Pancreas” to describe this
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form of diabetes and its diverse set of disease screening guidance differenti-
are not noted below. The 2020 Standards
etiologies. ated, and more information on the prev-
of Care contains, in addition to many
The “Gestational Diabetes Mellitus” alence of and screening for these diseases
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minor changes that clarify recommenda-


(GDM) section was revised, and the has been added to the text.
tions or reflect new evidence, the follow-
two-step approach for screening and di- Because infection with hepatitis C virus
ing more substantive revisions.
is associated with a higher prevalence of
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agnosing GDM no longer includes Na-


SECTION CHANGES tional Diabetes Data Group criteria. type 2 diabetes, discussion was added
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regarding glucose metabolism and erad-


Section 1. Improving Care and
Section 3. Prevention or Delay of ication of hepatitis C virus infection.
Promoting Health in Populations
The title of the hearing impairment
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Type 2 Diabetes
(https://doi.org/10.2337/dc20-S001)
(https://doi.org/10.2337/dc20-S003) section was changed to “Sensory Impair-
Additional information was included on
On the basis of a new consensus report, ment,” and new information was added,
the rising cost of medications, particu-
“Nutrition Therapy for Adults With Di- including content on impairment of smell.
larly insulin.
abetes or Prediabetes: A Consensus Evidence was updated in the section
A new section “Migrant and Seasonal
19

Report” (https://doi.org/10.2337/dci19- “Periodontal Disease.”


Agricultural Workers” was added to dis-
0014), published in April 2019, the sec- The section “Psychosocial/Emotional
cuss the challenges of managing type 2
tion “Nutrition” was updated and a new Disorders,” including anxiety disorders, de-
20

diabetes specific to this group.


recommendation (3.3) was added to rec- pression, disordered eating behavior, and
Section 2. Classification and Diagnosis ognize that a variety of eating patterns are serious mental illness, was moved to Sec-
tion 5 “Facilitating Behavior Change and
©

of Diabetes acceptable for people with prediabetes.


(https://doi.org/10.2337/dc20-S002) Additional resources and information Well-being to Improve Health Outcomes”
The debate as to whether slowly pro- were added regarding the National Di- (https://doi.org/10.2337/dc20-S005), in
gressive autoimmune diabetes with an abetes Prevention Program, Medicare order to combine it with existing psycho-
adult onset should be termed latent Diabetes Prevention Programs, and the social guidance found in that section.

© 2019 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
care.diabetesjournals.org Summary of Revisions S5

Section 5. Facilitating Behavior 2 inhibitors or glucagon-like peptide 1 New evidence and a recommendation
Change and Well-being to Improve (GLP-1) receptor agonists in patients with (9.6) were added on early combination
Health Outcomes cardiovascular disease meeting A1C goals therapy for type 2 diabetes to extend the
(https://doi.org/10.2337/dc20-S005) for cardiovascular benefit. time to treatment failure based on find-
The title of this section was previously A new recommendation (6.11) on ings from the VERIFY trial.
“Lifestyle Management” and was changed screening patients who are taking med- FDA approval of oral semaglutide has
to more appropriately emphasize how ef- ication that can lead to hypoglycemia for been included in the discussion of com-
fective behavior management and psycho- hypoglycemia unawareness was introduced. bination therapies.

n
logical well-being are foundational to Intranasal glucagon and glucagon so- Figure 9.1 has been revised to include
achieving treatment goals for people lution for subcutaneous injection were the latest trial findings on GLP-1 receptor

tio
with diabetes. included in the section “Hypoglycemia” agonists and SGLT2 inhibitors. It now
The section “Nutrition Therapy” was due to their recent approval by the U.S. suggests that these drugs should be con-

a
updated to include guidance and evi- Food and Drug Administration (FDA). sidered for patients when atherosclerotic
dence presented in “Nutrition Therapy

ci
This section was modified to include a cardiovascular disease (ASCVD), heart
for Adults With Diabetes or Prediabetes: new discussion on the use of continuous failure, or chronic kidney disease pre-

so
A Consensus Report” (https://doi.org/ glucose monitoring technology in hypo- dominates independent of A1C.
10.2337/dci19-0014), published in May glycemia prevention. Figure 9.2 has been simplified to more
2019. easily guide providers through intensifi-

As
Because of the emerging evidence from Section 7. Diabetes Technology cation to injectable therapies.
the CDC on deaths related to e-cigarettes, (https://doi.org/10.2337/dc20-S007)
more information was added discourag- This section was reorganized into three Section 10. Cardiovascular Disease
ing their use. broad categories titled “Self-Monitoring of

s
and Risk Management
Recommendations and supporting Blood Glucose,” “Continuous Glucose Mon- (https://doi.org/10.2337/dc20-S010)
evidence on anxiety disorders, depres-
sion, disordered eating behavior, and
te
itors,” and “Insulin Delivery.” Within these
revised sections, emphasis has been made
This section is endorsed for the second
consecutive year by the American Col-
be
serious mental illness previously found on how there is no “one-size-fits-all” lege of Cardiology.
at the end of Section 4 were moved to approach to technology use in people Blood pressure targets for pregnant
Section 5 and are included under “Psy- with diabetes. Due to the rapidly changing patients with pre-existing hypertension have
ia

chosocial Issues.” More information field of diabetes technology, the recom- been changed in the interest of reducing the
on psychosocial screening for social mendations in each category have been
D

risk for accelerated maternal hypertension


determinants of health and significant revised, and more evidence has been and minimizing fetal growth impairment.
changes in life circumstances was also added to support the recommendations Recommendations for statin treat-
an

added. throughout. ment (primary and secondary prevention,


10.19–10.28) have been revised to min-
Section 6. Glycemic Targets Section 8. Obesity Management for imize ASCVD risk and to align with the
ic

(https://doi.org/10.2337/dc20-S006) the Treatment of Type 2 Diabetes “2018 AHA/ACC/AACVPR/AAPA/ABC/


Based on the publication “Clinical Tar- (https://doi.org/10.2337/dc20-S008)
er

ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA
gets for Continuous Glucose Monitoring The body mass index (BMI) calculation Guideline on the Management of Blood
Data Interpretation: Recommendations recommendation (8.1) was modified to Cholesterol: Executive Summary: A Report
Am

From the International Consensus on Time recommend annual BMI calculations of the American College of Cardiology/
in Range” (https://doi.org/10.2337/dci19- rather than at every patient encounter. American Heart Association Task Force
0028) published in June 2019, new recom- More discussion was added on how on Clinical Practice Guidelines” (https://
mendations (6.4 and 6.5) were added on providers measure and record patient doi.org/10.1016/j.jacc.2018.11.002),
19

use of the ambulatory glucose profile (AGP) weight, including recommendations on published in June 2019.
report and time in range (TIR) for assess- how to manage these encounters to Discussion of REDUCE-IT was added to
ment of glycemic management. A discus- maximize patient comfort and engage- the section “Treatment of Other Lipo-
20

sion of AGP reports, time in range, and ment. Other considerationsdlike access protein Fractions or Targets,” and a new
glucose management indicators follow the to food and individual’s motivation recommendation (10.31) was included
new recommendations. An example of an leveldwere added to the section “Lifestyle on considering icosapent ethyl for re-
©

AGP report was also added (Fig. 6.1). Interventions.” ducing cardiovascular risk.
Table 6.1 was replaced with a simpli- Recommendations for treatment of
fied estimated average glucose table. Section 9. Pharmacologic Approaches cardiovascular disease (10.43a, 10.43b,
More discussion on the importance of to Glycemic Treatment 10.43c) are now individualized based on
reducing therapeutic inertia in the manage- (https://doi.org/10.2337/dc20-S009) patients’ existing ASCVD, risk of ASCVD,
ment of hyperglycemia and cardiovascular A discussion was added on access to diabetic kidney disease, or heart failure.
disease was included in the section “A1C analog insulins and how there are mul- Discussion of the trials CANVAS, CANVAS-
and Cardiovascular Disease Outcomes.” tiple approaches to insulin treatment, Renal, CREDENCE, DECLARE-TIMI 58,
Also new to “A1C and Cardiovascular with the goal of keeping patients safe REWIND, and CARMELINA were added
Disease Outcomes” is the strategy to and avoiding diabetic ketoacidosis and to the section “Glucose-Lowering Ther-
introduce sodium–glucose cotransporter significant hypo- or hyperglycemia. apies and Cardiovascular Outcomes.”
S6 Summary of Revisions Diabetes Care Volume 43, Supplement 1, January 2020

The cardiovascular outcomes trials of Section 12. Older Adults Section 14. Management of Diabetes
available antihyperglycemic medications (https://doi.org/10.2337/dc20-S012) in Pregnancy
completed after the issuance of FDA 2008 Within the section “Neurocognitive (https://doi.org/10.2337/dc20-S0014)
guidelines table (Table 10.3) has been Function,” more information was added Greater emphasis has been placed
divided into three tables by drug class on the importance of assessment for on preconception care for women
(Table 10.3A on DPP-4 Inhibitors; Table cognitive decline and impairment. with diabetes, and a recommendation
10.3B on GLP-1 receptor agonists; and A new recommendation (12.14) urg- (14.5) focusing on nutrition, diabetes
Table 10.3C on SGLT2 inhibitors). ing providers to consider cost of care education, and screening for diabetes

n
and insurance coverage when prescrib- related complications was added. A
Section 11. Microvascular Complications ing medications to older adults to reduce new table (Table 14.1) was also added

tio
and Foot Care the risk of cost-related nonadherence on preconception education, medical
(https://doi.org/10.2337/dc20-S011) was added to the section “Pharmacologic assessment, and screening.

a
The recommendation on screening for Therapy.” The GLP-1 receptor agonist Recommendations (14.9–14.12) on
chronic kidney disease (11.1) has been and SGLT2 inhibitor discussions were use of continuous glucose monitors

ci
modified toincludetwice-yearlyscreenings expanded in this section as well. and measuring glycemia in pregnancy
A new section titled “Special Con- were added to the section “Glycemic

so
for certain patients. A treatment recom-
mendation (11.3) was modified to provide siderations for Older Adults With Targets in Pregnancy” to provide more
more detail on use of SGLT2 inhibitors and Type 1 Diabetes” was added to ad- information on their utility.

As
GLP-1 receptor agonists in patients with dress the treatment of this growing Further discussion has been added
type 2 diabetes and diabetic kidney disease. population. regarding when insulin may not be
A new recommendation (11.5) was added an option for some women with GDM,
about avoiding discontinuation of RAS Section 13. Children and Adolescents and how oral agents may play a role in

s
blockade in response to minor increases (https://doi.org/10.2337/dc20-S013) treatment in certain circumstances.
in serum creatinine in the absence of
volume depletion.
te
To provide more detail for individual-
izing targets, new A1C goal recommen-
The section “Postpartum Care” was
expanded to include recommenda-
be
Additional information on acute kidney dations (13.21–13.24) were added to the tions (14.16–14.22) and supporting
injury was added to the section “Chronic section “Glycemic Control.” evidence on postpartum insulin re-
Kidney Disease,” with information on in- In the section “Management of Cardio- quirements, management of women
ia

creased serum creatinine levels. vascular Risk Factors,” the recommenda- with a history of GDM and risks of
More findings were added from the tions for screening and treatment of
D

type 2 diabetes, and psychosocial


CREDENCE trial. hypertension (13.31–13.35) have been assessment.
Screening for diabetic retinopathy rec- revised and include new criteria for ele-
an

ommendations (11.16 and 11.17) and vated blood pressure. The dyslipidemia Section 15. Diabetes Care in the
supportive text were revised to include testing recommendation (13.36) was Hospital
consideration of retinal photograph with also modified, and more evidence was (https://doi.org/10.2337/dc20-S0015)
ic

remote reading or use of a validated as- added to the dyslipidemia screening Discussion of new studies supporting
sessment tool as a way to improve screen- section. the use of closed-loop insulin delivery
er

ing access. The retinopathy screening recommen- with linked pump/sensor devices to
The section “Foot Care” was updated dation for type 1 diabetes (13.46) has been control blood glucose was added to
Am

with more evidence on therapeutic revised based on new evidence supporting the type 1 diabetes section “Transi-
footwear and evaluation for peripheral a lower frequency of eye examinations tioning Intravenous to Subcutaneous
arterial disease. than previously recommended. Insulin.”
Figure 11.1 was introduced (in place of A new recommendation (13.67) was New evidence was also added to
19

2019 Table 11.1dCKD Stages and Cor- added to the section “Pharmacologic Man- the section “Preventing Admissions and
responding Focus of Kidney-Related agement” for type 2 diabetes due to new Readmissions.”
Care) to show the risk of chronic kidney evidence and FDA approval of liraglutide in
20

disease progression, frequency of visits, children 10 years of age or older. Section 16. Diabetes Advocacy
and referral to nephrology according to A new recommendation (13.76) on (https://doi.org/10.2337/dc20-S016)
estimated glomerular filtration rate and pharmacologic treatment of hyperten- No changes have been made to this
©

albuminuria. sion in type 2 diabetes was also added. section.


Diabetes Care Volume 43, Supplement 1, January 2020 S7

1. Improving Care and Promoting American Diabetes Association

Health in Populations: Standards

n
of Medical Care in Diabetesd2020

tio
Diabetes Care 2020;43(Suppl. 1):S7–S13 | https://doi.org/10.2337/dc20-S001

a
ci
so
As
The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”

1. IMPROVING CARE AND PROMOTING HEALTH


includes the ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and
tools to evaluate quality of care. Members of the ADA Professional Practice

s
Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc20-
SPPC), are responsible for updating the Standards of Care annually, or more
te
frequently as warranted. For a detailed description of ADA standards, statements,
be
and reports, as well as the evidence-grading system for ADA’s clinical practice
recommendations, please refer to the Standards of Care Introduction (https://doi
.org/10.2337/dc20-SINT). Readers who wish to comment on the Standards of Care
ia

are invited to do so at professional.diabetes.org/SOC.


D

DIABETES AND POPULATION HEALTH


an

Recommendations
1.1 Ensure treatment decisions are timely, rely on evidence-based guidelines, and
are made collaboratively with patients based on individual preferences,
ic

prognoses, and comorbidities. B


1.2 Align approaches to diabetes management with the Chronic Care Model. This
er

model emphasizes person-centered team care, integrated long-term treat-


ment approaches to diabetes and comorbidities, and ongoing collaborative
Am

communication and goal setting between all team members. A


1.3 Care systems should facilitate team-based care and utilization of patient
registries, decision support tools, and community involvement to meet
patient needs. B
1.4 Assess diabetes health care maintenance (see Table 4.1) using reliable and
19

relevant data metrics to improve processes of care and health outcomes, with
simultaneous emphasis on care costs. B
20

Population health is defined as “the health outcomes of a group of individuals,


©

including the distribution of health outcomes within the group”; these outcomes can
be measured in terms of health outcomes (mortality, morbidity, health, and functional
status), disease burden (incidence and prevalence), and behavioral and metabolic
factors (exercise, diet, A1C, etc.) (1). Clinical practice recommendations for health care Suggested citation: American Diabetes Association.
providers are tools that can ultimately improve health across populations; however, 1. Improving care and promoting health in pop-
for optimal outcomes, diabetes care must also be individualized for each patient. Thus, ulations: Standards of Medical Care in Diabetesd
efforts to improve population health will require a combination of system-level and 2020. Diabetes Care 2020;43(Suppl. 1):S7–S13
patient-level approaches. With such an integrated approach in mind, the American © 2019 by the American Diabetes Association.
Diabetes Association (ADA) highlights the importance of patient-centered care, Readers may use this article as long as the work
is properly cited, the use is educational and not
defined as care that considers individual patient comorbidities and prognoses; is for profit, and the work is not altered. More infor-
respectful of and responsive to patient preferences, needs, and values; and ensures mation is available at http://www.diabetesjournals
that patient values guide all clinical decisions (2). Clinical practice recommendations, .org/content/license.
S8 Improving Care and Promoting Health Diabetes Care Volume 43, Supplement 1, January 2020

whether based on evidence or expert Chronic Care Model diabetes care delivery, including oppor-
opinion, are intended to guide an overall Numerous interventions to improve ad- tunities and challenges (15).
approach to care. The science and art of herence to the recommended standards
Strategies for System-Level Improvement
medicine come together when the clinician have been implemented. However, a
major barrier to optimal care is a delivery Optimal diabetes management requires
is faced with making treatment recommen-
system that is often fragmented, lacks an organized, systematic approach and
dations for a patient who may not meet the
clinical information capabilities, dupli- the involvement of a coordinated team
eligibility criteria used in the studies on
cates services, and is poorly designed of dedicated health care professionals
which guidelines are based. Recognizing
working in an environment where

n
that one size does not fit all, the standards for the coordinated delivery of chronic
care. The Chronic Care Model (CCM) patient-centered high-quality care is a
presented here provide guidance for when

tio
takes these factors into consideration priority (6,16,17). While many diabetes
and how to adapt recommendations for an
and is an effective framework for im- processes of care have improved nation-
individual.
ally in the past decade, the overall quality

a
proving the quality of diabetes care (8).
of care for patients with diabetes remains

ci
Care Delivery Systems Six Core Elements. The CCM includes six suboptimal (3). Efforts to increase the
The proportion of patients with diabetes core elements to optimize the care of quality of diabetes care include provid-

so
who achieve recommended A1C, blood patients with chronic disease: ing care that is concordant with evidence-
pressure, and LDL cholesterol levels has
based guidelines (18); expanding the
remained stagnant in recent years (3). In 1. Delivery system design (moving from a

As
role of teams to implement more in-
2013–2016, 64% of adults with diag- reactive to a proactive care delivery tensive disease management strategies
nosed diabetes met individualized A1C system where planned visits are coordi- (6,19,20); tracking medication-taking be-
target levels, 70% achieved recommen- nated through a team-based approach) havior at a systems level (21); redesigning

s
ded blood pressure control, 57% met the 2. Self-management support the organization of the care process
LDL cholesterol target level, and 85%

te
3. Decision support (basing care on (22); implementing electronic health record
were nonsmokers (3). Only 23% met evidence-based, effective care guide- tools (23,24); empowering and educating
targets for glycemic, blood pressure, lines)
be
patients (25,26); removing financial bar-
and cholesterol measures while also 4. Clinical information systems (using reg- riers and reducing patient out-of-pocket
avoiding smoking (3). The mean A1C istries that can provide patient-specific costs for diabetes education, eye exams,
ia

nationally among people with diabetes and population-based support to the diabetes technology, and necessary med-
increased slightly from 7.3% in 2005– care team) ications (6); assessing and addressing psy-
D

2008 to 7.5% in 2013–2016 based on the 5. Community resources and policies chosocial issues (27,28); and identifying,
National Health and Nutrition Examina- (identifying or developing resources developing, and engaging community re-
tion Survey (NHANES), with younger to support healthy lifestyles)
an

sources and public policies that support


adults, women, and non-Hispanic black 6. Health systems (to create a quality- healthy lifestyles (29). The National Di-
individuals less likely to meet treatment oriented culture) abetes Education Program maintains an
targets (3). Certain segments of the pop-
ic

online resource (www.betterdiabetescare


ulation, such as young adults and patients A 5-year effectiveness study of the CCM .nih.gov) to help health care professionals
with complex comorbidities, financial or
er

in 53,436 primary care patients with design and implement more effective
other social hardships, and/or limited type 2 diabetes suggested that the use health care delivery systems for those
English proficiency, face particular chal-
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of this model of care delivery reduced the with diabetes.


lenges to goal-based care (4–6). Even cumulative incidence of diabetes-related
after adjusting for these patient factors, complications and all-cause mortality (9). Care Teams
the persistent variability in the quality of Patients who were enrolled in the CCM The care team, which centers around the
diabetes care across providers and prac- experienced a reduction in cardiovascu- patient, should avoid therapeutic inertia
19

tice settings indicates that substantial lar disease (CVD) risk by 56.6%, micro- and prioritize timely and appropriate
system-level improvements are still vascular complications by 11.9%, and intensification of lifestyle and/or phar-
needed. mortality by 66.1% (9). The same study macologic therapy for patients who have
20

Diabetes poses a significant financial suggested that health care utilization was not achieved the recommended meta-
burden to individuals and society. It is lower in the CCM group, resulting in bolic targets (30–32). Strategies shown to
©

estimated that the annual cost of diag- health care savings of $7,294 per indi- improve care team behavior and thereby
nosed diabetes in 2017 was $327 billion, vidual over the study period (10). catalyze reductions in A1C, blood pres-
including $237 billion in direct medical Redefining the roles of the health care sure, and/or LDL cholesterol include en-
costs and $90 billion in reduced produc- delivery team and empowering patient gaging in explicit and collaborative goal
tivity. After adjusting for inflation, eco- self-management are fundamental to the setting with patients (33,34); identifying
nomic costs of diabetes increased by 26% successful implementation of the CCM (11). and addressing language, numeracy, or
from 2012 to 2017 (7). This is attributed to Collaborative, multidisciplinary teams are cultural barriers to care (35–37); inte-
the increased prevalence of diabetes and best suited to provide care for people with grating evidence-based guidelines and
the increased cost per person with di- chronic conditions such as diabetes and clinical information tools into the process
abetes. Ongoing population health strat- to facilitate patients’ self-management of care (18,38,39); soliciting performance
egies are needed in order to reduce costs (12–14). There are references to guide feedback, setting reminders, and provid-
and provide optimized care. the implementation of the CCM into ing structured care (e.g., guidelines,
care.diabetesjournals.org Improving Care and Promoting Health S9

formal case management, and patient patients who are prescribed insulin report and the use of accurate, reliable data
education resources) (6); and incorporat- cost-related insulin underuse (47). The cost metrics that include sociodemographic
ing care management teams including of insulin has continued to increase in variables to examine health equity within
nurses, dietitians, pharmacists, and other recent years for reasons that are not and across populations (59).
providers (19,40). Initiatives such as the entirely clear. There are recommenda- In addition to quality improvement
Patient-Centered Medical Home show tions from the ADA Insulin Access efforts, other strategies that simulta-
promise for improving health outcomes and Affordability Working Group for ap- neously improve the quality of care and
by fostering comprehensive primary care proaches to this issue from a systems potentially reduce costs are gaining mo-

n
and offering new opportunities for team- level. Recommendations including concepts mentum and include reimbursement
based chronic disease management (41). such as cost-sharing for insured people structures that, in contrast to visit-based

tio
with diabetes should be based on the billing, reward the provision of appropriate
Telemedicine
lowest price available, list price for insulins and high-quality care to achieve metabolic
Telemedicine is a growing field that may

a
that closely reflect net price, and health goals (60) and incentives that accommo-
increase access to care for patients with

ci
plans that ensure that people with di- date personalized care goals (6,61).
diabetes. Telemedicine is defined as the abetes can access insulin without undue
use of telecommunications to facilitate

so
administrative burden or excessive cost
remote delivery of health-related serv- (48). TAILORING TREATMENT FOR
ices and clinical information (42). A grow- SOCIAL CONTEXT

As
ing body of evidence suggests that Access to Care and Quality Improvement
Recommendations
various telemedicine modalities may The Affordable Care Act has resulted in
1.5 Providers should assess social con-
be effective at reducing A1C in patients increased access to care for many indi-
text, including potential food in-
with type 2 diabetes compared with viduals with diabetes with an emphasis

s
security, housing stability, and
usual care or in addition to usual care on the protection of people with preex-
financial barriers, and apply that

te
(43). For rural populations or those with isting conditions, health promotion, and
information to treatment deci-
limited physical access to health care, disease prevention (49). In fact, health
sions. A
be
telemedicine has a growing body of insurance coverage increased from 84.7%
1.6 Refer patients to local commu-
evidence for its effectiveness, particu- in 2009 to 90.1% in 2016 for adults with
nity resources when available. B
larly with regard to glycemic control as diabetes aged 18–64 years. Coverage for 1.7 Provide patients with self-
ia

measured by A1C (44–46). Interactive those $65 years remained near universal management support from lay
strategies that facilitate communication (50). Patients who have either private or
D

health coaches, navigators, or


between providers and patients, includ- public insurance coverage are more likely community health workers when
ing the use of web-based portals or text to meet quality indicators for diabetes care available. A
an

messaging and those that incorporate (51). As mandated by the Affordable Care
medication adjustment, appear more Act,theAgencyfor Healthcare Research and Health inequities related to diabetes and
effective. There is limited data avail- Quality developed a National Quality Strat- its complications are well documented
ic

able on the cost-effectiveness of these egy based on the triple aims that include and are heavily influenced by social de-
strategies. improving the health of a population,
er

terminants of health (62–66). Social de-


overall quality and patient experience of terminants of health are defined as the
Behaviors and Well-being
care, and per capita cost (52,53). As health economic, environmental, political, and
Am

Successful diabetes care also requires


care systems and practices adapt to the social conditions in which people live and
a systematic approach to supporting
changing landscape of health care, it will be are responsible for a major part of health
patients’ behavior change efforts. High-
important to integrate traditional disease- inequality worldwide (67). The ADA rec-
quality diabetes self-management ed-
specific metrics with measures of patient ognizes the association between social
ucation and support (DSMES) has
19

experience, as well as cost, in assessing the and environmental factors and the pre-
been shown to improve patient self-
quality of diabetes care (54,55). Informa- vention and treatment of diabetes and
management, satisfaction, and glucose
tion and guidance specific to quality im- has issued a call for research that seeks to
20

outcomes. National DSMES standards


provement and practice transformation for better understand how these social de-
call for an integrated approach that in-
diabetes care is available from the National terminants influence behaviors and how
cludes clinical content and skills, behav-
Diabetes Education Program practice trans-
©

ioral strategies (goal setting, problem the relationships between these varia-
solving), and engagement with psycho- formation website and the National In- bles might be modified for the preven-
social concerns (28). For more informa- stitute of Diabetes and Digestive and tion and management of diabetes (68).
tion on DSMES, see Section 5 “Facilitating Kidney Diseases report on diabetes care While a comprehensive strategy to re-
Behavior Change and Well-being to Im- and quality (56,57). Using patient registries duce diabetes-related health inequities
prove Health Outcomes” (https://doi and electronic health records, health sys- in populations has not been formally stud-
.org/10.2337/dc20-S005). tems can evaluate the quality of diabetes ied, general recommendations from other
care being delivered and perform inter- chronic disease models can be drawn upon
Cost Considerations vention cycles as part of quality improve- to inform systems-level strategies in di-
The cost of diabetes medications, partic- ment strategies (58). Critical to these abetes. For example, the National Academy
ularly insulin, is an ongoing barrier to efforts is provider adherence to clinical of Medicine has published a framework for
achieving glycemic goals. Up to 25% of practice recommendations (see Table 4.1) educating health care professionals on the
S10 Improving Care and Promoting Health Diabetes Care Volume 43, Supplement 1, January 2020

importance of social determinants of health with low adherence to taking medica- are homeless need secure places to keep
(69). Furthermore, there are resources tions appropriately and recommended their diabetes supplies, as well as re-
available for the inclusion of standardized self-care behaviors, depression, diabetes frigerator access to properly store their
sociodemographic variables in electronic distress, and worse glycemic control insulin and take it on a regular schedule.
medical records to facilitate the measure- when compared with individuals who Risk for homelessness can be ascertained
ment of health inequities as well as the are food secure (78,79). Older adults using a brief risk assessment tool de-
impact of interventions designed to re- with food insecurity are more likely to veloped and validated for use among
duce those inequities (70–72). have emergency department visits and veterans (85). Given the potential chal-

n
Social determinants of health are not hospitalizations compared with older lenges, providers who care for homeless
individuals should be familiar with re-

tio
always recognized and often go undis- adults who do not report food insecurity
cussed in the clinical encounter (65). A (80). Risk for food insecurity can be sources or have access to social workers
studyby Piette et al. (73) found that among assessed with a validated two-item that can facilitate temporary housing for

a
patients with chronic illnesses, two-thirds screening tool (81) that includes the their patients as a way to improve di-
statements: 1) “Within the past12 months

ci
of those who reported not taking medi- abetes care.
cations as prescribed due to cost never we worried whether our food would run

so
shared this with their physician. In a study out before we got money to buy more” Migrant and Seasonal Agricultural
using data from the National Health In- and 2) “Within the past 12 months the Workers
terview Survey (NHIS), Patel et al. (65) food we bought just didn’t last and we Migrant and seasonal agricultural workers

As
found that one-half of adults with diabetes didn’t have money to get more.” An may have a higher risk of type 2 diabetes
reported financial stress and one-fifth affirmative response to either statement than the overall population. While mi-
reported food insecurity. One population had a sensitivity of 97% and specificity of grant farmworker-specific data are lack-

s
in which such issues must be considered is 83%. ing, most agricultural workers in the U.S.
are Latino, a population with a high rate of

te
older adults, where social difficulties may
Treatment Considerations type 2 diabetes. Living in severe poverty
impair the quality of life and increase the
In those with diabetes and food insecu- brings with it food insecurity, high chronic
be
risk of functional dependency (74) (see
rity, the priority is mitigating the increased stress, and increased risk of diabetes;
Section 12 “Older Adults,” https://doi.org/
risk for uncontrolled hyperglycemia and there is also an association between
10.2337/dc20-S012, for a detailed discus-
severe hypoglycemia. Reasons for the
ia

sion of social considerations in older the use of certain pesticides and the
increased risk of hyperglycemia include incidence of diabetes (85a).
adults). Creating systems-level mecha-
the steady consumption of inexpensive
D

nisms to screen for social determinants Data from the Department of Labor
carbohydrate-rich processed foods, binge indicates that there are 2.5–3 million
of health may help overcome structural
eating, financial constraints to filling di- agricultural workers in the U.S., and these
barriers and communication gaps be-
an

abetes medication prescriptions, and agricultural workers travel throughout


tween patients and providers (65,75).
anxiety/depression leading to poor di- the country serving as the backbone
In addition, brief, validated screening
abetes self-care behaviors. Hypoglyce- for a multibillion-dollar agricultural in-
ic

tools for some social determinants of


mia can occur as a result of inadequate dustry. According to 2018 health center
health exist and could facilitate discussion
or erratic carbohydrate consumption
er

around factors that significantly impact data, 174 health centers across the U.S.
following the administration of sulfony- reported that they provided health care
treatment during the clinical encounter.
lureas or insulin. See Table 9.1 for drug- services to 579,806 adult agricultural
Am

Below is a discussion of assessment and


specific and patient factors, including patients, and 78,332 had encounters
treatment considerations in the context
of food insecurity, homelessness, and lim- cost and risk of hypoglycemia, for the for diabetes (13.5%) (86).
ited English proficiency/low literacy. treatment options for adults with food Migrant farmworkers encounter nu-
insecurity and type 2 diabetes. Providers merous and overlapping barriers to re-
19

Food Insecurity should consider these factors when mak- ceiving care. Migration, which may occur
Food insecurity is the unreliable avail- ing treatment decisions in people with as frequently as every few weeks for
ability of nutritious food and the inability food insecurity and seek local resources farmworkers, disrupts care. Cultural
20

to consistently obtain food without re- that might help patients with diabetes and and linguistic barriers, lack of transpor-
sorting to socially unacceptable practi- their family members to more regularly tation and money, lack of available work
ces. Over 18% of the U.S. population obtain nutritious food (82).
©

hours, unfamiliarity with new communi-


reported food insecurity between 2005– ties, lack of access to resources, and other
2014 (76). The rate is higher in some Homelessness barriers prevent migrant farmworkers
racial/ethnic minority groups, including Homelessness often accompanies many from accessing health care. Without reg-
African American and Latino popula- additional barriers to diabetes self- ular care, those with diabetes may suffer
tions, low-income households, and homes management, including food insecurity, severe and often expensive complica-
headed by a single mother. The rate of literacy and numeracy deficiencies, lack tions that affect quality of life.
food insecurity in individuals with dia- of insurance, cognitive dysfunction, Health care providers should be attuned
betes may be up to 20% (77). Addition- and mental health issues (83). The prev- to the working and living conditions of all
ally, the risk for type 2 diabetes is alence of diabetes in the homeless pop- patients. If a migrant farmworker with
increased twofold in those with food ulation is estimated to be around 8% (84). diabetes presents for care, appropriate
insecurity (68) and has been associated Additionally, patients with diabetes who referrals should be initiated to social
care.diabetesjournals.org Improving Care and Promoting Health S11

workers and community resources, as Intern Med. 12 August 2019 [Epub ahead of print] a large-scale hypertension program. JAMA 2013;
available, to assist with removing barriers DOI: 10.1001/jamainternmed.2019.2396 310:699–705
4. Kerr EA, Heisler M, Krein SL, et al. Beyond 20. Peikes D, Chen A, Schore J, Brown R. Effects
to care.
comorbidity counts: how do comorbidity type of care coordination on hospitalization, quality of
and severity influence diabetes patients’ treat- care, and health care expenditures among Medi-
Language Barriers ment priorities and self-management? J Gen care beneficiaries: 15 randomized trials. JAMA
Providers who care for non-English speakers Intern Med 2007;22:1635–1640 2009;301:603–618
should develop or offer educational pro- 5. Fernandez A, Schillinger D, Warton EM, et al. 21. Raebel MA, Schmittdiel J, Karter AJ,
grams and materials in multiple languages Language barriers, physician-patient language Konieczny JL, Steiner JF. Standardizing terminol-
concordance, and glycemic control among in- ogy and definitions of medication adherence and

n
with the specific goals of preventing di-
sured Latinos with diabetes: the Diabetes Study persistence in research employing electronic
abetes and building diabetes awareness in

tio
of Northern California (DISTANCE). J Gen Intern databases. Med Care 2013;51(Suppl. 3):S11–S21
people who cannot easily read or write in Med 2011;26:170–176 22. Feifer C, Nemeth L, Nietert PJ, et al. Different
English. The National Standards for Cultur- 6. TRIAD Study Group. Health systems, patients paths to high-quality care: three archetypes of

a
ally and Linguistically Appropriate Services factors, and quality of care for diabetes: a syn- top-performing practice sites. Ann Fam Med
in Health and Health Care (National CLAS thesis of findings from the TRIAD study. Diabetes 2007;5:233–241

ci
Care 2010;33:940–947 23. Reed M, Huang J, Graetz I, et al. Outpatient
Standards) provide guidance on how health electronic health records and the clinical care and
7. American Diabetes Association. Economic

so
care providers can reduce language barriers costs of diabetes in the U.S. in 2017. Diabetes outcomes of patients with diabetes mellitus. Ann
by improving their cultural competency, Care 2018;41:917–928 Intern Med 2012;157:482–489
addressing health literacy, and ensuring 8. Stellefson M, Dipnarine K, Stopka C. The 24. Cebul RD, Love TE, Jain AK, Hebert CJ.

As
communication with language assistance chronic care model and diabetes management Electronic health records and quality of diabetes
in US primary care settings: a systematic review. care. N Engl J Med 2011;365:825–833
(87). The National CLAS Standards website
Prev Chronic Dis 2013;10:E26 25. Battersby M, Von Korff M, Schaefer J, et al.
offers a number of resources and ma- 9. Wan EYF, Fung CSC, Jiao FF, et al. Five-year Twelve evidence-based principles for implement-
terials that can be used to improve the

s
effectiveness of the multidisciplinary Risk Assess- ing self-management support in primary care. Jt
quality of care delivery to non-English- ment and Management Programme-Diabetes Comm J Qual Patient Saf 2010;36:561–570
speaking patients (87).
te
Mellitus (RAMP-DM) on diabetes-related compli-
cations and health service uses-a population-based
26. Grant RW, Wald JS, Schnipper JL, et al. Practice-
linked online personal health records for type 2
be
Community Support and propensity-matched cohort study. Diabetes diabetes mellitus: a randomized controlled trial.
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Identification or development of com-
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ia

cost-effectiveness of the multidisciplinary Risk


styles is a core element of the CCM (8). Assessment and Management Programme-Diabe- for people with diabetes: a position statement of
Health care community linkages are tes Mellitus (RAMP-DM). Diabetes Care 2018;41: the American Diabetes Association. Diabetes
D

receiving increasing attention from the 250–257 Care 2016;39:2126–2140


11. Coleman K, Austin BT, Brach C, Wagner EH. 28. Beck J, Greenwood DA, Blanton L, et al.; 2017
American Medical Association, the
Evidence on the Chronic Care Model in the new Standards Revision Task Force. 2017 National
an

Agency for Healthcare Research and millennium. Health Aff (Millwood) 2009;28:75–85 standards for diabetes self-management education
Quality, and others as a means of pro- 12. Piatt GA, Anderson RM, Brooks MM, et al. 3- and support. Diabetes Care 2017;40:1409–1419
moting translation of clinical recommen- Year follow-up of clinical and behavioral im- 29. Pullen-Smith B, Carter-Edwards L, Leathers
ic

dations for lifestyle modification in provements following a multifaceted diabetes KH. Community health ambassadors: a model for
real-world settings (88). Community health care intervention: results of a randomized con- engaging community leaders to promote better
er

trolled trial. Diabetes Educ 2010;36:301–309 health in North Carolina. J Public Health Manag
workers (CHWs) (89), peer supporters
13. Katon WJ, Lin EHB, Von Korff M, et al. Col- Pract 2008;14(Suppl.):S73–S81
(90–92), and lay leaders (93) may assist laborative care for patients with depression and 30. Davidson MB. How our current medical care
Am

in the delivery of DSMES services (70,94), chronic illnesses. N Engl J Med 2010;363:2611– system fails people with diabetes: lack of timely,
particularly in underserved communities. 2620 appropriate clinical decisions. Diabetes Care
A CHW is defined by the American Public 14. Parchman ML, Zeber JE, Romero RR, Pugh JA. 2009;32:370–372
Risk of coronary artery disease in type 2 diabetes 31. Selby JV, Uratsu CS, Fireman B, et al. Treat-
Health Association as a “frontline public
and the delivery of care consistent with the ment intensification and risk factor control: to-
19

health worker who is a trusted member of chronic care model in primary care settings: ward more clinically relevant quality measures.
and/or has an unusually close understand- a STARNet study. Med Care 2007;45:1129–1134 Med Care 2009;47:395–402
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20

can be part of a cost-effective, evidence- management services for complex diabetes man- Intensification of antihyperglycemic therapy
based strategy to improve the manage- agement: a practical overview. Curr Diab Rep among patients with incident diabetes: a Surveil-
2018;18:135 lance Prevention and Management of Diabetes
ment of diabetes and cardiovascular risk
©

16. Tricco AC, Ivers NM, Grimshaw JM, et al. Mellitus (SUPREME-DM) study. Pharmacoepide-
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S14 Diabetes Care Volume 43, Supplement 1, January 2020

2. Classification and Diagnosis of American Diabetes Association

Diabetes: Standards of Medical

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Care in Diabetesd2020

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Diabetes Care 2020;43(Suppl. 1):S14–S31 | https://doi.org/10.2337/dc20-S002

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2. CLASSIFICATION AND DIAGNOSIS OF DIABETES

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”


includes the ADA’s current clinical practice recommendations and is intended to provide

s
the components of diabetes care, general treatment goals and guidelines, and tools

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to evaluate quality of care. Members of the ADA Professional Practice Committee
(https://doi.org/10.2337/dc20-SPPC), a multidisciplinary expert committee, are
be
responsible for updating the Standards of Care annually, or more frequently as warranted.
For a detailed description of ADA standards, statements, and reports, as well as the
evidence-grading system for ADA’s clinical practice recommendations, please refer to the
ia

Standards of Care Introduction (https://doi.org/10.2337/dc20-SINT). Readers who wish to


D

comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.


an

CLASSIFICATION
Diabetes can be classified into the following general categories:
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1. Type 1 diabetes (due to autoimmune b-cell destruction, usually leading to absolute


er

insulin deficiency)
2. Type 2 diabetes (due to a progressive loss of adequate b-cell insulin secretion
frequently on the background of insulin resistance)
Am

3. Gestational diabetes mellitus (diabetes diagnosed in the second or third trimester


of pregnancy that was not clearly overt diabetes prior to gestation)
4. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes
(such as neonatal diabetes and maturity-onset diabetes of the young), diseases of
19

the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or
chemical-induced diabetes (such as with glucocorticoid use, in the treatment of
HIV/AIDS, or after organ transplantation)
20

This section reviews most common forms of diabetes but is not comprehensive. For
©

additional information, see the American Diabetes Association (ADA) position


statement “Diagnosis and Classification of Diabetes Mellitus” (1).
Type 1 diabetes and type 2 diabetes are heterogeneous diseases in which clinical Suggested citation: American Diabetes Associa-
presentation and disease progression may vary considerably. Classification is tion. 2. Classification and diagnosis of diabetes:
important for determining therapy, but some individuals cannot be clearly classified Standards of Medical Care in Diabetesd2020.
as having type 1 or type 2 diabetes at the time of diagnosis. The traditional paradigms Diabetes Care 2020;43(Suppl. 1):S14–S31
of type 2 diabetes occurring only in adults and type 1 diabetes only in children are no © 2019 by the American Diabetes Association.
longer accurate, as both diseases occur in both age-groups. Children with type 1 Readers may use this article as long as the work
is properly cited, the use is educational and not
diabetes typically present with the hallmark symptoms of polyuria/polydipsia, and for profit, and the work is not altered. More infor-
approximately one-third present with diabetic ketoacidosis (DKA) (2). The onset of mation is available at http://www.diabetesjournals
type 1 diabetes may be more variable in adults; they may not present with the classic .org/content/license.
care.diabetesjournals.org Classification and Diagnosis of Diabetes S15

Table 2.1—Staging of type 1 diabetes (8,9)


Stage 1 Stage 2 Stage 3
Characteristics c Autoimmunity c Autoimmunity c New-onset hyperglycemia
c Normoglycemia c Dysglycemia c Symptomatic
c Presymptomatic c Presymptomatic

Diagnostic criteria c Multiple autoantibodies c Multiple autoantibodies c Clinical symptoms


c No IGT or IFG c Dysglycemia: IFG and/or IGT c Diabetes by standard criteria
c FPG 100–125 mg/dL (5.6–6.9 mmol/L)

n
c 2-h PG 140–199 mg/dL (7.8–11.0 mmol/L)
c A1C 5.7–6.4% (39–47 mmol/mol) or $10%

tio
increase in A1C

a
ci
symptoms seen in children and may expe- serve as a framework for future research mainly been demonstrated among indi-
rience temporary remission from the need and regulatory decision-making (8,9). There viduals who have impaired glucose tol-

so
for insulin (3–5). Occasionally, patients is debate as to whether slowly progressive erance (IGT) with or without elevated
with type 2 diabetes may present with autoimmune diabetes with an adult onset fasting glucose, not for individuals with
DKA (6), particularly ethnic minorities (7). should be termed latent autoimmune di- isolated impaired fasting glucose (IFG)

As
It is important for the provider to realize abetes in adults (LADA) or whether the or for those with prediabetes defined
that classification of diabetes type is not clinical priority is awareness that slow auto- by A1C criteria.
always straightforward at presentation and immune b-cell destruction means there may The same tests may be used to screen

s
that misdiagnosis is common (e.g., adults be long duration of marginal insulin secre- for and diagnose diabetes and to detect
with type 1 diabetes misdiagnosed as hav- tory capacity. For the purpose of this clas- individuals with prediabetes (Table 2.2
ing type 2 diabetes; individuals with matu-
rity-onset diabetes of the young [MODY] te
sification, all forms of diabetes mediated by
autoimmune b-cell destruction are included
and Table 2.5). Diabetes may be identi-
fied anywhere along the spectrum of
be
misdiagnosed as having type 1 diabetes, under the rubric of type 1 diabetes. clinical scenariosdin seemingly low-
etc.). Although difficulties in distinguish- The paths to b-cell demise and dys- risk individuals who happen to have glu-
ia

ing diabetes type may occur in all age- function are less well defined in type 2 cose testing, in individuals tested based on
groups at onset, the diagnosis becomes diabetes, but deficient b-cell insulin se- diabetes risk assessment, and in symp-
D

more obvious over time. cretion, frequently in the setting of in- tomatic patients.
In both type 1 and type 2 diabetes, sulin resistance, appears to be the
various genetic and environmental fac- common denominator. Characterization Fasting and 2-Hour Plasma Glucose
an

tors can result in the progressive loss of of subtypes of this heterogeneous dis- The FPG and 2-h PG may be used to
b-cell mass and/or function that mani- order have been developed and vali- diagnose diabetes (Table 2.2). The con-
fests clinically as hyperglycemia. Once dated in Scandinavian and Northern
ic

cordance between the FPG and 2-h


hyperglycemia occurs, patients with all European populations but have not PG tests is imperfect, as is the concor-
er

forms of diabetes are at risk for devel- been confirmed in other ethnic and ra- dance between A1C and either glucose-
oping the same chronic complications, cial groups. Type 2 diabetes is associated based test. Compared with FPG and
although rates of progression may differ. with insulin secretory defects related
Am

A1C cut points, the 2-h PG value di-


The identification of individualized ther- to inflammation and metabolic stress agnoses more people with prediabe-
apies for diabetes in the future will re- among other contributors, including tes and diabetes (15).
quire better characterization of the many genetic factors. Future classification
paths to b-cell demise or dysfunction (8). schemes for diabetes will likely focus A1C
19

Characterization of the underlying path- on the pathophysiology of the underly-


Recommendations
ophysiology is more developed in type 1 ing b-cell dysfunction (8,10,11).
2.1 To avoid misdiagnosis or missed
diabetes than in type 2 diabetes. It is now
20

diagnosis, the A1C test should be


clear from studies of first-degree relatives DIAGNOSTIC TESTS FOR DIABETES
performed using a method that is
of patients with type 1 diabetes that the Diabetes may be diagnosed based on
certified by the NGSP and stan-
©

persistent presence of two or more islet plasma glucose criteria, either the fast-
dardized to the Diabetes Control
autoantibodies is an almost certain pre- ing plasma glucose (FPG) value or the
and Complications Trial (DCCT)
dictor of clinical hyperglycemia and diabe- 2-h plasma glucose (2-h PG) value during
assay. B
tes. The rate of progression is dependent on a 75-g oral glucose tolerance test (OGTT),
2.2 Marked discordance between
the age at first detection of autoantibody, or A1C criteria (12) (Table 2.2).
measured A1C and plasma glu-
number ofautoantibodies, autoantibody Generally, FPG, 2-h PG during 75-g
cose levels should raise the pos-
specificity, and autoantibody titer. Glu- OGTT, and A1C are equally appropriate
sibility of A1C assay interference
cose and A1C levels rise well before the for diagnostic screening. It should be
due to hemoglobin variants (i.e.,
clinical onset of diabetes, making diag- noted that the tests do not necessarily
hemoglobinopathies) and con-
nosis feasible well before the onset of detect diabetes in the same individuals.
sideration of using an assay with-
DKA. Three distinct stages of type 1 di- The efficacy of interventions for primary
out interference or plasma blood
abetes can be identified (Table 2.1) and prevention of type 2 diabetes (13,14) has
S16 Classification and Diagnosis of Diabetes Diabetes Care Volume 43, Supplement 1, January 2020

cut point, greater cost, limited availabil- between measured A1C and plasma glu-
glucose criteria to diagnose di-
ity of A1C testing in certain regions of cose levels should prompt consideration
abetes. B
the developing world, and the imperfect that the A1C assay may not be reliable for
2.3 In conditions associated with an
correlation between A1C and average that individual. For patients with a hemo-
altered relationship between A1C
glucose in certain individuals. The A1C globin variant but normal red blood cell
and glycemia, such as sickle cell
test, with a diagnostic threshold of turnover, such as those with the sickle cell
disease, pregnancy (second and
$6.5% (48 mmol/mol), diagnoses only trait, an A1C assay without interference
third trimesters and the postpar-
30% of the diabetes cases identified col- from hemoglobin variants should be used.
tum period), glucose-6-phosphate

n
lectively using A1C, FPG, or 2-h PG, ac- An updated list of A1C assays with inter-
dehydrogenase deficiency, HIV,
cording to National Health and Nutrition ferences is available at www.ngsp.org/

tio
hemodialysis, recent blood loss
Examination Survey (NHANES) data (16). interf.asp.
or transfusion, or erythropoietin
When using A1C to diagnose diabetes, African Americans heterozygous for
therapy, only plasma blood glu-

a
it is important to recognize that A1C is the common hemoglobin variant HbS
cose criteria should be used to

ci
an indirect measure of average blood may have, for any given level of mean
diagnose diabetes. B
glucose levels and to take other factors glycemia, lower A1C by about 0.3% than

so
into consideration that may impact he- those without the trait (20). Another ge-
The A1C test should be performed using
moglobin glycation independently of netic variant, X-linked glucose-6-phosphate
a method that is certified by the NGSP
glycemia, such as hemodialysis, preg- dehydrogenase G202A, carried by 11% of

As
(www.ngsp.org) and standardized or
nancy, HIV treatment (17,18), age, race/ African Americans, was associated with a
traceable to the Diabetes Control and
ethnicity, pregnancy status, genetic back- decrease in A1C of about 0.8% in homo-
Complications Trial (DCCT) reference as-
ground, and anemia/hemoglobinopathies. zygous men and 0.7% in homozygous
say. Although point-of-care A1C assays

s
(See OTHER CONDITIONS ALTERING THE RELATION- women compared with those without
may be NGSP certified or U.S. Food and SHIP OF A1C AND GLYCEMIA below for more the variant (21).
Drug Administration approved for diag-
nosis, proficiency testing is not always
information.)
te Even in the absence of hemoglobin
variants, A1C levels may vary with race/
be
mandated for performing the test. There- Age
ethnicity independently of glycemia
fore, point-of-care assays approved for The epidemiological studies that formed
(22–24). For example, African Americans
diagnostic purposes should only be con- the basis for recommending A1C to
ia

may have higher A1C levels than non-


sidered in settings licensed to perform diagnose diabetes included only adult
Hispanic whites with similar fasting and
moderate-to-high complexity tests. As populations (16). However, recent ADA
D

postglucose load glucose levels (25), and


discussed in Section 6 “Glycemic Targets” clinical guidance concluded that A1C,
A1C levels may be higher for a given mean
(https://doi.org/10.2337/dc20-S006), FPG, or 2-h PG can be used to test for
glucose concentration when measured
an

point-of-care A1C assays may be more prediabetes or type 2 diabetes in children


with continuous glucose monitoring (26).
generally applied for assessment of gly- and adolescents (see SCREENING AND TESTING
Though conflicting data exists, African
FOR PREDIABETES AND TYPE 2 DIABETES IN CHILDREN
cemic control in the clinic. Americans may also have higher levels of
ic

AND ADOLESCENTS below for additional in-


A1C has several advantages com- fructosamine and glycated albumin and
formation) (19).
er

pared with FPG and OGTT, including lower levels of 1,5-anhydroglucitol, sug-
greater convenience (fasting not re- Race/Ethnicity/Hemoglobinopathies gesting that their glycemic burden (par-
quired), greater preanalytical stability, ticularly postprandially) may be higher
Am

Hemoglobin variants can interfere


and less day-to-day perturbations during with the measurement of A1C, al- (27,28). The association of A1C with risk
stress, diet, or illness. However, these though most assays in use in the for complications appears to be similar
advantages may be offset by the lower U.S. are unaffected by the most com- in African Americans and non-Hispanic
sensitivity of A1C at the designated mon variants. Marked discrepancies whites (29,30).
19

Table 2.2—Criteria for the diagnosis of diabetes Other Conditions Altering the Relationship
FPG $126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* of A1C and Glycemia
20

OR In conditions associated with increased


2-h PG $200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described red blood cell turnover, such as sickle
©

by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose cell disease, pregnancy (second and
dissolved in water.* third trimesters), glucose-6-phosphate
OR dehydrogenase deficiency (31,32), he-
A1C $6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that modialysis, recent blood loss or trans-
is NGSP certified and standardized to the DCCT assay.* fusion, or erythropoietin therapy, only
OR plasma blood glucose criteria should be
In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma used to diagnose diabetes (33). A1C is
glucose $200 mg/dL (11.1 mmol/L). less reliable than blood glucose mea-
DCCT, Diabetes Control and Complications Trial; FPG, fasting plasma glucose; OGTT, oral glucose surement in other conditions such as
tolerance test; WHO, World Health Organization; 2-h PG, 2-h plasma glucose. *In the absence of the postpartum state (34–36), HIV
unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or treated with certain drugs (17), and
in two separate test samples.
iron-deficient anemia (37).
care.diabetesjournals.org Classification and Diagnosis of Diabetes S17

Confirming the Diagnosis knowing the plasma glucose level is modest fasting hyperglycemia that can
Unless there is a clear clinical diagnosis critical because, in addition to confirm- rapidly change to severe hyperglycemia
(e.g., patient in a hyperglycemic crisis or ing that symptoms are due to diabetes, and/or DKA with infection or other stress.
with classic symptoms of hyperglycemia it will inform management decisions. Adults may retain sufficient b-cell func-
and a random plasma glucose $200 Some providers may also want to know tion to prevent DKA for many years; such
mg/dL [11.1 mmol/L]), diagnosis requires the A1C to determine how long a patient individuals may have remission or de-
two abnormal test results from the same has had hyperglycemia. The criteria to creased insulin needs for months or years
sample (38) or in two separate test diagnose diabetes are listed in Table 2.2. and eventually become dependent on

n
samples. If using two separate test sam- insulin for survival and are at risk for DKA
ples, it is recommended that the second TYPE 1 DIABETES (3–5,39,40). At this latter stage of the

tio
test, which may either be a repeat of the disease, there is little or no insulin se-
Recommendations
initial test or a different test, be per- cretion, as manifested by low or undetect-
2.4 Screening for type 1 diabetes risk

a
formed without delay. For example, if the able levels of plasma C-peptide. Immune-
with a panel of islet autoanti-
A1C is 7.0% (53 mmol/mol) and a repeat

ci
mediated diabetes is the most common
bodies is currently recommended
result is 6.8% (51 mmol/mol), the di- form of diabetes in childhood and ado-
in the setting of a research trial or

so
agnosis of diabetes is confirmed. If two lescence, but it can occur at any age, even
can be offered as an option for
different tests (such as A1C and FPG) are in the 8th and 9th decades of life.
first-degree family members of a
both above the diagnostic threshold Autoimmune destruction of b-cells
proband with type 1 diabetes. B

As
when analyzed from the same sample has multiple genetic predispositions
2.5 Persistence of autoantibodies is
or in two different test samples, this also and is also related to environmental
a risk factor for clinical diabetes
confirms the diagnosis. On the other factors that are still poorly defined. Al-
and may serve as an indication for
hand, if a patient has discordant results

s
though patients are not typically obese
intervention in the setting of
from two different tests, then the test when they present with type 1 diabetes,

te
a clinical trial. B
result that is above the diagnostic cut obesity is increasingly common in the
point should be repeated, with consid- general population and there is evidence
be
eration of the possibility of A1C assay Immune-Mediated Diabetes that it may also be a risk factor for type 1
interference. The diagnosis is made on This form, previously called “insulin- diabetes. As such, obesity should not
the basis of the confirmed test. For dependent diabetes” or “juvenile-onset
ia

preclude the diagnosis. People with


example, if a patient meets the diabetes diabetes,” accounts for 5–10% of diabe- type 1 diabetes are also prone to other
criterion of the A1C (two results $6.5%
D

tes and is due to cellular-mediated au- autoimmune disorders such as Hashi-


[48 mmol/mol]) but not FPG (,126 toimmune destruction of the pancreatic moto thyroiditis, Graves disease, celiac
mg/dL [7.0 mmol/L]), that person should b-cells. Autoimmune markers include disease, Addison disease, vitiligo, auto-
an

nevertheless be considered to have islet cell autoantibodies and autoanti- immune hepatitis, myasthenia gravis,
diabetes. bodies to GAD (GAD65), insulin, the and pernicious anemia (see Section
All the tests have preanalytic and tyrosine phosphatases IA-2 and IA-2b, 4 “Comprehensive Medical Evaluation
ic

analytic variability, so it is possible and zinc transporter 8 (ZnT8). Numer- and Assessment of Comorbidities,”
that an abnormal result (i.e., above
er

ous clinical studies are being conducted https://doi.org/10.2337/dc20-S004).


the diagnostic threshold), when re- to test various methods of preventing
peated, will produce a value below type 1 diabetes in those with evidence Idiopathic Type 1 Diabetes
Am

the diagnostic cut point. This scenario of islet autoimmunity (www.clinicaltrials Some forms of type 1 diabetes have no
is likely for FPG and 2-h PG if the glucose .gov). Stage 1 of type 1 diabetes is defined known etiologies. These patients have per-
samples remain at room temperature by the presence of two or more of these manent insulinopenia and are prone to DKA
and are not centrifuged promptly. Be- autoimmune markers. The disease has but have no evidence of b-cell autoimmu-
19

cause of the potential for preanalytic strong HLA associations, with linkage to nity. However, only a minority of patients
variability, it is critical that samples for the DQA and DQB genes. These HLA-DR/ with type 1 diabetes fall into this category.
plasma glucose be spun and separated DQ alleles can be either predisposing or Individuals with autoantibody-negative
20

immediately after they are drawn. If protective (Table 2.1). There are important type 1 diabetes of African or Asian ancestry
patients have test results near the mar- genetic considerations, as most of the mu- may suffer from episodic DKA and exhibit
gins of the diagnostic threshold, the
©

tations that cause diabetes are dominantly varying degrees of insulin deficiency be-
health care professional should discuss inherited. The importance of genetic testing tween episodes. This form of diabetes is
signs and symptoms with the patient and is in the genetic counseling that follows. strongly inherited and is not HLA associated.
repeat the test in 3–6 months. Some mutations are associated with other An absolute requirement for insulin re-
conditions, which then may prompt addi- placement therapy in affected patients
Diagnosis tional screenings. may be intermittent. Future research is
In a patient with classic symptoms, The rate of b-cell destruction is quite needed to determine the cause of b-cell
measurement of plasma glucose is suf- variable, being rapid in some individuals destruction in this rare clinical scenario.
ficient to diagnose diabetes (symptoms (mainly infants and children) and slow in
of hyperglycemia or hyperglycemic crisis others (mainly adults). Children and ado- Screening for Type 1 Diabetes Risk
plus a random plasma glucose $200 lescents may present with DKA as the first The incidence and prevalence of type 1
mg/dL [11.1 mmol/L]). In these cases, manifestation of the disease. Others have diabetes is increasing (41). Patients with
S18 Classification and Diagnosis of Diabetes Diabetes Care Volume 43, Supplement 1, January 2020

type 1 diabetes often present with acute PREDIABETES AND TYPE


2.13 Risk-based screening for predia-
symptoms of diabetes and markedly 2 DIABETES
betes and/or type 2 diabetes
elevated blood glucose levels, and ap- Recommendations should be considered after the
proximately one-third are diagnosed 2.6 Screening for prediabetes and onset of puberty or after 10 years
with life-threatening DKA (2). Multiple type 2 diabetes with an informal of age, whichever occurs earlier,
studies indicate that measuring islet assessment of risk factors or val- in children and adolescents with
autoantibodies in individuals genetically idated tools should be consid- overweight (BMI $85th percen-
at risk for type 1 diabetes (e.g., relatives ered in asymptomatic adults. B tile) or obesity (BMI $95th per-

n
of those with type 1 diabetes or indi- 2.7 Testing for prediabetes and/or centile) and who have one or
viduals from the general population

tio
type 2 diabetes in asymptomatic more risk factor for diabetes.
with type 1 diabetes–associated genetic people should be considered in (See Table 2.4 for evidence grad-
factors) identifies individuals who may adults of any age with over- ing of risk factors.)

a
develop type 1 diabetes (9). Such testing, weight or obesity (BMI $25

ci
coupled with education about diabetes kg/m2 or $23 kg/m2 in Asian
symptoms and close follow-up, may en- Prediabetes
Americans) and who have one or “Prediabetes” is the term used for indi-

so
able earlier identification of type 1 di- more additional risk factors for
abetes onset. A study reported the risk of viduals whose glucose levels do not meet
diabetes (Table 2.3). B the criteria for diabetes but are too high
progression to type 1 diabetes from the 2.8 Testing for prediabetes and/or

As
time of seroconversion to autoantibody to be considered normal (29,30). Patients
type 2 diabetes should be con- with prediabetes are defined by the
positivity in three pediatric cohorts from sidered in women planning
Finland, Germany, and the U.S. Of the presence of IFG and/or IGT and/or A1C
pregnancy with overweight or 5.7–6.4% (39–47 mmol/mol) (Table 2.5).

s
585 children who developed more than obesity and/or who have one or
two autoantibodies, nearly 70% devel- Prediabetes should not be viewed as a

te
more additional risk factor for clinical entity in its own right but rather
oped type 1 diabetes within 10 years and diabetes (Table 2.3). C
84% within 15 years (42). These findings as an increased risk for diabetes and
2.9 For all people, testing should
be
are highly significant because while the cardiovascular disease (CVD). Criteria
begin at age 45 years. B for testing for diabetes or prediabetes
German group was recruited from off- 2.10 If tests are normal, repeat testing in asymptomatic adults is outlined in
ia

spring of parents with type 1 diabetes, carried out at a minimum of


the Finnish and American groups were Table 2.3. Prediabetes is associated
3-year intervals is reasonable. C with obesity (especially abdominal or
D

recruited from the general population. 2.11 To test for prediabetes and type
Remarkably, the findings in all three visceral obesity), dyslipidemia with high
2 diabetes, fasting plasma glu- triglycerides and/or low HDL choles-
groups were the same, suggesting that
an

cose, 2-h plasma glucose during terol, and hypertension.


the same sequence of events led to clinical 75-g oral glucose tolerance test,
disease in both “sporadic” and familial and A1C are equally appropriate Diagnosis
cases of type 1 diabetes. Indeed, the risk IFG is defined as FPG levels between
ic

(Table 2.2 and Table 2.5). B


of type 1 diabetes increases as the number 2.12 In patients with prediabetes and 100 and 125 mg/dL (between 5.6 and
er

of relevant autoantibodies detected in- type 2 diabetes, identify and 6.9 mmol/L) (47,56) and IGT as 2-h PG
creases (43–45). In The Environmental De- treat other cardiovascular dis- during 75-g OGTT levels between 140
terminants of Diabetes in the Young and 199 mg/dL (between 7.8 and 11.0
Am

ease risk factors. B


(TEDDY) study, type 1 diabetes devel- mmol/L) (48). It should be noted that the
oped in 21% of 363 subjects with at least
one autoantibody at 3 years of age (46). Table 2.3—Criteria for testing for diabetes or prediabetes in asymptomatic adults
Although there is currently a lack of 1. Testing should be considered in overweight or obese (BMI $25 kg/m2 or $23 kg/m2 in Asian
19

accepted screening programs, one should Americans) adults who have one or more of the following risk factors:
c First-degree relative with diabetes
consider referring relatives of those with
c High-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American,
type 1 diabetes for islet autoantibody
20

Pacific Islander)
testing for risk assessment in the set- c History of CVD
ting of a clinical research study (see www c Hypertension ($140/90 mmHg or on therapy for hypertension)
c HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level .250 mg/dL
©

.diabetestrialnet.org). Widespread clini-


cal testing of asymptomatic low-risk in- (2.82 mmol/L)
dividuals is not currently recommended c Women with polycystic ovary syndrome
c Physical inactivity
due to lack of approved therapeutic inter-
c Other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis
ventions. Individuals who test positive nigricans)
should be counseled about the risk of
2. Patients with prediabetes (A1C $5.7% [39 mmol/mol], IGT, or IFG) should be tested yearly.
developing diabetes, diabetes symptoms,
3. Women who were diagnosed with GDM should have lifelong testing at least every 3 years.
and DKA prevention. Numerous clinical
4. For all other patients, testing should begin at age 45 years.
studies are being conducted to test vari-
5. If results are normal, testing should be repeated at a minimum of 3-year intervals, with
ous methods of preventing type 1 diabetes
consideration of more frequent testing depending on initial results and risk status.
in those with evidence of autoimmunity
(see www.clinicaltrials.gov). CVD, cardiovascular disease; GDM, gestational diabetes mellitus.
care.diabetesjournals.org Classification and Diagnosis of Diabetes S19

Table 2.4—Risk-based screening for type 2 diabetes or prediabetes in asymptomatic (Fig. 2.1) (diabetes.org/socrisktest). For
children and adolescents in a clinical setting (163) additional background regarding risk fac-
Testing should be considered in youth* who have overweight ($85th percentile) or obesity
tors and screening for prediabetes, see
($95th percentile) A and who have one or more additional risk factors based on the strength SCREENING AND TESTING FOR PREDIABETES AND
of their association with diabetes: TYPE 2 DIABETES IN ASYMPTOMATIC ADULTS and
c Maternal history of diabetes or GDM during the child’s gestation A also SCREENING AND TESTING FOR PREDIABETES
AND TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS
c Family history of type 2 diabetes in first- or second-degree relative A
below.
c Race/ethnicity (Native American, African American, Latino, Asian American, Pacific

n
Islander) A

tio
Type 2 Diabetes
c Signsof insulin resistance or conditions associated with insulin resistance (acanthosis
nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-
Type 2 diabetes, previously referred to
age birth weight) B as “noninsulin-dependent diabetes” or

a
“adult-onset diabetes,” accounts for 90–
GDM, gestational diabetes mellitus. *After the onset of puberty or after 10 years of age, whichever

ci
occurs earlier. If tests are normal, repeat testing at a minimum of 3-year intervals, or more 95% of all diabetes. This form encom-
frequently if BMI is increasing, is recommended. Reports of type 2 diabetes before age 10 years passes individuals who have relative

so
exist, and this can be considered with numerous risk factors. (rather than absolute) insulin deficiency
and have peripheral insulin resistance. At
least initially, and often throughout their

As
World Health Organization (WHO) and the high-risk participants in the Diabetes
lifetime, these individuals may not need
numerous other diabetes organizations Prevention Program (DPP) (51), and A1C
insulin treatment to survive.
define the IFG cutoff at 110 mg/dL at baseline was a strong predictor of
There are various causes of type 2
(6.1 mmol/L). the development of glucose-defined di-

s
diabetes. Although the specific etiologies
As with the glucose measures, several abetes during the DPP and its follow-up
are not known, autoimmune destruction

te
prospective studies that used A1C to (52). Hence, it is reasonable to consider
of b-cells does not occur and patients do
predict the progression to diabetes as an A1C range of 5.7–6.4% (39–47 mmol/
not have any of the other known causes
be
defined by A1C criteria demonstrated a mol) as identifying individuals with pre-
of diabetes. Most but not all patients with
strong, continuous association between diabetes. Similar to those with IFG and/or
type 2 diabetes have overweight or obe-
A1C and subsequent diabetes. In a sys- IGT, individuals with A1C of 5.7–6.4%
ia

sity. Excess weight itself causes some


tematic review of 44,203 individuals from (39–47 mmol/mol) should be informed
degree of insulin resistance. Patients who
16 cohort studies with a follow-up in- of their increased risk for diabetes and
D

do not have obesity or overweight by


terval averaging 5.6 years (range 2.8–12 CVD and counseled about effective strat-
traditional weight criteria may have an
years), those with A1C between 5.5% and egies to lower their risks (see Section
increased percentage of body fat distrib-
3 “Prevention or Delay of Type 2 Di-
an

6.0% (between 37 and 42 mmol/mol)


uted predominantly in the abdominal
had a substantially increased risk of di- abetes,” https://doi.org/10.2337/dc20-
region.
abetes (5-year incidence from 9% to S003). Similar to glucose measurements,
DKA seldom occurs spontaneously in
ic

25%). Those with an A1C range of 6.0– the continuum of risk is curvilinear, so as
type 2 diabetes; when seen, it usually
6.5% (42–48 mmol/mol) had a 5-year A1C rises, the diabetes risk rises dispro-
er

arises in association with the stress of


risk of developing diabetes between 25% portionately (49). Aggressive interven-
another illness such as infection or with
and 50% and a relative risk 20 times tions and vigilant follow-up should be
the use of certain drugs (e.g., cortico-
Am

higher compared with A1C of 5.0% pursued for those considered at very
steroids, atypical antipsychotics, and
(31 mmol/mol) (49). In a community- high risk (e.g., those with A1C .6.0%
sodium–glucose cotransporter 2 in-
based study of African American and [42 mmol/mol]).
hibitors) (53,54). Type 2 diabetes fre-
non-Hispanic white adults without dia- Table 2.5 summarizes the categories
quently goes undiagnosed for many
of prediabetes and Table 2.3 the cri-
19

betes, baseline A1C was a stronger pre-


years because hyperglycemia develops
dictor of subsequent diabetes and teria for prediabetes testing. The ADA
gradually and, at earlier stages, is often
cardiovascular events than fasting glucose diabetes risk test is an additional op-
not severe enough for the patient to
20

(50). Other analyses suggest that A1C of tion for assessment to determine the
notice the classic diabetes symptoms.
5.7% (39 mmol/mol) or higher is associated appropriateness of testing for diabetes
Nevertheless, even undiagnosed pa-
with a diabetes risk similar to that of or prediabetes in asymptomatic adults.
©

tients are at increased risk of develop-


ing macrovascular and microvascular
Table 2.5—Criteria defining prediabetes* complications.
FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) Whereas patients with type 2 diabetes
OR may have insulin levels that appear nor-
2-h PG during 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) mal or elevated, the higher blood glucose
OR levels in these patients would be expected
A1C 5.7–6.4% (39–47 mmol/mol) to result in even higher insulin values had
FPG, fasting plasma glucose; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; OGTT, their b-cell function been normal. Thus,
oral glucose tolerance test; 2-h PG, 2-h plasma glucose. *For all three tests, risk is continuous, insulin secretion is defective in these
extending below the lower limit of the range and becoming disproportionately greater at the patients and insufficient to compensate
higher end of the range. for insulin resistance. Insulin resistance
S20 Classification and Diagnosis of Diabetes Diabetes Care Volume 43, Supplement 1, January 2020

may improve with weight reduction diabetes are undiagnosed (47,56). Al- BMI and Ethnicity
and/or pharmacologic treatment of hy- though screening of asymptomatic indi- In general, BMI $25 kg/m2 is a risk factor
perglycemia but is seldom restored to viduals to identify those with prediabetes for diabetes. However, data suggest that
normal. or diabetes might seem reasonable, rig- the BMI cut point should be lower for the
The risk of developing type 2 diabetes orous clinical trials to prove the effective- Asian American population (60,61). The
increases with age, obesity, and lack of ness of such screening have not been BMI cut points fall consistently between
physical activity. It occurs more fre- conducted and are unlikely to occur. 23 and 24 kg/m2 (sensitivity of 80%) for
quently in women with prior gestational Based on a population estimate, diabe- nearly all Asian American subgroups

n
diabetes mellitus (GDM), in those with tes in women of childbearing age is (with levels slightly lower for Japanese
hypertension or dyslipidemia, and in underdiagnosed. Employing a probabi- Americans). This makes a rounded cut

tio
certain racial/ethnic subgroups (African listic model, Peterson et al. (57) dem- point of 23 kg/m2 practical. An argument
American, American Indian, Hispanic/ onstrated cost and health benefits of can be made to push the BMI cut point to

a
Latino, and Asian American). It is often preconception screening. lower than 23 kg/m2 in favor of increased
sensitivity; however, this would lead to

ci
associated with a strong genetic predis- A large European randomized con-
position or family history in first-degree trolled trial compared the impact of an unacceptably low specificity (13.1%).

so
relatives, more so than type 1 diabetes. screening for diabetes and intensive Data from the WHO also suggests that a
However, the genetics of type 2 diabetes multifactorial intervention with that of BMI of $23 kg/m2 should be used to
is poorly understood. In adults without screening and routine care (55). General define increased risk in Asian Americans

As
traditional risk factors for type 2 diabetes practice patients between the ages of (62). The finding that one-third to one-
and/or younger age, consider islet auto- 40 and 69 years were screened for di- half of diabetes in Asian Americans is
antibody testing (e.g., GAD65 autoanti- abetes and randomly assigned by prac- undiagnosed suggests that testing is
not occurring at lower BMI thresholds

s
bodies) to exclude the diagnosis of tice to intensive treatment of multiple
type 1 diabetes. risk factors or routine diabetes care. (63,64).

Screening and Testing for Prediabetes te


After 5.3 years of follow-up, CVD risk
factors were modestly but significantly
Evidence also suggests that other pop-
ulations may benefit from lower BMI cut
be
and Type 2 Diabetes in Asymptomatic improved with intensive treatment points. For example, in a large multieth-
Adults compared with routine care, but the nic cohort study, for an equivalent in-
incidence of first CVD events or mortal- cidence rate of diabetes, a BMI of 30
ia

Screening for prediabetes and type 2


diabetes risk through an informal assess- ity was not significantly different be- kg/m2 in non-Hispanic whites was equiv-
ment of risk factors (Table 2.3) or with alent to a BMI of 26 kg/m2 in African
D

tween the groups (48). The excellent


an assessment tool, such as the ADA risk care provided to patients in the routine Americans (65).
test (Fig. 2.1) (online at diabetes.org/ care group and the lack of an un-
an

Medications
socrisktest), is recommended to guide screened control arm limited the au-
providers on whether performing a di- thors’ ability to determine whether Certain medications, such as glucocor-
agnostic test (Table 2.2) is appropriate. screening and early treatment im- ticoids, thiazide diuretics, some HIV
ic

Prediabetes and type 2 diabetes meet proved outcomes compared with no medications, and atypical antipsy-
chotics (66), are known to increase
er

criteria for conditions in which early screening and later treatment after
detection is appropriate. Both conditions clinical diagnoses. Computer simula- the risk of diabetes and should be
are common and impose significant clin- tion modeling studies suggest that considered when deciding whether
Am

ical and public health burdens. There is major benefits are likely to accrue to screen.
often a long presymptomatic phase be- from the early diagnosis and treat- Testing Interval
fore the diagnosis of type 2 diabetes. ment of hyperglycemia and cardiovas- The appropriate interval between
Simple tests to detect preclinical disease cular risk factors in type 2 diabetes screening tests is not known (67). The
19

are readily available. The duration of (58); moreover, screening, beginning at rationale for the 3-year interval is
glycemic burden is a strong predictor age 30 or 45 years and independent of that with this interval, the number of
of adverse outcomes. There are effec- risk factors, may be cost-effective
20

false-positive tests that require confir-


tive interventions that prevent progres- (,$11,000 per quality-adjusted life- matory testing will be reduced and
sion from prediabetes to diabetes (see year gained) (59). individuals with false-negative tests
Section 3 “Prevention or Delay of Type 2
©

Additional considerations regard- will be retested before substantial


Diabetes,” https://doi.org/10.2337/dc20- ing testing for type 2 diabetes and time elapses and complications de-
S003) and reduce the risk of diabetes prediabetes in asymptomatic patients velop (67).
complications (see Section 10 “Cardiovas- include the following.
cular Disease and Risk Management,” Community Screening
https://doi.org/10.2337/dc20-S010, and Age Ideally, testing should be carried out
Section 11 “Microvascular Complications Age is a major risk factor for diabetes. within a health care setting because of
and Foot Care,” https://doi.org/10.2337/ Testing should begin at no later than the need for follow-up and treatment.
dc20-S011). age 45 years for all patients. Screening Community screening outside a health
Approximately one-quarter of people should be considered in adults of any care setting is generally not recom-
with diabetes in the U.S. and nearly half age with overweight or obesity and one mended because people with positive
of Asian and Hispanic Americans with or more risk factors for diabetes. tests may not seek, or have access to,
care.diabetesjournals.org Classification and Diagnosis of Diabetes S21

n
a tio
ci
so
As
s
te
be
ia
D
an
ic
er
Am
19
20
©

Figure 2.1—ADA risk test (diabetes.org/socrisktest).


S22 Classification and Diagnosis of Diabetes Diabetes Care Volume 43, Supplement 1, January 2020

appropriate follow-up testing and care. diabetes in children with cystic fibrosis or however, recent publications suggest
However, in specific situations where symptoms suggestive of acute onset of that an A1C cut point lower than 5.4%
an adequate referral system is estab- type 1 diabetes and only A1C assays (5.8% in a second study) would detect
lished beforehand for positive tests, without interference are appropriate more than 90% of cases and reduce
community screening may be consid- for children with hemoglobinopathies, patient screening burden (77,78). On-
ered. Community testing may also be the ADA continues to recommend A1C going studies are underway to validate
poorly targeted; i.e., it may fail to for diagnosis of type 2 diabetes in this this approach. Regardless of age, weight
reach the groups most at risk and in- cohort (74,75). loss or failure of expected weight gain

n
appropriately test those at very low risk is a risk for CFRD and should prompt
or even those who have already been screening (77,78). Continuous glucose

tio
CYSTIC FIBROSIS–RELATED
diagnosed (68). DIABETES monitoring or HOMA of b-cell function
(79) may be more sensitive than OGTT to
Screening in Dental Practices

a
Recommendations
detect risk for progression to CFRD;
Because periodontal disease is associated 2.14 Annual screening for cystic

ci
however, evidence linking these results
with diabetes, the utility of screening in a fibrosis–related diabetes (CFRD)
to long-term outcomes is lacking, and
dental setting and referral to primary care with an oral glucose tolerance

so
these tests are not recommended for
as a means to improve the diagnosis of test should begin by age 10 years
screening (80).
prediabetes and diabetes has been in all patients with cystic fibrosis
CFRD mortality has significantly de-

As
explored (69–71), with one study es- not previously diagnosed with
creased over time, and the gap in mor-
timating that 30% of patients $30 CFRD. B
tality between cystic fibrosis patients
years of age seen in general dental 2.15 A1C is not recommended as a
with and without diabetes has consid-
practices had dysglycemia (71). Further screening test for cystic fibrosis–

s
erably narrowed (81). There are limited
research is needed to demonstrate the related diabetes. B
clinical trial data on therapy for CFRD.

te
feasibility, effectiveness, and cost-effec- 2.16 Patients with cystic fibrosis–
The largest study compared three regi-
tiveness of screening in this setting. related diabetes should be
mens: premeal insulin aspart, repagli-
be
treated with insulin to attain
Screening and Testing for Prediabetes nide, or oral placebo in cystic fibrosis
individualized glycemic goals. A
and Type 2 Diabetes in Children and patients with diabetes or abnormal glu-
2.17 Beginning 5 years after the di-
ia

Adolescents cose tolerance. Participants all had


agnosis of cystic fibrosis–related
In the last decade, the incidence and weight loss in the year preceding treat-
diabetes, annual monitoring for
D

prevalence of type 2 diabetes in chil- ment; however, in the insulin-treated


complications of diabetes is rec-
dren and adolescents has increased group, this pattern was reversed, and
ommended. E
dramatically, especially in racial and patients gained 0.39 (60.21) BMI units
an

ethnic minority populations (41). See (P 5 0.02). The repaglinide-treated


Table 2.4 for recommendations on risk- Cystic fibrosis–related diabetes (CFRD) group had initial weight gain, but this
based screening for type 2 diabetes or is the most common comorbidity in was not sustained by 6 months. The
ic

prediabetes in asymptomatic children people with cystic fibrosis, occurring in placebo group continued to lose weight
er

and adolescents in a clinical setting about 20% of adolescents and 40–50% of (81). Insulin remains the most widely
(19). See Table 2.2 and Table 2.5 for adults (76). Diabetes in this population, used therapy for CFRD (82).
the criteria for the diagnosis of diabetes compared with individuals with type 1 or Additional resources for the clinical
Am

and prediabetes, respectively, which type 2 diabetes, is associated with worse management of CFRD can be found in
apply to children, adolescents, and nutritional status, more severe inflam- the position statement “Clinical Care
adults. See Section 13 “Children and matory lung disease, and greater mor- Guidelines for Cystic Fibrosis–Related
Adolescents” (https://doi.org/10.2337/ tality. Insulin insufficiency is the primary Diabetes: A Position Statement of the
19

dc20-S013) for additional information defect in CFRD. Genetically determined American Diabetes Association and a
on type 2 diabetes in children and b-cell function and insulin resistance Clinical Practice Guideline of the Cystic
adolescents. associated with infection and inflamma- Fibrosis Foundation, Endorsed by the
20

Some studies question the validity of tion may also contribute to the devel- Pediatric Endocrine Society” (83) and
A1C in the pediatric population, espe- opment of CFRD. Milder abnormalities in the International Society for Pedi-
©

cially among certain ethnicities, and sug- of glucose tolerance are even more com- atric and Adolescent Diabetes’s 2014
gest OGTT or FPG as more suitable mon and occur at earlier ages than CFRD. clinical practice consensus guidelines
diagnostic tests (72). However, many Whether individuals with IGT should be (84).
of these studies do not recognize that treated with insulin replacement has not
diabetes diagnostic criteria are based on currently been determined. Although POSTTRANSPLANTATION
long-term health outcomes, and valida- screening for diabetes before the age DIABETES MELLITUS
tions are not currently available in the of 10 years can identify risk for progres- Recommendations
pediatric population (73). The ADA ac- sion to CFRD in those with abnormal 2.18 Patients should be screened af-
knowledges the limited data supporting glucose tolerance, no benefit has been ter organ transplantation for
A1C for diagnosing type 2 diabetes in established with respect to weight, hyperglycemia, with a formal
children and adolescents. Although A1C height, BMI, or lung function. OGTT diagnosis of posttransplantation
is not recommended for diagnosis of is the recommended screening test;
care.diabetesjournals.org Classification and Diagnosis of Diabetes S23

acute infection (89–91). The OGTT is MONOGENIC DIABETES


diabetes mellitus being best
considered the gold standard test for SYNDROMES
made once a patient is stable
the diagnosis of PTDM (86,87,92,93).
on an immunosuppressive reg- Recommendations
However, screening patients using
imen and in the absence of an 2.21 All children diagnosed with di-
fasting glucose and/or A1C can identify
acute infection. E abetes in the first 6 months of
high-risk patients requiring further as-
2.19 The oral glucose tolerance test life should have immediate ge-
sessment and may reduce the number
is the preferred test to make netic testing for neonatal dia-
of overall OGTTs required.
a diagnosis of posttransplanta- betes. A

n
Few randomized controlled studies
tion diabetes mellitus. B 2.22 Children and those diagnosed
have reported on the short- and long-

tio
2.20 Immunosuppressive regimens in early adulthood who have
term use of antihyperglycemic agents in
shown to provide the best out- diabetes not characteristic of
the setting of PTDM (91,94,95). Most
comes for patient and graft type 1 or type 2 diabetes that

a
studies have reported that transplant
survival should be used, irre- occurs in successive generations

ci
patients with hyperglycemia and PTDM
spective of posttransplantation (suggestive of an autosomal
after transplantation have higher rates of
diabetes mellitus risk. E dominant pattern of inheri-

so
rejection, infection, and rehospitalization
tance) should have genetic test-
(89,91,96).
ing for maturity-onset diabetes
Several terms are used in the literature Insulin therapy is the agent of choice
of the young. A

As
to describe the presence of diabetes for the management of hyperglycemia,
2.23 In both instances, consultation
following organ transplantation (85). PTDM, and preexisting diabetes and di-
with a center specializing in di-
“New-onset diabetes after transplanta- abetes in the hospital setting. After dis-
abetes genetics is recommen-

s
tion” (NODAT) is one such designation charge, patients with preexisting diabetes
ded to understand the significance
that describes individuals who develop could go back on their pretransplant reg-

te
of these mutations and how best
new-onset diabetes following trans- imen if they were in good control before
to approach further evaluation,
plant. NODAT excludes patients with transplantation. Those with previously poor
be
treatment, and genetic counsel-
pretransplant diabetes that was undi- control or with persistent hyperglycemia
ing. E
agnosed as well as posttransplant hy- should continue insulin with frequent
ia

perglycemia that resolves by the time home self-monitoring of blood glucose to


of discharge (86). Another term, “post- determine when insulin dose reduc- Monogenic defects that cause b-cell
D

transplantation diabetes mellitus” (PTDM) tions may be needed and when it dysfunction, such as neonatal diabetes
(86,87), describes the presence of di- may be appropriate to switch to non- and MODY, represent a small fraction
abetes in the posttransplant setting insulin agents. of patients with diabetes (,5%). Ta-
an

irrespective of the timing of diabetes No studies to date have established ble 2.6 describes the most common
onset. which noninsulin agents are safest or causes of monogenic diabetes. For a com-
Hyperglycemia is very common during most efficacious in PTDM. The choice
ic

prehensive list of causes, see Genetic


the early posttransplant period, with of agent is usually made based on the side Diagnosis of Endocrine Disorders
;90% of kidney allograft recipients ex-
er

effect profile of the medication and (102).


hibiting hyperglycemia in the first few possible interactions with the patient’s
weeks following transplant (86–89). In immunosuppression regimen (91). Drug Neonatal Diabetes
Am

most cases, such stress- or steroid- dose adjustments may be required be- Diabetes occurring under 6 months of
induced hyperglycemia resolves by the cause of decreases in the glomerular age is termed “neonatal” or “congeni-
time of discharge (89,90). Although filtration rate, a relatively common com- tal” diabetes, and about 80–85% of
the use of immunosuppressive therapies plication in transplant patients. A small cases can be found to have an under-
19

is a major contributor to the develop- short-term pilot study reported that lying monogenic cause (103). Neonatal
ment of PTDM, the risks of transplant metformin was safe to use in renal trans- diabetes occurs much less often after
rejection outweigh the risks of PTDM and plant recipients (97), but its safety has 6 months of age, whereas autoimmune
20

the role of the diabetes care provider not been determined in other types of type 1 diabetes rarely occurs before
is to treat hyperglycemia appropriately organ transplant. Thiazolidinediones 6 months of age. Neonatal diabetes
©

regardless of the type of immunosup- have been used successfully in patients can either be transient or permanent.
pression (86). Risk factors for PTDM in- with liver and kidney transplants, but side Transient diabetes is most often due to
clude both general diabetes risks (such as effects include fluid retention, heart fail- overexpression of genes on chromo-
age, family history of diabetes, etc.) as ure, and osteopenia (98,99). Dipeptidyl some 6q24, is recurrent in about half
well as transplant-specific factors, such peptidase 4 inhibitors do not interact of cases, and may be treatable with
as use of immunosuppressant agents with immunosuppressant drugs and have medications other than insulin. Perma-
(91). Whereas posttransplantation hy- demonstrated safety in small clinical trials nent neonatal diabetes is most commonly
perglycemia is an important risk factor (100,101). Well-designed intervention due to autosomal dominant mutations in
for subsequent PTDM, a formal diagnosis trials examining the efficacy and safety the genes encoding the Kir6.2 subunit
of PTDM is optimally made once the of these and other antihyperglycemic (KCNJ11) and SUR1 subunit (ABCC8) of
patient is stable on maintenance immu- agents in patients with PTDM are the b-cell KATP channel. Correct diagnosis
nosuppression and in the absence of needed. has critical implications because most
S24 Classification and Diagnosis of Diabetes Diabetes Care Volume 43, Supplement 1, January 2020

Table 2.6—Most common causes of monogenic diabetes (102)


Gene Inheritance Clinical features
MODY
GCK AD GCK-MODY: stable, nonprogressive elevated fasting blood glucose; typically does not
require treatment; microvascular complications are rare; small rise in 2-h PG level on OGTT
(,54 mg/dL [3 mmol/L])
HNF1A AD HNF1A-MODY: progressive insulin secretory defect with presentation in adolescence or early
adulthood; lowered renal threshold for glucosuria; large rise in 2-h PG level on OGTT

n
(.90 mg/dL [5 mmol/L]); sensitive to sulfonylureas

tio
HNF4A AD HNF4A-MODY: progressive insulin secretory defect with presentation in adolescence or early
adulthood; may have large birth weight and transient neonatal hypoglycemia; sensitive to
sulfonylureas

a
HNF1B AD HNF1B-MODY: developmental renal disease (typically cystic); genitourinary abnormalities;
atrophy of the pancreas; hyperuricemia; gout

ci
Neonatal
diabetes

so
KCNJ11 AD Permanent or transient: IUGR; possible developmental delay and seizures; responsive to
sulfonylureas
INS AD Permanent: IUGR; insulin requiring

As
ABCC8 AD Permanent or transient: IUGR; rarely developmental delay; responsive to sulfonylureas
6q24 (PLAGL1, AD for paternal Transient: IUGR; macroglossia; umbilical hernia; mechanisms include UPD6, paternal
HYMA1) duplications duplication or maternal methylation defect; may be treatable with medications other than

s
insulin
GATA6 AD Permanent: pancreatic hypoplasia; cardiac malformations; pancreatic exocrine insufficiency;

EIF2AK3 AR
insulin requiring

te
Permanent: Wolcott-Rallison syndrome: epiphyseal dysplasia; pancreatic exocrine
be
insufficiency; insulin requiring
FOXP3 X-linked Permanent: immunodysregulation, polyendocrinopathy, enteropathy X-linked (IPEX)
syndrome: autoimmune diabetes; autoimmune thyroid disease; exfoliative dermatitis;
ia

insulin requiring
AD, autosomal dominant; AR, autosomal recessive; IUGR, intrauterine growth restriction; OGTT, oral glucose tolerance test; 2-h PG, 2-h plasma
D

glucose.
an

patients with KATP-related neonatal di- MODY (MODY3), and HNF4A-MODY HNF4A-MODY). Additionally, diagnosis can
abetes will exhibit improved glycemic (MODY1). lead to identification of other affected
ic

control when treated with high-dose For individuals with MODY, the treat- family members. Genetic screening is in-
oral sulfonylureas instead of insulin. ment implications are considerable and creasingly available and cost-effective
er

Insulin gene (INS) mutations are the warrant genetic testing (104,105). Clin- (104,105).
second most common cause of perma- ically, patients with GCK-MODY exhibit A diagnosis of MODY should be con-
Am

nent neonatal diabetes, and, while mild, stable, fasting hyperglycemia and sidered in individuals who have atypical
intensive insulin management is cur- do not require antihyperglycemic ther- diabetes and multiple family members
rently the preferred treatment strategy, apy except sometimes during pregnancy. with diabetes not characteristic of type
there are important genetic counseling Patients with HNF1A- or HNF4A-MODY 1 or type 2 diabetes, although admit-
considerations, as most of the mutations usually respond well to low doses of tedly “atypical diabetes” is becoming
19

that cause diabetes are dominantly in- sulfonylureas, which are considered increasingly difficult to precisely define
herited. first-line therapy. Mutations or deletions in the absence of a definitive set of tests
20

in HNF1B are associated with renal cysts for either type of diabetes (104–110). In
Maturity-Onset Diabetes of the Young and uterine malformations (renal cysts
MODY is frequently characterized by most cases, the presence of autoantibodies
and diabetes [RCAD] syndrome). Other for type 1 diabetes precludes further
©

onset of hyperglycemia at an early age extremely rare forms of MODY have been
(classically before age 25 years, although testing for monogenic diabetes, but
reported to involve other transcription
diagnosis may occur at older ages). the presence of autoantibodies in pa-
factor genes including PDX1 (IPF1) and
MODY is characterized by impaired in- tients with monogenic diabetes has been
NEUROD1.
sulin secretion with minimal or no de- reported (111). Individuals in whom
fects in insulin action (in the absence of Diagnosis of Monogenic Diabetes monogenic diabetes is suspected should
coexistent obesity). It is inherited in A diagnosis of one of the three most be referred to a specialist for further
an autosomal dominant pattern with common forms of MODY, including GCK- evaluation if available, and consultation
abnormalities in at least 13 genes on MODY, HNF1A-MODY, and HNF4A-MODY, is available from several centers. Readily
different chromosomes identified to allows for more cost-effective therapy available commercial genetic testing fol-
date. The most commonly reported (no therapy for GCK-MODY; sulfonylureas lowing the criteria listed below now
forms are GCK-MODY (MODY2), HNF1A- as first-line therapy for HNF1A-MODY and enables a cost-effective (112), often
care.diabetesjournals.org Classification and Diagnosis of Diabetes S25

cost-saving, genetic diagnosis that is in- pancreoprivic diabetes (1). The diverse Definition
creasingly supported by health insur- set of etiologies includes pancreatitis For many years, GDM was defined as
ance. A biomarker screening pathway (acute and chronic), trauma or pancre- any degree of glucose intolerance that
such as the combination of urinary atectomy, neoplasia, cystic fibrosis (ad- was first recognized during preg-
C-peptide/creatinine ratio and antibody nancy (49), regardless of the degree
dressed elsewhere in this chapter),
screening may aid in determining who of hyperglycemia. This definition facili-
hemochromatosis, fibrocalculous pan-
should get genetic testing for MODY tated a uniform strategy for detection
creatopathy, rare genetic disorders
(113). It is critical to correctly diagnose and classification of GDM, but this defi-
(117), and idiopathic forms (1). A distin-

n
one of the monogenic forms of diabetes nition has serious limitations (126). First,
because these patients may be incor- guishing feature is concurrent pancreatic the best available evidence reveals that

tio
rectly diagnosed with type 1 or type 2 exocrine insufficiency (according to the many, perhaps most, cases of GDM rep-
diabetes, leading to suboptimal, even monoclonal fecal elastase 1 test or direct resent preexisting hyperglycemia that is

a
potentially harmful, treatment regimens function tests), pathological pancreatic detected by routine screening in preg-
imaging (endoscopic ultrasound, MRI, nancy, as routine screening is not widely

ci
and delays in diagnosing other family
members (114). The correct diagnosis is computed tomography) and absence of performed in nonpregnant women of

so
especially critical for those with GCK- type 1 diabetes–associated autoimmu- reproductive age. It is the severity of
MODY mutations where multiple studies nity (118–122). There is loss of both hyperglycemia that is clinically important
have shown that no complications ensue insulin and glucagon secretion and often with regard to both short- and long-term

As
in the absence of glucose-lowering ther- maternal and fetal risks. Universal pre-
higher-than-expected insulin require-
apy (115). Genetic counseling is recom- conception and/or first trimester screen-
ments. Risk for microvascular complica-
mended to ensure that affected ing is hampered by lack of data and
tions is similar to other forms of diabetes. In

s
individuals understand the patterns of consensus regarding both appropriate
the context of pancreatectomy, islet auto-
inheritance and the importance of a diagnostic thresholds and outcomes. A

te
transplantation can be done to retain insulin
correct diagnosis. compelling argument for further work in
secretion (123,124). In some cases, this can
The diagnosis of monogenic diabetes this area is the fact that hyperglycemia
be
lead to insulin independence. In others,
should be considered in children and that would be diagnostic of diabetes
it may decrease insulin requirements
adults diagnosed with diabetes in outside of pregnancy and is present at
(125).
the time of conception is associated with
ia

early adulthood with the following


findings: an increased risk of congenital malfor-
D

GESTATIONAL DIABETES MELLITUS mations that is not seen with lower


c Diabetes diagnosed within the first glucose levels (127,128).
Recommendations
6 months of life (with occasional cases The ongoing epidemic of obesity and
2.24 Test for undiagnosed predia-
an

presenting later, mostly INS and diabetes has led to more type 2 diabetes
betes and diabetes at the first
ABCC8 mutations) (103,116) in women of reproductive age, with an
prenatal visit in those with risk
c Diabetes without typical features of increase in the number of pregnant
ic

factors using standard diagnos-


type 1 or type 2 diabetes (negative women with undiagnosed type 2 diabe-
tic criteria. B
er

diabetes-associatedautoantibodies,non- tes in early pregnancy (129–132). Be-


2.25 Test for gestational diabetes
obese, lacking other metabolic features cause of the number of pregnant women
mellitus at 24–28 weeks of ges-
especially with strong family history of with undiagnosed type 2 diabetes, it is
Am

tation in pregnant women not


diabetes) reasonable to test women with risk fac-
previously found to have diabe-
c Stable, mild fasting hyperglycemia tors for type 2 diabetes (133) (Table 2.3)
tes. A
(100–150 mg/dL [5.5–8.5 mmol/L]), at their initial prenatal visit, using stan-
2.26 Test women with gestational
stable A1C between 5.6 and 7.6% dard diagnostic criteria (Table 2.2).
diabetes mellitus for prediabe-
19

(between 38 and 60 mmol/mol), es- Women found to have diabetes by the


tes or diabetes at 4–12 weeks
pecially if nonobese standard diagnostic criteria used outside
postpartum, using the 75-g oral
of pregnancy should be classified as
20

glucose tolerance test and clin-


PANCREATIC DIABETES OR having diabetes complicating pregnancy
DIABETES IN THE CONTEXT ically appropriate nonpregnancy
(most often type 2 diabetes, rarely type 1
OF DISEASE OF THE diagnostic criteria. B
©

diabetes or monogenic diabetes) and


EXOCRINE PANCREAS 2.27 Women with a history of ges-
managed accordingly. Women who
tational diabetes mellitus should
Pancreatic diabetes includes both struc- meet the lower glycemic criteria for
have lifelong screening for the
tural and functional loss of glucose- GDM should be diagnosed with that
development of diabetes or pre-
normalizing insulin secretion in the context condition and managed accordingly.
diabetes at least every 3 years. B
of exocrine pancreatic dysfunction and Other women should be rescreened
2.28 Women with a history of ges-
is commonly misdiagnosed as type 2 for GDM between 24 and 28 weeks of
tational diabetes mellitus found
diabetes. Hyperglycemia due to general gestation (see Section 14 “Management
to have prediabetes should re-
pancreatic dysfunction has been called of Diabetes in Pregnancy,” https://doi
ceive intensive lifestyle inter-
“type 3c diabetes” and, more recently, .org/10.2337/dc20-S014). The Interna-
ventions and/or metformin to
diabetes in the context of disease of tional Association of the Diabetes and
prevent diabetes. A
the exocrine pancreas has been termed Pregnancy Study Groups (IADPSG) GDM
S26 Classification and Diagnosis of Diabetes Diabetes Care Volume 43, Supplement 1, January 2020

diagnostic criteria for the 75-g OGTT as well normal for pregnancy. For most compli- study population. This one-step strategy
as the GDM screening and diagnostic cri- cations, there was no threshold for risk. was anticipated to significantly increase
teria used in the two-step approach were These results have led to careful recon- the incidence of GDM (from 5–6% to 15–
not derived from data in the first half of sideration of the diagnostic criteria for 20%), primarily because only one abnor-
pregnancy, so the diagnosis of GDM in GDM. mal value, not two, became sufficient to
early pregnancy by either FPG or OGTT GDM diagnosis (Table 2.7) can be ac- make the diagnosis (142). Many regional
values is not evidence based (134) and complished with either of two strate- studies have investigated the impact of
further work is needed. gies: adopting IADPSG criteria on prevalence

n
GDM is often indicative of underly- and have seen a roughly one- to threefold
ing b-cell dysfunction (135), which 1. The “one-step” 75-g OGTT derived increase (143). The anticipated increase

tio
confers marked increased risk for later from the IADPSG criteria or in the incidence of GDM could have a
development of diabetes, generally but 2. The older “two-step” approach with a substantial impact on costs and medical

a
not always type 2 diabetes, in the mother 50-g (nonfasting) screen followed by infrastructure needs and has the poten-
a 100-g OGTT for those who screen tial to “medicalize” pregnancies previ-

ci
after delivery (136,137). As effective pre-
vention interventions are available positive, based on the work of Car- ously categorized as normal. A recent

so
(138,139), women diagnosed with GDM penter and Coustan’s interpretation follow-up study of women participating
should receive lifelong screening for pre- of the older O’Sullivan (141a) criteria. in a blinded study of pregnancy OGTTs
diabetes to allow interventions to reduce found that 11 years after their pregnan-

As
diabetes risk and for type 2 diabetes to Different diagnostic criteria will iden- cies, women who would have been di-
allow treatment at the earliest pos- tify different degrees of maternal hyper- agnosed with GDM by the one-step
sible time (140). glycemia and maternal/fetal risk, leading approach, as compared with those

s
some experts to debate, and disagree on, without, were at 3.4-fold higher risk
Diagnosis optimal strategies for the diagnosis of of developing prediabetes and type 2
GDM carries risks for the mother, fetus,
and neonate. The Hyperglycemia and
GDM.
te diabetes and had children with a higher
risk of obesity and increased body fat,
be
One-Step Strategy
Adverse Pregnancy Outcome (HAPO) suggesting that the larger group of
The IADPSG defined diagnostic cut points
study (141), a large-scale multinational women identified by the one-step ap-
for GDM as the average fasting, 1-h, and 2-h
ia

cohort study completed by more than proach would benefit from increased
23,000 pregnant women, demonstrated PG values during a 75-g OGTT in women at screening for diabetes and prediabetes
24–28 weeks of gestation who participated
D

that risk of adverse maternal, fetal, and that would accompany a history of GDM
neonatal outcomes continuously in- in the HAPO study at which odds for ad- (144). The ADA recommends the IADPSG
creased as a function of maternal glyce- verse outcomes reached 1.75 times the diagnostic criteria with the intent of
an

mia at 24–28 weeks of gestation, even estimated odds of these outcomes at the optimizing gestational outcomes be-
within ranges previously considered mean fasting, 1-h, and 2-h PG levels of the cause these criteria were the only
ones based on pregnancy outcomes
ic

rather than end points such as prediction


Table 2.7—Screening for and diagnosis of GDM
er

One-step strategy
of subsequent maternal diabetes.
Perform a 75-g OGTT, with plasma glucose measurement when patient is fasting and at 1 The expected benefits of using IADPSG to
the offspring are inferred from intervention
Am

and 2 h, at 24–28 weeks of gestation in women not previously diagnosed with diabetes.
The OGTT should be performed in the morning after an overnight fast of at least 8 h. trials that focused on women with lower
The diagnosis of GDM is made when any of the following plasma glucose values are met or levels of hyperglycemia than identified
exceeded: using older GDM diagnostic criteria. Those
c Fasting: 92 mg/dL (5.1 mmol/L) trials found modest benefits including re-
19

c 1 h: 180 mg/dL (10.0 mmol/L) duced rates of large-for-gestational-age


c 2 h: 153 mg/dL (8.5 mmol/L) births and preeclampsia (145,146). It is
Two-step strategy important to note that 80–90% of women
20

Step 1: Perform a 50-g GLT (nonfasting), with plasma glucose measurement at 1 h, at 24– being treated for mild GDM in these two
28 weeks of gestation in women not previously diagnosed with diabetes. randomized controlled trials could be man-
If the plasma glucose level measured 1 h after the load is $130, 135, or 140 mg/dL (7.2, 7.5, or
©

aged with lifestyle therapy alone. The


7.8 mmol/L, respectively), proceed to a 100-g OGTT.
OGTT glucose cutoffs in these two trials
Step 2: The 100-g OGTT should be performed when the patient is fasting.
overlapped with the thresholds recom-
The diagnosis of GDM is made when at least two* of the following four plasma glucose levels
(measured fasting and at 1, 2, and 3 h during OGTT) are met or exceeded (Carpenter-Coustan mended by the IADPSG, and in one trial
criteria [154]): (146), the 2-h PG threshold (140 mg/dL
c Fasting: 95 mg/dL (5.3 mmol/L) [7.8 mmol/L]) was lower than the cutoff
c 1 h: 180 mg/dL (10.0 mmol/L) recommended by the IADPSG (153 mg/
c 2 h: 155 mg/dL (8.6 mmol/L) dL [8.5 mmol/L]). No randomized con-
c 3 h: 140 mg/dL (7.8 mmol/L)
trolled trials of treating versus not
GDM, gestational diabetes mellitus; GLT, glucose load test; OGTT, oral glucose tolerance test. treating GDM diagnosed by the IADPSG
*American College of Obstetricians and Gynecologists notes that one elevated value can be used criteria but not the Carpenter-Coustan
for diagnosis (150).
criteria have been published to date.
care.diabetesjournals.org Classification and Diagnosis of Diabetes S27

Data are also lacking on how the treat- of neonatal macrosomia, large-for- approaches have been inconsistent to
ment of lower levels of hyperglycemia gestational-age births (153), and shoulder date (159,160). In addition, pregnancies
affects a mother’s future risk for the dystocia, without increasing small-for- complicated by GDM per the IADPSG
development of type 2 diabetes and her gestational-age births. ACOG currently criteria, but not recognized as such,
offspring’s risk for obesity, diabetes, supports the two-step approach but have outcomes comparable to preg-
and other metabolic disorders. Addi- notes that one elevated value, as op- nancies with diagnosed GDM by the
tional well-designed clinical studies are posed to two, may be used for the di- more stringent two-step criteria (161,162).
needed to determine the optimal in- agnosis of GDM (150). If this approach There remains strong consensus that

n
tensity of monitoring and treatment of is implemented, the incidence of GDM establishing a uniform approach to di-
agnosing GDM will benefit patients,

tio
women with GDM diagnosed by the by the two-step strategy will likely in-
one-step strategy (147,148). crease markedly. ACOG recommends caregivers, and policy makers. Longer-
either of two sets of diagnostic thresh- term outcome studies are currently
Two-Step Strategy

a
olds for the 3-h 100-g OGTTdCarpenter- underway.
In 2013, the National Institutes of Health

ci
(NIH) convened a consensus develop- Coustan or National Diabetes Data References
ment conference to consider diagnostic Group (154,155). Each is based on dif- 1. American Diabetes Association. Diagnosis

so
criteria for diagnosing GDM (149). The ferent mathematical conversions of the and classification of diabetes mellitus. Diabetes
15-member panel had representatives original recommended thresholds by Care 2014;37(Suppl. 1):S81–S90
O’Sullivan (141a), which used whole 2. Dabelea D, Rewers A, Stafford JM, et al.;

As
from obstetrics and gynecology, maternal-
SEARCH for Diabetes in Youth Study Group.
fetal medicine, pediatrics, diabetes re- blood and nonenzymatic methods for Trends in the prevalence of ketoacidosis at
search, biostatistics, and other related glucose determination. A secondary diabetes diagnosis: the SEARCH for Diabetes
fields. The panel recommended a two- analysis of data from a randomized in Youth Study. Pediatrics 2014;133:e938–

s
step approach to screening that used a clinical trial of identification and treat- e945

te
ment of mild GDM (156) demonstrated 3. Humphreys A, Bravis V, Kaur A, et al. Individual
1-h 50-g glucose load test (GLT) followed
and diabetes presentation characteristics asso-
by a 3-h 100-g OGTT for those who that treatment was similarly benefi-
ciated with partial remission status in children
be
screened positive. The American College cial in patients meeting only the lower and adults evaluated up to 12 months following
of Obstetricians and Gynecologists thresholds per Carpenter-Coustan (154) diagnosis of type 1 diabetes: an ADDRESS-2 (After
(ACOG) recommends any of the com- and in those meeting only the higher Diagnosis Diabetes Research Support System-2)
ia

monly used thresholds of 130, 135, or thresholds per National Diabetes Data study analysis. Diabetes Res Clin Pract 2019;155:
107789
140 mg/dL for the 1-h 50-g GLT (150). A Group (155). If the two-step approach is
D

4. Thomas NJ, Lynam AL, Hill AV, et al. Type 1 di-


systematic review for the U.S. Preventive used, it would appear advantageous to abetes defined by severe insulin deficiency occurs
Services Task Force compared GLT cut- use the Carpenter-Coustan lower diag- after 30 years of age and is commonly treated as
an

offs of 130 mg/dL (7.2 mmol/L) and nostic thresholds as shown in step 2 in type 2 diabetes. Diabetologia 2019;62:1167–1172
140 mg/dL (7.8 mmol/L) (151). The Table 2.7. 5. Hope SV, Wienand-Barnett S, Shepherd M,
et al. Practical classification guidelines for diabetes
higher cutoff yielded sensitivity of 70– Future Considerations
ic

in patients treated with insulin: a cross-sectional


88% and specificity of 69–89%, while the The conflicting recommendations from study of the accuracy of diabetes diagnosis. Br J
lower cutoff was 88–99% sensitive and
er

expert groups underscore the fact that Gen Pract 2016;66:e315–e322


66–77% specific. Data regarding a cutoff there are data to support each strategy. A 6. Zhong VW, Juhaeri J, Mayer-Davis EJ. Trends
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cost-benefit estimation comparing the
Am

screening tests, choice of a cutoff is based in adults with type 1 and type 2 diabetes in Eng-
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19

for GDM does not function as well as the diabetes (157). The decision of which biochemical differences. Arch Intern Med 2004;
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Key factors cited by the NIH panel in made based on the relative values placed
20

ferentiation of diabetes by pathophysiology,


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©

based on correlation studies rather


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2005;28:307–311 and a clinical practice guideline of the Cystic management of diabetes mellitus after trans-
68. Tabaei BP, Burke R, Constance A, et al. Fibrosis Foundation, endorsed by the Pediatric plantation. Am J Transplant 2004;4:2135–
20

Community-based screening for diabetes in Endocrine Society. Diabetes Care 2010;33:2697– 2138
Michigan. Diabetes Care 2003;26:668–670 2708 100. Strøm Halden TA, Åsberg A, Vik K,
69. Lalla E, Kunzel C, Burkett S, Cheng B, Lamster 84. Moran A, Pillay K, Becker DJ, Acerini CL; Hartmann A, Jenssen T. Short-term efficacy
©

IB. Identification of unrecognized diabetes and International Society for Pediatric and Adoles- and safety of sitagliptin treatment in long-
pre-diabetes in a dental setting. J Dent Res 2011; cent Diabetes. ISPAD Clinical Practice Consensus term stable renal recipients with new-onset
90:855–860 Guidelines 2014. Management of cystic fibrosis- diabetes after transplantation. Nephrol Dial
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nosed hyperglycemia. J Dent Res 2013;92:888– 85. Shivaswamy V, Boerner B, Larsen J. Post- Wrenshall LE, Stevens RB. Sitagliptin therapy in
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116. Greeley SAW, Naylor RN, Philipson LH, Bell Chen L, Wintfeld N. Trends in the incidence of 145. Landon MB, Spong CY, Thom E, et al.; Eunice
GI. Neonatal diabetes: an expanding list of genes diabetes, its clinical sequelae, and associated Kennedy Shriver National Institute of Child Health
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146. Crowther CA, Hiller JE, Moss JR, McPhee AJ, and diagnosis of gestational diabetes mellitus. the St. Carlos Gestational Diabetes Study. Di-
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drate Intolerance Study in Pregnant Women 153. Horvath K, Koch K, Jeitler K, et al. Effects of 159. Wei Y, Yang H, Zhu W, et al. International
(ACHOIS) Trial Group. Effect of treatment of treatment in women with gestational diabetes Association of Diabetes and Pregnancy Study
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comes. N Engl J Med 2005;352:2477–2486 BMJ 2010;340:c1395 mellitus diagnosis: further evidence from China.
147. Tam WH, Ma RCW, Ozaki R, et al. In utero 154. Carpenter MW, Coustan DR. Criteria for Chin Med J (Engl) 2014;127:3553–3556
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Practice Bulletin No. 190: gestational diabetes Screening for gestational diabetes mellitus: are nancy study group criteria for the screening and
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151. Donovan L, Hartling L, Muise M, Guthrie A, of the Diabetes and Pregnancy Study Groups cost- Gynecol 2015;212:224.e1–224.e9

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Vandermeer B, Dryden DM. Screening tests for effective? Diabetes Care 2012;35:529–535 163. Hutchins J, Barajas RA, Hale D, Escaname E,
gestational diabetes: a systematic review for the 158. Duran A, Sáenz S, Torrejón MJ, et al. In- Lynch J. Type 2 diabetes in a 5-year-old and single
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Med 2013;159:115–122 and diagnosis of gestational diabetes mellitus under 10. Pediatr Diabetes 2017;18:674–677
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an
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er
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©
S32 Diabetes Care Volume 43, Supplement 1, January 2020

3. Prevention or Delay of Type 2 American Diabetes Association

Diabetes: Standards of Medical

n
Care in Diabetesd2020

tio
Diabetes Care 2020;43(Suppl. 1):S32–S36 | https://doi.org/10.2337/dc20-S003

a
ci
so
As
The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”
3. PREVENTION OR DELAY OF TYPE 2 DIABETES

includes the ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and tools
to evaluate quality of care. Members of the ADA Professional Practice Committee, a

s
multidisciplinary expert committee (https://doi.org/10.2337/dc20-SPPC), are re-

te
sponsible for updating the Standards of Care annually, or more frequently as
warranted. For a detailed description of ADA standards, statements, and reports, as
be
well as the evidence-grading system for ADA’s clinical practice recommendations,
please refer to the Standards of Care Introduction (https://doi.org/10.2337/
ia

dc20-SINT). Readers who wish to comment on the Standards of Care are invited to
do so at professional.diabetes.org/SOC.
D

For guidelines related to screening for increased risk for type 2 diabetes (prediabetes),
please refer to Section 2 “Classification and Diagnosis of Diabetes” (https://doi.org/10
an

.2337/dc20-S002).
Recommendation
ic

3.1 At least annual monitoring for the development of type 2 diabetes in those
with prediabetes is suggested. E
er

Screening for prediabetes and type 2 diabetes risk through an informal assessment of
Am

risk factors (Table 2.3) or with an assessment tool, such as the American Diabetes
Association risk test (Fig. 2.1), is recommended to guide providers on whether
performing a diagnostic test for prediabetes (Table 2.5) and previously undiagnosed
type 2 diabetes (Table 2.2) is appropriate (see Section 2 “Classification and Diagnosis
19

of Diabetes,” https://doi.org/10.2337/dc20-S002). Those who are determined to be


at high risk for type 2 diabetes, including people with A1C 5.7–6.4% (39–47
mmol/mol), impaired glucose tolerance, or impaired fasting glucose, are ideal
20

candidates for diabetes prevention efforts. Using A1C to screen for prediabetes may
be problematic in the presence of certain hemoglobinopathies or conditions that
affect red blood cell turnover. See Section 2 “Classification and Diagnosis of
©

Diabetes” (https://doi.org/10.2337/dc20-S002) and Section 6 “Glycemic Targets”


(https://doi.org/10.2337/dc20-S006) for additional details on the appropriate
use of the A1C test. Suggested citation: American Diabetes Associa-
tion. 3. Prevention or delay of type 2 diabetes:
LIFESTYLE INTERVENTIONS Standards of Medical Care in Diabetesd2020.
Diabetes Care 2020;43(Suppl. 1):S32–S36
Recommendations
© 2019 by the American Diabetes Association.
3.2 Refer patients with prediabetes to an intensive behavioral lifestyle inter- Readers may use this article as long as the work
vention program modeled on the Diabetes Prevention Program (DPP) to is properly cited, the use is educational and not
achieve and maintain 7% loss of initial body weight and increase moderate- for profit, and the work is not altered. More infor-
intensity physical activity (such as brisk walking) to at least 150 min/week. A mation is available at http://www.diabetesjournals
.org/content/license.
care.diabetesjournals.org Prevention or Delay of Type 2 Diabetes S33

The 7% weight loss goal was selected Nutrition


3.3 A variety of eating patterns are
because it was feasible to achieve and Structured behavioral weight loss ther-
acceptable for persons with pre-
maintain and likely to lessen the risk of apy, including a reduced calorie meal
diabetes. B
developing diabetes. Participants were plan and physical activity, is of para-
3.4 Based on patient preference,
encouraged to achieve the 7% weight mount importance for those at high risk
technology-assisted diabetes pre-
loss during the first 6 months of the for developing type 2 diabetes who
vention interventions may be effec-
intervention. However, longer-term (4- have overweight or obesity (1,9). Be-
tive in preventing type 2 diabetes
year) data reveal maximal prevention cause weight loss through lifestyle
and should be considered. B

n
of diabetes observed at about 7–10% changes alone can be difficult to maintain
3.5 Given the cost-effectiveness of
weight loss (9). The recommended pace long term (6), people being treated with

tio
diabetes prevention, such inter-
of weight loss was 1–2 lb/week. Calorie weight loss therapy should have access
vention programs should be cov-
goals were calculated by estimating the to ongoing support and additional ther-
ered by third-party payers. B

a
daily calories needed to maintain the apeutic options (such as pharmacother-
apy) if needed. Based on intervention

ci
participant’s initial weight and subtracting
The Diabetes Prevention Program 500–1,000 calories/day (depending on trials, a variety of eating patterns may

so
Several major randomized controlled initial body weight). The initial focus be appropriate for patients with pre-
trials, including the Diabetes Prevention was on reducing total dietary fat. After diabetes (10), including Mediterranean
Program (DPP) (1), the Finnish Diabetes several weeks, the concept of calorie (11–13) and low-calorie, low-fat eating

As
Prevention Study (DPS) (2), and the Da Qing balance and the need to restrict calories patterns (8). An eating pattern repre-
Diabetes Prevention Study (Da Qing study) as well as fat was introduced (8). sents the totality of all foods and
(3), demonstrate that lifestyle/behavioral The goal for physical activity was se- beverages consumed (14). In addition,
evidence suggests that the overall

s
therapy featuring an individualized re- lected to approximate at least 700
duced calorie meal plan is highly effective kcal/week expenditure from physical ac- quality of food consumed (as mea-
in preventing type 2 diabetes and im-
proving other cardiometabolic markers te
tivity. For ease of translation, this goal was
described as at least 150 min of moderate-
sured by the Healthy Eating Index,
Alternative Healthy Eating Index, and
be
(such as blood pressure, lipids, and in- intensity physical activity per week Dietary Approaches to Stop Hyperten-
flammation) (4). The strongest evidence similar in intensity to brisk walking. Par- sion [DASH] score), with an emphasis
on whole grains, legumes, nuts, fruits
ia

for diabetes prevention in the U.S. comes ticipants were encouraged to distribute
from the DPP trial (1). The DPP demon- their activity throughout the week with a and vegetables and minimal refined
and processed foods, is also important
D

strated that an intensive lifestyle inter- minimum frequency of three times per
vention could reduce the incidence of week and at least 10 min per session. A (15–18).
type 2 diabetes by 58% over 3 years. maximum of 75 min of strength training As is the case for those with di-
an

Follow-up of three large studies of lifestyle could be applied toward the total abetes, individualized medical nutri-
intervention for diabetes prevention has 150 min/week physical activity goal (8). tion therapy (see Section 5 “Facilitating
shown sustained reduction in the rate of To implement the weight loss and Behavior Change and Well-being to
ic

conversion to type 2 diabetes: 39% re- physical activity goals, the DPP used Improve Health Outcomes,” https://
doi.org/10.2337/dc20-S005, for more
er

duction at 30 years in the Da Qing study (5), an individual model of treatment rather
43% reduction at 7 years in the Finnish DPS than a group-based approach. This choice detailed information) is effective in
(2), and 34% reduction at 10 years (6) and was based on a desire to intervene lowering A1C in individuals diagnosed
Am

27% reduction at 15 years (7) in the U.S. before participants had the possibility with prediabetes (19).
Diabetes Prevention Program Outcomes of developing diabetes or losing inter-
Study (DPPOS). Notably, in the 30-year est in the program. The individual ap- Physical Activity
follow-up for the Da Qing study, reduc- proach also allowed for tailoring of Just as 150 min/week of moderate-
19

tions in all-cause mortality, cardiovascular interventions to reflect the diversity of intensity physical activity, such as brisk
disease–related mortality, and microvascu- the population (8). walking, showed beneficial effects in
lar complications were observed for the The DPP intervention was adminis- those with prediabetes (1), moderate-
20

lifestyle intervention groups compared tered as a structured core curriculum intensity physical activity has been
with the control group (5). followed by a more flexible mainte- shown to improve insulin sensitivity
and reduce abdominal fat in children
©

The two major goals of the DPP in- nance program of individual sessions,
tensive, behavioral lifestyle intervention group classes, motivational campaigns, and young adults (20,21). On the basis
were to achieve and maintain a minimum and restart opportunities. The 16-session of these findings, providers are encour-
of 7% weight loss and 150 min of physical core curriculum was completed within aged to promote a DPP-style program,
activity similar in intensity to brisk walk- the first 24 weeks of the program and including its focus on physical activity, to
ing per week. The DPP lifestyle interven- included sections on lowering calories, all individuals who have been identified
tion was a goal-based intervention: all increasing physical activity, self-monitor- to be at an increased risk of type 2
participants were given the same weight ing, maintaining healthy lifestyle be- diabetes. In addition to aerobic activity,
loss and physical activity goals, but in- haviors, and psychological, social, and an exercise regimen designed to prevent
dividualization was permitted in the motivational challenges. For further de- diabetes may include resistance training
specific methods used to achieve the tails on the core curriculum sessions, (8,22,23). Breaking up prolonged sed-
goals (8). refer to ref. 8. entary time may also be encouraged,
S34 Prevention or Delay of Type 2 Diabetes Diabetes Care Volume 43, Supplement 1, January 2020

as it is associated with moderately producing weight loss and diabetes risk PHARMACOLOGIC
lower postprandial glucose levels reduction (39–42). The use of community INTERVENTIONS
(24,25). The preventive effects of health workers to support DPP efforts Recommendations
exercise appear to extend to the pre- has been shown to be effective with 3.6 Metformin therapy for preven-
vention of gestational diabetes mellitus cost savings (43,44) (see Section 1 “Im- tion of type 2 diabetes should be
(GDM) (26). proving Care and Promoting Health considered in those with predia-
in Populations,” https://doi.org/10 betes, especially for those with
Tobacco Use .2337/dc20-S001, for more informa- BMI $35 kg/m2, those aged ,60

n
Smoking may increase the risk of type 2 tion). Given the cost-effectiveness of years, and women with prior
diabetes (27); therefore, evaluation for diabetes prevention, such intervention

tio
gestational diabetes mellitus. A
tobacco use and referral for tobacco programs should be covered by third- 3.7 Long-term use of metformin may
cessation, if indicated, should be part party payers. be associated with biochemical

a
of routine care for those at risk for The CDC coordinates the National Di- vitamin B12 deficiency, and pe-

ci
diabetes. Of note, the years immedi- abetes Prevention Program (National DPP), riodic measurement of vitamin
ately following smoking cessation may a resource designed to bring evidence- B12 levels should be considered

so
represent a time of increased risk for based lifestyle change programs for pre- in metformin-treated patients,
diabetes (27–29) and patients should venting type 2 diabetes to communities especially in those with anemia
be monitored for diabetes develop- (www.cdc.gov/diabetes/prevention/index or peripheral neuropathy. B

As
ment and receive evidence-based inter- .htm). This online resource includes loca-
ventions for diabetes prevention as tions of CDC-recognized diabetes preven-
described in this section. See Section tion lifestyle change programs (available Pharmacologic agents including met-
5 “Facilitating Behavior Change and formin, a-glucosidase inhibitors, glu-

s
at nccd.cdc.gov/DDT_DPRP/Programs
Well-being to Improve Health Outcomes” .aspx). To be eligible for this program, cagon-like peptide 1 receptor agonists,
(https://doi.org/10.2337/dc20-S005) for
more detailed information. te
patients must have a BMI in the over-
weight range and be at risk for diabetes
thiazolidinediones, and several agents
approved for weight loss have been
be
based on laboratory testing or a posi- shown in research studies to decrease
Technology-Assisted Interventions to tive risk test (available at www.cdc.gov/ the incidence of diabetes to various
ia

Deliver Lifestyle Interventions prediabetes/takethetest/). Results from degrees in those with prediabetes
Technology-assisted interventions may the CDC’s National DPP during the first (1,47–53), though none are approved
D

effectively deliver the DPP lifestyle 4 years of implementation are promis- by the U.S. Food and Drug Administra-
intervention, reducing weight and, ing (45). The CDC has also developed tion specifically for diabetes preven-
therefore, diabetes risk (30–35). Such the Diabetes Prevention Impact Tool tion. The risk versus benefit of each
an

technology-assisted interventions may Kit (available at nccd.cdc.gov/toolkit/ medication must be weighed. Metfor-
deliver content through smartphone diabetesimpact) to help organizations min has the strongest evidence base
and web-based applications and tele- assess the economics of providing or (54) and demonstrated long-term
ic

health (30). The Centers for Disease covering the National DPP lifestyle safety as pharmacologic therapy for
er

Control and Prevention (CDC) Diabetes change program (46). diabetes prevention (52). For other
Prevention Recognition Program (DPRP) drugs, cost, side effects, and durable
(www.cdc.gov/diabetes/prevention/ National Policy efficacy require consideration.
Am

requirements-recognition.htm) certifies In an effort to expand preventive services Metformin was overall less effective
technology-assisted modalities as ef- using a cost-effective model that began than lifestyle modification in the DPP,
fective vehicles for DPP-based inter- in April 2018, the Centers for Medicare though group differences declined over
ventions; such programs must use an & Medicaid Services expanded Medi- time in the DPPOS (7), and metformin
19

approved curriculum, include interac- care reimbursement coverage for the may be cost-saving over a 10-year
tion with a coach, and attain the DPRP National DPP lifestyle intervention to period (38). During initial follow up
outcomes of participation, physical organizations recognized by the CDC in the DPP, metformin was as effective
20

activity reporting, and weight loss. that become Medicare suppliers for this as lifestyle modification in participants
The selection of an in-person or virtual service (online at innovation.cms.gov/ with BMI $35 kg/m2 but not signifi-
©

program should be based on patient initiatives/medicare-diabetes-prevention- cantly better than placebo in those over
preference. program/). The locations of Medicare 60 years of age (1). In the DPP, for
DPPs are available online at innovation women with a history of GDM, met-
Cost-effectiveness .cms.gov/initiatives/medicare-diabetes- formin and intensive lifestyle modifi-
A cost-effectiveness model suggested prevention-program/mdpp-map.html. cation led to an equivalent 50%
that the lifestyle intervention used in To qualify for Medicare coverage, patients reduction in diabetes risk (55), and
the DPP was cost-effective (36,37). Ac- must have a BMI in the overweight both interventions remained highly ef-
tual cost data from the DPP and DPPOS range and laboratory testing consistent fective during a 10-year follow-up pe-
confirmed this (38). Group delivery of with prediabetes in the last year. Med- riod (56). By the time of the 15-year
DPP content in community or primary icaid coverage of the DPP lifestyle follow-up (DPPOS), exploratory analy-
care settings has the potential to re- intervention is also expanding on a ses demonstrated that participants
duce overall program costs while still state-by-state basis. with a higher baseline fasting glucose
care.diabetesjournals.org Prevention or Delay of Type 2 Diabetes S35

($110 mg/dL vs. 95–109 mg/dL) and Change and Well-being to Improve 9. Hamman RF, Wing RR, Edelstein SL, et al.
women with a history of GDM (vs. Health Outcomes,” https://doi.org/10 Effect of weight loss with lifestyle intervention
on risk of diabetes. Diabetes Care 2006;29:2102–
women without a history of GDM) ex- .2337/dc20-S005) can also apply to people 2107
perienced higher risk reductions with with prediabetes. Currently, there are sig- 10. Evert AB, Dennison M, Gardner CD, et al.
metformin (compared with the placebo nificant barriers to the provision of educa- Nutrition therapy for adults with diabetes or
arm) (57). In the Indian Diabetes Pre- tion and support to those with prediabetes. prediabetes: a consensus report. Diabetes Care
vention Program (IDPP-1), metformin and However, the strategies for supporting 2019;42:731–754
11. Salas-Salvadó J, Guasch-Ferré M, Lee C-H,
the lifestyle intervention reduced diabetes successful behavior change and the
Estruch R, Clish CB, Ros E. Protective effects of

n
risk similarly at 30 months; of note, the healthy behaviors recommended for the Mediterranean diet on type 2 diabetes and
lifestyle intervention in IDPP-1 was less people with prediabetes are compara-

tio
metabolic syndrome. J Nutr 2016;146:920S–
intensive than that in the DPP (58). Based ble to those for people with diabetes. 927S
on findings from the DPP, metformin should Although reimbursement remains a bar- 12. Bloomfield HE, Koeller E, Greer N, MacDonald

a
R, Kane R, Wilt TJ. Effects on health outcomes of a
be recommended as an option for high-risk rier, studies show that providers of di- Mediterranean diet with no restriction on fat

ci
individuals (e.g., those with a history of abetes self-management education and intake: a systematic review and meta-analysis.
GDM or those with BMI $35 kg/m2). support are particularly well equipped to Ann Intern Med 2016;165:491–500

so
Consider monitoring vitamin B12 levels assist people with prediabetes in develop- 13. Estruch R, Ros E, Salas-Salvadó J, et al.;
in those taking metformin chronically to ing and maintaining behaviors that can PREDIMED Study Investigators. Primary pre-
vention of cardiovascular disease with a Med-
check for possible deficiency (56) (see Sec- prevent or delay the development of di-

As
iterranean diet supplemented with extra-virgin
tion 9 “Pharmacologic Approaches to Gly- abetes (19,63). olive oil or nuts. N Engl J Med 2018;378:e34
cemic Treatment,” https://doi.org/10 14. Department of Health and Human Services
.2337/dc20-S009, for more details). and Department of Agriculture. Dietary Guide-
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32. Bian RR, Piatt GA, Sen A, et al. The effect of 45. Ely EK, Gruss SM, Luman ET, et al. A national tion Program and Diabetes Prevention Program
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Internet Res 2017;19:e76 Prevention Program. Diabetes Care 2017;40: Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes
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The cost-effectiveness of lifestyle modification patients. Diabetes Care 2004;27:155–161 between prediabetes and risk of cardiovascular
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adults with impaired glucose tolerance. Ann Obesity Prediabetes NN8022-1839 Study view and meta-analysis. BMJ 2016;355:i5953
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©

37. Chen F, Su W, Becker SH, et al. Clinical and for type 2 diabetes risk reduction and weight Research Group. Effect of intensive versus stan-
economic impact of a digital, remotely-delivered management in individuals with prediabetes: dard blood pressure treatment according to
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e0163627 (Diabetes REduction Assessment with ramipril and 63. Butcher MK, Vanderwood KK, Hall TO,
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DPPOS [published correction appears in Diabetes trial. Lancet 2006;368:1096–1105 Health Manag Pract 2011;17:242–247
Diabetes Care Volume 43, Supplement 1, January 2020 S37

4. Comprehensive Medical American Diabetes Association

Evaluation and Assessment of

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Comorbidities: Standards of

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Medical Care in Diabetesd2020

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Diabetes Care 2020;43(Suppl. 1):S37–S47 | https://doi.org/10.2337/dc20-S004

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4. MEDICAL EVALUATION AND COMORBIDITIES


The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”
includes the ADA’s current clinical practice recommendations and is intended to provide

s
the components of diabetes care, general treatment goals and guidelines, and tools to

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evaluate quality of care. Members of the ADA Professional Practice Committee, a
multidisciplinary expert committee (https://doi.org/10.2337/dc20-SPPC), are responsible
be
for updating the Standards of Care annually, or more frequently as warranted. For a
detailed description of ADA standards, statements, and reports, as well as the evidence-
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grading system for ADA’s clinical practice recommendations, please refer to the Standards
of Care Introduction (https://doi.org/10.2337/dc20-SINT). Readers who wish to comment
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on the Standards of Care are invited to do so at professional.diabetes.org/SOC.


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PATIENT-CENTERED COLLABORATIVE CARE


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Recommendations
4.1 A patient-centered communication style that uses person-centered and
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strength-based language and active listening; elicits patient preferences


and beliefs; and assesses literacy, numeracy, and potential barriers to
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care should be used to optimize patient health outcomes and health-related


quality of life. B
4.2 Diabetes care should be managed by a multidisciplinary team that may draw
from primary care physicians, subspecialty physicians, nurse practitioners,
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physician assistants, nurses, dietitians, exercise specialists, pharmacists,


dentists, podiatrists, and mental health professionals. E
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A successful medical evaluation depends on beneficial interactions between the


patient and the care team. The Chronic Care Model (1–3) (see Section 1 “Improving
©

Care and Promoting Health in Populations,” https://doi.org/10.2337/dc20-S001)


is a patient-centered approach to care that requires a close working relationship
between the patient and clinicians involved in treatment planning. People with
Suggested citation: American Diabetes Associa-
diabetes should receive health care from an interdisciplinary team that may include tion. 4. Comprehensive medical evaluation and
physicians, nurse practitioners, physician assistants, nurses, dietitians, exercise special- assessment of comorbidities: Standards of Med-
ists, pharmacists, dentists, podiatrists, and mental health professionals. Individuals with ical Care in Diabetesd2020. Diabetes Care
diabetes must assume an active role in their care. The patient, family or support people, 2020;43(Suppl. 1):S37–S47
physicians, and health care team should together formulate the management plan, © 2020 by the American Diabetes Association.
which includes lifestyle management (see Section 5 “Facilitating Behavior Change and Readers may use this article as long as the work is
properly cited, the use is educational and not for
Well-being to Improve Health Outcomes,” https://doi.org/10.2337/dc20-S005). profit, and the work is not altered. More infor-
The goals of treatment for diabetes are to prevent or delay complications and optimize mation is available at http://www.diabetesjournals
quality of life (Fig. 4.1). Treatment goals and plans should be created with patients based .org/content/license.
S38 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 43, Supplement 1, January 2020

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Figure 4.1—Decision cycle for patient-centered glycemic management in type 2 diabetes. Reprinted from Davies et al. (99).
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on their individual preferences, values, and “nonadherence” when the outcomes language in diabetes care and education
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goals. The management plan should take of self-management are not optimal (8). can help to inform and motivate people,
into account the patient’s age, cognitive The familiar terms “noncompliance” and yet language that shames and judges may
abilities, school/work schedule and con- “nonadherence” denote a passive, obe- undermine this effort. The American Diabe-
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ditions, health beliefs, support systems, dient role for a person with diabetes in tes Association (ADA) and the American
“following doctor’s orders” that is at odds
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eating patterns, physical activity, social Association of Diabetes Educators consen-


situation, financial concerns, cultural fac- with the active role people with diabetes sus report, “The Use of Language in Diabetes
tors, literacy and numeracy (mathematical take in directing the day-to-day decision- Care and Education,” provides the authors’
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literacy), diabetes complications and du- making, planning, monitoring, evaluation, expert opinion regarding the use of language
ration of disease, comorbidities, health and problem-solving involved in diabetes by health care professionals when speaking
priorities, other medical conditions, pref- self-management. Using a nonjudgmental or writing about diabetes for people with
erences for care, and life expectancy. Var- approach that normalizes periodic lapses diabetes or for professional audiences (14).
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ious strategies and techniques should be in self-management may help minimize Although further research is needed to ad-
used to support patients’ self-management patients’ resistance to reporting problems dress the impact of language on diabetes
efforts, including providing education with self-management. Empathizing and outcomes, the report includes five key
20

on problem-solving skills for all aspects using active listening techniques, such as consensus recommendations for lan-
of diabetes management. open-ended questions, reflective state- guage use:
Provider communication with patients ments, and summarizing what the patient
©

and families should acknowledge that said, can help facilitate communication. c Use language that is neutral, nonjudg-
multiple factors impact glycemic manage- Patients’ perceptions about their own mental, and based on facts, actions, or
ment but also emphasize that collabo- ability, or self-efficacy, to self-manage physiology/biology.
ratively developed treatment plans and diabetes are one important psychosocial c Use language free from stigma.
a healthy lifestyle can significantly im- factor related to improved diabetes self- c Use language that is strength based, respect-
prove disease outcomes and well-being management and treatment outcomes in ful, and inclusive and that imparts hope.
(4–7). Thus, the goal of provider-patient diabetes (9–13) and should be a target of c Use language that fosters collabora-
communication is to establish a collaborative ongoing assessment, patient education, tion between patients and providers.
relationship and to assess and address and treatment planning. c Use language that is person centered
self-management barriers without blam- Language has a strong impact on percep- (e.g., “person with diabetes” is pre-
ing patients for “noncompliance” or tions and behavior. The use of empowering ferred over “diabetic”).
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S39

COMPREHENSIVE MEDICAL support a patient. In addition to the Immunizations


EVALUATION medical history, physical examination,
Recommendations
and laboratory tests, providers should
Recommendations 4.7 Provide routinely recommen-
assess diabetes self-management behav-
4.3 A complete medical evaluation ded vaccinations for children
iors, nutrition, and psychosocial health (see
should be performed at the initial and adults with diabetes as in-
Section 5 “Facilitating Behavior Change and
visit to: dicated by age. C
Well-being to Improve Health Outcomes,”
c Confirm the diagnosis and classify 4.8 Annual vaccination against in-
https://doi.org/10.2337/dc20-S005) and
diabetes. B fluenza is recommended for all

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give guidance on routine immunizations.
c Evaluate for diabetes complica- people $6 months of age, es-
The assessment of sleep pattern and

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tions and potential comorbid pecially those with diabetes. C
duration should be considered; a recent
conditions. B 4.9 Vaccination against pneumo-
meta-analysis found that poor sleep
c Review previous treatment and coccal disease, including pneu-

a
quality, short sleep, and long sleep
risk factor control in patients with mococcal pneumonia, with

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were associated with higher A1C in
established diabetes. B 13-valent pneumococcal conju-
people with type 2 diabetes (15). In-
c Begin patient engagement in the gate vaccine (PCV13) is recom-

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terval follow-up visits should occur at
formulation of a care manage- mended for children before age
least every 3–6 months, individualized
ment plan. B 2 years. People with diabetes
to the patient, and then annually.
c Develop a plan for continuing care. B

As
ages 2 through 64 years should
Lifestyle management and psychoso-
4.4 A follow-up visit should include also receive 23-valent pneumo-
cial care are the cornerstones of diabetes
most components of the initial coccal polysaccharide vaccine
management. Patients should be re-
comprehensive medical evalua- (PPSV23). At age $65 years,

s
ferred for diabetes self-management ed-
tion, including interval medical his- regardless of vaccination his-
ucation and support, medical nutrition

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tory, assessment of medication- tory, additional PPSV23 vacci-
therapy, and assessment of psychosocial/
taking behavior and intolerance/ nation is necessary. C
emotional health concerns if indicated.
be
side effects, physical examination, 4.10 Administer a 2- or 3-dose series
Patients should receive recommended
laboratory evaluation as appro- of hepatitis B vaccine, depend-
preventive care services (e.g., immuniza-
priate to assess attainment of ing on the vaccine, to unvacci-
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tions, cancer screening, etc.); smoking


A1C and metabolic targets, and nated adults with diabetes ages
cessation counseling; and ophthalmolog-
assessment of risk for complica- 18 through 59 years. C
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ical, dental, and podiatric referrals.


tions, diabetes self-management 4.11 Consider administering a 3-dose
The assessment of risk of acute and
behaviors, nutrition, psychosocial series of hepatitis B vaccine to
chronic diabetes complications and treat-
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health, and the need for referrals, unvaccinated adults with


ment planning are key components of
immunizations, or other routine diabetes $60 years of age. C
initial and follow-up visits (Table 4.2). The
health maintenance screening. B
risk of atherosclerotic cardiovascular
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4.5 Ongoing management should Children and adults with diabetes should
disease and heart failure (Section 10
be guided by the assessment receive vaccinations according to age-
“Cardiovascular Disease and Risk Man-
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of diabetes complications and appropriate recommendations (16,17). The


agement,” https://doi.org/10.2337/dc20-
shared decision-making to set Centers for Disease Control and Prevention
S010), chronic kidney disease staging
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therapeutic goals. B (CDC) provides vaccination schedules


(Section 11 “Microvascular Complica-
4.6 The 10-year risk of a first atheroscle- specifically for children, adolescents, and
tions and Foot Care,” https://doi.org/10
rotic cardiovascular disease event adults with diabetes at cdc.gov/vaccines/
.2337/dc20-S011), and risk of treatment-
should be assessed using the race-
associated hypoglycemia (Table 4.3) schedules/.
19

and sex-specific Pooled Cohort Equa- People with diabetes are at higher risk
should be used to individualize targets
tionstobetter stratifyatherosclerotic
for glycemia (Section 6 “Glycemic Targets,” for hepatitis B infection and are more
cardiovascular disease risk. B likely to develop complications from in-
https://doi.org/10.2337/dc20-S006), blood
20

pressure, and lipids and to select specific fluenza and pneumococcal disease. The
The comprehensive medical evalua-
glucose-lowering medication (Section CDC Advisory Committee on Immunization
tion includes the initial and follow-up
9 “Pharmacologic ApproachestoGlycemic
©

Practices (ACIP) recommends influenza,


evaluations, assessment of complica-
Treatment,” https://doi.org/10.2337/dc20- pneumococcal, and hepatitis B vaccina-
tions, psychosocial assessment, manage- S009), antihypertension medication, and tions specifically for people with diabetes.
ment of comorbid conditions, and statin treatment intensity. Vaccinations against tetanus-diphtheria-
engagement of the patient throughout Additional referrals should be arranged pertussis, measles-mumps-rubella, human
the process. While a comprehensive list is as necessary (Table 4.4). Clinicians should papillomavirus, and shingles are also im-
provided in Table 4.1, in clinical practice ensure that individuals with diabetes are portant for adults with diabetes, as they are
the provider may need to prioritize the appropriately screened for complications for the general population.
components of the medical evaluation and comorbidities. Discussing and imple-
given the available resources and time. menting an approach to glycemic control Influenza
The goal is to provide the health care with the patient is a part, not the sole goal, Influenza is a common, preventable in-
team information so it can optimally of the patient encounter. fectious disease associated with high
S40 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 43, Supplement 1, January 2020

n
a tio
ci
so
As
s
te
be
ia
D
an
ic
er
Am
19
20
©

Continued on p. S41
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S41

n
a tio
ci
so
As
s
te
be
ia
D
an
ic
er
Am
19
20

mortality and morbidity in vulnerable with a mortality rate as high as 50% (19). be due to contact with infected blood or
populations, including youth, older The ADA endorses recommendations from through improper equipment use (glucose
adults, and people with chronic dis- the CDC ACIP that adults age $65 years, monitoring devices or infected needles).
©

eases. Influenza vaccination in people who are at higher risk for pneumococcal Because of the higher likelihood of trans-
with diabetes has been found to sig- disease, receive an additional 23-valent mission, hepatitis B vaccine is recommen-
nificantly reduce influenza and diabe- pneumococcal polysaccharide vaccine ded for adults with diabetes age ,60 years.
tes-related hospital admissions (18). (PPSV23), regardless of prior pneumococcal Foradultsage$60years, hepatitisBvaccine
vaccination history. See detailed recom- may be administered at the discretion of the
Pneumococcal Pneumonia
mendations at www.cdc.gov/vaccines/hcp/ treating clinician based on the patient’s
Like influenza, pneumococcal pneumo-
acip-recs/vacc-specific/pneumo.html. likelihood of acquiring hepatitis B infection.
nia is a common, preventable disease.
People with diabetes are at increased risk Hepatitis B
for the bacteremic form of pneumococ- Compared with the general population, ASSESSMENT OF COMORBIDITIES
cal infection and have been reported to people with type 1 or type 2 diabetes Besides assessing diabetes-related com-
have a high risk of nosocomial bacteremia, have higher rates of hepatitis B. This may plications, clinicians and their patients
S42 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 43, Supplement 1, January 2020

Table 4.2—Assessment and treatment plan* endometrium, colon/rectum, breast,


and bladder (33). The association may
Assessing risk of diabetes complications
result from shared risk factors between
c ASCVD and heart failure history
c ASCVD risk factors and 10-year ASCVD risk assessment
type 2 diabetes and cancer (older age,
c Staging of chronic kidney disease (see Table 11.1) obesity, and physical inactivity) but may
c Hypoglycemia risk (Table 4.3) also be due to diabetes-related factors
Goal setting (34), such as underlying disease physiol-
c Set A1C/blood glucose target ogy or diabetes treatments, although

n
c If hypertension is present, establish blood pressure target evidence for these links is scarce. Patients
c Diabetes self-management goals with diabetes should be encouraged to

tio
Therapeutic treatment plans undergo recommended age- and sex-
c Lifestyle management
appropriate cancer screenings and to
c Pharmacologic therapy: glucose lowering

a
c Pharmacologic therapy: cardiovascular disease risk factors and renal
reduce their modifiable cancer risk fac-

ci
c Use of glucose monitoring and insulin delivery devices
tors (obesity, physical inactivity, and
c Referral to diabetes education and medical specialists (as needed) smoking). New onset of atypical diabetes

so
ASCVD, atherosclerotic cardiovascular disease. *Assessment and treatment planning are essential
(lean body habitus, negative family his-
components of initial and all follow-up visits. tory) in a middle-aged or older patient
may precede the diagnosis of pancreatic

As
adenocarcinoma (35). However, in the
need to be aware of common comorbid- diseases, with thyroid disease, celiac dis- absence of other symptoms (e.g., weight
ities that affect people with diabetes and ease, and pernicious anemia (vitamin B12 loss, abdominal pain), routine screen-

s
may complicate management (20–24). deficiency) being among the most common ing of all such patients is not currently
Diabetes comorbidities are conditions (25). Other associated conditions include recommended.
that affect people with diabetes more
often than age-matched people without te
autoimmune hepatitis, primary adrenal in-
sufficiency (Addison disease), dermatomyo- Cognitive Impairment/Dementia
be
diabetes. This section discusses many of sitis, and myasthenia gravis (26–29). Type 1 Recommendation
the common comorbidities observed in diabetes may also occur with other auto- 4.14 In the presence of cognitive im-
ia

patients with diabetes but is not neces- immune diseases in the context of specific pairment, diabetes treatment regi-
sarily inclusive of all the conditions that genetic disorders or polyglandular autoim- mens should be simplified as much
D

have been reported. mune syndromes (30). Given the high prev- as possible and tailored to min-
alence, nonspecific symptoms, and imize the risk of hypoglycemia. B
Autoimmune Diseases insidious onset of primary hypothyroidism,
an

Recommendations routine screening for thyroid dysfunction is


4.12 Patients with type 1 diabetes recommended for all patients with type 1 Diabetes is associated with a signifi-
diabetes. Screening for celiac disease should cantly increased risk and rate of cogni-
ic

should be screened for autoim-


mune thyroid disease soon af- be considered in adult patients with sug- tive decline and an increased risk of
dementia (36,37). A recent meta-analysis
er

ter diagnosis and periodically gestive symptoms (e.g., diarrhea, malab-


thereafter. B sorption, abdominal pain) or signs (e.g., of prospective observational studies in
4.13 Adult patients with type 1 di- osteoporosis, vitamin deficiencies, iron de- people with diabetes showed 73% in-
Am

abetes should be screened for ficiency anemia) (31,32). Measurement of creased risk of all types of dementia,
celiac disease in the presence of vitamin B12 levels should be considered for 56% increased risk of Alzheimer demen-
gastrointestinal symptoms, signs, patients with type 1 diabetes and peripheral tia, and 127% increased risk of vascular
or laboratory manifestations sug- neuropathy or unexplained anemia. dementia compared with individuals
19

gestive of celiac disease. B without diabetes (38). The reverse is


Cancer also true: people with Alzheimer de-
People with type 1 diabetes are at in- Diabetes is associated with increased mentia are more likely to develop di-
20

creased risk for other autoimmune risk of cancers of the liver, pancreas, abetes than people without Alzheimer
dementia. In a 15-year prospective
©

study of community-dwelling people


Table 4.3—Assessment of hypoglycemia risk
Factors that increase risk of treatment-associated hypoglycemia .60 years of age, the presence of di-
c Use of insulin or insulin secretagogues (i.e., sulfonylureas, meglitinides) abetes at baseline significantly increased
c Impaired kidney or hepatic function the age- and sex-adjusted incidence of
c Longer duration of diabetes all-cause dementia, Alzheimer dementia,
c Frailty and older age
and vascular dementia compared with
c Cognitive impairment
rates in those with normal glucose tol-
c Impaired counterregulatory response, hypoglycemia unawareness
c Physical or intellectual disability that may impair behavioral response to hypoglycemia
erance (39).
c Alcohol use
c Polypharmacy (especially ACE inhibitors, angiotensin receptor blockers, nonselective b-blockers) Hyperglycemia
In those with type 2 diabetes, the de-
See references 100–104.
gree and duration of hyperglycemia are
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S43

Table 4.4—Referrals for initial care management mediated, at least in part, by weight loss
c Eye care professional for annual dilated eye exam (53–55).
c Family planning for women of reproductive age

c Registered dietitian nutritionist for medical nutrition therapy Hepatitis C Infection


c Diabetes self-management education and support Infection with hepatitis C virus (HCV) is
c Dentist for comprehensive dental and periodontal examination associated with a higher prevalence of
c Mental health professional, if indicated type 2 diabetes, which is present in up to
one-third of individuals with chronic HCV

n
infection. HCV may impair glucose me-

tio
related to dementia. More rapid cog- low reporting rate for cognitive-related tabolism by several mechanisms, in-
nitive decline is associated with both adverse events, including cognitive dys- cluding directly via viral proteins and
increased A1C and longer duration of function or dementia, with statin ther- indirectly by altering proinflammatory

a
diabetes (38). The Action to Control apy, similar to rates seen with other cytokine levels (56). The use of newer

ci
Cardiovascular Risk in Diabetes (ACCORD) commonly prescribed cardiovascular direct-acting antiviral drugs produces a
study found that each 1% higher A1C medications (46). Therefore, fear of sustained virological response (cure) in

so
level was associated with lower cog- cognitive decline should not be a bar- nearly all cases and has been reported
nitive function in individuals with rier to statin use in individuals with to improve glucose metabolism in in-

As
type 2 diabetes (40). However, the diabetes and a high risk for cardiovas- dividuals with diabetes (57). A meta-
ACCORD study found no difference cular disease. analysis of mostly observational stud-
in cognitive outcomes in participants ies found a mean reduction in A1C
randomly assigned to intensive and Nonalcoholic Fatty Liver Disease levels of 0.45% (95% CI 20.60 to

s
standard glycemic control, supporting 20.30) and reduced requirement for
Recommendation

te
the recommendation that intensive glucose-lowering medication use fol-
4.15 Patients with type 2 diabetes or lowing successful eradication of HCV
glucose control should not be advised prediabetes and elevated liver
be
for the improvement of cognitive func- infection (58).
enzymes (ALT) or fatty liver on
tion in individuals with type 2 diabetes ultrasound should be evaluated Pancreatitis
(41).
ia

for presence of nonalcoholic stea-


tohepatitis and liver fibrosis. C Recommendation
Hypoglycemia 4.16 Islet autotransplantation should
D

In type 2 diabetes, severe hypoglycemia Diabetes is associated with the develop- be considered for patients re-
is associated with reduced cognitive ment of nonalcoholic fatty liver disease, quiring total pancreatectomy
an

function, and those with poor cognitive including its more severe manifesta- for medically refractory chronic
function have more severe hypoglyce- tions of nonalcoholic steatohepatitis, pancreatitis to prevent postsur-
mia. In a long-term study of older pa- liver fibrosis, cirrhosis, and hepatocel- gical diabetes. C
ic

tients with type 2 diabetes, individuals lular carcinoma (47). Elevations of he-
with one or more recorded episodes of
er

patic transaminase concentrations are Diabetes is linked to diseases of the


severe hypoglycemia had a stepwise in- associated with higher BMI, waist cir- exocrine pancreas such as pancreatitis,
crease in risk of dementia (42). Likewise, cumference, and triglyceride levels and which may disrupt the global architec-
Am

the ACCORD trial found that as cognitive lower HDL cholesterol levels. Noninva- ture or physiology of the pancreas, often
function decreased, the risk of severe sive tests, such as elastography or fibrosis resulting in both exocrine and endocrine
hypoglycemia increased (43). Tailoring biomarkers, may be used to assess risk of dysfunction. Up to half of patients with
glycemic therapy may help to prevent fibrosis, but referral to a liver specialist diabetes may have some degree of im-
19

hypoglycemia in individuals with cogni- and liver biopsy may be required for paired exocrine pancreas function (59).
tive dysfunction. definitive diagnosis (48). Interventions People with diabetes are at an approx-
that improve metabolic abnormalities imately twofold higher risk of developing
20

Nutrition
In one study, adherence to the Mediter- in patients with diabetes (weight loss, acute pancreatitis (60).
ranean diet correlated with improved glycemic control, and treatment with Conversely, prediabetes and/or diabe-
©

cognitive function (44). However, a re- specific drugs for hyperglycemia or dyslip- tes has been found to develop in approx-
cent Cochrane review found insufficient idemia) are also beneficial for fatty liver imately one-third of patients after an
evidence to recommend any dietary disease (49,50). Pioglitazone and vitamin E episode of acute pancreatitis (61); thus,
change for the prevention or treatment treatment of biopsy-proven nonalcoholic the relationship is likely bidirectional.
of cognitive dysfunction (45). steatohepatitis have been shown to im- Postpancreatitis diabetes may include
prove liver histology, but effects on longer- either new-onset disease or previously
Statins term clinical outcomes are not known unrecognized diabetes (62). Studies of
A systematic review has reported that data (51,52). Treatment with liraglutide and patients treated with incretin-based ther-
do not support an adverse effect of statins with sodium–glucose cotransporter 2 in- apies for diabetes have also reported that
on cognition (46). The U.S. Food and Drug hibitors (dapagliflozin and empagliflozin) pancreatitis may occur more frequently
Administration postmarketing surveil- has also shown some promise in prelim- with these medications, but results have
lance databases have also revealed a inary studies, although benefits may be been mixed (63,64).
S44 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 43, Supplement 1, January 2020

Islet autotransplantation should be twice as prevalent in people with diabetes diabetes. Among patients with HIV
considered for patients requiring total compared with those without, after and diabetes, preventive health care
pancreatectomy for medically refractory adjusting for age and other risk factors using an approach similar to that used
chronic pancreatitis to prevent postsur- for hearing impairment (75). Low HDL, in patients without HIV is critical to
gical diabetes. Approximately one-third coronary heart disease, peripheral neu- reduce the risks of microvascular and
of patients undergoing total pancreatec- ropathy, and general poor health have macrovascular complications.
tomy with islet autotransplantation are been reported as risk factors for hearing For patients with HIV and ARV-associated
insulin free 1 year postoperatively, and impairment for people with diabetes, hyperglycemia, it may be appropriate to

n
observational studies from different cen- but an association of hearing loss with consider discontinuing the problematic
ters have demonstrated islet graft func- ARV agents if safe and effective alter-

tio
blood glucose levels has not been
tion up to a decade after the surgery in consistently observed (76). In the Di- natives are available (82). Before making
some patients (65–69). Both patient and abetes Control and Complications Trial/ ARV substitutions, carefully consider

a
disease factors should be carefully con- Epidemiology of Diabetes Interventions the possible effect on HIV virological

ci
sidered when deciding the indications and Complications (DCCT/EDIC) cohort, control and the potential adverse ef-
and timing of this surgery. Surgeries time-weighted mean A1C was associated fects of new ARV agents. In some cases,

so
should be performed in skilled facilities with increased risk of hearing impairment antihyperglycemic agents may still be
that have demonstrated expertise in islet when tested after long-term (.20 years) necessary.
autotransplantation. follow-up (77). Impairment in smell, but

As
not taste, has also been reported in in- Low Testosterone in Men
Fractures
dividuals with diabetes (78).
Recommendation
Age-specific hip fracture risk is signifi- 4.18 In men with diabetes who have

s
cantly increased in both people with HIV symptoms or signs of hypogo-

te
type 1 diabetes (relative risk 6.3) and Recommendation nadism, such as decreased sex-
those with type 2 diabetes (relative risk 4.17 Patients with HIV should be ual desire (libido) or activity, or
be
1.7) in both sexes (70). Type 1 diabetes is screened for diabetes and pre- erectile dysfunction, consider
associated with osteoporosis, but in type 2 diabetes with a fasting glucose screening with a morning se-
diabetes, an increased risk of hip fracture test before starting antiretroviral rum testosterone level. B
ia

is seen despite higher bone mineral den- therapy, at the time of switching
sity (BMD) (71). In three large observa-
D

antiretroviral therapy, and 3–6 Mean levels of testosterone are lower


tional studies of older adults, femoral neck months after starting or switch- in men with diabetes compared with age-
BMD T score and the World Health ing antiretroviral therapy. If ini- matched men without diabetes, but
an

Organization Fracture Risk Assessment tial screening results are normal, obesity is a major confounder (83,84).
Tool (FRAX) score were associated with fasting glucose should be checked Treatment in asymptomatic men is con-
hip and nonspine fractures. Fracture annually. E troversial. Testosterone replacement in
ic

risk was higher in participants with


men with symptomatic hypogonadism
diabetes compared with those without Diabetes risk is increased with certain
er

may have benefits including improved


diabetes for a given T score and age or protease inhibitors (PIs) and nucleoside sexual function, well-being, muscle mass
for a given FRAX score (72). Providers reverse transcriptase inhibitors (NRTIs). and strength, and bone density (85). In
Am

should assess fracture history and risk New-onset diabetes is estimated to men with diabetes who have symp-
factors in older patients with diabetes occur in more than 5% of patients toms or signs of low testosterone
and recommend measurement of BMD infected with HIV on PIs, whereas (hypogonadism), a morning total testos-
if appropriate for the patient’s age and more than 15% may have prediabetes terone level should be measured using
19

sex. Fracture prevention strategies for (79). PIs are associated with insulin an accurate and reliable assay. In men
people with diabetes are the same resistance and may also lead to apo- who have total testosterone levels close
as for the general population and in- ptosis of pancreatic b-cells. NRTIs also to the lower limit, it is reasonable to check
20

clude vitamin D supplementation. For


affect fat distribution (both lipohyper- sex hormone–binding globulin, as it is
patients with type 2 diabetes with fracture
trophy and lipoatrophy), which is asso- often low in diabetes and associated with
risk factors, thiazolidinediones (73) and
©

ciated with insulin resistance. lower testosterone levels. Further test-


sodium–glucose cotransporter 2 inhibi-
Individuals with HIV are at higher risk ing (such as luteinizing hormone and
tors (74) should be used with caution.
for developing prediabetes and diabetes follicle-stimulating hormone levels) may
on antiretroviral (ARV) therapies, so a be needed to determine if the patient
Sensory Impairment screening protocol is recommended (80). has hypogonadism. Testosterone re-
Hearing impairment, both in high-frequency The A1C test may underestimate glyce- placement in older men with hypogonad-
and low- to mid-frequency ranges, is more mia in people with HIV; it is not recom- ism has been associated with increased
common in people with diabetes than in mended for diagnosis and may present coronary artery plaque volume and, in
those without, perhaps due to neuropathy challenges for monitoring (81). In those some studies, an increase in cardiovas-
and/or vascular disease. In a National Health with prediabetes, weight loss through cular events, which should be considered
and Nutrition Examination Survey (NHANES) healthy nutrition and physical activity when assessing the risks and benefits of
analysis, hearing impairment was about may reduce the progression toward treatment (86,87).
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S45

Obstructive Sleep Apnea treatment and risk of complications in patients 18. Goeijenbier M, van Sloten TT, Slobbe L, et al.
Age-adjusted rates of obstructive sleep with type 2 diabetes (UKPDS 33). Lancet 1998; Benefits of flu vaccination for persons with di-
apnea, a risk factor for cardiovascular 352:837–853 abetes mellitus: a review. Vaccine 2017;35:
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10-fold) with obesity, especially with The effect of intensive treatment of diabetes on pneumococcal vaccines in people with diabetes.
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as 23%, and the prevalence of any sleep- Rutledge BN; DCCT/EDIC Research Group. Effect 21. Grant RW, Ashburner JM, Hong CS, Chang Y,
disordered breathing may be as high as

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of glycemic exposure on the risk of microvascular Barry MJ, Atlas SJ. Defining patient complexity
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a
(Look AHEAD) trial, it exceeded 80% (91). 995–1001 Ann Intern Med 2012;157:152]. Ann Intern Med
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Malone J, Tamborlane WV; Diabetes Control and 22. Tinetti ME, Fried TR, Boyd CM. Designing
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so
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As
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for a treatment effect on glycemic con- tes care. Diabetes Educ 2000;26:597–604 abetes: systematic review of epidemiologic

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be
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support are associated with diabetes self- analysis. Eur J Endocrinol 2019;180:135–144
diabetes than in those without and has management behaviors. Diabetes Care 2010;33: 26. De Block CE, De Leeuw IH, Van Gaal LF. High
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D

751–753 prevalence of manifestations of gastric autoim-


(94–96). Longitudinal studies suggest 11. Nouwen A, Urquhart Law G, Hussain S, munity in parietal cell antibody-positive type 1
that people with periodontal disease McGovern S, Napier H. Comparison of the (insulin-dependent) diabetic patients. The Bel-
an

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Current evidence suggests that peri- distress in adolescents with type 1 diabetes. 27. Triolo TM, Armstrong TK, McFann K, et al.
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ic

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(24,97). In a randomized clinical trial, diabetes. Diabetes Spectr 2013;26:172–178 28. Hughes JW, Riddlesworth TD, DiMeglio LA,
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Am

efficacy, outcome expectations, and diabetes Clinic Network. Autoimmune diseases in children
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19

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©

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35. Aggarwal G, Kamada P, Chari ST. Prevalence steatohepatitis and prediabetes or type 2 diabetes summary of an NIDDK workshop. Ann Surg
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Testosterone treatment and coronary artery A, Batayha WQ. Periodontal status of diabetics JE, Sinclair AJ. Hypoglycemia in older people - a

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status in men and women: National Health and 2009-2014. J Am Dent Assoc 2018;149:576–588.e6 for prevention. Drugs Aging 2004;21:511–530
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S48 Diabetes Care Volume 43, Supplement 1, January 2020

5. Facilitating Behavior Change American Diabetes Association

and Well-being to Improve Health

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Outcomes: Standards of Medical

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Care in Diabetesd2020

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Diabetes Care 2020;43(Suppl. 1):S48–S65 | https://doi.org/10.2337/dc20-S005

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As
5. FACILITATING BEHAVIOR CHANGE AND WELL-BEING

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The American Diabetes Association (ADA) “Standards of Medical Care in Diabe-

te
tes” includes the ADA’s current clinical practice recommendations and is intended
to provide the components of diabetes care, general treatment goals and guide-
be
lines, and tools to evaluate quality of care. Members of the ADA Professional
Practice Committee, a multidisciplinary expert committee (https://doi.org/10
ia

.2337/dc20-SPPC), are responsible for updating the Standards of Care annu-


ally, or more frequently as warranted. For a detailed description of ADA stan-
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dards, statements, and reports, as well as the evidence-grading system for ADA’s
clinical practice recommendations, please refer to the Standards of Care In-
troduction (https://doi.org/10.2337/dc20-SINT). Readers who wish to com-
an

ment on the Standards of Care are invited to do so at professional.diabetes


.org/SOC.
ic
er

Effective behavior management and psychological well-being are foundational


to achieving treatment goals for people with diabetes (1,2). Essential to achieving
Am

these goals are diabetes self-management education and support (DSMES), med-
ical nutrition therapy (MNT), routine physical activity, smoking cessation counsel-
ing when needed, and psychosocial care. Following an initial comprehensive medical
evaluation (see Section 4, “Comprehensive Medical Evaluation and Assessment of
Comorbidities,” https://doi.org/10.2337/dc20-S004), patients and providers are
19

encouraged to engage in person-centered collaborative care (3–6), which is guided


by shared decision-making in treatment regimen selection, facilitation of obtaining
needed medical and psychosocial resources, and shared monitoring of agreed-upon
20

regimen and lifestyle (7). Re-evaluation during routine care should include not only
assessment of medical health but also behavioral and mental health outcomes,
©

especially during times of deterioration in health and well-being.

DIABETES SELF-MANAGEMENT EDUCATION AND SUPPORT


Suggested citation: American Diabetes Associa-
Recommendations tion. 5. Facilitating behavior change and well-
being to improve health outcomes: Standards of
5.1 In accordance with the national standards for diabetes self-management
Medical Care in Diabetesd2020. Diabetes Care
education and support, all people with diabetes should participate in diabetes 2020;43(Suppl. 1):S48–S65
self-management education and receive the support needed to facilitate the © 2019 by the American Diabetes Association.
knowledge, decision-making, and skills mastery necessary for diabetes self- Readers may use this article as long as the work
care. A is properly cited, the use is educational and not
5.2 There are four critical times to evaluate the need for diabetes self- for profit, and the work is not altered. More infor-
management education to promote skills acquisition in support of regimen mation is available at http://www.diabetesjournals
.org/content/license.
care.diabetesjournals.org Facilitating Behavior Change and Well-being to Improve Health Outcomes S49

judgmental words with increased feelings lower A1C (14,16–18), lower self-reported
implementation, medical nutri-
of shame and guilt, providers are encour- weight (19,20), improved quality of life
tion therapy, and well-being: at
aged to consider the impact that language (17,21), reduced all-cause mortality risk
diagnosis, annually, when com-
has on building therapeutic relationships (22), healthy coping (5,23), and reduced
plicating factors arise, and when
and to choose positive, strength-based health care costs (24–26). Better out-
transitions in care occur. E
words and phrases that put people first comes were reported for DSMES inter-
5.3 Clinical outcomes, health status,
(4,10). Patient performance of self-man- ventions that were over 10 h in total
and well-being are key goals of
agement behaviors, as well as psychosocial duration (18), included ongoing support
diabetes self-management edu-

n
factors with the potential to impact the (12,27), were culturally (28,29) and age
cation and support that should
person’s self-management, should be appropriate (30,31), were tailored to

tio
be measured as part of routine
monitored. Please see Section 4 “Compre- individual needs and preferences, and
care. C
hensive Medical Evaluation and Assess- addressed psychosocial issues and incor-
5.4 Diabetes self-management edu-

a
ment of Comorbidities”(https://doi.org/ porated behavioral strategies (13,23,32,33).
cation and support should be pa-

ci
10.2337/dc20-S004) for more on use of Individual and group approaches are
tient centered, may be given in
language. effective (20,34,35), with a slight ben-
group or individual settings and/

so
DSMES and the current national stan- efit realized by those who engage in
or use technology, and should be
dards guiding it (2,11) are based on evi- both (18).
communicated with the entire
dence of benefit. Specifically, DSMES Emerging evidence demonstrates the
diabetes care team. A

As
helps people with diabetes to identify benefit of internet-based DSMES services
5.5 Because diabetes self-management
and implement effective self-management for diabetes prevention and the man-
educationandsupportcanimprove
strategies and cope with diabetes at four agement of type 2 diabetes (36–38).
outcomes and reduce costs B,

s
critical time points (see below) (2). On- Technology-enabled diabetes self-man-
reimbursement by third-party
going DSMES helps people with diabetes agement solutions improve A1C most

te
payers is recommended. C
to maintain effective self-management effectively when there is two-way com-
throughout a lifetime of diabetes as they munication between the patient and the
be
Diabetes self-management education face new challenges and as advances in health care team, individualized feed-
and support (DSMES) services facilitate treatment become available (12). back, use of patient-generated health
ia

the knowledge, decision-making, and Four critical time points have been data, and education (38). Current re-
skills mastery necessary for optimal dia- defined when the need for DSMES is to search supports nurses, dietitians, and
D

betes self-care and incorporate the be evaluated by the medical care pro- pharmacists as providers of DSMES who
needs, goals, and life experiences of vider and/or multidisciplinary team, may also tailor curriculum to the person’s
the person with diabetes. The overall with referrals made as needed (2): needs (39–41). Members of the DSMES
an

objectives of DSMES are to support in- team should have specialized clinical
formed decision-making, self-care be- 1. At diagnosis knowledge in diabetes and behavior
havior, problem-solving, and active 2. Annually for assessment of education, change principles. Certification as a diabetes
ic

collaboration with the health care nutrition, and emotional needs educator (see www.ncbde.org) and/or
er

team to improve clinical outcomes, 3. When new complicating factors (health board certification in advanced diabetes
health status, and well-being in a cost- conditions, physical limitations, emo- management (see www.diabeteseducator
effective manner (2). Providers are en- tional factors, or basic living needs) .org/education/certification/bc_adm) dem-
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couraged to consider the burden of arise that influence self-management onstrates an individual’s specialized training
treatment and the patient’s level of 4. When transitions in care occur in and understanding of diabetes manage-
confidence/self-efficacy for management ment and support. (11). Additionally, there
behaviors as well as the level of social and DSMES focuses on supporting patient is growing evidence for the role of com-
19

family support when providing DSMES. empowerment by providing people munity health workers (42,43), as well as
Patient performance of self-manage- with diabetes the tools to make informed peer (42–46) and lay leaders (47), in pro-
ment behaviors, including its effect on self-management decisions (13). Diabe- viding ongoing support.
20

clinical outcomes, health status, and tes care has shifted to an approach that DSMES is associated with an increased
quality of life, as well as the psychosocial places the person with diabetes and his use of primary care and preventive ser-
or her family/support system at the center
©

factors impacting the person’s ability vices (24,48,49) and less frequent use of
to self-manage should be monitored as of the care model, working in collaboration acute care and inpatient hospital services
part of routine clinical care. A randomized with health care professionals. Patient- (19). Patients who participate in DSMES
controlled trial testing a decision-making centered care is respectful of and respon- are more likely to follow best practice
education and skill-building program (8) sive to individual patient preferences, treatment recommendations, particu-
showed that addressing these targets needs, and values. It ensures that patient larly among the Medicare population,
improved health outcomes in a popu- values guide all decision-making (14). and have lower Medicare and insurance
lation in need of health care resources. claim costs (25,48). Despite these bene-
Furthermore, following a DSMES cur- Evidence for the Benefits fits, reports indicate that only 5–7%
riculum improves quality of care (9). Studies have found that DSMES is of individuals eligible for DSMES through
In addition, in response to the grow- associated with improved diabetes Medicare or a private insurance plan
ing literature that associates potentially knowledge and self-care behaviors (14,15), actually receive it (50,51). This low
S50 Facilitating Behavior Change and Well-being to Improve Health Outcomes Diabetes Care Volume 43, Supplement 1, January 2020

participation may be due to lack of with A1C decreases of 1.0–1.9% for peo- team be knowledgeable about nutrition
referral or other identified barriers ple with type 1 diabetes (57) and 0.3– therapy principles for people with all
such as logistical issues (accessibility, 2.0% for people with type 2 diabetes (57). types of diabetes and be supportive of
timing, costs) and the lack of a perceived See Table 5.1 for specific nutrition rec- their implementation. Members of the
benefit (52). Thus, in addition to educat- ommendations. Because of the progres- health care team should complement
ing referring providers about the benefits sive nature of type 2 diabetes, behavior MNT by providing evidence-based guid-
of DSMES and the critical times to refer modification alone may not be adequate ance that helps people with diabetes
(2), alternative and innovative models to maintain euglycemia over time. How- make healthy food choices that meet

n
of DSMES delivery need to be explored ever, after medication is initiated, nu- their individualized needs and improve
and evaluated. trition therapy continues to be an overall health. A variety of eating pat-

tio
important component and should be terns are acceptable for the management
Reimbursement integrated with the overall treatment of diabetes (41,58,60). Until the evidence

a
Medicare reimburses DSMES when that plan (55). surrounding comparative benefits of dif-
service meets the national standards

ci
ferent eating patterns in specific individ-
(2,11) and is recognized by the Ameri- Goals of Nutrition Therapy for Adults uals strengthens, health care providers

so
can Diabetes Association (ADA) or other With Diabetes should focus on the key factors that are
approval bodies. DSMES is also covered 1. To promote and support healthful common among the patterns: 1) empha-
by most health insurance plans. Ongoing eating patterns, emphasizing a variety size nonstarchy vegetables, 2) minimize

As
support has been shown to be instru- of nutrient-dense foods in appropri- added sugars and refined grains, and 3)
mental for improving outcomes when ate portion sizes, to improve overall choose whole foods over highly pro-
it is implemented after the completion health and: cessed foods to the extent possible
of education services. DSMES is fre-

s
c achieve and maintain body weight (41). An individualized eating pattern
quently reimbursed when performed goals also considers the individual’s health
in person. However, although DSMES
can also be provided via phone calls
te
c attain individualized glycemic, blood
pressure, and lipid goals
status, skills, resources, food preferen-
ces, and health goals. Referral to an RD/
be
and telehealth, these remote versions c delay or prevent the complications RDN is essential to assess the overall
may not always be reimbursed. Changes of diabetes nutrition status of, and to work collab-
in reimbursement policies that increase
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2. To address individual nutrition needs oratively with, the patient to create


DSMES access and utilization will result based on personal and cultural pref- a personalized meal plan that coordi-
in a positive impact to beneficiaries’
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erences, health literacy and numeracy, nates and aligns with the overall treat-
clinical outcomes, quality of life, health access to healthful foods, willingness ment plan, including physical activity
care utilization, and costs (53,54). and ability to make behavioral changes, and medication use. The Mediterranean-
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and existing barriers to change style (61,62), low-carbohydrate (63–


MEDICAL NUTRITION THERAPY 3. To maintain the pleasure of eating by 65), and vegetarian or plant-based
Please refer to the ADA consensus report providing nonjudgmental messages (66,67) eating patterns are all examples
ic

“Nutrition Therapy for Adults With Di- about food choices while limiting of healthful eating patterns that have
er

abetes or Prediabetes: A Consensus Re- food choices only when indicated shown positive results in research, but
port” for more information on nutrition by scientific evidence individualized meal planning should fo-
therapy (41). For many individuals with 4. To provide an individual with diabe- cus on personal preferences, needs, and
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diabetes, the most challenging part of tes the practical tools for developing goals. Reducing overall carbohydrate in-
the treatment plan is determining what healthy eating patterns rather than take for individuals with diabetes has
to eat. There is not a “one-size-fits-all” focusing on individual macronutrients, demonstrated the most evidence for
eating pattern for individuals with diabe- micronutrients, or single foods improving glycemia and may be applied
19

tes, and meal planning should be individ- in a variety of eating patterns that meet
ualized. Nutrition therapy plays an Eating Patterns, Macronutrient individual needs and preferences. For
integral role in overall diabetes manage- Distribution, and Meal Planning individuals with type 2 diabetes not
20

ment, and each person with diabetes Evidence suggests that there is not an meeting glycemic targets or for whom
should be actively engaged in education, ideal percentage of calories from carbo- reducing glucose-lowering drugs is a
©

self-management, and treatment plan- hydrate, protein, and fat for people with priority, reducing overall carbohydrate
ning with his or her health care team, diabetes. Therefore, macronutrient dis- intake with a low- or very-low-carbohy-
including the collaborative development tribution should be based on an individ- drate eating pattern is a viable option
of an individualized eating plan (41,55). ualized assessment of current eating (63–65). As research studies on some
All individuals with diabetes should be patterns, preferences, and metabolic low-carbohydrate eating plans generally
referred for individualized MNT provided goals. Consider personal preferences indicate challenges with long-term sus-
by a registered dietitian nutritionist (RD/ (e.g., tradition, culture, religion, health tainability, it is important to reassess and
RDN) who is knowledgeable and skilled beliefs and goals, economics) as well as individualize meal plan guidance regu-
in providing diabetes-specific MNT (56) metabolic goals when working with in- larly for those interested in this ap-
at diagnosis and as needed throughout dividuals to determine the best eating proach. This eating pattern is not
the life span, similar to DSMES. MNT pattern for them (41,58,59). It is impor- recommended at this time for women
delivered by an RD/RDN is associated tant that each member of the health care who are pregnant or lactating, people
care.diabetesjournals.org Facilitating Behavior Change and Well-being to Improve Health Outcomes S51

Table 5.1—Medical nutrition therapy recommendations


Topic Recommendation Evidence rating
Effectiveness of 5.6 An individualized medical nutrition therapy program as needed to achieve treatment goals, A
nutrition therapy provided by a registered dietitian nutritionist (RD/RDN), preferably one who has
comprehensive knowledge and experience in diabetes care, is recommended for all people
with type 1 or type 2 diabetes, prediabetes, and gestational diabetes mellitus.
5.7 Because diabetes medical nutrition therapy can result in cost savings B and improved B, A, E
outcomes (e.g., A1C reduction, reduced weight, decrease in cholesterol) A, medical nutrition

n
therapy should be adequately reimbursed by insurance and other payers. E
Energy balance 5.8 For all patients with overweight or obesity, lifestyle modification to achieve and maintain A

tio
a minimum weight loss of 5% is recommended for all patients with diabetes and prediabetes.
Eating patterns and 5.9 There is no single ideal dietary distribution of calories among carbohydrates, fats, and proteins E

a
macronutrient for people with diabetes; therefore, meal plans should be individualized while keeping total
distribution calorie and metabolic goals in mind.

ci
5.10 A variety of eating patterns are acceptable for the management of type 2 diabetes and B
prediabetes.

so
Carbohydrates 5.11 Carbohydrate intake should emphasize nutrient-dense carbohydrate sources that are B
high in fiber and minimally processed. Eating plans should emphasize nonstarchy vegetables,
minimal added sugars, fruits, whole grains, as well as dairy products.

As
5.12 Reducing overall carbohydrate intake for individuals with diabetes has demonstrated the B
most evidence for improving glycemia and may be applied in a variety of eating patterns
that meet individual needs and preferences.
5.13 For people with diabetes who are prescribed a flexible insulin therapy program, education A, B

s
on how to use carbohydrate counting A and on dosing for fat and protein content B should

te
be used to determine mealtime insulin dosing.
5.14 For adults using fixed insulin doses, consistent pattern of carbohydrate intake with respect to B
time and amount, while considering the insulin action time, can result in improved glycemia
be
and reduce the risk for hypoglycemia.
5.15 People with diabetes and those at risk are advised to replace sugar-sweetened beverages B, A
(including fruit juices) with water as much as possible in order to control glycemia and weight
ia

and reduce their risk for cardiovascular disease and fatty liver B and should minimize the
consumption of foods with added sugar that have the capacity to displace healthier, more
D

nutrient-dense food choices. A


Protein 5.16 In individuals with type 2 diabetes, ingested protein appears to increase insulin response B
without increasing plasma glucose concentrations. Therefore, carbohydrate sources high in
an

protein should be avoided when trying to treat or prevent hypoglycemia.


Dietary fat 5.17 An eating plan emphasizing elements of a Mediterranean-style eating pattern rich in B
monounsaturated and polyunsaturated fats may be considered to improve glucose
ic

metabolism and lower cardiovascular disease risk.


5.18 Eating foods rich in long-chain n-3 fatty acids, such as fatty fish (EPA and DHA) and nuts and B, A
er

seeds (ALA), is recommended to prevent or treat cardiovascular disease B; however, evidence


does not support a beneficial role for the routine use of n-3 dietary supplements. A
Am

Micronutrients and 5.19 There is no clear evidence that dietary supplementation with vitamins, minerals (such as C
herbal supplements chromium and vitamin D), herbs, or spices (such as cinnamon or aloe vera) can improve
outcomes in people with diabetes who do not have underlying deficiencies, and they are
not generally recommended for glycemic control.
Alcohol 5.20 Adults with diabetes who drink alcohol should do so in moderation (no more than one drink C
19

per day for adult women and no more than two drinks per day for adult men).
5.21 Educating people with diabetes about the signs, symptoms, and self-management of delayed B
hypoglycemia after drinking alcohol, especially when using insulin or insulin secretagogues,
20

is recommended. The importance of glucose monitoring after drinking alcoholic


beverages to reduce hypoglycemia risk should be emphasized.
Sodium 5.22 As for the general population, people with diabetes and prediabetes should limit sodium B
©

consumption to ,2,300 mg/day.


Nonnutritive 5.23 The use of nonnutritive sweeteners may have the potential to reduce overall calorie and B
sweeteners carbohydrate intake if substituted for caloric (sugar) sweeteners and without compensation by
intake of additional calories from other food sources. For those who consume sugar-
sweetened beverages regularly, a low-calorie or nonnutritive-sweetened beverage may serve
as a short-term replacement strategy, but overall, people are encouraged to decrease both
sweetened and nonnutritive-sweetened beverages and use other alternatives, with an
emphasis on water intake.
S52 Facilitating Behavior Change and Well-being to Improve Health Outcomes Diabetes Care Volume 43, Supplement 1, January 2020

with or at risk for disordered eating, or involving both aerobic and resistance importance of providing guidance on
people who have renal disease, and it exercise (73,76,77) and a healthy eating an individualized meal plan containing
should be used with caution in patients plan, such as a Mediterranean-style eating nutrient-dense foods, such as vegeta-
taking sodium–glucose cotransporter pattern (78). bles, fruits, legumes, dairy, lean sources
2 inhibitors due to the potential risk For many individuals with overweight of protein (including plant-based sources
of ketoacidosis (68,69). There is inade- and obesity with type 2 diabetes, 5% as well as lean meats, fish, and poultry),
quate research in type 1 diabetes to weight loss is needed to achieve bene- nuts, seeds, and whole grains, cannot be
support one eating pattern over another ficial outcomes in glycemic control, lipids, overemphasized (92), as well as guidance

n
at this time. and blood pressure (79). It should be on achieving the desired energy deficit
The diabetes plate method is com- noted, however, that the clinical benefits (93–96). Any approach to meal planning

tio
monly used for providing basic meal of weight loss are progressive, and more should be individualized considering the
planning guidance (70) and provides a intensive weight loss goals (i.e., 15%) may health status, personal preferences, and

a
visual guide showing how to portion be appropriate to maximize benefit de- ability of the person with diabetes to

ci
calories (featuring a 9-inch plate) and pending on need, feasibility, and safety sustain the recommendations in the plan.
carbohydrates (by limiting them to what (80,81). In select individuals with type 2

so
fits in one-quarter of the plate) and places diabetes, an overall healthy eating plan Carbohydrates
an emphasis on low-carbohydrate (or non- that results in energy deficit in conjunc- Studies examining the ideal amount
starchy) vegetables. Providing a visual/ tion with weight loss medications and/or of carbohydrate intake for people with

As
small graphic of the diabetes plate method metabolic surgery should be considered diabetes are inconclusive, although mon-
is preferred, as descriptions of the concept to help achieve weight loss and mainte- itoring carbohydrate intake and con-
can be confusing when unfamiliar. nance goals, lower A1C, and reduce CVD sidering the blood glucose response to

s
risk (82–84). Overweight and obesity dietary carbohydrate are key for improv-
Weight Management are also increasingly prevalent in people ing postprandial glucose management
Management and reduction of weight
is important for people with type 1 di- te
with type 1 diabetes and present clinical
challenges regarding diabetes treatment
(97,98). The literature concerning gly-
cemic index and glycemic load in in-
be
abetes, type 2 diabetes, or prediabetes and CVD risk factors (85,86). Sustaining dividuals with diabetes is complex, often
and overweight or obesity. To support weight loss can be challenging (79,87) but yielding mixed results, though in some
ia

weight loss and improve A1C, cardio- has long-term benefits; maintaining studies lowering the glycemic load of
vascular disease (CVD) risk factors, and weight loss for 5 years is associated consumed carbohydrates has demon-
D

well-being in adults with overweight/ with sustained improvements in A1C and strated A1C reductions of 0.2% to 0.5%
obesity and prediabetes or diabetes, lipid levels (88). MNT guidance from an (99,100). Studies longer than 12 weeks
MNT and DSMES services should include RD/RDN with expertise in diabetes and report no significant influence of glycemic
an

an individualized eating plan in a format weight management, throughout the index or glycemic load independent of
that results in an energy deficit in com- course of a structured weight loss plan, weight loss on A1C; however, mixed
bination with enhanced physical activ- is strongly recommended. results have been reported for fasting
ic

ity (41). Lifestyle intervention programs People with diabetes and prediabetes glucose levels and endogenous insulin
er

should be intensive and have frequent should be screened and evaluated during levels.
follow-up to achieve significant reduc- DSMES and MNT encounters for disor- Reducing overall carbohydrate intake
tions in excess body weight and improve dered eating, and nutrition therapy for individuals with diabetes has dem-
Am

clinical indicators. There is strong and should be individualized to accommo- onstrated evidence for improving gly-
consistent evidence that modest persis- date disorders (41). Disordered eating cemia and may be applied in a variety
tent weight loss can delay the progres- can make following an eating plan chal- of eating patterns that meet individ-
sion from prediabetes to type 2 diabetes lenging, and individuals should be re- ual needs and preferences (41). For
19

(58,71,72) (see Section 3 “Prevention or ferred to a mental health professional as people with type 2 diabetes or predia-
Delay of Type 2 Diabetes,” https://doi needed. Studies have demonstrated that betes, low-carbohydrate eating plans
.org/10.2337/dc20-S003) and is benefi- a variety of eating plans, varying in mac- show potential to improve glycemia
20

cial to the management of type 2 diabe- ronutrient composition, can be used and lipid outcomes for up to 1 year
tes (see Section 8 “Obesity Management effectively and safely in the short term (63,65,90,101–104). Part of the chal-
©

for the Treatment of Type 2 Diabetes,” (1–2 years) to achieve weight loss in lenge in interpreting low-carbohydrate
https://doi.org/10.2337/dc20-S008). people with diabetes. This includes struc- research has been due to the wide range
In prediabetes, the weight loss goal tured low-calorie meal plans with meal of definitions for a low-carbohydrate
is 7–10% for preventing progression to replacements (80,88,89) and the Medit- eating plan (65,100). As research stud-
type 2 diabetes (73). In conjunction erranean-style eating pattern (78), as well ies on low-carbohydrate eating plans
with lifestyle therapy, medication-assisted as low-carbohydrate meal plans (90). generally indicate challenges with long-
weight loss can be considered for peo- However, no single approach has been term sustainability, it is important to
ple at risk for type 2 diabetes when proven to be consistently superior reassess and individualize meal plan
needed to achieve and sustain 7–10% (41,91,92), and more data are needed guidance regularly for those interested
weight loss (74,75). People with predia- to identify and validate those meal plans in this approach. Providers should main-
betes at a healthy weight should also that are optimal with respect to long-term tain consistent medical oversight and
be considered for lifestyle intervention outcomes and patient acceptability. The recognize that certain groups are not
care.diabetesjournals.org Facilitating Behavior Change and Well-being to Improve Health Outcomes S53

appropriate for low-carbohydrate eating and/or high-protein mixed meals is is not an ideal percentage of calories
plans, including women who are preg- recommended to address delayed hy- from fat for people with or at risk for
nant or lactating, children, and people perglycemia that may occur 3 h or more diabetes and that macronutrient distri-
who have renal disease or disordered after eating (41). Checking glucose 3 h bution should be individualized accord-
eating behavior, and these plans should after eating may help to determine if ing to the patient’s eating patterns,
be used with caution in those taking additional insulin adjustments are required preferences, and metabolic goals (41).
sodium–glucose cotransporter 2 inhibitors (112,113). Continuous glucose monitoring The type of fats consumed is more im-
because of the potential risk of ketoacidosis or self-monitoring of blood glucose portant than total amount of fat when

n
(68,69). There is inadequate research should guide decision making for admin- looking at metabolic goals and CVD
about dietary patterns for type 1 diabe- istration of additional insulin. For indi- risk, and it is recommended that the

tio
tes to support one eating plan over viduals on a fixed daily insulin schedule, percentage of total calories from satu-
another at this time. meal planning should emphasize a rel- rated fats should be limited (78,105,

a
Most individuals with diabetes re- atively fixed carbohydrate consump- 119–121). Multiple randomized con-

ci
port a moderate intake of carbohydrate tion pattern with respect to both time trolled trials including patients with
(44–46% of total calories) (58). Efforts and amount, while considering insulin type 2 diabetes have reported that a

so
to modify habitual eating patterns are action time (41). Mediterranean-style eating pattern (78,
often unsuccessful in the long term; 122–127), rich in polyunsaturated and
people generally go back to their usual Protein monounsaturated fats, can improve both

As
macronutrient distribution (58). Thus, There is no evidence that adjusting the glycemic management and blood lipids.
the recommended approach is to indi- daily level of protein intake (typically 1– However, supplements do not seem to
vidualize meal plans to meet caloric goals 1.5 g/kg body wt/day or 15–20% total have the same effects as their whole-
calories) will improve health in individ-

s
with a macronutrient distribution that is food counterparts. A systematic review
more consistent with the individual’s uals without diabetic kidney disease, and concluded that dietary supplements
usual intake to increase the likelihood
for long-term maintenance. te
research is inconclusive regarding the
ideal amount of dietary protein to opti-
with n-3 fatty acids did not improve
glycemic management in individuals
be
As for all individuals in developed mize either glycemic management or with type 2 diabetes (99). Randomized
countries, both children and adults CVD risk (99,114). Therefore, protein controlled trials also do not support
intake goals should be individualized
ia

with diabetes are encouraged to mini- recommending n-3 supplements for pri-
mize intake of refined carbohydrates and based on current eating patterns. mary or secondary prevention of CVD
Some research has found successful
D

added sugars and instead focus on carbo- (128–132). People with diabetes should
hydrates from vegetables, legumes, fruits, management of type 2 diabetes with be advised to follow the guidelines for
dairy (milk and yogurt), and whole grains. meal plans including slightly higher levels the general population for the recom-
an

The consumption of sugar-sweetened of protein (20–30%), which may contrib- mended intakes of saturated fat, die-
beverages (including fruit juices) and pro- ute to increased satiety (115). tary cholesterol, and trans fat (105). In
cessed food products with high amounts Those with diabetic kidney disease general, trans fats should be avoided.
ic

of refined grains and added sugars is (with albuminuria and/or reduced esti- In addition, as saturated fats are progres-
mated glomerular filtration rate) should
er

strongly discouraged (105–107). sively decreased in the diet, they should


Individuals with type 1 or type 2 di- aim to maintain dietary protein at the be replaced with unsaturated fats and not
abetes taking insulin at mealtime should recommended daily allowance of 0.8 g/kg with refined carbohydrates (126).
Am

be offered intensive and ongoing edu- body wt/day. Reducing the amount of
cation on the need to couple insulin dietary protein below the recommended Sodium
administration with carbohydrate intake. daily allowance is not recommended be- As for the general population, people
For people whose meal schedule or car- cause it does not alter glycemic meas- with diabetes are advised to limit their
19

bohydrate consumption is variable, reg- ures, cardiovascular risk measures, or the sodium consumption to ,2,300 mg/day
ular counseling to help them understand rate at which glomerular filtration rate (41). Restriction below 1,500 mg, even
the complex relationship between car- declines (116,117). for those with hypertension, is generally
20

bohydrate intake and insulin needs In individuals with type 2 diabetes, not recommended (133–135). Sodium
is important. In addition, education on protein intake may enhance or increase intake recommendations should take
the insulin response to dietary carbohy-
©

using the insulin-to-carbohydrate ratios into account palatability, availability, af-


for meal planning can assist them with drates (118). Therefore, use of carbohy- fordability, and the difficulty of achiev-
effectively modifying insulin dosing from drate sources high in protein (such as ing low-sodium recommendations in a
meal to meal and improving glycemic milk and nuts) to treat or prevent hypo- nutritionally adequate diet (136).
management (58,97,108–111). Results glycemia should be avoided due to the
from recent high-fat and/or high-protein potential concurrent rise in endogenous Micronutrients and Supplements
mixed meals studies continue to support insulin. There continues to be no clear evidence
previous findings that glucose response of benefit from herbal or nonherbal
to mixed meals high in protein and/or fat Fats (i.e., vitamin or mineral) supplemen-
along with carbohydrate differ among The ideal amount of dietary fat for in- tation for people with diabetes without
individuals; therefore, a cautious approach dividuals with diabetes is controver- underlying deficiencies (41). Metformin
to increasing insulin doses for high-fat sial. New evidence suggests that there is associated with vitamin B12 deficiency
S54 Facilitating Behavior Change and Well-being to Improve Health Outcomes Diabetes Care Volume 43, Supplement 1, January 2020

per a report from the Diabetes Preven- reduce overall calorie and carbohydrate
be interrupted every 30 min for
tion Program Outcomes Study (DPPOS), intake (58). Most systematic reviews and
blood glucose benefits. C
suggesting that periodic testing of vita- meta-analyses show benefits for nonnu-
5.28 Flexibility training and balance
min B12 levels should be considered tritive sweetener use in weight loss
training are recommended 2–3
in patients taking metformin, particularly (142,143); however, some research sug-
times/week for older adults with
in those with anemia or peripheral gests an association with weight gain
diabetes. Yoga and tai chi may
neuropathy (137). Routine supplemen- (144). When use of sugar substitutes
be included based on individual
tation with antioxidants, such as vita- is meant to reduce overall caloric and
preferences to increase flexibil-

n
mins E and C and carotene, is not advised carbohydrate intake, people should be
ity, muscular strength, and bal-
due to lack of evidence of efficacy and counseled to avoid compensating with

tio
ance. C
concern related to long-term safety. In intake of additional calories from other
addition, there is insufficient evidence to food sources (41). Regulatory agencies

a
support the routine use of herbal supple- set acceptable daily intake levels for each Physical activity is a general term that

ci
ments and micronutrients, such as cin- nonnutritive sweetener, defined as the includes all movement that increases
namon (138), curcumin, vitamin D (139), amount that can be safely consumed energy use and is an important part of

so
aloe vera, or chromium, to improve gly- over a person’s lifetime (41,145). For the diabetes management plan. Exercise
cemia in people with diabetes (41,140). those who consume sugar-sweetened is a more specific form of physical activ-
However, for special populations, in- beverages regularly, a low-calorie or ity that is structured and designed to

As
cluding pregnant or lactating women, nonnutritive-sweetened beverage may improve physical fitness. Both physical
older adults, vegetarians, and people serve as a short-term replacement strat- activity and exercise are important. Ex-
following very low-calorie or low-carbo- egy, but overall, people are encour- ercise has been shown to improve blood

s
hydrate diets, a multivitamin may be aged to decrease both sweetened and glucose control, reduce cardiovascu-
necessary. nonnutritive-sweetened beverages and lar risk factors, contribute to weight

Alcohol on water intake (146). te


use other alternatives, with an emphasis loss, and improve well-being (147). Phys-
ical activity is as important for those with
be
Moderate alcohol intake does not have type 1 diabetes as it is for the general
major detrimental effects on long-term population, but its specific role in the
PHYSICAL ACTIVITY
ia

blood glucose management in people prevention of diabetes complications


with diabetes. Risks associated with al- Recommendations
and the management of blood glucose
D

cohol consumption include hypogly- 5.24 Children and adolescents with is not as clear as it is for those with type 2
cemia and/or delayed hypoglycemia type 1 or type 2 diabetes or diabetes. A recent study suggested that
(particularly for those using insulin or the percentage of people with diabetes
an

prediabetes should engage in


insulin secretagogue therapies), weight 60 min/day or more of moder- who achieved the recommended exer-
gain, and hyperglycemia (for those con- ate- or vigorous-intensity aerobic cise level per week (150 min) varied by
suming excessive amounts) (41,140). race. Objective measurement by accel-
ic

activity, with vigorous muscle-


People with diabetes should be educated strengthening and bone-strength- erometer showed that 44.2%, 42.6%, and
er

about these risks and encouraged to ening activities at least 3 days/ 65.1% of whites, African Americans, and
monitor blood glucose frequently after week. C Hispanics, respectively, met the thresh-
drinking alcohol to minimize such risks. old (148). It is important for diabetes care
Am

5.25 Most adults with type 1 C and


People with diabetes can follow the same type 2 B diabetes should engage management teams to understand the
guidelines as those without diabetes if in 150 min or more of moderate- difficulty that many patients have reach-
they choose to drink. For women, no to vigorous-intensity aerobic ac- ing recommended treatment targets and
more than one drink per day, and for tivity per week, spread over at to identify individualized approaches to
19

men, no more than two drinks per day is least 3 days/week, with no more improve goal achievement.
recommended (one drink is equal to a than 2 consecutive days without Moderate to high volumes of aerobic
12-oz beer, a 5-oz glass of wine, or 1.5 oz activity are associated with substantially
20

activity. Shorter durations (min-


of distilled spirits). imum 75 min/week) of vigorous- lower cardiovascular and overall mortal-
intensity or interval training may ity risks in both type 1 and type 2 diabetes
©

Nonnutritive Sweeteners be sufficient for younger and (149). A recent prospective observational
For some people with diabetes who more physically fit individuals. study of adults with type 1 diabetes
are accustomed to sugar-sweetened 5.26 Adults with type 1 C and type 2 B suggested that higher amounts of phys-
products, nonnutritive sweeteners (con- diabetes should engage in 2–3 ical activity led to reduced cardiovascular
taining few or no calories) may be an sessions/week of resistance ex- mortality after a mean follow-up time of
acceptable substitute for nutritive sweet- ercise on nonconsecutive days. 11.4 years for patients with and without
eners (those containing calories, such 5.27 All adults, and particularly those chronic kidney disease (150). Addition-
as sugar, honey, and agave syrup) when with type 2 diabetes, should ally, structured exercise interventions of
consumed in moderation. While use decrease the amount of time at least 8 weeks’ duration have been
of nonnutritive sweeteners does not spent in daily sedentary behav- shown to lower A1C by an average of
appear to have a significant effect on ior. B Prolonged sitting should 0.66% in people with type 2 diabetes,
glycemic management (141), they can even without a significant change in BMI
care.diabetesjournals.org Facilitating Behavior Change and Well-being to Improve Health Outcomes S55

(151). There are also considerable data more than 2 days to elapse between resistance training in older adults with
for the health benefits (e.g., increased exercise sessions, is recommended to type 2 diabetes (169) and for an additive
cardiovascular fitness, greater muscle decrease insulin resistance, regardless benefit of combined aerobic and resis-
strength, improved insulin sensitivity, of diabetes type (161,162). Over time, tance exercise in adults with type 2 di-
etc.) of regular exercise for those with activities should progress in intensity, abetes (170). If not contraindicated,
type 1 diabetes (152). A recent study frequency, and/or duration to at least patients with type 2 diabetes should
suggested that exercise training in type 1 150 min/week of moderate-intensity ex- be encouraged to do at least two weekly
diabetes may also improve several im- ercise. Adults able to run at 6 miles/h sessions of resistance exercise (exercise

n
portant markers such as triglyceride (9.7 km/h) for at least 25 min can benefit with free weights or weight machines),
level, LDL, waist circumference, and sufficiently from shorter-intensity activ- with each session consisting of at least

tio
body mass (153). Higher levels of exercise ity (75 min/week) (156). Many adults, one set (group of consecutive repetitive
intensity are associated with greater including most with type 2 diabetes, exercise motions) of five or more differ-

a
improvements in A1C and in fitness would be unable or unwilling to partic- ent resistance exercises involving the

ci
(154). Other benefits include slowing ipate in such intense exercise and should large muscle groups (169).
the decline in mobility among over- engage in moderate exercise for the For type 1 diabetes, although exercise

so
weight patients with diabetes (155). recommended duration. Adults with di- in general is associated with improve-
The ADA position statement “Physical abetes should engage in 2–3 sessions/ ment in disease status, care needs to be
Activity/Exercise and Diabetes” reviews week of resistance exercise on noncon- taken in titrating exercise with respect

As
the evidence for the benefits of exercise secutive days (163). Although heavier to glycemic management. Each individ-
in people with type 1 and type 2 diabetes resistance training with free weights ual with type 1 diabetes has a variable
and offers specific recommendation (156). and weight machines may improve glycemic response to exercise. This var-

s
Physical activity and exercise should be glycemic control and strength (164), iability should be taken into consider-
recommended and prescribed to all indi- resistance training of any intensity is ation when recommending the type
viduals with diabetes as part of manage-
ment of glycemia and overall health. te
recommended to improve strength,
balance, and the ability to engage in
and duration of exercise for a given in-
dividual (171).
be
Specific recommendations and precau- activities of daily living throughout the Women with preexisting diabetes,
tions will vary by the type of diabetes, life span. Providers and staff should help particularly type 2 diabetes, and those
ia

age, activity done, and presence of di- patients set stepwise goals toward meet- at risk for or presenting with gestational
abetes-related health complications. ing the recommended exercise targets. diabetes mellitus should be advised to
D

Recommendations should be tailored As persons intensify their exercise pro- engage in regular moderate physical
to meet the specific needs of each in- gram, medical monitoring may be indi- activity prior to and during their preg-
dividual (156). cated to ensure safety and evaluate the nancies as tolerated (156).
an

effects on glucose management. (See


Exercise and Children the section PHYSICAL ACTIVITY AND GLYCEMIC Pre-exercise Evaluation
CONTROL below) As discussed more fully in Section 10
ic

All children, including children with di-


abetes or prediabetes, should be en- Recent evidence supports that all in- “Cardiovascular Disease and Risk Man-
er

couraged to engage in regular physical dividuals, including those with diabetes, agement” (https://doi.org/10.2337/
activity. Children should engage in at should be encouraged to reduce the dc20-S010), the best protocol for as-
amount of time spent being sedentary sessing asymptomatic patients with
Am

least 60 min of moderate to vigorous


aerobic activity every day with muscle- (e.g., working at a computer, watching diabetes for coronary artery disease re-
and bone-strengthening activities at television) by breaking up bouts of sed- mains unclear. The ADA consensus report
least 3 days per week (157). In general, entary activity (.30 min) by briefly “Screening for Coronary Artery Disease in
youth with type 1 diabetes benefit from standing, walking, or performing other Patients With Diabetes” (172) concluded
19

being physically active, and an active light physical activities (165,166). Avoid- that routine testing is not recommended.
lifestyle should be recommended to ing extended sedentary periods may help However, providers should perform a
prevent type 2 diabetes for those at risk careful history, assess cardiovascular
20

all (158). Youth with type 1 diabetes


who engage in more physical activity and may also aid in glycemic control for risk factors, and be aware of the atypical
may have better health outcomes those with diabetes. presentation of coronary artery disease
©

and health-related quality of life (159, A wide range of activities, including in patients with diabetes. Certainly, high-
160). yoga, tai chi, and other types, can have risk patients should be encouraged to
significant impacts on A1C, flexibility, start with short periods of low-intensity
Frequency and Type of Physical muscle strength, and balance (147, exercise and slowly increase the inten-
Activity 167,168). Flexibility and balance exercises sity and duration as tolerated. Providers
People with diabetes should perform may be particularly important in older should assess patients for conditions
aerobic and resistance exercise regularly adults with diabetes to maintain range that might contraindicate certain types
(156). Aerobic activity bouts should ide- of motion, strength, and balance (156). of exercise or predispose to injury, such as
ally last at least 10 min, with the goal of uncontrolled hypertension, untreated
;30 min/day or more, most days of the Physical Activity and Glycemic Control proliferative retinopathy, autonomic
week for adults with type 2 diabetes. Clinical trials have provided strong evi- neuropathy, peripheral neuropathy, and
Daily exercise, or at least not allowing dence for the A1C-lowering value of a history of foot ulcers or Charcot foot. The
S56 Facilitating Behavior Change and Well-being to Improve Health Outcomes Diabetes Care Volume 43, Supplement 1, January 2020

patient’s age and previous physical activity an ophthalmologist prior to engaging SMOKING CESSATION: TOBACCO
level should be considered. The provider in an intense exercise regimen may be AND E-CIGARETTES
should customize the exercise regimen appropriate. Recommendations
to the individual’s needs. Those with 5.29 Advise all patients not to use
Peripheral Neuropathy
complications may require a more thorough cigarettes and other tobacco
Decreased pain sensation and a higher
evaluation prior to beginning an exer- products A or e-cigarettes. A
pain threshold in the extremities can
cise program (171). 5.30 After identification of tobacco or
result in an increased risk of skin break-
e-cigarette use, include smoking

n
down, infection, and Charcot joint de-
Hypoglycemia struction with some forms of exercise. cessation counseling and other

tio
In individuals taking insulin and/or insulin forms of treatment as a routine
Therefore, a thorough assessment
secretagogues, physical activity may component of diabetes care. A
should be done to ensure that neurop-
cause hypoglycemia if the medication

a
athy does not alter kinesthetic or pro-
dose or carbohydrate consumption is Results from epidemiological, case-
prioceptive sensation during physical

ci
not altered. Individuals on these thera- control, and cohort studies provide con-
pies may need to ingest some added activity, particularly in those with more vincing evidence to support the causal

so
carbohydrate if pre-exercise glucose lev- severe neuropathy. Studies have shown link between cigarette smoking and
els are ,90 mg/dL (5.0 mmol/L), depend- that moderate-intensity walking may health risks (178). Recent data show
ing on whether they are able to lower not lead to an increased risk of foot

As
tobacco use is higher among adults
insulin doses during the workout (such ulcers or reulceration in those with with chronic conditions (179) as well as
as with an insulin pump or reduced pre- peripheral neuropathy who use proper in adolescents and young adults with
exercise insulin dosage), the time of day footwear (174). In addition, 150 min/week diabetes (180). Smokers with diabetes

s
exercise is done, and the intensity and of moderate exercise was reported to (and people with diabetes exposed to

te
duration of the activity (156,171). In improve outcomes in patients with pre- second-hand smoke) have a height-
some patients, hypoglycemia after diabetic neuropathy (175). All individuals ened risk of CVD, premature death,
be
exercise may occur and last for several with peripheral neuropathy should wear microvascular complications, and worse
hours due to increased insulin sensitivity. glycemic control when compared with
proper footwear and examine their feet
Hypoglycemia is less common in patients nonsmokers (181–183). Smoking may
daily to detect lesions early. Anyone
ia

with diabetes who are not treated with have a role in the development of type 2
with a foot injury or open sore should
insulin or insulin secretagogues, and no diabetes (184–187).
D

routine preventive measures for hypo- be restricted to non–weight-bearing


The routine and thorough assessment
glycemia are usually advised in these activities.
of tobacco use is essential to prevent
cases. Intense activities may actually
an

Autonomic Neuropathy smoking or encourage cessation. Numer-


raise blood glucose levels instead of Autonomic neuropathy can increase the ous large randomized clinical trials have
lowering them, especially if pre-exercise risk of exercise-induced injury or ad- demonstrated the efficacy and cost-
ic

glucose levels are elevated (152). Be- verse events through decreased cardiac effectiveness of brief counseling in
cause of the variation in glycemic re- responsiveness to exercise, postural hy- smoking cessation, including the use of
er

sponse to exercise bouts, patients need potension, impaired thermoregulation, telephone quit lines, in reducing tobacco
to be educated to check blood glucose impaired night vision due to impaired use. Pharmacologic therapy to assist with
Am

levels before and after periods of ex- papillary reaction, and greater suscepti- smoking cessation in people with diabe-
ercise and about the potential pro- bility to hypoglycemia (176). Cardiovas- tes has been shown to be effective (188),
longed effects (depending on intensity and for the patient motivated to quit, the
cular autonomic neuropathy is also an
and duration) (see the section DIABETES addition of pharmacologic therapy to
independent risk factor for cardiovascu-
19

SELF-MANAGEMENT EDUCATION AND SUPPORT


lar death and silent myocardial ischemia counseling is more effective than either
above).
(177). Therefore, individuals with diabetic treatment alone (189). Special consider-
autonomic neuropathy should undergo ations should include assessment of level
20

Exercise in the Presence of of nicotine dependence, which is asso-


cardiac investigation before beginning
Microvascular Complications ciated with difficulty in quitting and re-
See Section 11 “Microvascular Compli- physical activity more intense than
lapse (190). Although some patients may
©

cations and Foot Care” (https://doi.org/ that to which they are accustomed.
gain weight in the period shortly after
10.2337/dc20-S011) for more informa- Diabetic Kidney Disease
smoking cessation (191), recent research
tion on these long-term complications. Physical activity can acutely increase has demonstrated that this weight gain
urinary albumin excretion. However, does not diminish the substantial CVD
Retinopathy
If proliferative diabetic retinopathy or there is no evidence that vigorous- benefit realized from smoking cessation
severe nonproliferative diabetic retinop- intensity exercise accelerates the rate (192). One study in smokers with newly
athy is present, then vigorous-intensity of progression of diabetic kidney disease, diagnosed type 2 diabetes found that
aerobic or resistance exercise may be and there appears to be no need for smoking cessation was associated with
contraindicated because of the risk of specific exercise restrictions for people amelioration of metabolic parameters
triggering vitreous hemorrhage or ret- with diabetic kidney disease in general and reduced blood pressure and albu-
inal detachment (173). Consultation with (173). minuria at 1 year (193).
care.diabetesjournals.org Facilitating Behavior Change and Well-being to Improve Health Outcomes S57

In recent years e-cigarettes have multifaceted issues when integrating as feeling overwhelmed or stressed by
gained public awareness and popularity diabetes care into daily life (11). having diabetes (see the section DIABETES
because of perceptions that e-cigarette Emotional well-being is an important DISTRESS below), changes in finances, or
use is less harmful than regular cigarette part of diabetes care and self-management. competing medical demands (e.g., the
smoking (194,195). However, in light of Psychological and social problems can diagnosis of a comorbid condition). In
recent Centers for Disease Control and impair the individual’s (11,197–201) or circumstances where persons other
Prevention evidence (196) of deaths re- family’s (200) ability to carry out di- than the patient are significantly in-
lated to e-cigarette use, no persons abetes care tasks and therefore poten- volved in diabetes management, these

n
should be advised to use e-cigarettes, tially compromise health status. There issues should be explored with non-
either as a way to stop smoking tobacco medical care providers (205). Standard-

tio
are opportunities for the clinician to
or as a recreational drug. routinely assess psychosocial status ized and validated tools for psychosocial
in a timely and efficient manner for monitoring and assessment can also be
PSYCHOSOCIAL ISSUES

a
referral to appropriate services (202, used by providers (1), with positive
findings leading to referral to a mental

ci
Recommendations 203). A systematic review and meta-
5.31 Psychosocial care should be in- analysis showed that psychosocial in- health provider specializing in diabetes

so
tegrated with a collaborative, terventions modestly but significantly for comprehensive evaluation, diagno-
patient-centered approach and improved A1C (standardized mean dif- sis, and treatment.
provided to all people with di- ference –0.29%) and mental health out-

As
Diabetes Distress
abetes, with the goals of opti- comes (204). However, there was a
mizing health outcomes and limited association between the effects Recommendation
health-related quality of life. A on A1C and mental health, and no in- 5.35 Routinely monitor people with
5.32 Psychosocial screening and

s
tervention characteristics predicted ben- diabetes for diabetes distress,
follow-up may include, but are efit on both outcomes. particularly when treatment
not limited to, attitudes about
diabetes, expectations for med- Screening
te targets are not met and/or at
the onset of diabetes complica-
be
ical management and outcomes, Key opportunities for psychosocial screen- tions. B
affect or mood, general and ing occur at diabetes diagnosis, during
regularly scheduled management visits,
ia

diabetes-related quality of life, Diabetes distress is very common and is


available resources (financial, during hospitalizations, with new onset distinct from other psychological disor-
of complications, during significant tran-
D

social, and emotional), and psy- ders (207–209). Diabetes distress refers
chiatric history. E sitions in care such as from pediatric to to significant negative psychological re-
5.33 Providers should consider assess- adult care teams (205), or when prob- actions related to emotional burdens and
an

ment for symptoms of diabetes lems with achieving A1C goals, quality of worries specific to an individual’s expe-
distress, depression, anxiety, dis- life, or self-management are identified rience in having to manage a severe,
ordered eating, and cognitive (2). Patients are likely to exhibit psycho- complicated, and demanding chronic
ic

capacities using appropriate logical vulnerability at diagnosis, when disease such as diabetes (208–210).
their medical status changes (e.g., end
er

standardized and validated tools The constant behavioral demands (med-


at the initial visit, at periodic of the honeymoon period), when the ication dosing, frequency, and titration;
intervals, and when there is a need for intensified treatment is ev- monitoring blood glucose, food intake,
Am

change in disease, treatment, or ident, and when complications are dis- eating patterns, and physical activity) of
life circumstance. Including care- covered. Significant changes in life diabetes self-management and the po-
givers and family members in this circumstances, often called social deter- tential or actuality of disease progression
assessment is recommended. B minants of health, are known to con- are directly associated with reports of
19

5.34 Consider screening older adults siderably affect a person’s ability to diabetes distress (208). The prevalence
(aged $65 years) with diabetes self-manage their illness. Thus, screen- of diabetes distress is reported to be 18–
for cognitive impairment and ing for social determinants of health 45% with an incidence of 38–48% over
20

depression. B (e.g., loss of employment, birth of a child, 18 months in persons with type 2 di-
or other family-based stresses) should abetes (210). In the second Diabetes
also be incorporated into routine care
©

Please refer to the ADA position state- Attitudes, Wishes and Needs (DAWN2)
ment “Psychosocial Care for People With (206). study, significant diabetes distress was
Diabetes” for a list of assessment tools Providers can start with informal ver- reported by 45% of the participants, but
and additional details (1). bal inquires, for example, by asking only 24% reported that their health care
Complex environmental, social, be- whether there have been persistent teams asked them how diabetes affected
havioral, and emotional factors, known changes in mood during the past 2 weeks their lives (207). High levels of diabetes
as psychosocial factors, influence living or since the patient’s last visit and distress significantly impact medication-
with diabetes, both type 1 and type 2, whether the person can identify a trig- taking behaviors and are linked to higher
and achieving satisfactory medical out- gering event or change in circumstan- A1C, lower self-efficacy, and poorer
comes and psychological well-being. ces. Providers should also ask whether dietary and exercise behaviors (5,208,210).
Thus, individuals with diabetes and their there are new or different barriers to DSMES has been shown to reduce diabe-
families are challenged with complex, treatment and self-management, such tes distress (5). It may be helpful to
S58 Facilitating Behavior Change and Well-being to Improve Health Outcomes Diabetes Care Volume 43, Supplement 1, January 2020

provide counseling regarding expected ADA Mental Health Provider Directory measures is provided in the ADA position
diabetes-related versus generalized psy- (professional.diabetes.org/mhp_listing). statement “Psychosocial Care for People
chological distress, at diagnosis and when Ideally, psychosocial care providers with Diabetes” (1).
disease state or treatment changes (211). should be embedded in diabetes care
Diabetes distress should be routinely settings. Although the clinician may not Anxiety Disorders
monitored (212) using person-based feel qualified to treat psychological prob- Recommendations
diabetes-specific validated measures (1). lems (214), optimizing the patient-pro- 5.36 Consider screening for anxiety
If diabetes distress is identified, the person vider relationship as a foundation may in people exhibiting anxiety

n
should be referred for specific diabetes increase the likelihood of the patient or worries regarding diabetes
education to address areas of diabetes accepting referral for other services.

tio
complications, insulin admin-
self-care causing the patient distress Collaborative care interventions and a istration, and taking medications,
and impacting clinical management. team approach have demonstrated ef- as well as fear of hypoglyce-

a
People whose self-care remains im- ficacy in diabetes self-management, out- mia and/or hypoglycemia un-

ci
paired after tailored diabetes education comes of depression, and psychosocial awareness that interferes with
should be referred by their care team to a functioning (5,6). self-management behaviors, and

so
behavioral health provider for evaluation in those who express fear,
and treatment. Psychosocial/Emotional Distress dread, or irrational thoughts
Other psychosocial issues known to Clinically significant psychopathologic di- and/or show anxiety symp-

As
affect self-management and health out- agnoses are considerably more preva- toms such as avoidance be-
comes include attitudes about the illness, lent in people with diabetes than in haviors, excessive repetitive
expectations for medical management those without (215,216). Symptoms, behaviors, or social withdrawal.

s
and outcomes, available resources (fi- both clinical and subclinical, that inter- Refer for treatment if anxiety is
nancial, social, and emotional) (213), and fere with the person’s ability to carry out present. B
psychiatric history.
te
daily diabetes self-management tasks
must be addressed. In addition to im-
5.37 People with hypoglycemia un-
awareness, which can co-occur
be
Referral to a Mental Health Specialist pacting a person’s ability to carry out with fear of hypoglycemia, should
Indications for referral to a mental health self-management, and the association of be treated using blood glucose
ia

specialist familiar with diabetes manage- mental health diagnosis and poorer awareness training (or other ev-
ment may include positive screening for short-term glycemic stability, symptoms idence-based intervention) to
D

overall stress related to work-life bal- of emotional distress are associated with help re-establish awareness of
ance, diabetes distress, diabetes man- mortality risk (215). Providers should symptoms of hypoglycemia and
agement difficulties, depression, anxiety, consider an assessment of symptoms reduce fear of hypoglycemia. A
an

disordered eating, and cognitive dysfunc- of depression, anxiety, disordered eat-


tion (see Table 5.2 for a complete list). It ing, and cognitive capacities using ap- Anxiety symptoms and diagnosable dis-
orders (e.g., generalized anxiety disorder,
ic

is preferable to incorporate psychosocial propriate standardized/validated tools at


assessment and treatment into routine the initial visit, at periodic intervals when body dysmorphic disorder, obsessive-
er

care rather than waiting for a specific patient distress is suspected, and when compulsive disorder, specific phobias,
problem or deterioration in metabolic or there is a change in health, treatment, or and posttraumatic stress disorder) are
common in people with diabetes (217).
Am

psychological status to occur (32,207). life circumstance. Inclusion of caregivers


Providers should identify behavioral and and family members in this assessment The Behavioral Risk Factor Surveillance
mental health providers, ideally those is recommended. Diabetes distress is ad- System (BRFSS) estimated the lifetime
who are knowledgeable about diabetes dressed as an independent condition (see prevalence of generalized anxiety disorder
treatment and the psychosocial aspects the section DIABETES DISTRESS above), as this to be 19.5% in people with either type 1 or
19

of diabetes, to whom they can refer pa- state is very common and expected and type 2 diabetes (218). Common diabetes-
tients. The ADA provides a list of mental is distinct from the psychological dis- specific concerns include fears related to
health providers who have received orders discussed below (1). A list of age- hypoglycemia (219,220), not meeting
20

additional education in diabetes at the appropriate screening and evaluation blood glucose targets (217), and insulin
©

Table 5.2—Situations that warrant referral of a person with diabetes to a mental health provider for evaluation and treatment
c If self-care remains impaired in a person with diabetes distress after tailored diabetes education

c If a person has a positive screen on a validated screening tool for depressive symptoms
c In the presence of symptoms or suspicions of disordered eating behavior, an eating disorder, or disrupted patterns of eating
c If intentional omission of insulin or oral medication to cause weight loss is identified
c If a person has a positive screen for anxiety or fear of hypoglycemia
c If a serious mental illness is suspected
c In youth and families with behavioral self-care difficulties, repeated hospitalizations for diabetic ketoacidosis, or significant distress
c If a person screens positive for cognitive impairment
c Declining or impaired ability to perform diabetes self-care behaviors
c Before undergoing bariatric or metabolic surgery and after surgery if assessment reveals an ongoing need for adjustment support
care.diabetesjournals.org Facilitating Behavior Change and Well-being to Improve Health Outcomes S59

injections or infusion (221). Onset of


treatment approaches in con- with symptoms of disordered eat-
complications presents another critical
junction with collaborative care ing behavior, an eating disorder, or
point in the disease course when anxiety
with the patient’s diabetes treat- disrupted patterns of eating. B
can occur (1). People with diabetes who
ment team. A 5.42 Consider screening for disor-
exhibit excessive diabetes self-manage-
dered or disrupted eating using
ment behaviors well beyond what is
History of depression, current depres- validated screening measures
prescribed or needed to achieve glyce-
sion, and antidepressant medication use when hyperglycemia and weight
mic targets may be experiencing symp-
are risk factors for the development loss are unexplained based on

n
toms of obsessive compulsive disorder
of type 2 diabetes, especially if the in- self-reported behaviors related
(222).

tio
dividual has other risk factors such as to medication dosing, meal plan,
General anxiety is a predictor of in- obesity and family history of type 2 di- and physical activity. In addi-
jection-related anxiety and associated abetes (228–230). Elevated depressive tion, a review of the medical

a
with fear of hypoglycemia (220,223). symptoms and depressive disorders af- regimen is recommended to iden-

ci
Fear of hypoglycemia and hypoglyce- fect one in four patients with type 1 or tify potential treatment-related
mia unawareness often co-occur. In- type 2 diabetes (199). Thus, routine effects on hunger/caloric intake. B

so
terventions aimed at treating one often screening for depressive symptoms is
benefit both (224). Fear of hypoglycemia indicated in this high-risk population in- Estimated prevalence of disordered
may explain avoidance of behaviors as-

As
cluding people with type 1 or type 2 eating behavior and diagnosable eat-
sociated with lowering glucose such as diabetes, gestational diabetes mellitus, ing disorders in people with diabetes
increasing insulin doses or frequency of and postpartum diabetes. Regardless varies (234–236). For people with
monitoring. If fear of hypoglycemia is of diabetes type, women have signifi- type 1 diabetes, insulin omission causing

s
identified and a person does not have cantly higher rates of depression than glycosuria in order to lose weight is the
symptoms of hypoglycemia, a structured

te
men (231). most commonly reported disordered eat-
program of blood glucose awareness Routine monitoring with appropriate ing behavior (237,238); in people with
training delivered in routine clinical prac-
be
validated measures (1) can help to identify type 2 diabetes, bingeing (excessive food
tice can improve A1C, reduce the rate if referral is warranted. Adult patients intake with an accompanying sense of loss
of severe hypoglycemia, and restore with a history of depressive symptoms of control) is most commonly reported.
ia

hypoglycemia awareness (225,226). If or disorder need ongoing monitoring of For people with type 2 diabetes treated
not available within the practice setting, depression recurrence within the context with insulin, intentional omission is also
D

a structured program targeting both of routine care (228). Integrating mental frequently reported (239). People with
fear of hypoglycemia and unawareness and physical health care can improve diabetes and diagnosable eating disorders
should be sought out and implemented
an

outcomes. When a patient is in psycho- have high rates of comorbid psychiatric


by a qualified behavioral practitioner logical therapy (talk therapy), the mental disorders (240). People with type 1 di-
(224,227). health provider should be incorporated abetes and eating disorders have high
ic

into the diabetes treatment team (232). rates of diabetes distress and fear of
Depression
As with DSMES, person-centered collab- hypoglycemia (241).
er

Recommendations orative care approaches have been


5.38 Providers should consider an- shown to improve both depression When evaluating symptoms of disor-
Am

nual screening of all patients and medical outcomes (233). dered or disrupted eating (when the
with diabetes, especially those Various randomized controlled trials individual exhibits eating behavior that
with a self-reported history of have shown improvements in diabetes is nonvolitional and maladaptive) in
depression, for depressive symp- and depression health outcomes when people with diabetes, etiology and
toms with age-appropriate de- depression is treated (233). It is impor- motivation for the behavior should be
19

pression screening measures, tant to note that medical regimen should considered (236,242). Adjunctive med-
recognizing that further evalu- also be monitored in response to re- ication such as glucagon-like peptide 1
receptor agonists (243) may help indi-
20

ation will be necessary for in- duction in depressive symptoms. People


dividuals who have a positive may agree to or adopt previously refused viduals not only to meet glycemic tar-
screen. B treatment strategies (improving ability gets but also to regulate hunger and
©

5.39 Beginning at diagnosis of com- to follow recommended treatment be- food intake, thus having the potential to
plications or when there are haviors), which may include increased reduce uncontrollable hunger and bu-
significant changes in medical physical activity and intensification of limic symptoms.
status, consider assessment for regimen behaviors and monitoring, result-
depression. B Serious Mental Illness
ing in changed glucose profiles.
5.40 Referrals for treatment of de- Recommendations
Disordered Eating Behavior
pression should be made to 5.43 Incorporate active monitoring
mental health providers with Recommendations of diabetes self-care activities
experience using cognitive be- 5.41 Providers should consider reeval- into treatment goals for people
havioral therapy, interpersonal uating the treatment regimen of with diabetes and serious men-
therapy, or other evidence-based people with diabetes who present tal illness. B
S60 Facilitating Behavior Change and Well-being to Improve Health Outcomes Diabetes Care Volume 43, Supplement 1, January 2020

American Association of Diabetes Educators, of the effect on glycemic control. Patient Educ
5.44 Annually screen people who are and the Academy of Nutrition and Dietetics. Couns 2016;99:926–943
prescribed atypical antipsychotic Diabetes Care 2015;38:1372–1382 19. Steinsbekk A, Rygg LØ, Lisulo M, Rise MB,
medications for prediabetes or 3. Rutten GEHM, Alzaid A. Person-centred type 2 Fretheim A. Group based diabetes self-management
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5.45 If a second-generation antipsy-
4. Dickinson JK, Guzman SJ, Maryniuk MD, et al. atic review with meta-analysis. BMC Health Serv
chotic medication is prescribed The use of language in diabetes care and edu- Res 2012;12:213
for adolescents or adults with cation. Diabetes Care 2017;40:1790–1799 20. Deakin T, McShane CE, Cade JE, Williams
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glycemic control, and choles- a pragmatic trial to reduce diabetes distress. ment strategies in people with type 2 diabetes

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terol levels should be carefully Diabetes Care 2013;36:2551–2558 mellitus. Cochrane Database Syst Rev 2005;2:
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a
and diabetes mellitus: a systematic review and ity of life outcomes following diabetes self-
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ci
Studies of individuals with serious men- 7. Hill-Briggs F. Problem solving in diabetes self- 815–823
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so
management behavior. Ann Behav Med 2003;25: management education reduces risk of all-cause
and other thought disorders, show sig-
182–193 mortality in type 2 diabetes patients: a systematic
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As
abetes (244). People with schizophrenia Effect of DECIDE (Decision-making Education for 712–731
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te
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ia

value of the diabetes educator. Diabetes Educ


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D

In addition, those taking second-gener- 11. Beck J, Greenwood DA, Blanton L, et al.; 2017 GF, Howell BL. One-year outcomes of diabetes
ation (atypical) antipsychotics, such as Standards Revision Task Force. 2017 National self-management training among Medicare ben-
Standards for Diabetes Self-Management Edu- eficiaries newly diagnosed with diabetes. Med
an

olanzapine, require greater monitoring


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ic

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©

port. Diabetes Care 2013;37(Suppl. 1):S144–S153 427–438


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S66 Diabetes Care Volume 43, Supplement 1, January 2020

6. Glycemic Targets: Standards of American Diabetes Association

Medical Care in Diabetesd2020

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Diabetes Care 2020;43(Suppl. 1):S66–S76 | https://doi.org/10.2337/dc20-S006

a tio
ci
so
As
The American Diabetes Association (ADA) “Standards of Medical Care in Diabe-
tes” includes the ADA’s current clinical practice recommendations and is intended to
provide the components of diabetes care, general treatment goals and guidelines,
and tools to evaluate quality of care. Members of the ADA Professional Practice

s
Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc20-

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6. GLYCEMIC TARGETS

SPPC), are responsible for updating the Standards of Care annually, or more
frequently as warranted. For a detailed description of ADA standards, statements,
be
and reports, as well as the evidence-grading system for ADA’s clinical practice
recommendations, please refer to the Standards of Care Introduction (https://doi
.org/10.2337/dc20-SINT). Readers who wish to comment on the Standards of Care
ia

are invited to do so at professional.diabetes.org/SOC.


D
an

ASSESSMENT OF GLYCEMIC CONTROL


Glycemic management is primarily assessed with the A1C test, which was the
measure studied in clinical trials demonstrating the benefits of improved glycemic
ic

control. Patient self-monitoring of blood glucose (SMBG) may help with self-
management and medication adjustment, particularly in individuals taking insulin.
er

Continuous glucose monitoring (CGM) also has an important role in assessing the
effectiveness and safety of treatment in many patients with type 1 diabetes, and
Am

limited data suggest it may also be helpful in selected patients with type 2 diabetes,
such as those on intensive insulin regimens (1).

A1C Testing
19

Recommendations
6.1 Perform the A1C test at least two times a year in patients who are meeting
treatment goals (and who have stable glycemic control). E
20

6.2 Perform the A1C test quarterly in patients whose therapy has changed or
who are not meeting glycemic goals. E
6.3 Point-of-care testing for A1C provides the opportunity for more timely
©

treatment changes. E

A1C reflects average glycemia over approximately 3 months. The performance of Suggested citation: American Diabetes Associa-
the test is generally excellent for National Glycohemoglobin Standardization tion. 6. Glycemic targets: Standards of Medical
Program (NGSP)-certified assays (see www.ngsp.org). The test is the major tool Care in Diabetesd2020. Diabetes Care 2020;
for assessing glycemic control and has strong predictive value for diabetes 43(Suppl. 1):S66–S76
complications (1–3). Thus, A1C testing should be performed routinely in all patients © 2019 by the American Diabetes Association.
with diabetesdat initial assessment and as part of continuing care. Measurement Readers may use this article as long as the work
is properly cited, the use is educational and not
approximately every 3 months determines whether patients’ glycemic targets have for profit, and the work is not altered. More infor-
been reached and maintained. The frequency of A1C testing should depend on mation is available at http://www.diabetesjournals
the clinical situation, the treatment regimen, and the clinician’s judgment. The .org/content/license.
care.diabetesjournals.org Glycemic Targets S67

use of point-of-care A1C testing may also inform the accuracy of the patient’s ethnic groups in the regression lines
provide an opportunity for more timely meter (or the patient’s reported SMBG between A1C and mean glucose, al-
treatment changes during encounters results) and the adequacy of the SMBG though the study was underpowered
between patients and providers. Pa- testing schedule. to detect a difference and there was a
tients with type 2 diabetes with stable trend toward a difference between the
glycemia well within target may do well Correlation Between SMBG and A1C African/African American and non-Hispanic
with A1C testing only twice per year. Table 6.1 shows the correlation between white cohorts, with higher A1C values
Unstable or intensively managed pa- A1C levels and mean glucose levels based observed in Africans/African Americans

n
tients or people not at goal with treat- on the international A1C-Derived Average compared with non-Hispanic whites
ment adjustments may require testing for a given mean glucose. Other studies

tio
Glucose (ADAG) study, which assessed the
more frequently (every 3 months) (4). correlation between A1C and frequent have also demonstrated higher A1C levels
SMBG and CGM in 507 adults (83% non- in African Americans than in whites

a
A1C Limitations Hispanic whites) with type 1, type 2, and at a given mean glucose concentration

ci
The A1C test is an indirect measure of no diabetes (6), and an empirical study of (8,9).
average glycemia and, as such, is sub- the average blood glucose levels at pre- A1C assays are available that do not

so
ject to limitations. As with any labo- meal, postmeal, and bedtime associated demonstrate a statistically significant
ratory test, there is variability in the with specified A1C levels using data from difference in individuals with hemoglo-
measurement of A1C. Although such the ADAG trial (7). The American Diabe- bin variants. Other assays have statisti-

As
variability is less on an intraindividual tes Association (ADA) and the American cally significant interference, but the
basis than that of blood glucose measure- Association for Clinical Chemistry have difference is not clinically significant.
ments, clinicians should exercise judg- determined that the correlation (r 5 Use of an assay with such statistically

s
ment when using A1C as the sole basis 0.92) in the ADAG trial is strong enough significant interference may explain a
for assessing glycemic control, particu- to justify reporting both the A1C result report that for any level of mean glyce-
larly if the result is close to the threshold
that might prompt a change in medica- te
and the estimated average glucose (eAG)
result when a clinician orders the A1C
mia, African Americans heterozygous for
the common hemoglobin variant HbS
be
tion therapy. Conditions that affect red test. Clinicians should note that the had lower A1C by about 0.3 percentage
blood cell turnover (hemolytic and other mean plasma glucose numbers in Table points when compared with those with-
6.1 are based on ;2,700 readings per A1C
ia

anemias, glucose-6-phosphate dehydro- out the trait (10,11). Another genetic


genase deficiency, recent blood trans- in the ADAG trial. In a recent report, mean variant, X-linked glucose-6-phosphate
D

fusion, use of drugs that stimulate glucose measured with CGM versus cen- dehydrogenase G202A, carried by 11%
erythropoesis, end-stage kidney disease, tral laboratory–measured A1C in 387 of African Americans, was associated
and pregnancy) may result in discrep- participants in three randomized trials with a decrease in A1C of about 0.8%
an

ancies between the A1C result and the demonstrated that A1C may underesti- in hemizygous men and 0.7% in homo-
patient’s true mean glycemia. Hemoglo- mate or overestimate mean glucose (5). zygous women compared with those
bin variants must be considered, partic- Thus, as suggested, a patient’s CGM pro- without the trait (12).
ic

ularly when the A1C result does not file has considerable potential for opti- A small study comparing A1C to CGM
er

correlate with the patient’s SMBG levels. mizing his or her glycemic management data in children with type 1 diabetes
However, most assays in use in the U.S. (5). found a highly statistically significant
are accurate in individuals heterozy- correlation between A1C and mean
Am

gous for the most common variants A1C Differences in Ethnic Populations blood glucose, although the correlation
(see www.ngsp.org/interf.asp). Other and Children (r 5 0.7) was significantly lower than in
measures of average glycemia such as In the ADAG study, there were no sig- the ADAG trial (13). Whether there are
fructosamine and 1,5-anhydroglucitol nificant differences among racial and clinically meaningful differences in how
19

are available, but their translation into


average glucose levels and their prog- Table 6.1—Estimated average glucose (eAG)
nostic significance are not as clear as for
20

A1C (%) mg/dL* mmol/L


A1C. Though some variability in the re-
lationship between average glucose lev- 5 97 (76–120) 5.4 (4.2–6.7)
6 126 (100–152) 7.0 (5.5–8.5)
©

els and A1C exists among different


individuals, generally the association be- 7 154 (123–185) 8.6 (6.8–10.3)
tween mean glucose and A1C within an 8 183 (147–217) 10.2 (8.1–12.1)
individual correlates over time (5). 9 212 (170–249) 11.8 (9.4–13.9)
A1C does not provide a measure of 10 240 (193–282) 13.4 (10.7–15.7)
glycemic variability or hypoglycemia. For 11 269 (217–314) 14.9 (12.0–17.5)
patients prone to glycemic variability, 12 298 (240–347) 16.5 (13.3–19.3)
especially patients with type 1 diabetes Data in parentheses are 95% CI. A calculator for converting A1C results into eAG, in either mg/dL or
or type 2 diabetes with severe insulin mmol/L, is available at professional.diabetes.org/eAG. *These estimates are based on ADAG data
deficiency, glycemic control is best of ;2,700 glucose measurements over 3 months per A1C measurement in 507 adults with type 1,
type 2, or no diabetes. The correlation between A1C and average glucose was 0.92 (6,7). Adapted from
evaluated by the combination of results
Nathan et al. (6).
from SMBG or CGM and A1C. A1C may
S68 Glycemic Targets Diabetes Care Volume 43, Supplement 1, January 2020

A1C relates to average glucose in children response to therapy and assess whether providers. Reports can be generated
or in different ethnicities is an area for glycemic targets are being safely achieved. from CGM that will allow the provider
further study (8,14,15). Until further The international consensus on time in to determine time in range (TIR) and to
evidence is available, it seems prudent range provides guidance on standardized assess hypoglycemia, hyperglycemia, and
to establish A1C goals in these popula- CGM metrics (see Table 6.2) and consid- glycemic variability. As discussed in a re-
tions with consideration of both individ- erations for clinical interpretation and cent consensus document, a report for-
ualized SMBG and A1C results. care (17). To make these metrics more matted as shown in Fig. 6.1 can be
actionable, standardized reports with generated (17). Published data sug-

n
Glucose Assessment visual cues such as the Ambulatory Glu- gest a strong correlation between TIR
cose Profile (see Fig. 6.1) are recommended and A1C, with a goal of 70% TIR aligning

tio
Recommendations
(17) and may help the patient and the with an A1C of ;7% in two prospective
6.4 Standardized, single-page glu-
provider interpret the data and use it to studies (18,19).
cose reports with visual cues

a
guide treatment decisions. Integrating
such as the Ambulatory Glucose A1C GOALS

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SMBG and CGM results into diabetes
Profile (AGP) should be consid-
management can be useful for guiding For glycemic goals in older adults, please
ered as a standard printout for

so
all CGM devices. E
medical nutrition therapy and physical refer to Section 12 “Older Adults” (https://
activity, preventing hypoglycemia, and doi.org/10.2337/dc20-S012). For glycemic
6.5 Time in range (TIR) is associated
adjusting medications. As recently re- goals in children, please refer to Section

As
with the risk of microvascular
viewed, while A1C is currently the primary 13 “Children and Adolescents” (https://
complications and should be an
measure guiding glucose management doi.org/10.2337/dc20-S013). For glycemic
acceptable end point for clinical
and a valuable marker of the risk of goals in pregnant women, please refer to
trials and can be used for assess-
Section 14 “Management of Diabetes in

s
developing diabetes complications, the
ment of glycemic control. Addi-
Glucose Management Indicator (GMI) along Pregnancy” (https://doi.org/10.2337/dc20-

te
tionally, time below target (,70
with the other CGM metrics are suggested S014).
and ,54 mg/dL [3.9 and 3.0
to provide for a much more personalized
be
mmol/L]) and time above target
diabetes management plan. The incorpo- Recommendations
(.180 mg/dL [10.0 mmol/L]) are
ration of these metrics into clinical prac- 6.6 An A1C goal for many nonpreg-
useful parameters for reevaluation
ia

tice is in evolution, and optimization of nant adults of ,7% (53 mmol/mol)


of the treatment regimen. E
CGM terminology will evolve to suit pa- is appropriate. A
D

tient and provider needs. The patient’s 6.7 On the basis of provider judge-
For many people with diabetes, glucose specific needs and goals should dictate ment and patient preference,
monitoring is key for the achievement of SMBG frequency and timing or the con-
an

achievement of lower A1C levels


glycemic targets. Major clinical trials of sideration of CGM use. Please refer to (such as ,6.5%) may be accept-
insulin-treated patients have included Section 7 “Diabetes Technology” (https:// able if this can be achieved safely
SMBG as part of multifactorial interven- doi.org/10.2337/dc20-S007) for a fuller
ic

without significant hypoglyce-


tions to demonstrate the benefit of in- discussion of the use of SMBG and CGM. mia or other adverse effects of
er

tensive glycemic control on diabetes treatment. C


complications (16). SMBG is thus an in- Glucose Assessment Using 6.8 Less stringent A1C goals (such as
tegral component of effective therapy of
Am

Continuous Glucose Monitoring ,8% [64 mmol/mol]) may be


patients taking insulin. In recent years, With the advent of new technology, CGM appropriate for patients with a
CGM has emerged as a complementary has evolved rapidly in both accuracy and history of severe hypoglycemia,
method for the assessment of glucose affordability. As such, many patients have limited life expectancy, advanced
levels. Glucose monitoring allows pa- these data available to assist with both microvascular or macrovascular
19

tients to evaluate their individual self-management and assessment by


20

Table 6.2—Standardized continuous glucose monitoring (CGM) metrics for clinical care
1. Number of days CGM device is worn (recommend 14 days)
©

2. Percentage of time CGM device is active (recommend 70% of data from 14 days)
3. Mean glucose
4. Glucose management indicator (GMI)
5. Glycemic variability (%CV) target #36%*
6. Time above range (TAR): % of readings and time .250 mg/dL (.13.9 mmol/L) Level 2
7. Time above range (TAR): % of readings and time 181–250 mg/dL (10.1–13.9 mmol/L) Level 1
8. Time in range (TIR): % of readings and time 70–180 mg/dL (3.9–10.0 mmol/L) In range
9. Time below range (TBR): % of readings and time 54–69 mg/dL (3.0–3.8 mmol/L) Level 1
10. Time below range (TBR): % of readings and time ,54 mg/dL (,3.0 mmol/L) Level 2
CGM, continuous glucose monitoring; CV, coefficient of variation. *Some studies suggest that lower %CV targets (,33%) provide additional protection
against hypoglycemia for those receiving insulin or sulfonylureas. Adapted from Battelino et al. (17).
care.diabetesjournals.org Glycemic Targets S69

n
a tio
ci
so
As
s
Figure 6.1—Sample Ambulatory Glucose Profile (AGP) report. Adapted from Battelino et al. (17).

te
glycemic separation between the treat- low hypoglycemia risk with a long life
be
complications, extensive comorbid
ment groups diminished and disappeared expectancy.
conditions, or long-standing dia-
during follow-up. Given the substantially increased risk
betes in whom the goal is difficult
The Kumamoto Study (22) and UK of hypoglycemia in type 1 diabetes and
ia

to achieve despite diabetes self-


Prospective Diabetes Study (UKPDS) with polypharmacy in type 2 diabetes,
management education, appropri-
(23,24) confirmed that intensive glyce- the risks of lower glycemic targets may
D

ate glucose monitoring, and ef-


fective doses of multiple glucose- mic control significantly decreased rates outweigh the potential benefits on
lowering agents including insulin. of microvascular complications in pa- microvascular complications. Three land-
an

B tients with short-duration type 2 diabe- mark trials (Action to Control Cardiovas-
6.9 Reassess glycemic targets over tes. Long-term follow-up of the UKPDS cular Risk in Diabetes [ACCORD], Action
cohorts showed enduring effects of early in Diabetes and Vascular Disease: Pre-
ic

time based on the criteria in


Fig. 6.2 or, in older adults, glycemic control on most microvascular terax and Diamicron MR Controlled Eval-
er

Table 12.1. E complications (25). uation [ADVANCE], and Veterans Affairs


Therefore, achieving A1C targets Diabetes Trial [VADT]) were conducted
of ,7% (53 mmol/mol) has been shown to test the effects of near normalization
Am

A1C and Microvascular Complications to reduce microvascular complications of blood glucose on cardiovascular out-
Hyperglycemia defines diabetes, and gly- of type 1 and type 2 diabetes when comes in individuals with long-standing
cemic control is fundamental to diabetes instituted early in the course of disease type 2 diabetes and either known car-
management. The Diabetes Control and (26). Epidemiologic analyses of the DCCT diovascular disease (CVD) or high cardio-
19

Complications Trial (DCCT) (16), a pro- (16) and UKPDS (27) demonstrate a cur- vascular risk. These trials showed that
spective randomized controlled trial of lower A1C levels were associated with
vilinear relationship between A1C and
intensive (mean A1C about 7% [53 reduced onset or progression of some
20

microvascular complications. Such anal-


mmol/mol]) versus standard (mean A1C microvascular complications (28–30).
yses suggest that, on a population level,
about 9% [75 mmol/mol]) glycemic control The concerning mortality findings in
the greatest number of complications
©

in patients with type 1 diabetes, showed the ACCORD trial (31), discussed below,
will be averted by taking patients from
definitively that better glycemic control and the relatively intense efforts re-
is associated with 50–76% reductions very poor control to fair/good control. quired to achieve near euglycemia should
in rates of development and progres- These analyses also suggest that further also be considered when setting glycemic
sion of microvascular (retinopathy, neu- loweringofA1Cfrom7%to6%[53mmol/mol targets for individuals with long-standing
ropathy, and diabetic kidney disease) to 42 mmol/mol] is associated with fur- diabetes such as those studied in ACCORD,
complications. Follow-up of the DCCT ther reduction in the risk of microvascular ADVANCE, and VADT. Findings from these
cohorts in the Epidemiology of Diabetes complications, although the absolute risk studies suggest caution is needed in
Interventions and Complications (EDIC) reductions become much smaller. The im- treating diabetes aggressively to near-
study (20,21) demonstrated persistence plication of these findings is that there is no normal A1C goals in people with long-
of these microvascular benefits over need to deintensify therapy for an individ- standing type 2 diabetes with or at
two decades despite the fact that the ual with an A1C between 6% and 7% and significant risk of CVD. However, on the
S70 Glycemic Targets Diabetes Care Volume 43, Supplement 1, January 2020

basis of physician judgment and patient years of observational follow-up, those targets, therapeutic approaches, and
preferences, select patients, especially originally randomized to intensive glyce- population characteristics (41).
those with little comorbidity and long mic control had significant long-term Mortality findings in ACCORD (31) and
life expectancy, may benefit from adopt- reductions in MI (15% with sulfonylurea subgroup analyses of VADT (42) suggest
ing more intensive glycemic targets if or insulin as initial pharmacotherapy, that the potential risks of intensive gly-
they can achieve it safely without hy- 33% with metformin as initial pharma- cemic control may outweigh its benefits
poglycemia or significant therapeutic cotherapy) and in all-cause mortality in higher-risk patients. In all three trials,
burden. (13% and 27%, respectively) (25). severe hypoglycemia was significantly

n
ACCORD, ADVANCE, and VADT sug- more likely in participants who were
A1C and Cardiovascular Disease gested no significant reduction in CVD randomly assigned to the intensive gly-

tio
Outcomes outcomes with intensive glycemic con- cemic control arm. Those patients with
Cardiovascular Disease and Type 1 Diabetes trol in participants followed for shorter long duration of diabetes, a known history

a
CVD is a more common cause of death durations (3.5–5.6 years) and who had of hypoglycemia, advanced atherosclero-
than microvascular complications in pop-

ci
more advanced type 2 diabetes than sis, or advanced age/frailty may benefit
ulations with diabetes. There is evidence UKPDS participants. All three trials from less aggressive targets (43,44).
for a cardiovascular benefit of intensive

so
were conducted in relatively older par- As discussed further below, severe
glycemic control after long-term follow-up ticipants with longer known duration of hypoglycemia is a potent marker of
of cohorts treated early in the course of diabetes (mean duration 8–11 years) and high absolute risk of cardiovascular

As
type 1 diabetes. In the DCCT, there was a either CVD or multiple cardiovascular risk events and mortality (45). Providers
trend toward lower risk of CVD events factors. The target A1C among intensive- should be vigilant in preventing hypo-
with intensive control. In the 9-year control subjects was ,6% (42 mmol/mol) glycemia and should not aggressively
post-DCCT follow-up of the EDIC cohort, in ACCORD, ,6.5% (48 mmol/mol) in

s
attempt to achieve near-normal A1C
participants previously randomized to ADVANCE, and a 1.5% reduction in A1C levels in patients in whom such tar-
the intensive arm had a significant 57%
reduction in the risk of nonfatal myo-
te
compared with control subjects in VADT,
with achieved A1C of 6.4% vs. 7.5%
gets cannot be safely and reasonably
achieved. As discussed in Section 9 “Phar-
be
cardial infarction (MI), stroke, or car- (46 mmol/mol vs. 58 mmol/mol) in macologic Approaches to Glycemic Treat-
diovascular death compared with those ACCORD, 6.5% vs. 7.3% (48 mmol/mol ment” (https://doi.org/10.2337/dc20-S009),
previously randomized to the standard
ia

vs. 56 mmol/mol) in ADVANCE, and 6.9% addition of specific sodium–glucose co-


arm (32). The benefit of intensive gly- vs. 8.4% (52 mmol/mol vs. 68 mmol/mol) transporter 2 inhibitors (SGLT2i) or gluca-
cemic control in this cohort with type 1
D

in VADT. Details of these studies are gon-like peptide 1 receptor agonists (GLP-1
diabetes has been shown to persist for reviewed extensively in “Intensive Gly- RA) that have demonstrated CVD benefit
several decades (33) and to be associ- cemic Control and the Prevention of are recommended for use in patients with
an

ated with a modest reduction in all- Cardiovascular Events: Implications of established CVD or indicators of high risk.
cause mortality (34). the ACCORD, ADVANCE, and VA Diabetes As outlined in more detail in Section 9
Cardiovascular Disease and Type 2 Diabetes Trials” (38). “Pharmacologic Approaches to Glycemic
ic

In type 2 diabetes, there is evidence The glycemic control comparison in Treatment” (https://doi.org/10.2337/dc20-
S009) and Section 10 “Cardiovascular Dis-
er

that more intensive treatment of glyce- ACCORD was halted early due to an
mia in newly diagnosed patients may increased mortality rate in the intensive ease and Risk Management” (https://doi
reduce long-term CVD rates. In addi- compared with the standard treatment .org/10.2337/dc20-S010), the cardiovas-
Am

tion, data from the Swedish National arm (1.41% vs. 1.14% per year; hazard cular benefits of SGLT2i or GLP-1 RA are
Diabetes Registry and Joint Asia Diabetes ratio 1.22 [95% CI 1.01–1.46]), with a not dependent upon A1C lowering, so
Evaluation (JADE) demonstrate greater similar increase in cardiovascular deaths. initiation can be considered in people with
proportions of people with diabetes be- Analysis of the ACCORD data did not type 2 diabetes and CVD independent of
19

ing diagnosed at ,40 years of age and a identify a clear explanation for the ex- the current A1C or A1C goal. Based on
demonstrably increased burden of heart cess mortality in the intensive treat- these considerations, the following two
disease and years of life lost in people ment arm (31). strategies are offered (46):
20

diagnosed at a younger age (35–37). Longer-term follow-up has shown no


Thus, for prevention of both microvas- evidence of cardiovascular benefit or 1. If already on dual therapy or multiple
glucose-lowering therapies and not
©

cular and macrovascular complications harm in the ADVANCE trial (39). The
of diabetes, there is a major call to end-stage renal disease rate was lower on an SGLT2i or GLP-1 RA, consider
overcome therapeutic inertia and treat in the intensive treatment group over switching to one of these agents with
to target for an individual patient (37). follow-up. However, 10-year follow-up of proven cardiovascular benefit.
During the UKPDS, there was a 16% the VADT cohort (40) showed a reduction 2. Introduce SGLT2i or GLP-1 RA in pa-
reduction in CVD events (combined fa- in the risk of cardiovascular events (52.7 tients with CVD at A1C goal for car-
tal or nonfatal MI and sudden death) [control group] vs. 44.1 [intervention diovascular benefit.
in the intensive glycemic control arm group] events per 1,000 person-years) Setting and Modifying A1C Goals
that did not reach statistical signifi- with no benefit in cardiovascular or over- Numerous factors must be considered
cance (P 5 0.052), and there was no all mortality. Heterogeneity of mortal- when setting glycemic targets. The ADA
suggestion of benefit on other CVD out- ity effects across studies was noted, proposes general targets appropriate
comes (e.g., stroke). However, after 10 which may reflect differences in glycemic for many patients but emphasizes the
care.diabetesjournals.org Glycemic Targets S71

in Table 6.3. The recommendations in-


clude blood glucose levels that appear
to correlate with achievement of an
A1C of ,7% (53 mmol/mol). Pregnancy
recommendations are discussed in
more detail in Section 14 “Management
of Diabetes in Pregnancy” (https://doi
.org/10.2337/dc20-S014).

n
The issue of preprandial versus post-
prandial SMBG targets is complex (48).

tio
Elevated postchallenge (2-h oral glucose
tolerance test) glucose values have been

a
associated with increased cardiovascu-

ci
lar risk independent of fasting plasma
glucose in some epidemiologic studies,

so
but intervention trials have not shown
postprandial glucose to be a cardiovas-
cular risk factor independent of A1C. In

As
subjects with diabetes, surrogate meas-
ures of vascular pathology, such as
endothelial dysfunction, are negatively

s
affected by postprandial hyperglycemia.
It is clear that postprandial hypergly-

te cemia, like preprandial hyperglycemia,


contributes to elevated A1C levels, with
be
Figure 6.2—Depicted are patient and disease factors used to determine optimal A1C targets. its relative contribution being greater at
Characteristics and predicaments toward the left justify more stringent efforts to lower A1C; A1C levels that are closer to 7% (53 mmol/
those toward the right suggest less stringent efforts. A1C 7% 5 53 mmol/mol. Adapted with
ia

permission from Inzucchi et al. (47).


mol). However, outcome studies have
clearly shown A1C to be the primary
D

predictor of complications, and landmark


importance of individualization based on Diabetes is a chronic disease that trials of glycemic control such as the DCCT
key patient characteristics. Glycemic tar- progresses over decades. Thus, a goal and UKPDS relied overwhelmingly on pre-
an

gets must be individualized in the context that might be appropriate for an indi- prandial SMBG. Additionally, a random-
of shared decision-making to address the vidual early in the course of the disease ized controlled trial in patients with
needs and preferences of each patient may change over time. Newly diag- known CVD found no CVD benefit of
ic

and the individual characteristics that nosed patients and/or those without insulin regimens targeting postprandial
er

influence risks and benefits of therapy comorbidities that limit life expectancy glucose compared with those targeting
for each patient. may benefit from intensive control proven preprandial glucose (49). Therefore, it is
The factors to consider in individual- to prevent microvascular complications. reasonable for postprandial testing to be
Am

izing goals are depicted in Fig. 6.2. Figure Both DCCT/EDIC and UKPDS demon- recommended for individuals who have
6.2 is not designed to be applied rigidly strated metabolic memory, or a legacy premeal glucose values within target but
but to be used as a broad construct to effect, in which a finite period of intensive have A1C values above target. Measuring
guide clinical decision-making (47) and control yielded benefits that extended for postprandial plasma glucose 1–2 h after
19

engage in shared decision-making in both decades after that control ended. Thus, the start of a meal and using treatments
type 1 and type 2 diabetes. More strin- a finite period of intensive control to near- aimed at reducing postprandial plasma
normal A1C may yield enduring benefits glucosevaluesto,180mg/dL(10.0mmol/L)
20

gent targets may be recommended if


they can be achieved safely and with even if control is subsequently deintensi- may help to lower A1C.
acceptable burden of therapy and if life fied as patient characteristics change. An analysis of data from 470 partici-
Over time, comorbidities may emerge,
©

pants in the ADAG study (237 with type 1


expectancy is sufficient to reap benefits
decreasing life expectancy and thereby diabetes and 147 with type 2 diabetes)
of stringent targets. Less stringent tar-
potential to reap benefits from intensive found that the glucose ranges high-
gets (A1C up to 8% [64 mmol/mol]) may
control. Also, with longer duration of lighted in Table 6.1 are adequate to
be recommended if the life expectancy of disease, diabetes may become more meet targets and decrease hypoglycemia
the patient is such that the benefits of an difficult to control, with increasing risks (7,50). These findings support that pre-
intensive goal may not be realized, or if and burdens of therapy. Thus, A1C tar- meal glucose targets may be relaxed
the risks and burdens outweigh the po- gets should be reevaluated over time to without undermining overall glycemic
tential benefits. Severe or frequent hy- balance the risks and benefits as patient control as measured by A1C. These
poglycemia is an absolute indication for factors change. data prompted the revision in the
the modification of treatment regimens, Recommended glycemic targets for ADA-recommended premeal glucose tar-
including setting higher glycemic goals. many nonpregnant adults are shown get to 80–130 mg/dL (4.4–7.2 mmol/L)
S72 Glycemic Targets Diabetes Care Volume 43, Supplement 1, January 2020

but did not affect the definition of hy- Table 6.3—Summary of glycemic recommendations for many nonpregnant adults
poglycemia. with diabetes
A1C ,7.0% (53 mmol/mol)*
HYPOGLYCEMIA Preprandial capillary plasma glucose 80–130 mg/dL* (4.4–7.2 mmol/L)
Recommendations Peak postprandial capillary plasma glucose† ,180 mg/dL* (10.0 mmol/L)
6.10 Individuals at risk for hypogly- *More or less stringent glycemic goals may be appropriate for individual patients. Goals should be
cemia should be asked about individualized based on duration of diabetes, age/life expectancy, comorbid conditions, known
CVD or advanced microvascular complications, hypoglycemia unawareness, and individual patient
symptomatic and asymptom-

n
considerations. †Postprandial glucose may be targeted if A1C goals are not met despite reaching
atic hypoglycemia at each en- preprandial glucose goals. Postprandial glucose measurements should be made 1–2 h after the

tio
counter. C beginning of the meal, generally peak levels in patients with diabetes.
6.11 In patients taking medication
that can lead to hypoglycemia,

a
investigate, screen, and assess If a patient has level 2 hypoglycemia
at least several weeks in order to

ci
risk for or occurrence of un- without adrenergic or neuroglycopenic
partially reverse hypoglycemia
recognized hypoglycemia, con- symptoms, they likely have hypoglycemia

so
unawareness and reduce risk of
sidering that patients may unawareness (discussed further below).
future episodes. A
have hypoglycemia unaware- This clinical scenario warrants investiga-
6.16 Ongoing assessment of cogni-
ness. C

As
tion and review of the medical regimen.
tive function is suggested with
6.12 Glucose (15–20 g) is the preferred Lastly, level 3 hypoglycemia is defined as a
increased vigilance for hypogly-
treatment for the conscious in- severe event characterized by altered
cemia by the clinician, patient,
dividual with blood glucose ,70 mental and/or physical functioning
and caregivers if low cognition

s
mg/dL [3.9 mmol/L]), although that requires assistance from another
or declining cognition is found. B

te
any form of carbohydrate that person for recovery.
contains glucose may be used. Symptoms of hypoglycemia include,
be
Fifteen minutes after treatment, Hypoglycemia is the major limiting but are not limited to, shakiness, irrita-
if SMBG shows continued hypo- factor in the glycemic management of bility, confusion, tachycardia, and hun-
glycemia,thetreatmentshouldbe type 1 and type 2 diabetes. Recommen- ger. Hypoglycemia may be inconvenient
ia

repeated. Once SMBG returns to dations regarding the classification of or frightening to patients with diabetes.
normal, the individual should con- hypoglycemia are outlined in Table 6.4 Level 3 hypoglycemia may be recognized
D

sume a meal or snack to prevent (51–56). Level 1 hypoglycemia is defined or unrecognized and can progress to
recurrence of hypoglycemia. B as a measurable glucose concentration loss of consciousness, seizure, coma,
6.13 Glucagon should be prescribed ,70 mg/dL (3.9 mmol/L) but $54 mg/dL
an

or death. It is reversed by administration


for all individuals at increased risk (3.0 mmol/L). A blood glucose concen- of rapid-acting glucose or glucagon. Hy-
of level 2 hypoglycemia, defined tration of 70 mg/dL (3.9 mmol/L) has poglycemia can cause acute harm to the
ic

as blood glucose ,54 mg/dL been recognized as a threshold for neu- person with diabetes or others, espe-
(3.0 mmol/L), so it is available roendocrine responses to falling glucose cially if it causes falls, motor vehicle
er

should it be needed. Caregivers, in people without diabetes. Because accidents, or other injury. Recurrent
school personnel, or family mem- many people with diabetes demonstrate level 2 hypoglycemia and/or level 3 hy-
Am

bers of these individuals should impaired counterregulatory responses poglycemia is an urgent medical issue
know where it is and when and to hypoglycemia and/or experience hy- and requires intervention with medical
how to administer it. Glucagon poglycemia unawareness, a measured regimen adjustment, behavioral inter-
administration is not limited to glucose level ,70 mg/dL (3.9 mmol/L) is vention, and, in some cases, use of
health care professionals, partic- considered clinically important, inde- technology to assist with hypoglycemia
19

ularly with the availability of intra- pendent of the severity of acute hypo- prevention and identification (52,57–60).
nasal and stable soluble glucagon glycemic symptoms. Level 2 hypoglycemia A large cohort study suggested that
available in autoinjector pens. E
20

(defined as a blood glucose concentration among older adults with type 2 diabetes,
6.14 Hypoglycemia unawareness or ,54 mg/dL [3.0 mmol/L]) is the thresh- a history of level 3 hypoglycemia was
one or more episodes of level old at which neuroglycopenic symp- associated with greater risk of dementia
©

3 hypoglycemia should trigger toms begin to occur and requires immediate (61). Conversely, in a substudy of the
hypoglycemia avoidance edu- action to resolve the hypoglycemic event. ACCORD trial, cognitive impairment at
cation and reevaluation of the
treatment regimen. E
Table 6.4—Classification of hypoglycemia
6.15 Insulin-treated patients with hy-
Glycemic criteria/description
poglycemia unawareness, one
level 3 hypoglycemic event, or Level 1 Glucose ,70 mg/dL (3.9 mmol/L) and $54 mg/dL (3.0 mmol/L)
a pattern of unexplained level 2 Level 2 Glucose ,54 mg/dL (3.0 mmol/L)
hypoglycemia should be advised Level 3 A severe event characterized by altered mental and/or physical status requiring
to raise their glycemic targets to assistance for treatment of hypoglycemia
strictly avoid hypoglycemia for Reprinted from Agiostratidou et al. (51).
care.diabetesjournals.org Glycemic Targets S73

baseline or decline in cognitive function and hypoglycemia unawareness that per- use of glucagon, including where
during the trial was significantly associ- sists despite medical treatment, human the glucagon product is kept and
ated with subsequent episodes of level islet transplantation may be an option, when and how to administer. An in-
3 hypoglycemia (62). Evidence from but the approach remains experimental dividual does not need to be a health
DCCT/EDIC, which involved adolescents (72,73). care professional to safely administer
and younger adults with type 1 diabetes, In 2015, the ADA changed its prepran- glucagon. In addition to traditional glu-
found no association between fre- dial glycemic target from 70–130 mg/dL cagon injection powder that requires
quency of level 3 hypoglycemia and (3.9–7.2 mmol/L) to 80–130 mg/dL (4.4– reconstitution prior to injection, intra-

n
cognitive decline (63), as discussed in 7.2 mmol/L). This change reflects the nasal glucagon and glucagon solution
Section 13 “Children and Adolescents” results of the ADAG study, which dem- for subcutaneous injection recently re-

tio
(https://doi.org/10.2337/dc20-S013). onstrated that higher glycemic targets ceived U.S. Food and Drug Administra-
Studies of rates of level 3 hypoglycemia corresponded to A1C goals (7). An addi- tion approval. Care should be taken to

a
that rely on claims data for hospitaliza- tional goal of raising the lower range of ensure that glucagon products are not

ci
tion, emergency department visits, and the glycemic target was to limit over- expired.
ambulance use substantially underesti- treatment and provide a safety margin

so
mate rates of level 3 hypoglycemia (64) in patients titrating glucose-lowering Hypoglycemia Prevention
yet find high burden of hypoglycemia in drugs such as insulin to glycemic targets. Hypoglycemia prevention is a critical
adults over 60 years of age in the com- component of diabetes management.

As
munity (65). African Americans are at Hypoglycemia Treatment SMBG and, for some patients, CGM
substantially increased risk of level 3 hy- Providers should continue to counsel are essential tools to assess therapy
poglycemia (65,66). In addition to age patients to treat hypoglycemia with and detect incipient hypoglycemia. Pa-
fast-acting carbohydrates at the hypo- tients should understand situations that

s
and race, other important risk factors
found in a community-based epidemi- glycemia alert value of 70 mg/dL increase their risk of hypoglycemia, such
ologic cohort of older black and white
adults with type 2 diabetes include insulin te
(3.9 mmol/L) or less. This should be
reviewed at each patient visit. Hypogly-
as when fasting for tests or procedures,
when meals are delayed, during and after
be
use, poor or moderate versus good gly- cemia treatment requires ingestion of the consumption of alcohol, during and
cemic control, albuminuria, and poor glucose- or carbohydrate-containing foods after intense exercise, and during sleep.
(74–76). The acute glycemic response Hypoglycemia may increase the risk of
ia

cognitive function (65). Level 3 hypo-


glycemia was associated with mortal- correlates better with the glucose con- harm to self or others, such as with
tent of food than with the carbohy- driving. Teaching people with diabetes
D

ity in participants in both the standard


and the intensive glycemia arms of the drate content of food. Pure glucose is the to balance insulin use and carbohydrate
ACCORD trial, but the relationships be- preferred treatment, but any form of intake and exercise are necessary, but
an

tween hypoglycemia, achieved A1C, and carbohydrate that contains glucose will these strategies are not always sufficient
treatment intensity were not straightfor- raise blood glucose. Added fat may retard for prevention.
ward. An association of level 3 hypo- and then prolong the acute glycemic In type 1 diabetes and severely insulin
ic

glycemia with mortality was also found response. In type 2 diabetes, ingested deficient type 2 diabetes, hypoglycemia
protein may increase insulin response unawareness (or hypoglycemia-associated
er

in the ADVANCE trial (67). An association


between self-reported level 3 hypoglyce- without increasing plasma glucose con- autonomic failure) can severely com-
mia and 5-year mortality has also been centrations (77). Therefore, carbohy- promise stringent diabetes control and
Am

reported in clinical practice (68) drate sources high in protein should not quality of life. This syndrome is char-
Young children with type 1 diabetes be used to treat or prevent hypogly- acterized by deficient counterregu-
and the elderly, including those with cemia. Ongoing insulin activity or latory hormone release, especially in
type 1 and type 2 diabetes (61,69), insulin secretagogues may lead to older adults, and a diminished auto-
19

are noted as particularly vulnerable to recurrent hypoglycemia unless more nomic response, which are both risk
hypoglycemia because of their reduced food is ingested after recovery. Once factors for, and caused by, hypoglyce-
ability to recognize hypoglycemic symp- the glucose returns to normal, the in- mia. A corollary to this “vicious cycle” is
20

toms and effectively communicate their dividual should be counseled to eat a that several weeks of avoidance of
needs. Individualized glucose targets, meal or snack to prevent recurrent hypoglycemia has been demonstrated
hypoglycemia. to improve counterregulation and hy-
©

patient education, dietary intervention


(e.g., bedtime snack to prevent overnight Glucagon poglycemia awareness in many patients
hypoglycemia when specifically needed The use of glucagon is indicated for (78). Hence, patients with one or more
to treat low blood glucose), exercise the treatment of hypoglycemia in peo- episodes of clinically significant hypo-
management, medication adjustment, ple unable or unwilling to consume glycemia may benefit from at least
glucose monitoring, and routine clinical carbohydrates by mouth. Those in close short-term relaxation of glycemic tar-
surveillance may improve patient out- contact with, or having custodial care gets and availability of glucagon (79).
comes (70). CGM with automated low of, people with hypoglycemia-prone di-
glucose suspend has been shown to be abetes (family members, roommates, Use of CGM Technology in
effective in reducing hypoglycemia in school personnel, childcare providers, Hypoglycemia Prevention
type 1 diabetes (71). For patients with correctional institution staff, or cow- With the advent of CGM and CGM-
type 1 diabetes with level 3 hypoglycemia orkers) should be instructed on the assisted pump therapy, there has been a
S74 Glycemic Targets Diabetes Care Volume 43, Supplement 1, January 2020

promise of alarm-based prevention of hyperglycemia requires temporary ad- 11. Rohlfing C, Hanson S, Little RR. Measure-
hypoglycemia (80,81). To date, there justment of the treatment regimen ment of hemoglobin A1c in patients with sickle
cell trait. JAMA 2017;317:2237
have been six randomized controlled and immediate interaction with the di- 12. Wheeler E, Leong A, Liu C-T, et al.; EPIC-CVD
trials in adults with type 1 diabetes abetes care team. The patient treated Consortium; EPIC-InterAct Consortium; Lifelines
and seven in adults and children with with noninsulin therapies or medical Cohort Study. Impact of common genetic deter-
type 1 diabetes using real-time CGM. nutrition therapy alone may require in- minants of Hemoglobin A1c on type 2 diabetes
These studies had differing A1C at entry sulin. Adequate fluid and caloric intake risk and diagnosis in ancestrally diverse popu-
lations: A transethnic genome-wide meta-
and differing primary end points and thus must be ensured. Infection or dehydra- analysis. PLoS Med 2017;14:e1002383

n
must be interpreted carefully. Real-time tion is more likely to necessitate hospi- 13. Wilson DM, Kollman; Diabetes Research in
CGM studies can be divided into studies talization of the person with diabetes

tio
Children Network (DirecNet) Study Group. Re-
with elevated A1C with the primary end than the person without diabetes. lationship of A1C to glucose concentrations in
point of A1C reduction and studies with A physician with expertise in diabe- children with type 1 diabetes: assessments by

a
high-frequency glucose determinations by sen-
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