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American Diabetes Association

Cure

Care

Commitment

ADA-SAP
Module 2

Pharmacological Treatment of Hyperglycemia

American Diabetes Association Self-Assessment Program


Multiple Choice Questions Assessment and Educational (Learning) Critiques Components

2008 American Diabetes Association. All rights reserved.

PEI

Developed and Published by: Professional Evaluation, Inc. Developing Medical Specialty Board Category 1 CME Programs for Over Three Decades Professional Evaluation Inc. 4 Midland Avenue, Suite 105, Berwyn, PA 19312-1687 | www.proevalinc.com

American Diabetes Association Self-Assessment Program (ADA-SAP )


TM

Module 2

Pharmacological Treatment of Hyperglycemia

Table of Contents
3 3 4 5 6 7 15 45 46 47 48 53 87 Learning Objectives Accreditation Faculty Disclosure Statement General Instructions Syllabus Multiple Choice Questions (MCQs) Appendix I. Diagnosis of Impaired Glucose Tolerance (IGT) and Impaired Fasting Glucose (IFG) II. Diagnosis of Type 2 Diabetes III. Summary of Recommendations for Adults with Diabetes Educational Critiques Answer Sheet & Program Evaluation Form

American Diabetes Association

Cure

Care

Commitment

Dear Health Care Professional: The American Diabetes Association (ADA), in cooperation with Professional Evaluation, Inc. (PEI), has developed the American Diabetes Association Self-Assessment Program (ADA-SAP TM) series. Module 2 of ADA-SAP TM series covers the Pharmacological Treatment of Hyperglycemia. Future modules in the ADA-SAP TM series will cover topics such as, combination therapy for type 2 diabetes, insulin use, and management of co-morbidities. Module 2 of ADA-SAP TM is sponsored by the ADA for up to 5.0 AMA PRA Category 1 Credit(s)TM for physicians and for continuing education credit(s) for nurses, nurse practitioners, pharmacists, dietitians, and diabetes educators. The multiple choice questions component of Module 2 of ADA-SAP TM was developed by PEI at the upper level of difculty similar in type and format to a board certifying examination. It was designed to objectively assess, strengthen and reinforce your knowledge of diabetes and to provide you with an in-depth learning experience of active engagement. Once you have properly completed Module 2 in its entirety (see General Instructions on page 6), your knowledge of the options available for managing patients with advanced type 2 diabetes mellitus should be greatly enhanced. The ADA looks forward to your participation in this important new program of continuing education, as part of your commitment to lifelong learning. Sincerely,

Michael H. Davidson M.D., FACC, FACP Program Chair Chief Medical Ofcer, PEI Clinical Professor of Medicine, Director of Preventive Cardiology The University of Chicago Pritzker School of Medicine

M. Sue Kirkman, M.D. Vice President, Clinical Affairs American Diabetes Association

American Diabetes Association Self-Assessment Program

Target Audience
Primary Care Physicians, General Internists, Family Physicians, Doctors of Osteopathy, Registered Nurses, Nurse Practitioners, Pharmacists, Physician Assistants, Dietitians, and Certied Diabetes Educators.

Learning Objectives
By completing this CME/CE enduring materials activity (Module 2), participants will be better able to: Interpret and utilize ADA Guidelines and Treatment Algorithms. Incorporate combination therapy for management of patients with advanced type 2 diabetes and achieve A1C targets. Utilize insulin for management of patients with acute hyperglycemia. Manage medication-induced hypoglycemia. Regulate secondary disorders in patients with severe hyperglycemia, such as those with chronic renal insufciency, congestive heart failure, and hepatic dysfunction.

Nurses: The ADA is approved as a provider of continuing education in nursing by the Virginia Nurses Association (VNA) which is accredited as an approver of continuing education in nursing by the American Nurses Credentialing Centers Commission on Accreditation. The ADA is located at 1701 North Beauregard Street, Alexandria, VA 22311. VNA Provider Number: 07-03-02. This educational activity is approved by the VNA which is accredited by the American Nurses Credentialing Centers Commission on Accreditation as an approver of Continuing Education in Nursing for a maximum 5.0 VNA Contact Hours. The VNA is located at 7113 Three Chopt Road, Suite 204, Richmond, VA 23226. California Board of Registered Nursing: The ADA is also a provider approved by the California Board of Registered Nursing, Provider No. CEP-12196. This activity is approved for 5.0 contact hours. Nurse Practitioners: An application will be made to the American Academy of Nurse Practitioners for continuing education credit. Determination of credit is pending. Pharmacists: The ADA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity provides up to 5.0 contact hours of continuing pharmacy education credit. The ACPE UPN is 239-000-08-006-H01-P. Each pharmacist should claim only those hours of credit that he/she spent in the education activity. Dietitians: The ADA is a Continuing Professional Education (CPE) Accredited Provider with the Commission on Dietetic Registration (CDR). Registered Dietitians (RDs) and dietetic technicians, registered (DTRs) will receive 5.0 continuing professional education units (CPEUs) for completion of this program/material. Certied Diabetes Educators: To satisfy the requirement for renewal of certication by continuing education for the National Certication Board for Diabetes Educators (NCBDE), continuing education activities must be diabetes related and approved by a provider on the NCBDE List of Approved Providers (www.ncbde.org). NCBDE does not approve continuing education. The ADA is on the NCBDE List of Approved Providers. The estimated time for completion of this activity is 5 hours. This continuing education activity was planned and produced in accordance with ACCME Standards. Release Date: October, 2008. Credits valid through October 31, 2010. Certicates will be sent to you via email 68 weeks upon receipt of post-test evaluation.

Accreditation
Physicians: The American Diabetes Association (ADA) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The ADA designates this education activity for a maximum of 5 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity. Family Physicians: An application for CME credit has been led with the American Academy of Family Physicians. Determination of credit is pending. International Physicians: The American Medical Association (AMA) has determined that physicians not licensed in the US who participate in this CME activity are eligible for AMA PRA category 1 credit. Doctors of Osteopathy: Category 2 credit will be awarded for formal educational programs that are ACCME-accredited or AAFP-approved. Physician Assistants: The American Academy of Physician Assistants (AAPA) accepts Category I credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 CME credit for the organizations accredited by ACCME. ADA is an accredited provider through the ACCME.

American Diabetes Association Self-Assessment Program

Faculty Chair
Michael H. Davidson, M.D., FACC, FACP Clinical Professor Director of Preventive Cardiology The University of Chicago Executive Medical Director Radiant Research Chicago, IL

Chief Editor and Publisher


Dante S. LaRocca, Ph.D. President Professional Evaluation, Inc. Ambler, PA

Reviewers
Martha M. Funnell, MS, RN, CDE Research Investigator Michigan Diabetes Research and Training Center Juvenile Diabetes Research Foundation Center for the Study of the Complications in Diabetes Ann Arbor, MI M. Sue Kirkman, M.D. Vice President, Clinical Affairs American Diabetes Association Alexandria, VA Russell D. White, M.D., FAFP, FACSM, MACE Professor of Medicine Director, Sports Medicine Fellowship Program University of Missouri Kansas City School of Medicine Truman Medical CenterLakewood Kansas City, MO Craig Williams, Pharm.D. Associate Professor of Pharmacy Associate Professor of Medicine OSU School of Pharmacy OHSU School of Medicine Portland, OR

Faculty
Suma Dronavalli, M.D. Instructor of Medicine The University of Chicago Pritzker School of Medicine Chicago, IL Ben Gerber, M.D., MPH Assistant Professor of Medicine Section of Health Promotion Research University of Illinois at Chicago Chicago, IL Stanley Schwartz, M.D., FACP Clinical Associate Professor of Medicine Director, Diabetes Disease Management University of Pennsylvania Health System Philadelphia, PA

American Diabetes Association Self-Assessment Program

Disclaimer Statement
The suggestions and information contained in this publication are generally consistent with the Clinical Practice Recommendations and other policies of the American Diabetes Association, but they do not represent the policy or position of the Association or any of its boards or committees. Reasonable steps have been taken to ensure the accuracy of the information presented. However, the American Diabetes Association cannot ensure the safety or efcacy of any product or service described in this publication. Individuals are advised to consult a physician before undertaking any diet or exercise program or taking any medication referred to in this publication. Professionals must use and apply their own professional judgment, experience and training and should not rely solely on the information contained in this publication before prescribing any diet, exercise or medication. The American Diabetes Associationits ofcers, directors, employees, volunteers, and membersassumes no responsibility or liability for personal or other injury, loss, or damage that may result from the suggestions or information in this publication. Content Validation Statement All recommendations involving clinical medicine are based on evidence accepted within the profession of medicine as adequate justication for their indications and contraindications in the care of patients; AND/OR All scientic research referred to or reported in support or justication of a patient care recommendation conforms to generally accepted standards of experimental design, data collection, and analysis.

Disclosures
Michael H. Davidson, M.D., FACC, FACP Advisory Board/Board of Directors: Abbott Laboratories, Access Health, Angiogen, AstraZeneca Pharmaceuticals, Atherogenics, Daiichi-Sankyo, Inc., Kinemed, Merck & Co., Inc., Merck/Schering-Plough, Oscient Pharmaceuticals, Pzer Laboratories, PreEmptive Meds, Professional Evaluation, Inc., Sonogene, Takeda Pharmaceuticals. Consultant: Abbott Laboratories, AstraZeneca Pharmaceuticals, Daiichi-Sankyo, Inc, diaDexus, Inc., Merck & Co., Inc., Merck/ScheringPlough, Pzer Laboratories, Roche Pharmaceuticals, sano-aventis, Synarc, Takeda Pharmaceuticals. Research Support: Abbott Laboratories, AstraZeneca Pharmaceuticals, Daiichi-Sankyo, Inc., Merck & Co., Inc., Merck/Schering-Plough, Pzer Laboratories, Roche Pharmaceuticals, and Takeda Pharmaceuticals. Speakers Bureau: Abbott Laboratories, AstraZeneca Pharmaceuticals, Daiichi-Sankyo, Inc, diaDexus, Inc., Merck & Co., Inc., Merck/Schering-Plough, Oscient Pharmaceuticals, Pzer Laboratories, Takeda Pharmaceuticals. Suma Dronavalli, M.D. Research Support: Novo Nordisk, Inc. Martha M. Funnell, MS, RN, CDE Board Member/Advisory Panel: Eli Lilly, HDI, Intuity Medical, Nodensa, Novo Nordisk, Inc. Consultant: sano-aventis. Ben Gerber, M.D., MPH Disclosed no conict of interest. M. Sue Kirkman, M.D. Disclosed no conict of interest. Dante S. LaRocca, Ph.D. Disclosed no conict of interest. Stanley Schwartz, M.D. Board Member/Advisory Panel: CVT, Eli Lilly, Takeda Pharmaceuticals. Speakers Bureau: Amylin, Eli Lilly, Merck & Co., Inc., sano-aventis, Takeda Pharmaceuticals. Russell D. White, M.D., FAFP, FACSM, MACE Consultant: Novo Nordisk, Inc. Speakers Bureau: American Academy of Family Physicians, American Diabetes Association, The National Procedures Institute, University of Missouri-Kansas City. Craig Williams, Pharm.D. Research Support: Merck & Co., Inc. Speakers Bureau: Merck & Co., Inc., Schering-Plough.

Disclosure Statement
As a provider of continuing education through the Accreditation Council for Continuing Medical Education, Virginia Nurses Association, Accreditation Council for Pharmacy Education, the American Psychological Association, and the Commission on Dietetic Registration, it is the Associations policy to ensure balance, independence, objectivity, and scientic rigor in all of its educational activities. All participating faculty, course directors, and planning committee members are required to disclose to the program audience any nancial relationships related to the subject matter of this program. Disclosure information is reviewed in advance in order to manage and resolve any possible conicts of interest. The intent of this disclosure is not to prevent a planner or presenter from being involved in the activity, but rather to provide participants with information on which they can make their own judgments.

American Diabetes Association Self-Assessment Program

General Instructions for Completion of ADA-SAP


Module 2 of ADA-SAP consists of the following components: Multiple Choice Questions (MCQs) Assessment Component This consists of both multiple true false questions and one best choice questions. The rst 15 questions are multiple true false and require that you respond either T (true) or F (false) to each of the three, four or ve lettered options for each item. The remaining 76 are clinical problem-solving MCQs. Here, your task is to select the one lettered option among four or ve offered that BEST answers each MCQ. Appendix This is a comprehensive summary of the recommendations of the ADA for diagnosis and management of type 2 diabetes. It is based on peer-reviewed publications and is designed to assist you to complete the Assessment and Educational Components of ADA-SAP. Computer-Scored Answer Sheet This is located on page 88. Please detach it along the perforation. Your selection of all true or false options and of the one lettered option that BEST answers each MCQ is to be marked on the answer sheet adjacent to the number for that MCQ. Please refer to the sample for how to mark your answers on the answer sheet. Your completed answer sheet must be returned to Professional Evaluation, Inc. (PEI) in the accompanying postage-paid envelope in order to receive CME/CE Credit. Educational (Learning) Critiques Component IN ORDER TO MAXIMIZE YOUR LEARNING EXPERIENCE IT IS IMPORTANT THAT YOU DO NOT LOOK AT THE EDUCATIONAL CRITIQUES COMPONENT UNTIL AFTER YOU HAVE COMPLETED MARKING YOUR ANSWERS FOR THE MCQs ON THE ANSWER SHEET. The critiques component contains detailed explanations for the correct and incorrect answers for the MCQs based on the most current peer-reviewed published information. Once you have read the Educational Critiques, the bibliographic references should be utilized as follow-up study for those MCQs which you answered incorrectly. The critiques are the teaching and learning component of ADA-SAP. They are to be used in combination with the MCQ assessment component to provide you with a positive, active learning experience. DO NOT CHANGE THE ANSWERS MARKED ON YOUR ANSWER SHEET WHILE READING THE CRITIQUES. THE INTENT OF ADA-SAP IS LEARNING NEW KNOWLEDGE AND REINFORCING PREVIOUSLY LEARNED KNOWLEDGE. THERE IS NO PASS-FAIL SCORE. Program Evaluation Form Component After you have completed the MCQ and Critique components as instructed, turn to the reverse side of your computer-scored answer sheet. Please select the one lettered option that BEST answers each program evaluation question and mark it on the answer sheet.

Note
After you have completed the Answer Sheet & Program Evaluation Form it is important that you return them to Professional Evaluation, Inc. in the enclosed self-addressed, no postage required envelope, in order to receive CME/CE credit from the ADA for up to 5.0 AMA PRA Category 1 Credit(s). PLEASE ALLOW 68 WEEKS FOR RECEIPT OF CREDIT FROM THE ADA. Certicates will be sent via email.

American Diabetes Association Self-Assessment Program

American Diabetes Association Self-Assessment Program


Syllabus

Syllabus

American Diabetes Association Self-Assessment Program

An Overview of Standards of Medical Care in Diabetes 2008


These standards of care are intended to provide clinicians, patients, researchers, payors, and other interested individuals with the components of diabetes care, treatment goals, and tools to evaluate the quality of care. While individual preferences, comorbidities, and other patient factors may require modication of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to preclude more extensive evaluation and management of the patient by other specialists as needed. The recommendations included are screening, diagnostic, and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system developed by the American Diabetes Association and modeled after existing methods was utilized to clarify and codify the evidence that forms the basis for the recommendations. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E. For more detailed information, refer to the full document: Standards of Medical Care in Diabetes2008.
A1C

Medical Nutrition Therapy (MNT)


General Recommendations

Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control). (E) Perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals. (E) Use of point-of-care testing for A1C allows for timely decisions on therapy changes, when needed. (E)
Glycemic Goals

Individuals who have pre-diabetes or diabetes should receive individualized MNT as needed to achieve treatment goals, preferably provided by a registered dietitian familiar with the components of diabetes MNT. (B) MNT should be covered by insurance and other payors. (E)
Energy Balance, Overweight, and Obesity

Lowering A1C to an average of ~7% has clearly been shown to reduce microvascular and neuropathic complications of diabetes and, possibly, macrovascular disease. Therefore, the A1C goal for nonpregnant adults in general is 7%. (A) Epidemiologic studies have suggested an incremental (albeit, in absolute terms, a small) benet to lowering A1C from 7% into the normal range. Therefore, the A1C goal for selected individual patients is as close to normal (6%) as possible without signicant hypoglycemia. (B) Less stringent A1C goals may be appropriate for patients with a history of severe hypoglycemia, patients with limited life expectancies, children, individuals with comorbid conditions, and those with longstanding diabetes and minimal or stable microvascular complications. (E)

In overweight and obese insulin resistant individuals, modest weight loss has been shown to reduce insulin resistance. Thus, weight loss is recommended for all overweight or obese individuals who have or are at risk for diabetes. (A) For weight loss, either low-carbohydrate or low-fat calorie-restricted diets may be effective in the short term (up to 1 year). (A) For patients on low-carbohydrate diets, monitor lipid proles, renal function and protein intake (in those with nephropathy), and adjust hypoglycemic therapy as needed. (E) Physical activity and behavior modication are important components of weight loss programs and are most helpful in maintenance of weight loss. (B)
Primary Prevention of Diabetes

Among individuals at high risk for developing type 2 diabetes, structured programs that emphasize lifestyle changes that include moderate weight loss (7% body weight) and regular physical activity (150 min/week), with dietary strategies including reduced calories and reduced intake of dietary fat, can reduce the risk for developing diabetes and are therefore recommended. (A)
8 American Diabetes Association Self-Assessment Program Syllabus

Individuals at high risk for type 2 diabetes should be encouraged to achieve the U.S. Department of Agriculture (USDA) recommendation for dietary ber (14 g ber/1000 kcal) and foods containing whole grains (one-half of grain intake). (B)
Dietary Fat Intake in Diabetes Management

Physical Activity

Saturated fat intake should be 7% of total calories. (A) Intake of trans fat should be minimized. (E)
Carbohydrate Intake in Diabetes Management

People with diabetes should be advised to perform at least 150 min/week of moderate-intensity aerobic physical activity (5070% of maximum heart rate). (A) In the absence of contraindications, people with type 2 diabetes should be encouraged to perform resistance training three times per week. (A)
Psychosocial Assessment and Care

Monitoring carbohydrate, whether by carbohydrate counting, exchanges, or experience-based estimation, remains a key strategy in achieving glycemic control. (A) For individuals with diabetes, the use of the glycemic index and glycemic load may provide a modest additional benet for glycemic control over that observed when total carbohydrate is considered alone. (B)
Other Nutrition Recommendations

Sugar alcohols and nonnutritive sweeteners are safe when consumed within the acceptable daily intake levels established by the Food and Drug Administration (FDA). (A) If adults with diabetes choose to use alcohol, daily intake should be limited to a moderate amount (one drink/day or less for adult women and two drinks/day or less for adult men). (E) Routine supplementation with antioxidants, such as vitamins E and C and carotene, is not advised because of lack of evidence of efcacy and concern related to long-term safety. (A) Benet from chromium supplementation in people with diabetes or obesity has not been conclusively demonstrated and, therefore, cannot be recommended. (E)
Diabetes Self-Management Education (DSME)

Assessment of psychological and social situation should be included as an ongoing part of the medical management of diabetes. (E) Psychosocial screening and follow-up should include, but is not limited to, attitudes about the illness, expectations for medical management and outcomes, affect/mood, general and diabetes-related quality of life, resources (nancial, social, and emotional), and psychiatric history. (E) Screen for psychosocial problems such as depression, anxiety, eating disorders, and cognitive impairment when adherence to the medical regimen is poor. (E)
Hypoglycemia

People with diabetes should receive DSME according to national standards when their diabetes is diagnosed and as needed thereafter. (B) Self-management behavior change is the key outcome of DSME and should be measured and monitored as part of care. (E) DSME should address psychosocial issues, since emotional well-being is strongly associated with positive diabetes outcomes. (C) DSME should be reimbursed by third party payors. (E)

Glucose (1520 g) is the preferred treatment for the conscious individual with hypoglycemia, although any form of carbohydrate that contains glucose may be used. If self-monitoring of blood glucose (SMBG) 15 min after treatment shows continued hypoglycemia, the treatment should be repeated. Once SMBG glucose returns to normal, the individual should consume a meal or snack to prevent recurrence of hypoglycemia. (E) Glucagon should be prescribed for all individuals at signicant risk of severe hypoglycemia, and caregivers or family members of these individuals should be instructed in its administration. Glucagon administration is not limited to health care professionals. (E) Individuals with hypoglycemia unawareness or one or more episodes of severe hypoglycemia should be advised to raise their glycemic targets to strictly avoid further hypoglycemia for at least several weeks in order to partially reverse hypoglycemia unawareness and reduce risk of future episodes. (B)

Syllabus

American Diabetes Association Self-Assessment Program

Immunization

Annually provide an inuenza vaccine to all diabetic patients 6 months of age. (C) Provide at least one lifetime pneumococcal vaccine for adults with diabetes. A one-time revaccination is recommended for individuals 65 years of age previously immunized when they were 65 years of age if the vaccine was administered 5 years ago. Other indications for repeat vaccination include nephrotic syndrome, chronic renal disease, and other immunocompromised states, such as after transplantation. (C)

Multiple drug therapy (two or more agents at maximal doses) is generally required to achieve blood pressure targets. (B) If ACE inhibitors, ARBs, or diuretics are used, kidney function and serum potassium levels should be closely monitored. (E) In pregnant patients with diabetes and chronic hypertension, blood pressure target goals of 110129/6579 mm Hg are suggested in the interest of long-term maternal health and minimizing impaired fetal growth. ACE inhibitors and ARBs are contraindicated during pregnancy. (E)

Hypertension/Blood Pressure Control


Screening and Diagnosis

Dyslipidemia/Lipid Management
Screening

Blood pressure should be measured at every routine diabetes visit. Patients found to have systolic blood pressure 130 mm Hg or diastolic blood pressure 80 mm Hg should have blood pressure conrmed on a separate day. Repeat systolic blood pressure 130 mm Hg or diastolic blood pressure 80 mm Hg conrms a diagnosis of hypertension. (C)
Goals

In most adult patients, measure fasting lipid prole at least annually. In adults with low-risk lipid values (LDL cholesterol 100 mg/dL, HDL-C 50 mg/dL, and triglycerides 150 mg/dL), lipid assessments may be repeated every 2 years. (E)
Treatment Recommendations and Goals

Patients with diabetes should be treated to a systolic blood pressure 130 mm Hg. (C) Patients with diabetes should be treated to a diastolic blood pressure 80 mm Hg. (B)
Treatment

Patients with a systolic blood pressure of 130139 mm Hg or a diastolic blood pressure of 8089 mm Hg may be given lifestyle therapy alone for a maximum of 3 months, and then, if targets are not achieved, be treated with addition of pharmacological agents. (E) Patients with more severe hypertension (systolic blood pressure 140 or diastolic blood pressure 90 mm Hg) at diagnosis or follow-up should receive pharmacologic therapy in addition to lifestyle therapy. (A) Pharmacologic therapy for patients with diabetes and hypertension should be with a regimen that includes either an ACE inhibitor or an angiotensin receptor blocker (ARB). If one class is not tolerated, the other should be substituted. If needed to achieve blood pressure targets, a thiazide diuretic should be added to those with an estimated glomerular ltration rate (GFR) 50 ml/min per 1.73 m2 and a loop diuretic for those with an estimated GFR 50 ml/min per 1.73 m2. (E)
10 American Diabetes Association Self-Assessment Program Syllabus

Lifestyle modication focusing on the reduction of saturated fat, trans fat, and cholesterol intake; weight loss (if indicated); and increased physical activity should be recommended to improve the lipid prole in patients with diabetes. (A) Statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels, for diabetic patients: With overt cardiovascular disease (CVD). (A) Without CVD who are over the age of 40 and have one or more other CVD risk factors. (A) For patients at lower risk than those mentioned above (e.g., without overt CVD and under the age of 40), statin therapy should be considered in addition to lifestyle therapy if LDL-C remains 100 mg/dL or in those with multiple CVD risk factors. (E) In individuals without overt CVD, the primary goal is an LDL-C 100 mg/dL (2.6 mol/l). (A) In individuals with overt CVD, a lower LDL-C goal of 70 mg/dL (1.8 mol/l), using a high dose of a statin, is an option. (E) If drug-treated patients do not reach the above targets on maximal tolerated statin therapy, a reduction in LDL-C of ~40% from baseline is an alternative therapeutic goal. (A)

Triglyceride levels 150 mg/dL (1.7 mol/l) and HDL cholesterol levels 40 mg/dL (1.0 mol/l) in men and 50 mg/dL (1.3 mol/l) in women are desirable. However, LDL-Ctargeted statin therapy remains the preferred strategy. (C) Combination therapy using statins and other lipidlowering agents may be considered to achieve lipid targets but has not been evaluated in outcome studies for either CVD outcomes or safety. (E) Statin therapy is contraindicated in pregnancy. (E)
Antiplatelet Agents

Coronary Heart Disease (CHD) Screening and Treatment


Screening

In asymptomatic patients, evaluate risk factors to stratify patients by 10-year risk, and treat risk factors accordingly. (B)
Treatment

Use aspirin therapy (75162 mg/day) as a secondary prevention strategy in diabetic individuals with a history of CVD. (A) Use aspirin therapy (75162 mg/day) as a primary prevention strategy in those with type 1 or type 2 diabetes at increased cardiovascular risk, including those who are 40 years of age or who have additional risk factors (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria). (A) Aspirin therapy is not recommended in people under 30 years of age, due to lack of evidence of benet, and is contraindicated in patients under the age of 21 years because of the associated risk of Reye syndrome. (E) Combination therapy using other antiplatelet agents such as clopidrogel in addition to aspirin should be used in patients with severe and progressive CVD. (C) Other antiplatelet agents may be a reasonable alternative for high-risk patients with aspirin allergy, with bleeding tendency, who are receiving anticoagulant therapy, with recent gastrointestinal bleeding, and with clinically active hepatic disease who are not candidates for aspirin therapy. (E)
Smoking Cessation

In patients with known CVD, ACE inhibitor, aspirin, and statin therapy (if not contraindicated) should be used to reduce the risk of cardiovascular events. (A) In patients with a prior myocardial infarction, add -blockers (if not contraindicated) to reduce mortality. (A) In patients 40 years of age with another cardiovascular risk factor (hypertension, family history, dyslipidemia, microalbuminuria, cardiac autonomic neuropathy, or smoking), ACE inhibitor, aspirin, and statin therapy (if not contraindicated) should be used to reduce the risk of cardiovascular events. (B) In patients with treated congestive heart failure (CHF), metformin and thiazolidinedione (TZD) use are contraindicated. (C)

Nephropathy Screening and Treatment


General Recommendations

To reduce the risk or slow the progression of nephropathy, optimize glucose control. (A) To reduce the risk or slow the progression of nephropathy, optimize blood pressure control. (A)
Screening

Advise all patients not to smoke. (A) Include smoking cessation counseling and other forms of treatment as a routine component of diabetes care. (B)

Perform an annual test to assess urine albumin excretion in type 1 diabetic patients with diabetes duration of 5 years and in all type 2 diabetic patients, starting at diagnosis. (E) Measure serum creatinine at least annually in all adults with diabetes regardless of the degree of urine albumin excretion. The serum creatinine should be used to estimate GFR and stage the level of chronic kidney disease (CKD), if present. (E)

Syllabus

American Diabetes Association Self-Assessment Program

11

Treatment

Retinopathy Screening and Treatment


General Recommendations

In the treatment of the nonpregnant patient with micro- or macroalbuminuria, either ACE inhibitors or ARBs should be used. (A) While there are no adequate head-to-head comparisons of ACE inhibitors and ARBs, there is clinical trial support for each of the following statements: In patients with type 1 diabetes, with hypertension and any degree of albuminuria, ACE inhibitors have been shown to delay the progression of nephropathy. (A) In patients with type 2 diabetes, hypertension, and microalbuminuria, both ACE inhibitors and ARBs have been shown to delay the progression to macroalbuminuria. (A) In patients with type 2 diabetes, hypertension, macroalbuminuria, and renal insufciency (serum creatinine 1.5 mg/dL), ARBs have been shown to delay the progression of nephropathy. (A) If one class is not tolerated, the other should be substituted. (E) Reduction of protein intake to 0.81.0 g kg body wt -1 day -1 in individuals with diabetes and the earlier stages of chronic kidney disease (CKD) and to 0.8 g kg body wt -1 day -1 in the later stages of CKD may improve measures of renal function (e.g., urine albumin excretion rate and GFR) and is recommended. (B) When ACE inhibitors, ARBs, or diuretics are used, monitor serum creatinine and potassium levels for the development of acute kidney disease and hyperkalemia. (E) Continued monitoring of urine albumin excretion to assess both the response to therapy and the progression of disease is recommended. (E) Consider referral to a physician experienced in the care of kidney disease when there is uncertainty about the etiology of kidney disease (active urine sediment, absence of retinopathy, rapid decline in GFR), difcult management issues, or advanced kidney disease. (B)

To reduce the risk or slow the progression of retinopathy, optimize glycemic control. (A) To reduce the risk or slow the progression of retinopathy, optimize blood pressure control. (A)
Screening

Adults and adolescents with type 1 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist within 5 years after the onset of diabetes. (B) Patients with type 2 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist shortly after the diagnosis of diabetes. (B) Subsequent examinations for type 1 and type 2 diabetic patients should be repeated annually by an ophthalmologist or optometrist. Less frequent exams (every 23 years) may be considered following one or more normal eye exams. Examinations will be required more frequently if retinopathy is progressing. (B) Women with preexisting diabetes who are planning pregnancy or who have become pregnant should have a comprehensive eye examination and be counseled on the risk of development and/or progression of diabetic retinopathy. Eye examination should occur in the rst trimester with close follow-up throughout pregnancy and for 1 year postpartum. (B)
Treatment

Promptly refer patients with any level of macular edema, severe nonproliferative diabetic retinopathy (NPDR), or any proliferative diabetic retinopathy (PDR) to an ophthalmologist who is knowledgeable and experienced in the management and treatment of diabetic retinopathy. (A) Laser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with highrisk PDR, clinically signicant macular edema, and in some cases of severe NPDR. (A) The presence of retinopathy is not a contraindication to aspirin therapy for cardioprotection, as this therapy does not increase the risk of retinal hemorrhage. (A)

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American Diabetes Association Self-Assessment Program

Syllabus

Neuropathy Screening and Treatment

Children and Adolescents


Glycemic Control

All patients should be screened for distal symmetric polyneuropathy (DPN) at diagnosis and at least annually thereafter, using simple clinical tests. (B) Electrophysiological testing is rarely needed, except in situations where the clinical features are atypical. (E) Educate all patients about self-care of the feet. For those with DPN, facilitate enhanced foot care education and refer for special footware. (B) Screening for signs and symptoms of autonomic neuropathy should be instituted at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes. Special testing is rarely needed and may not affect management or outcomes. (E) Medications for the relief of specic symptoms related to DPN and autonomic neuropathy are recommended, as they improve the quality of life of the patient. (E)
Foot Care

Consider age when setting glycemic goals in children and adolescents with type 1 diabetes, with less stringent goals for younger children. (E)
Nephropathy

Annual screening for microalbuminuria, with a random spot urine sample for microalbumin-tocreatinine ratio, should be initiated once the child is 10 years of age and has had diabetes for 5 years. (E) Conrmed, persistently elevated microalbumin levels on two additional urine specimens should be treated with an ACE inhibitor, titrated to normalization of microalbumin excretion if possible. (E)
Hypertension

For all patients with diabetes, perform an annual comprehensive foot examination to identify risk factors predictive of ulcers and amputations. The foot examination can be accomplished in a primary care setting and should include the use of a monolament, tuning fork, palpation, and a visual examination. (B) Provide general foot self-care education to all patients with diabetes. (B) A multidisciplinary approach is recommended for individuals with foot ulcers and high-risk feet, especially those with a history of prior ulcer or amputation. (B) Refer patients who smoke, have loss of protective sensation and structural abnormalities, or have history of prior lower-extremity complications to foot care specialists for ongoing preventive care and life-long surveillance. (C) Initial screening for peripheral arterial disease (PAD) should include a history for claudication and an assessment of the pedal pulses. Consider obtaining an ankle-brachial index (ABI), as many patients with PAD are asymptomatic. (C) Refer patients with signicant claudication or a positive ABI for further vascular assessment and consider exercise, medications, and surgical options. (C)

Treatment of high-normal blood pressure (systolic or diastolic blood pressure consistently above the 90th percentile for age, sex, and height) should include dietary intervention and exercise, aimed at weight control and increased physical activity if appropriate. If target blood pressure is not reached with 36 months of lifestyle intervention, pharmacologic treatment should be initiated. (E) Pharmacologic treatment of hypertension (systolic or diastolic blood pressure consistently above the 95th percentile for age, sex, and height or consistently 130/80 mm Hg, if 95% exceeds that value) should be initiated as soon as the diagnosis is conrmed. (E) ACE inhibitors should be considered for the initial treatment of hypertension. (E)
Dyslipidemia

Screening If there is a family history of hypercholesterolemia (total cholesterol 240 mg/dL) or a cardiovascular event before age 55 years, or if family history is unknown, then a fasting lipid prole should be performed on children 2 years of age soon after diagnosis (after glucose control has been established). If family history is not of concern, then the rst lipid screening should be performed at puberty ( 10 years). All children diagnosed with diabetes at or after puberty should have a fasting lipid prole performed soon after diagnosis (after glucose control has been established). (E)

Syllabus

American Diabetes Association Self-Assessment Program

13

For both age groups, if lipids are abnormal, annual monitoring is recommended. If LDL-C values are within the accepted risk levels (100 mg/dL [2.6 mol/l]), a lipid prole should be repeated every 5 years. (E) Treatment Initial therapy should consist of optimization of glucose control and MNT using a Step 2 American Heart Association diet aimed at a decrease in the amount of saturated fat in the diet. (E) After the age of 10 years, the addition of a statin is recommended in patients who, after MNT and lifestyle changes, have LDL cholesterol 160 mg/dL (4.1 mol/l) or LDL cholesterol 130 mg/dL (3.4 mol/l) and one or more CVD risk factors. (E) The goal of therapy is an LDL cholesterol value 100 mg/dL (2.6 mol/l). (E)
Retinopathy

The rst ophthalmologic examination should be obtained once the child is 10 years of age and has had diabetes for 35 years. (E) After the initial examination, annual routine followup is generally recommended. Less frequent examinations may be acceptable on the advice of an eye care professional. (E)

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American Diabetes Association Self-Assessment Program

Syllabus

American Diabetes Association Self-Assessment Program


Multiple Choice Questions (MCQs)

MCQs

American Diabetes Association Self-Assessment Program

15

Section A: Multiple True False Questions


Directions
For items 115 only please answer TRUE or FALSE to each of the four or ve lettered options in each item. In a given item all, some, or none of the lettered options may be true. For each option that you think is TRUE in each item, completely blacken the corresponding lettered circle in the column labeled T for that item on Section A of the answer sheet. For each option that you think is FALSE, completely blacken the corresponding lettered circle in the column labeled F.
1
T F A A B B C C D D E E

Items 115
A 52-year-old African American woman with type 2 diabetes mellitus for 3 years presents to you for the rst time for evaluation and treatment. Medications are metformin 1000 mg b.i.d.; pioglitazone 30 mg/qd; and glimepiride 4 mg qd. She has not seen a physician in over 12 months. She recently changed employment with a new health plan in which her former primary care physician is no longer in the network. She is married with 4 grown children and 6 grandchildren. She drinks 12 glasses of wine on social occasions and quit smoking 1 year ago, with a previous 40 packs/year history (2 packs/day from age 22 to 51). Both her parents are deceased, mother at age 63 of a stroke and father at age 70 of congestive heart failure. Two siblings, a brother age 56 and sister age 58, have type 2 diabetes mellitus. Her only complaint is occasional lightheadedness, especially after eating meals. Vitals:
Heart Rate Blood Pressure Respiratory Rate Height Weight 80 152/86 mm Hg 14 52 210 lbs.

Signicant physical ndings:


Fundoscopic Exam: Heart: dot hemorrhages positive for S4

Neuro: decreased monolament sensation in both feet

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American Diabetes Association Self-Assessment Program

MCQs

Lab results:
Total Cholesterol HDL-C LDL-C Triglycerides A1C Fasting Glucose TSH ALT AST Creatinine Glomerular Filtratration Rate (GFR) 180 mg/dL 35 mg/dL 95 mg/dL 300 mg/dL 8.5% 150 mg/dL 1.0 U/L 56 U/L (normal 40) 40 U/L (normal 30) 1.8 mg/dL 45 mL/min/1.73 m2 body sensitive area

1.

Which of the following statements regarding A1C testing and goals is/are TRUE based on ADA guidelines? (A) Perform the A1C test at least 2 times a year in patients who are meeting treatment goals and who have stable glycemic control. (B) The A1C goal for patients in general is 6.5%. (C) The goal for the selected individual patient is an A1C as close to normal (6%) as possible without signicant hypoglycemia. (D) Perform the A1C test bimonthly in patients whose therapy has changed or who are not meeting glycemia goals. (E) Postprandial glucose levels should be checked in patients with A1C 8.0%.

2.

Which of the following additional test(s) or referrals in this patient is/are recommended according to ADA guidelines? (A) Dilated fundoscopic exam. (B) Urine albumin measurement. (C) Foot exam by podiatrist. (D) Liver ultrasound for hepatic fat. (E) Referral for medical nutrition therapy.

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3.

In regard to nutritional counseling, which of the following statements is/are TRUE? (A) Monitoring carbohydrates whether by carbohydrate counting, exchange, or experience-based estimation, remains a key strategy in achieving glycemic control. (B) Sugar alcohols and other non-nutritive sweeteners should be discouraged. (C) Routine supplementation with vitamin E 400 IU is recommended for patients with type 2 diabetes mellitus with at least one other CVD risk factor. (D) Chromium supplementation for patients with diabetes or obesity is not recommended. (E) Saturated fat intake should be 7% of total calories.

4.

Which of the following additional treatments is/are recommended for this patient according to ADA guidelines? (A) Statins to achieve at least a 40% reduction in LDL-C level. (B) An ACE inhibitor or ARB. (C) Aspirin 81 mg. (D) Inuenza vaccine. (E) Pneumococcal vaccine.

5.

Which of the following is/are her recommended goal(s) or desirable level(s) with treatment? (A) A1C 7.0%. (B) Blood pressure 130/80 mm Hg. (C) LDL 100 mg/dL. (D) Triglycerides 150 mg/dL. (E) HDL 40 mg/dL.

6.

Which of the following modications of treatment is/are appropriate to improve her A1C levels? (A) Continue her present medications and initiate basal insulin. (B) Discontinue the metformin and increase the doses of pioglitazone and glimepiride. (C) Discontinue metformin and add sitagliptin. (D) Discontinue metformin and add exenatide. (E) Discontinue metformin, pioglitazone, and glimepiride and initiate basal insulin.

7.

She has been placed on a statin and continues to have elevated triglycerides (TGs) and low HDL-C level. Which of the following potential drug interactions or safety concerns regarding brate therapy is/are TRUE? (A) The dose of simvastatin should not exceed 10 mg if used in conjunction with gembrozil. (B) Gembrozil will increase the AUC (area under the curve) and, therefore, increase the hypoglycemic effect of repaglimide and rosiglitazone. (C) In conjunction with fenobrate, the dose of simvastatin should not exceed 20 mg. (D) Fenobrate increases both creatinine and homocysteine levels. (E) Fenobrate does not require a dosage adjustment in patients with severe renal impairment.

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American Diabetes Association Self-Assessment Program

MCQs

8.

Which of the following statements is/are TRUE in regard to her hypertension and renal impairment? (A) In patients with type 2 diabetes mellitus, hypertension, and microalbuminurea, both ACE inhibitors and ARBs have been shown to delay the progression of nephropathy. (B) A combination of ACE and ARB has been shown to reduce CVD events more than either treatment alone. (C) In patients with a GFR 50 mL/min per 1.73 m2, a loop diuretic should be used rather than a thiazide diuretic to improve blood pressure control. (D) Reduction in protein intake to 0.81.0 g per kg body weight per 1 day in individuals with diabetes and earlier stages of CKD is recommended. (E) Once urine albumin is found to be increased, continued monitoring to assess the progression of disease is not necessary.

9.

In regard to her retinopathy, which of the following statements is/are TRUE? (A) Patients with type 2 diabetes mellitus should have an initial dilated and comprehensive eye exam by an ophthalmologist or optometrist shortly after the diagnosis of diabetes and annually thereafter. (B) Optimizing both glycemic control and blood pressure reduces the risk or slows the progression of retinopathy. (C) Aspirin therapy is contraindicated if retinopathy is present due to the increased risk of retinal hemorrhage. (D) Laser photocoagulation therapy is indicated to reduce vision loss in patients with severe non-proliferative diabetic retinopathy (NPDR) but not in patients with proliferative diabetic retinopathy (PDR). (E) At present, there is a lack of evidence that photocoagulation surgery decreases the risk for severe visual loss.

10. Which of the following statements is/are TRUE regarding her neuropathy treatment and foot care? (A) Patients with type 2 diabetes mellitus should have electrophysiological testing performed at diagnosis and biannually thereafter. (B) Medications for the relief of specic symptoms related to distal symmetric polyneuropathy are ineffective and, therefore, not recommended. (C) An ankle-brachial index (ABI) is not recommended unless the patients with type 2 diabetes mellitus have symptoms of claudication. (D) Referral to a foot care specialist is recommended if the patient with type 2 diabetes mellitus smokes, has loss of protective sensation, or has a history of prior lower extremity complications. (E) Evaluation of bladder dysfunction should be considered for patients with diabetes who have recurrent urinary tract infections, pyelonephrotic incontinence, or palpable bladder.

MCQs

American Diabetes Association Self-Assessment Program

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Items 1112
This patients managed care plan has just instituted pay for performance for achievement of the HEDIS 2008 NCQA guidelines. Which of the following is/are utilized to assess the quality of comprehensive care in adult patients with diabetes? 11. (A) A1C 7.0%. (B) LDL-C 100 mg/dL. (C) TGs 150 mg/dL. (D) Medical attention for nephropathy. (E) Foot examination. 12. (A) Eye exam (retinal) performed. (B) Blood pressure 130/80 mm Hg. (C) Smoking status and cessation advice or treatment. (D) Inuenza vaccination. (E) HDL 40 mg/dL.

Items 1315
Based on an ADA consensus group algorithm in regard to her treatment, which of the following statements is/are TRUE for each of the categories of pharmacological therapies? 13. For the use of insulin: (A) Advantages: most effective, relatively inexpensive, and improved lipid prole. (B) Disadvantages: injections, monitoring, hypoglycemia, and weight gain. (C) Insulin therapy has benecial effects on peripheral insulin sensitivity. (D) Insulin plus glitazones may increase the risk of uid retention. (E) Insulin should only be used third line if 2 oral agents, including metformin, have failed to achieve the A1C target. 14. For the use of thiazolidinediones: (A) Advantages: pioglitazone increases HDL-C and lowers triglycerides. (B) Disadvantages: two-fold increased risk of CHF and weight gain. (C) Black-box warning for both rosiglitazone and for pioglitazone for potential increased risk of MI. (D) Increased risk for fractures. (E) Dosage adjustment for patients with severe renal impairment.

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American Diabetes Association Self-Assessment Program

MCQs

15. For the use of sulfonyluryea: (A) Advantage: inexpensive. (B) Disadvantages: increased risk of hypoglycemia and weight gain. (C) No dosage adjustment required in patients with severe renal impairment. (D) Increases -cell survival. (E) Proven to reduce cardiovascular events.

MCQs

American Diabetes Association Self-Assessment Program

21

Section B: One Best Choice Questions


Directions
Items 1691 consist of a question or an incomplete statement followed by three, four or ve lettered options. Your task is to select the one BEST lettered option that answers each item. After you have selected the one lettered option that BEST answers each item, completely blacken the corresponding lettered circle for that item on Section B of the answer sheet. Please use only a #2 soft lead pencil. 16. A 68-year-old man with a history of type 2 diabetes mellitus is admitted to the hospital with increased dyspnea, extremity edema, and a 10 lb. weight gain. He has a history of coronary artery disease and experienced a myocardial infarction four years ago. During the hospitalization, there were no changes noted in EKGs, and CPK-mb and troponin were negative. He was treated with lasix with substantial improvement. A stress test showed a xed inferior defect and a reversible anterolateral defect, with estimated ejection fraction of 30%. The patient currently takes aspirin, metoprolol, furosemide, enalapril, atorvastatin, and glyburide. Metformin and pioglitazone were discontinued at time of admission. Glucose levels in the hospital ranged from 98231 mg/dL. Results of laboratory studies include an A1C level of 7.9%, BUN of 43, and creatinine of 1.6 mg/dL. Which one of the following is the BEST approach for glycemic management for this patient upon discharge? (A) Reinstitute metformin only. (B) Reinstitute both metformin and pioglitazone. (C) Reinstitute pioglitazone only. (D) Stop glyburide and start basal insulin. (E) Continue glyburide only and monitor glucose levels. 17. A 34-year-old obese woman with a history of type 2 diabetes presents to her physician for continuity of care. She reports that she is overall doing well and maintains good adherence to prescribed therapies. She occasionally has low blood glucose readings in the mornings, especially when she does not eat a late night snack. Upon further questioning, she reports nightmares that wake her up from sleep, and this has been causing her some distress. Her medications include an ACE inhibitor, glargine insulin 30 U at bedtime, and aspart insulin, 4 U before meals daily. Her blood glucose log is reviewed and reveals fasting glucose levels before breakfast 49238 mg/dL (mean 208), before lunch 72188 mg/dL (mean 160), before dinner 61183 mg/dL (mean 145), and at bedtime 63177 mg/dL (mean 133). One glucose level at 3 a.m. was 52. Her A1C test was 7.0%. Which one of the following insulin recommendations is MOST appropriate to improve her glycemic control? (A) Decrease aspart insulin at dinner. (B) Increase aspart insulin at meals. (C) Decrease aspart insulin at meals. (D) Decrease glargine insulin at bedtime. (E) Increase glargine insulin at bedtime.

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American Diabetes Association Self-Assessment Program

MCQs

18. A 51-year-old woman with a history of type 2 diabetes, hypertension, and hyperlipidemia presents to her doctor for chronic disease management. She has no complaints and takes her medications regularly. She has had no recent problems with hypoglycemia. She takes metformin 1 g b.i.d. and glargine insulin 32 U/day in the morning. In the past she took glyburide, but this was discontinued due to a skin rash. She takes three antihypertensive medications, including an ACE inhibitor. On physical exam, the patient is obese (BMI 32 kg/m2), pulse rate 78/minute, and blood pressure 122/76 mm Hg. She has no JVD, clear lungs, and an unremarkable cardiovascular exam, with trace, symmetrical lower extremity edema. Her labs reveal an A1C level of 9.5%. She brings her glucose logbook which reveals the following: fasting breakfast glucose range 88127 mg/dL (mean 106), pre-lunch 90176 mg/dL (mean 140), and pre-dinner 111193 mg/dL (mean 152). On occasion she has checked her glucose levels after eating; her postprandial glucose levels were between 235288 mg/dL when obtained. Which one of following medication adjustments will be the BEST option in improving her glycemic control? (A) Add NPH insulin in the morning. (B) Add bolus insulin (aspart or lispro) with meals. (C) Add second dose of glargine insulin at bedtime. (D) Change glargine insulin to detemir. (E) Increase metformin dose. 19. Which one of the following statements is INCORRECT regarding postprandial hyperglycemia? (A) There are randomized control trials demonstrating that lowering postprandial glucose levels independent of fasting glucose levels will reduce the risk of cardiovascular disease. (B) Postprandial hyperglycemia results in overproduction of free radicals and increases endothelial dysfunction. (C) Individuals with pre-meal glucose levels within target range but have A1C levels above goal should have treatment directed at reducing postprandial glucose levels. (D) None of the above. 20. A 60-year-old man with a history of signicant mitral valve stenosis is admitted to the hospital for valve replacement. He has a history of impaired glucose tolerance, and has followed a diet with a low glycemic index. The surgery itself was uneventful; however, two days postoperative he developed fever, respiratory distress, and hypotension, and was then transferred to the surgical intensive care unit, where he was intubated and started on pressors and antibiotic therapy. Laboratory studies demonstrated a white blood cell count of 14.8 and creatinine of 1.3 mg/dL, and an initial plasma glucose level of 183 mg/dL. Which one of the following is the BEST management of his blood glucose levels at this time? (A) Sliding scale of regular insulin. (B) Glargine insulin, 10 U/day. (C) Continuous IV insulin. (D) Glyburide 5 mg/day. (E) Observation.

MCQs

American Diabetes Association Self-Assessment Program

23

21. An 81-year-old African American woman with a history of type 2 diabetes mellitus for over 10 years, coronary artery disease, NYHA class III congestive heart failure, osteoporosis and emphysema is brought to the physician by her granddaughter for follow up chronic disease management. The patient has poor mobility related to weakness and imbalance; however, she lives with two family members who are very supportive in her medical care and housework. More recently, she has been feeling depressed with complaints of fatigue during the day and poor sleep at night. She has fallen twice at home during the past three months. Her medications include lisinopril, furosemide, nitroglycerin, simvastatin, aspirin, glyburide, calcium, and vitamin D. On physical examination, her blood pressure is 142/78 mm Hg. She has bibasilar rales on lung exam. Cardiac exam reveals an S3 gallop. She has symmetric 1+ lower extremity edema that has not changed since the previous visit. She has decreased sensation in her feet by monolament testing. Laboratory studies reveal an A1C level of 8.0%. A three-hour postprandial glucose level in the ofce is 224 mg/dL. Which one of the following is the best recommendation regarding her blood glucose management? (A) Begin low-dose basal insulin once daily. (B) Add pioglitazone 15 mg/day. (C) Add metformin 500 mg/day. (D) Increase glyburide to twice daily. (E) Continue current therapy. 22. A 56-year-old woman presents to the ofce for follow up chronic disease management. She has a 3-year history of type 2 diabetes. She takes maximum doses of metformin and glimepiride. She has refused insulin therapy because she is concerned about experiencing weight gain. Her provider has provided suggestions to improve her diet, including caloric restriction to promote weight loss. She walks regularly three times a week at a brisk pace. Her fasting glucose levels are usually above 180 mg/dL and her A1C is 8.0%. Which one of the following would be the MOST appropriate medication to add to her current oral therapy? (A) Acarbose. (B) Exenatide. (C) Pioglitazone. (D) Sibutramine. (E) Continue current therapy.

Items 2325
A 44-year-old man was recently diagnosed with type 2 diabetes three months prior to presentation to the physician. He currently takes no medications. He is obese (BMI 32 kg/m2) and he reports that his weight has been increasing over the past two years. Since he was diagnosed with diabetes, he has been trying to implement various strategies to lose weight. He has been referred to a dietitian for nutritional counseling and weight management (he has made two visits so far to the dietitian). His A1C is currently 8.2%. 23. Which one of the following is the BEST management option for his type 2 diabetes at this point? (A) Continue lifestyle modications. (B) Start glipizide. (C) Start metformin. (D) Start exenatide. (E) Start daily glargine insulin.
24 American Diabetes Association Self-Assessment Program MCQs

24. Which one of the following would be MOST likely to provide the greatest reduction in his A1C level as monotherapy? (A) Alpha-glucosidase inhibitor. (B) Exenatide. (C) Metformin. (D) Pramlintide. 25. Based on the ADOPT trial, which one of the following drugs, as monotherapy, delays the need for additional pharmacologic therapy the LEAST for patients with type 2 diabetes? (A) Biguanide. (B) Thiazolidinedione. (C) Sulfonylurea. (D) No difference between oral agents. 26. Which one of the following is NOT an advantage to using sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, for glycemic control in diabetes management? (A) It provides a modest level of weight loss. (B) It has low risk of hypoglycemia compared with sulfonylureas. (C) It can be used as monotherapy. (D) It can be used in combination with metformin. (E) It improves -cell function. 27. A 46-year-old man with a history of type 2 diabetes presents to his primary care physician for follow up diabetes management. He has had diabetes for nine years and has no known complications. He has no complaints and denies having any episodes of hypoglycemia. His current medications include metformin 1 g b.i.d., pioglitazone 30 mg/day, and insulin (glargine 30 U every morning, and aspart 20 U before each meal). At home he monitors his glucose levels at various times during the day on different days. On physical exam, he is afebrile, and has a blood pressure of 153/92 mm Hg and pulse of 72. He is obese with a BMI of 36 kg/m2. His cardiovascular exam is unremarkable. He has no extremity edema. Monolament testing was negative for decits in sensation. Deep tendon reexes were intact. His logbook is reviewed and range values (mg/dL) for various times of the day are as follows:
Time Pre-breakfast Pre-lunch Post-lunch (2 hrs.) Pre-dinner Post-dinner (2 hrs.) Mean 211 231 201 217 204 Minimum 160 188 183 165 194 Maximum 241 284 229 237 255

MCQs

American Diabetes Association Self-Assessment Program

25

Which one of the following measures is MOST appropriate to improve his glycemic control? (A) Increase pre-meal aspart insulin. (B) Decrease pre-meal aspart insulin. (C) Increase morning glargine insulin. (D) Decrease morning glargine insulin. (E) Add morning NPH insulin. 28. A 48-year-old man presents to his primary care physician for management of newly-diagnosed type 2 diabetes. He denies drinking any alcohol or using tobacco. He is obese with a BMI of 36 kg/m2. Lab results include an ALT 102, AST 98, alkaline phosphatase 74, BUN 45, and creatinine 1.8 mg/dL. A1C is 7.5%. Viral hepatitis B and C serologies are negative. Ultrasound of the liver shows a diffuse increase in echogenicity, or a bright liver. A liver biopsy reveals steatosis with inammation, brosis, and necrosis. Which one of the following has been shown to improve liver biopsy results in patients with NASH? (A) Low fat diet. (B) Pioglitazone. (C) Insulin. (D) Glyburide. (E) Metformin. 29. A 58-year-old man presents to the ofce for follow up of diabetes care. He has a history of type 2 diabetes for 12 years. He is now taking metformin 1 g b.i.d. and glyburide 10 mg b.i.d.. He reports good adherence to this therapy, and states he has not missed any doses of medication in the past week. He has no specic complaints and overall feels well, maintaining an active lifestyle. His last A1C test result was 9.2% two months prior. In the ofce, his blood glucose level is 210 mg/dL fasting. He denies any history of hypoglycemia. Which one of the following is the BEST option to improve his blood glucose management? (A) Add a thiazolidenedione. (B) Add a thiazolidenedione and increase metformin. (C) Start exenatide. (D) Start insulin. (E) Repeat A1C, monitor home glucose levels, and continue current therapy.

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American Diabetes Association Self-Assessment Program

MCQs

30. A 34-year-old obese woman with a history of type 2 diabetes presents to the ofce for follow up. She has been on oral medication therapy for two years, including glyburide and pioglitazone (the latter started six months ago). She reports that her morning fasting blood glucose was 163 mg/dL. She denies any recent episodes of hypoglycemia. Point of care testing A1C is 8.1%, and last level was 7.9% three months ago. She has normal renal function. Her last dilated eye exam was without evidence of retinopathy. She requests a urine pregnancy screen and test result is positive for pregnancy. Her last menstrual period was six weeks ago. What is the BEST treatment choice for this patient at this time? (A) Stop glyburide and pioglitazone, monitor glucose levels frequently at home, and refer for intensive nutritional and physical activity counseling. (B) Stop glyburide and pioglitazone and start insulin, NPH at bedtime with lispro before meals. (C) Add insulin, 70/30 premixed every morning. (D) Stop glyburide and start glargine insulin, every morning. (E) Stop pioglitazone and start detemir insulin, every morning. 31. A 50-year-old woman with a history of type 2 diabetes for three years, hypertension, and hyperlipidemia presents for routine chronic disease care. She has no specic complaints during the visit and reports great effort in following recommended dietary and exercise plans. She eats three moderate-sized meals each day with snacks between meals. She walks for 30 minutes on alternate weekdays every week, usually in the evenings on her home treadmill. She works full-time and reports a busy schedule during the day. Her medications include metformin 850 mg b.i.d., lisinopril 20 mg/day, atorvastatin 20 mg at nighttime, and a daily baby aspirin. On physical exam, her BMI is 30 kg/m2 and her blood pressure is 125/78 mm Hg. Her cardiopulmonary exam is unremarkable. Abdomen is soft and non-tender. She has trace lower extremity edema. Monolament testing is without sensory decits. Her A1C level is 7.4%, higher than the previous level of 6.6% six months ago. Her glucose level in the ofce is 236 mg/dL, two hours after breakfast. She monitors her blood glucose frequently at home and at work. Her logbook includes the following (mg/dL):
Time Pre-breakfast Post-breakfast (2 hrs.) Pre-lunch Post-lunch (2 hrs.) Pre-dinner Post-dinner (2 hrs.) Minimum 82 154 106 85 78 165 Maximum 132 251 140 159 153 288

Which one is the following is the BEST option to improve her glycemic control? (A) Add repaglinide. (B) Add glargine. (C) Add aspart insulin before meals on days where patients does not exercise. (D) Increase metformin to 1000 mg b.i.d.. (E) Increase exercise therapy to 45 minutes per session.
MCQs American Diabetes Association Self-Assessment Program 27

32. A 67-year-old man with a history of obesity, type 2 diabetes, hypertension, and hyperlipidemia presents to his physician after recently having dyspnea with exertion. He has since had an abnormal stress test and is scheduled for a heart catheterization in one week. He has a creatinine level of 1.3 mg/dL and microalbuminuria. He currently takes metformin 850 mg b.i.d. and pioglitazone 15 mg/day. Which one of the following is recommended for this patient prior to catheterization? (A) Discontinue all diabetes medications. (B) Hold pioglitazone only the morning of procedure and maintain adequate hydration. (C) Hold metformin only the morning of procedure and maintain adequate hydration. (D) None of the above.

Items 3337
For each numbered clinical scenario (3337), select the one lettered medication (A, B, C, D, E) that is MOST appropriate to reach target glucose levels. Each lettered medication man be selected only once. (A) Metformin. (B) Glipizide. (C) Pioglitazone. (D) Basal insulin. (E) No additional medication therapy. 33. A 52-year-old obese woman was recently diagnosed with type 2 diabetes. She has not yet tried making lifestyle modications, but is motivated to do so. Her A1C level is 8.2% and creatinine level is 1.1 mg/dL. 34. A 38-year-old man has a history of type 2 diabetes for four years. He has not tolerated metformin due to gastrointestinal side effects. His A1C is 8.0% and postprandial glucose level in the ofce is 233 mg/dL. He has no health insurance or drug coverage plan. 35. A 65-year-old woman has a history of type 2 diabetes for nearly 20 years, has no complications, and is concerned about increased blood glucose levels. She actively volunteers in her community. She is currently taking combination therapy of metformin/glipizide. Her A1C level is 8.7%. 36. A 76-year-old man has a history of type 2 diabetes for 12 years and Alzheimer disease with dementia for six years and was recently hospitalized three months ago for congestive heart failure. Rosiglitazone was discontinued at the time of admission. At his follow up appointment, his A1C level is 7.9%. He now takes no medications for diabetes and his spouse is concerned about his overall current burden of medication therapy for other conditions. 37. A 72 year women with a history of type 2 diabetes has elevated glucose levels and a A1C of 7.5%. Her last creatinine level was 1.5 mg/dL. She stopped taking low-dose glyburide six months ago due to hypoglycemia, and has not taken any medications for diabetes since then with concern for low blood glucose levels.

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American Diabetes Association Self-Assessment Program

MCQs

38. A 60-year-old woman with a history of type 2 diabetes for 12 years, hypertension and hyperlipidemia presents to her physician for glycemic management. She has no known complications of diabetes, but had microalbuminuria noted on the most recent urinalysis. She currently takes a baby aspirin, glipizide, metformin, lisinopril, hydrochlorothiazide, and simvastatin. Exenatide was initiated and was discontinued because of intractable vomiting. She is making a strong attempt at reducing her weight through dietary modications and regular walking on weekdays. On physical exam, she is obese (BMI 31 kg/m2) with a blood pressure of 124/72 mm Hg. Funduscopic exam is unremarkable. Lungs are clear. Cardiovascular exam with normal heart sounds, no S3 or S4. She has trace lower extremity edema. Distal lower extremity reexes are intact. Monolament is negative for sensation loss. Her fasting glucose level in the ofce is 191 mg/dL and her A1C is 8.4%. Most recent laboratory values include a creatinine level of 1.1 mg/dL, AST 34, ALT 42, LDL 98 mg/dL, and HDL 39 mg/dL. Which one of the following is the MOST appropriate change to her medical therapy for optimal glycemic control? (A) Stop metformin and add pioglitazone. (B) Start detemir insulin every morning. (C) Start 70/30 premixed insulin every morning. (D) Start aspart insulin with each meal.

Items 3941
A 70-year-old man with a history of type 2 diabetes, hypertension, and chronic obstructive pulmonary disease presents to the emergency room after being found unresponsive by his wife at home. His wife provides additional history, stating that he was doing well until three days ago when he saw his physician for increasing cough, dyspnea, and associated changes in sputum. She states that his chest x-ray did not show any new changes, and he was prescribed ciprooxacin for a are of chronic bronchitis. Since then, he has improved with less dyspnea, but has a residual cough. His appetite has recently been low but she reports he ate a good breakfast and lunch prior to calling 911 (after he was found unresponsive). He has a history of type 2 diabetes for three years and does not have any known complications. He takes glyburide 5 mg b.i.d., lisinopril 20 mg/day, aspirin 81 mg/day, atorvastatin 20 mg at night, and a combivent inhaler. He has been on a stable medication regimen for the past year. He does not smoke or drink any alcohol. His wife reports that his fasting glucose levels range from 90 to 160 mg/dL in the mornings. His last A1C level was 6.8% one month ago. On physical exam in the emergency room, he is afebrile, with blood pressure of 132/78 mm Hg, and pulse regular at 110. He was not found to be orthostatic. He is conscious in the emergency room but somewhat confused. His skin is mildly diaphoretic. Cardiac exam was tachycardic rate and regular rhythm. Lungs with decreased breath sounds throughout, prolonged expiratory phase, and no rales. No lower extremity edema. Review of the ambulance record in the emergency room reveals that the patient had a ngerstick glucose level of 27 mg/dL when found at this home, and he was started on IV dextrose solution. 39. Which one of the following is the MOST likely cause of his hypoglycemia? (A) Overdose of glyburide. (B) Fluoroquinolone-sulfonylurea interaction. (C) Acute renal failure. (D) Limited oral intake. (E) Adrenal insufciency.

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40. Which one of the following is the MOST appropriate management for this patient? (A) Hospitalization and continued intravenous dextrose. (B) Hospitalization, continue intravenous dextrose, and add solumedrol. (C) Continue intravenous dextrose in the emergency room and discharge when glucose level normalizes and patient is able to eat. (D) Glucagon, continued intravenous dextrose, and discharge when glucose level normalizes and patient is able to eat. (E) Hospitalization, octreotide, and switch intravenous uids to 0.9 normal saline. 41. Which one of the following factors is LEAST likely to inuence the development of severe hypoglycemia in this patient? (A) Longer duration of diabetes and patient age. (B) Hypoglycemic unawareness. (C) Use of intensive insulin therapy. (D) Use of exenatide therapy. (E) Use of excessive alcohol. 42. A 59-year-old man with a long-standing history of type 2 diabetes, hypertension, and hyperlipidemia presents for diabetes management. He has developed mild background retinopathy. For his diabetes, he is taking metformin 850 mg t.i.d., pioglitazone 30 mg/day, glyburide 10 mg b.i.d., and glargine insulin 30 U every morning. For his hypertension, he takes amlodipine 5 mg/day, lisinopril 40 mg/day, and hydrochlorothiazide 12.5 mg/day. On physical exam, his blood pressure is 122/69 mm Hg and pulse rate is 77. His exam is notable for 1+ bilateral lower extremity edema. His A1C level is 8.3%. His glucose logbook is reviewed and shows (mg/dL):
Time Pre-breakfast Post-breakfast (2 hrs.) Pre-lunch Pre-dinner Post-dinner (2 hrs.) Minimum 90 242 103 134 215 Maximum 164 285 212 217 292

Which one of the following is the BEST option for blood glucose management in this patient at this time? (A) Stop glyburide and start repaglinide before meals. (B) Stop glyburide and start aspart insulin before meals. (C) Stop glyburide and start glimepiride 8 mg/day. (D) Increase pioglitazone to 45 mg/day. (E) Add a second dose of glargine (10 U at night).

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43. A 53-year-old woman with a history of recently-diagnosed type 2 diabetes presents to her physician with concerns regarding her blood glucose levels when checked at home. Her fasting glucose levels were between 123 and 174 mg/dL, while postprandial glucose level ranged from 135 to 206 mg/dL. She currently takes metformin 1 g b.i.d. She states that she wants to avoid taking insulin and having to self-administer injections. She has made signicant changes in her diet over the past year, eating portion-controlled meals and drinking diet instead of regular cola beverages. She has met with a dietitian regularly over six months and lost 10 lbs. during this time period (her BMI is now 31 kg/m2). She has attempted aerobic exercises (walking, biking) but has had trouble due to knee pain related to a previous injury. She plans to try either swimming or water aerobics in the near future. Her A1C level is currently 7.1%. She is not satised with her weight or blood glucose levels, and wishes to pursue additional therapy. Which one of the following would be the BEST recommendation for management of her type 2 diabetes? (A) Add pioglitazone. (B) Add exenatide. (C) Add glipizide. (D) Increase metformin. (E) Add resistance training. 44. Hyperglycemia experienced by hospitalized patients is associated with increased length of stay as well as morbidity and mortality. A scheduled sliding scale of short-acting insulin for patients in non-critical care settings has been available for years, and its use remains prevalent today. In general, which one of the following statements is CORRECT regarding sliding scale insulin therapy vs basal-bolus insulin therapy? (A) It is associated with greater hypoglycemia . (B) It is associated with less hyperglycemia. (C) It is associated with improved clinical outcomes. (D) None of the above.

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Items 4547
Twenty-four adult patients with uncontrolled type 2 diabetes, aged 3070 years of age, were enrolled in a research study. All of the subjects received extended-release glipizide 5 mg/day for two weeks during a washout period prior to an insulin-based intervention. Then, patients were randomized to receive either glipizide + NPH insulin versus glipizide + glargine insulin for 12 weeks. Insulin doses were provided at bedtime and titrated according to a protocol. During the nal week of the intervention, continuous glucose monitoring was performed for three days. For each numbered treatment (4547), select the one lettered continuous glucose monitoring recording (A, B, C) associated with it. Each lettered continuous glucose monitoring recording may be selected only once. (A)
Glucose mg/dL 400 300 200
180

100
68

0 03:00 06:00 09:00 12:00 15:00 18:00 21:00

(B)
Glucose mg/dL

400 300 200


180

100 0
36

03:00

06:00

09:00

12:00

15:00

18:00

21:00

(C)
Glucose mg/dL

400 300 200


180

100 0
36

03:00

06:00

09:00

12:00

15:00

18:00

21:00

Wang XL, et al: Evaluation of the superiority of insulin glargine as basal insulin replacement by continuous glucose monitoring system. Diabetes Res Clin Pract Apr 2007;76(1):3036.

45. Extended-release glipizide + NPH insulin at bedtime. 46. Extended-release glipizide + glargine insulin at bedtime. 47. Extended-release glipizide only (during washout).

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48. A patient with type 2 diabetes who has been on multiple non-insulin treatments, (pioglitazone, metformin, exenatide, and a sulfonylurea), still has fasting ngerstick blood glucose levels ~180190 mg/dL (none were 140), postprandial ngerstick glucose levels 200 mg/dL and A1C 8.1% after more than 3 months. Which one of the following courses of action would you recommend for this patient? (A) Begin insulin. (B) Observation on better diet, encourage compliance by threatening need for insulin. (C) Observation on better exercise, encourage compliance by threatening need for insulin. (D) Observation and hope external life stresses dissipate. (E) Observation and look for unrecognized hypoglycemia.

Items 4953
For each numbered logical explanation for maintaining non-insulin modality treatment (4953) in patients with type 2 diabetes being treated with basal-bolus insulin for both fasting and postprandial elevated glucose levels, select the one lettered non-insulin modality MOST closely associated with it. Each lettered non-insulin modality may be selected only once. (A) Metformin. (B) Pioglitazone. (C) Incretins. (D) Rosiglitazone/sulfonylurea. (E) Acarbose. 49. Decrease postprandial glucose levels by improving glucose-dependent insulin release. 50. Decrease advanced glycosylation end-product (AGE) production. 51. Delay glucose absorption by shifting absorption to distal small intestinal sites. 52. Decrease TGs and increase high density lipoproteins. 53. No logic.

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54. Ideal insulin therapy in patients with type 1 diabetes does NOT include which one of the following? (A) Use of NPH insulin. (B) Use of fast analog insulin. (C) Use of regular human insulin. (D) Use of an insulin pump. (E) Matching insulin pharmacokinetics to the patients lifestyle and nutritional source or eating pattern. 55. Which one of the following is NOT a rationale for the use of fast analog insulin over regular human insulin in any regimen which involves prandial dosing? (A) It addresses the issue of gastroparesis better than regular insulin. (B) It is associated with less 4 hr hypoglycemia. (C) It is associated with less postprandial area under curve hyperglycemia. (D) It may be given immediately after eating at times when the patient doesnt know how much they plan to eat. (E) It is associated with less 2 hr hyperglycemia. 56. Advantages of appropriate doses of a fast analog insulin versus regular insulin in hospital settings does NOT include which one of the following? (A) Reduction of the occurrence of hypoglycemia several hours after eating when the next meal is delayed because the patient comes back to the oor late from a study. (B) Reduced risk of hypoglycemia due to stacking effects of recurrent insulin doses every 34 hours. (C) It can be given after eating at reduced doses in patients with inconsistent oral intake. (D) It can be given IV with reduced risk of hypoglycemia.

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Items 5759
A physician and his 45-year-old male patient with type 2 diabetes chose to start a basal insulin glargine while continuing to use 3 oral agents with a goal of controlling his fasting glucose with the basal insulin and seeing if the metformin pioglitazone, sitagliptin combination also controlled postprandial glucose levels. Glargine was started at 10 U at night and was titrated by phone calls to the physicians ofce so that at 26 U, his fasting glucose was 90120 mg/dL; most of his postprandials were 120160 mg/dL. He came back 1 month later and his weight was up 1 lb. However, when he had noticed that occasional fasting glucose levels were elevated, he, on his own, increased his glargine insulin to 34 U. It did not help and he still saw intermittent elevated fasting glucose levels sometimes even worse than before and he gained 4 lbs. in a month. He frequently wakes up with headaches and complains of nightmares and night sweats. 57. Which one of the following is the MOST likely explanation for this patients problem? (A) Noncompliance with diet, intermittently. (B) Dawn effect. (C) Middle of night hypoglycemia with a.m. rebound. (D) Misinjection/administration insulin. 58. Which one of the following is the MOST important therapeutic intervention for this patient? (A) Decrease glargine dosage. (B) Advise the patient on high glycemic index foods. (C) Advise the patient to monitor 3 a.m. glucose levels. (D) Check the patients insulin injection technique. 59. You see the patient 3 months later. His insulin glargine was adjusted to 23 U with good control of the fasting glucose levels roughly 100 to 120 mg/dL. He was maintained on metformin, pioglitazone, and sitagliptin. However, gradually over time his postprandial glucose levels increased to 160 mg/dL and not infrequently over 180 mg/dL. You recommend basal-bolus insulin q.i.d., but he refuses. He agrees to begin a premixed preparation of intermediate-acting insulin with fast analog, twice daily, before breakfast and dinner. Which one of the following statements is INCORRECT regarding premixed insulin preparations? (A) They provide a more accurate injection of correct dose than self-mixture of NPH and a short acting insulin. (B) They offer no problem in titrating doses. (C) They require eating a consistent amount of food at approximately the same time each day. (D) They are more convenient to use. (E) They are available with regular as well as fast analogs.

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60. Which one of the following is NOT an advantage of insulin pump therapy over multiple daily injections (MDI)? (A) It covers dawn phenomena. (B) It is easier to deal with changes in glucose levels with intermittent exercise. (C) There is no difference in risk of diabetic ketoacidosis (DKA). (D) It is easier to manage delayed carbohydrate absorption with meals containing complex carbohydrates; higher fat content meals; higher ber meals; and gastroparesis. (E) It results in less hypoglycemia.

Items 6166
For each numbered mechanism (6166), select the one lettered oral hypoglycemic agent (A, B, C, D, E) associated with it. Each lettered oral hypoglycemic agent may be selected once, more than one, or not at all. (A) Metformin. (B) Pioglitazone/Rosiglitazone. (C) Sulfonylurea/Glinide. (D) Exenatide/Sitagliptin. (E) Acarbose. 61. Decreases insulin resistance at the liver. 62. Increases insulin sensitivity at muscle/fat. 63. Decreases rate of carbohydrate breakdown in the proximal small intestine. 64. Decreases glucagon. 65. Increases insulin secretion (of remaining -cells), glucose-dependent manner. 66. Increases insulin secretion (of remaining -cells), glucose-independent manner.

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67. According to an ADA consensus group algorithm, initial therapy for patients with type 2 diabetes includes diet, lifestyle changes, and which one of the following oral agents? (A) Sulfonylureas. (B) Metformin. (C) Thiazolidinediones. (D) Alpha glucosidase inhibitors. 68. Which one of the following is NOT a risk factor for hypoglycemia in patients with type 2 diabetes? (A) Missed or delayed meal. (B) Elderly age. (C) Substitution of intermediate-acting insulins (such as NPH or 70/30) with long-acting insulins (such as glargine or detemir). (D) Renal insufciency. (E) Alcohol consumption. 69. Intensive treatment of patients with type 1 diabetes has been shown to decrease the incidence of which one of the following complications over time? (A) Retinopathy. (B) Nephropathy. (C) Neuropathy. (D) Cardiovascular disease. (E) All of the above. 70. Which one of the following statements regarding acute hyperglycemic crises is INCORRECT? (A) The most common precipitating factors in the development of diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) and are inadequate/inappropriate insulin therapy and infection. (B) The mortality rates for both DKA and HHS have both decreased over time and are roughly equivalent. (C) Patients with low normal potassium at presentation have severe depletion of total body potassium stores and need to be aggressively repleted and carefully monitored. (D) The average uid decit is greater in HHS (810 liters) compared to DKA (36 liters). (E) The treatment of choice for both DKA and HHS is intravenous insulin.

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Items 7174
A 62-year-old Caucasian man seeks to establish care with you. His past medical history includes type 2 diabetes, hypertension, and renal insufciency. He reports his diabetes was initially controlled with diet but an oral agent, glyburide, was added 4 years ago. For his hypertension he takes ramipril 20 mg/day. He states he watches his carbohydrate and salt intake. He does not get any regular exercise. His physical exam is remarkable for BMI of 34 kg/m2, blood pressure of 132/88 mm Hg, decreased sensation bilaterally with monolament testing. The remainder of his exam is normal. Labs results are as follows:
Total Cholesterol HDL-C Fasting Plasma Glucose A1C Creatinine Urinary Albumin/Creatinine 181 mg/dL 42 mg/dL 175 mg/dL 8.3% 1.6 mg/dL 100 mg/g

71.

Since he is overweight and does not get any regular exercise, you suggest that increasing his physical activity may be helpful in controlling his diabetes. Which one of the following statements is INCORRECT regarding diabetes control, weight, and activity? (A) Weight loss of at least 7% of initial body weight with diet and exercise would likely improve glycemic control. (B) A mean sustained weight loss of 20 kg has resulted in remission of hyperglycemia in studies of obese subjects undergoing bariatric surgery. (C) Long-term adherence and injury are major problems in continuing exercise therapy. (D) Diet and exercise therapy, if maintained long-term, will likely allow maintenance of euglycemia. (E) The major environmental risk factors that increase the risk of type 2 diabetes are overnutrition and sedentary lifestyle.

72. The patient does not feel he can take time to increase his activity over the next several months because of his current job situation. According to the ADA treatment algorithm for type 2 diabetes, the next MOST appropriate treatment option would be which one of the following? (A) Add metformin. (B) Add exenatide as this will likely signicantly improve his fasting blood glucose levels. (C) Add either a basal insulin or a thiazolidinodione.

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73. The patient develops hypoglycemia with the new regimen. Which one of the following statements is INCORRECT regarding his hypoglycemia? (A) Glyburide is more likely to cause hypoglycemia than other sulfonylureas. (B) Utilization of sulfonylureas in the setting of renal insufciency increases his risk of hypoglycemia. (C) The incidence of hypoglycemia increases with higher dosages of sulfonylureas. (D) Because of its long half-life, glyburide suppresses hepatic glucose output. (E) Sulfonylureas are more likely to cause hypoglycemia in patients who are overweight. 74. Upon review of his blood pressure and urine results, which one of the following statements is CORRECT? (A) He has macroalbuminuria. (B) An additional agent (a thiazide diuretic) should be added. (C) An additional agent (an angiotensin receptor blocker [ARB]) should be added. (D) His blood pressure is at goal and he does not need any additional agents. (E) His angiotensin-converting enzyme inhibitor (ACE-I) should be changed to an ARB.

Items 7576
You are consulted for glycemic control in a 51-year-old obese woman who is being discharged after hospitalization for deep venous thrombosis. Her past medical history includes type 2 diabetes for the last 2 years, hypertension, mild COPD, and hyperlipidemia. Her BMI is 34 kg/m2. She had been off all diabetic medications for the last 6 months because of inability to afford her medications. Her lab tests are as follows:
A1C Creatinine AST ALT 7.9% 1.2 mg/dL 93 (normal 45) 88 (normal 40)

75.

Which one of the following statements regarding her condition is INCORRECT? (A) Weight loss is likely to improve her liver abnormalities. (B) Her condition is benign and will not progress to more advanced liver disease. (C) She is more likely to have positive hepatitis C antibodies than the general population. (D) Alcohol should be avoided because of its toxic effects on the liver.

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76. Which one of the following statements about liver disease and diabetes is INCORRECT? (A) Diabetes is the most common co-morbidity for liver disease in the U.S. (B) Statins appear to be safe in patients with diabetes and liver disease. (C) Patients with hepatitis C are more likely to develop diabetes than patients with hepatitis B. (D) Liver biopsy is necessary to make the diagnosis of nonalcoholic fatty liver disease (NAFLD). (E) There have been case reports of idiosyncratic heptotoxicity with ACE inhibitors. 77. Which one of the following conditions is NOT a risk factor for the development of heart failure during treatment of patients with type 2 diabetes with thiazolidinediones (TZDs)? (A) Hypertension. (B) Advanced age (70 years old). (C) Mild renal insufciency (creatinine of 1.5 mg/dL). (D) Co-administration with insulin. (E) Coronary artery disease.

Items 7883
You have admitted a 54-year-old obese man with new diagnosis of heart failure. He has an 8-year history of well-controlled type 2 diabetes. His outpatient diabetes regimen includes metformin XR 2000 mg/day, pioglitazone 30 mg/day and glipizide XL 20 mg/day. 78. Which one of the following statements about diabetes and heart failure is INCORRECT? (A) An independent association between diabetes and the incidence of heart failure has not been proven. (B) Diabetes is a risk factor for the progression of heart failure. (C) Diabetes is a predictor of mortality in patients with heart failure. (D) Heart failure itself is associated with insulin resistance and the development of diabetes. 79. Which one of the following courses of action will allow you to BEST manage his diabetes as an inpatient? (A) Discontinue the pioglitazone only. (B) Discontinue pioglitazone and metformin. (C) Discontinue all oral medications and start insulin. (D) Continue metformin and glipizide and add insulin. (E) Continue glipizide and add insulin.

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80. During his hospitalization, he has an echocardiogram which shows an ejection fraction of 40%. He is placed on a heart failure regimen including diuretics, ACE inhibitor and a -blocker. At discharge, he has no symptoms of heart failure at rest or with exertion (New York Heart Association Class I) and has normal renal and hepatic function. Which one of the following will you order on discharge if his main goal is to lose weight? (A) Insulin since it is the only medication that is safe in patients with heart failure. (B) Metformin, glipizide and pioglitazone. (C) Metformin, glipizide and exenatide. (D) Metformin, glipizide, and sitagliptin. (E) Metformin, glipizide and insulin. 81. What is his A1C goal as an outpatient? (A) 7%. (B) 78%. (C) 89%. (D) 9%. 82. What is the increased risk of uid retention and heart failure in patients with type 2 diabetes treated with thiazolidinediones? (A) No increased risk. (B) 2-fold. (C) 4-fold. (D) 8-fold. 83. Which one of the following is a recently recognized side effect of thiazolidinediones? (A) Increased incidence of fractures. (B) Increase in visceral fat. (C) Increased risk of hypoglycemia. (D) Weight gain only if used in combination with insulin. 84. DPP-IV inhibitors are currently FDA approved for treatment of patients with type 2 diabetes in all the following settings EXCEPT: (A) As monotherapy. (B) In combination with metformin. (C) In combination with pioglitazone. (D) In combination glimepiride. (E) In combination with exenatide.

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85. Which one of the following regimens has the HIGHEST risk of hypoglycemia in patients with type 2 diabetes? (A) Sitagliptin and sulfonylurea. (B) Exenatide, metformin, and sulfonylurea. (C) Metformin and sulfonylurea. (D) Exenatide and thiazolidinedione. 86. Which one of the following is a precaution against using exenatide in patients with type 2 diabetes? (A) Renal insufciency (creatinine clearance less than 30 ml/min). (B) Normal weight. (C) Mild chronic hepatitis C. (D) Current treatment with insulin. 87. For a patient with type 2 diabetes who is inadequately controlled on metformin monotherapy, by how much would the addition of sitagliptin be expected to drop A1C level (absolute %)? (A) 0.2%. (B) 0.4%. (C) 0.7%. (D) 1%. (E) 1.5%. 88. In deciding on how to improve A1C control in a patient with type 2 diabetes, currently on maximal doses of metformin and sulfonylurea, you are deciding between the addition of basal insulin versus exenatide. Which one of the following statements is INCORRECT? (A) Addition of exenatide is more likely to cause weight loss compared to addition of basal insulin. (B) Addition of exenatide is more likely to cause GI side effects compared to addition of basal insulin. (C) Both treatments are equally likely to decrease fasting plasma glucose. (D) Both treatments are likely to cause an increased risk of hypoglycemia. (E) Both treatments are likely to decrease A1C by a roughly equivalent amount. 89. In examining the long-term studies of exenatide as a treatment addition to metformin and/or sulfonylurea, which one of the following statements is MOST accurate? (A) The effects of exenatide decrease over time. (B) Only one half of patients lose weight. (C) Patients with the greatest weight loss will likely have the greatest reduction in A1C. (D) The average decrease in A1C will be about 2%. (E) At 1 year, the average weight loss will be about 10 kg.

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90. You are seeing a 57-year-old obese woman on hemodialysis with a 13-year history of type 2 diabetes. She has been on insulin in the remote past but has had good control over the last year on a short-acting sulfonylurea. However, she had a recent hospitalization for severe hypoglycemia. She is discharged without any medications for diabetes and in your ofce her fasting ngerstick glucose is 114 mg/dL and her A1C is 7.6%. What treatment should you recommend for her? (A) Restart the sulfonylurea. (B) Start sitagliptin. (C) Start basal insulin. (D) Metformin. 91. Which one of the following statements regarding pramlintide is INCORRECT? (A) It is only approved as adjunctive treatment to insulin. (B) It is approved for use only in patients with type 1 diabetes. (C) The main side effect is nausea. (D) It is injected prior to each meal. (E) Pramlintide can be associated with mild weight loss.

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Notes

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Appendix
I. American Diabetes Association Guidelines and Treatment Algorithms At-a-Glance

Appendix

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Denition and Description of Diabetes Mellitus


Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels.

I. Diagnosis of Impaired Glucose Tolerance (IGT) and Impaired Fasting Glucose (IFG)
This group is dened as having fasting plasma glucose (FPG) levels 100 mg/dL (5.6 mmol/L) but 126 mg/dL (7.0 mmol/L) or 2-h values in the oral glucose tolerance test (OGTT) of 140 mg/dL (7.8 mmol/L) but 200 mg/dL (11.1 mmol/L). Thus, the categories of FPG values are as follows: FPG 100 mg/dL (5.6 mmol/L) normal fasting glucose; FPG 100125 mg/dL (5.66.9 mmol/L) = IFG; FPG 126 mg/dL (7.0 mmol/L) provisional diagnosis of diabetes (the diagnosis must be conrmed, as described below). The corresponding categories when the OGTT is used are the following: 2-h post load glucose 140 mg/dL (7.8 mmol/L) normal glucose tolerance; 2-h post load glucose 140199 mg/dL (7.811.1 mmol/L) = IGT; 2-h post load glucose 200 mg/dL (11.1 mmol/L) provisional diagnosis of diabetes (the diagnosis must be conrmed, as described below). Patients with IFG and/or IGT are now referred to as having pre-diabetes indicating the relatively high risk for development of diabetes in these patients.
Table 1. Treatment Recommendation for Individuals with IFG, IGT, or Both. Population IFG or IGT. Individuals with IFG and IGT and any of the following: 60 years of age. BMI 35 kg/m2. Family history of diabetes in rst-degree relatives. Elevated triglycerides. Reduced HDL-C. Hypertension. A1C 6.0%.
* Metformin 850 mg twice/day.

Treatment Lifestyle modication (i.e., 510% weight loss and moderate intensity physical activity 30 min/day). Lifestyle modication (as above) and consider metformin*.

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Appendix

II. Diagnosis of Type 2 Diabetes


Table 2. Criteria for Testing for Diabetes in Asymptomatic Adult Individuals. 1. Testing for diabetes should be considered in all individuals at age 45 years and above, particularly in those with a BMI 25 kg/m2*, and, if normal, should be repeated at 3-year intervals. 2. Testing should be considered at a younger age or be carried out more frequently in individuals who are overweight (BMI 25 kg/m2*) and have additional risk factors: Are habitually physically inactive. Have a rst-degree relative with diabetes. Are members of a high-risk ethnic population (e.g., African-American, Latino, Native American, Asian American, Pacic Islander). Have delivered a baby weighing 9 lbs or have been diagnosed with GDM. Are hypertensive ( 140/90 mm Hg). Have an HDL-C level 35 mg/dL (0.90 mmol/L) and/or a triglyceride level 250 mg/dL (2.82 mmol/L). Have PCOS (polycystic ovary syndrome). On previous testing, had IGT or IFG. Have other clinical conditions associated with insulin resistance (e.g., PCOS or acanthosis nigricans). Have a history of vascular disease.
* May not be correct for all ethnic groups.

Table 3. Testing for Type 2 Diabetes in Children. Criteria Overweight (BMI 85th percentile for age and sex, weight for height 85th percentile, or weight 120% of ideal for height). Plus any two of the following risk factors: Family history of type 2 diabetes in rst- or second- degree relative. Race/ethnicity (Native American, African-American, Latino, Asian American, Pacic Islander). Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or PCOS). Maternal history of diabetes or GDM. Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age. Frequency: every 2 years. Test: FPG preferred.
Clinical judgment should be used to test for diabetes in high-risk patients who do not meet these criteria.

Table 4. Criteria for the Diagnosis of Diabetes Mellitus. 1. Symptoms of diabetes plus casual plasma glucose concentration 200 mg/dL (11.1 mmol/L). 1). Casual is dened as any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss. OR 2. FPG 126 mg/dL (7.0 mmol/L). Fasting is dened as no caloric intake for at least 8 hours. OR 3. 2-h post load glucose 200 mg/dL (11.1 mmol/L) during an OGTT. The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.
In the absence of unequivocal hyperglycemia, these criteria should be conrmed by repeat testing on a different day. The third measure (OGTT) is not recommended for routine clinical use. Appendix American Diabetes Association Guidelines and Treatment Algorithms At-A-Glance 47

III. Summary of Recommendations for Adults with Diabetes.


Glycemic Control A1C Preprandial capillary plasma glucose Peak postprandial capillary plasma glucose Blood pressure Lipids LDL-C Triglycerides HDL-C
100 mg/dL (2.6 mmol/L) 150 mg/dL (1.7 mmol/L) 40 mg/dL (1.0 mmol/L) 7.0%*

90130 mg/dL (5.07.2 mmol/L)


180 mg/dL (10.0 mmol/L) 130/80 mm Hg

Key concepts in setting glycemic goals: A1C is the primary target for glycemic control. Goals should be individualized. Certain populations (children, pregnant women, and elderly) require special considerations. More stringent glycemic goals (i.e., a normal A1C, 6%) may further reduce complications at the cost of increased risk of hypoglycemia. Less intensive glycemic goals may be indicated in patients with severe or frequent hypoglycemia. Postprandial glucose may be targeted if A1C goals are not met despite reaching preprandial glucose goals.
* Referenced to a non-diabetic range of 4.06.0% using a DCCT-based assay. Postprandial glucose measurements should be made 12 hours after the beginning of the meal, generally peak levels in patients with diabetes. Current NCEP/ATP III guidelines suggest that in patients with triglycerides 200 mg/dL, the non-HDL-C (total cholesterol minus HDL) be utilized. The goal is 130 mg/dL (121). For women, it has been suggested that the HDL-C goal be increased by 10 mg/dL.

Table 5. Detailed Diabetes History and Evaluation. Past medical history should include: Prior glucose values including A1C, symptoms, treatments, and history of self-monitoring. History of complications: hypoglycemia and/or ketoacidosis including frequency, severity, and causes. Self-management, self-monitoring education, attitudes, health beliefs. Mood disorder. Prior or current infections, particularly skin, foot, dental, and genitourinary. Current microvascular symptoms and complications (eye, kidney, nerves). Current macrovascular symptoms and complications (evaluation of cardiovascular risk factors and cardiovascular disease). Sexual dysfunction. Review of past/present lifestyle modication Eating patterns Smoking history Diet history Alcohol history Weight history Controlled substances Exercise history Other medications evaluate for effect on blood glucose. Family history of diabetes and CVD. Referrals Eye exam. Family planning for women of reproductive age. Dietitian for medical nutrition therapy (MNT). Diabetes educator. Foot specialist. Dentist.

Adapted from American Diabetes Association Clinical Practice Recommendations, 2006. Diabetes Care 2006;29(suppl. 1):S9. 48 American Diabetes Association Guidelines and Treatment Algorithms At-A-Glance Appendix

Table 6. Follow-up Testing Recommendations with Diabetes. Potential Complications Hyperglycemia Test A1C Fasting blood glucose Self-monitoring of blood glucose Hypertension Autonomic Neuropathy (Orthostatic Hypotension) Dyslipidemia Foot Care Blood pressure Sitting and standing blood pressure Lipid panel Quantitative somato-sensory threshold test using Semmes-Weinstein 5.07 (10 g) monolament, tuning fork, palpation, and visual inspection Serum creatinine Albumin/Creatinine ratio (Random spot urine) Frequency of Evaluation Measure A1C 2 times/year if at goal, quarterly if therapy changed, or not at goal Varies depending on prescription regime Frequency/timing should be individualized to facilitate reaching goals Measure at every visit Appropriate patients/each visit Test annually More often if not at goal or when changing therapy Perform a visual inspection at each routine visit for people with neuropathy. Annual comprehensive foot exam Annually Type 2 diabetes mellitus Annual screening Type 1 diabetes mellitus Annual screening with duration of diabetes 5 years Type 1 & 2 diabetes mellitus 2 of 3 specimens within a 36 month period should be abnormal before considering a new diagnosis Retinopathy Comprehensive eye exam Type 2 diabetes mellitus Annual dilated & comprehensive exam Type 1 diabetes mellitus Initial dilated & comprehensive exam within 5 years of onset; annual exams thereafter Periodontal disease (common in type 2 diabetes mellitus) Inuenza and pneumonia Dental evaluation Immunization Annually Annual inuenza vaccination

Nephropathy

Adapted from American Diabetes Association Clinical Practice Recommendations, 2006. Diabetes Care 2006;29(suppl. 1):S442.

Appendix

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49

Diagnosis Lifestyle Intervention + Metformin No Add Basal Insulin (Most effective) No A1C 7% Yes* No A1C 7% Yes* Add Glitazone (No hypoglycemia) Yes* No A1C 7% Yes*

Add Sulfonylurea (Least expensive) A1C 7%

Intensify Insulin No A1C

Add Glitazone 7% Yes*

Add Basal Insulin No A1C

Add Sulfonylurea 7% Yes*

Add Basal or Intensify Insulin Intensive Insulin + Metformin +/- Glitazone Figure 1. Consensus Algorithm for the Metabolic Management of Type 2 Diabetes. Reinforce Lifestyle Intervention at Every Visit.
* Check A1C every 3 months until 7% and then at least every 6 months. Although three oral agents can be used, initiation and intensication of insulin therapy is preferred based on effectiveness and expense.

Each anti-diabetic medication class possesses differences with regard to contraindications, adverse effects and mechanisms of action that may dictate which medication is the best for an individual patient (Table 7). Sulfonylurea therapy may be most useful in thin patients with insulinopenia, while metformin may be most useful in obese patients with dyslipidemia. The -glucosidase inhibitors and meglitinides may be most useful in patients with exaggerated postprandial increases in blood glucose, however the -glucosidase inhibitors can be used with sulfonylureas while the meglitinides can be used with metformin. The thiazolidinediones may be most useful in patients with insulin resistance or azotemia. Insulin may be useful in patients who will not be able to reach their glycemic goal with the use of the other adjunct therapies just mentioned. Exenatide injection is the rst in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics. Exenatide increases glucose-dependent insulin secretion, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes who are taking sulfonylurea, metformin, a TZD or combinations of these agents but have not achieved adequate glycemic control.

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Appendix

Table 7. Drug Choices Based on Drug & Patient Characteristics


Sitagliptin (Dpp-4 inhibtor) 1x daily

Metformin Dosing frequency 23x daily

Thiazolidinedione Sulfonylurea Pioglitazone: 1x daily Weeks Rosiglitazone: 2x daily

Repaglinide/ Nateglinide* Exenatide Inject before breakfast and dinner Day

Acarbose/ Miglitol 3x daily with meals

Glime- Glipizide/ * 1 with pramide: Glyburide: each meal 1x daily 2x daily Day Day

Speed of action FBS/ppg Efcacy Postprandial FBS HgA1 Concern/ side-effects

Weeks/weeks

Day

Months

xx xxx xxx GI upset, lactic acidosis: avoid in patients with CHF, liver disease, acute illness, other acidosis, Cr >1.4, hospitalized patients and hold 2 days after IV contrast until Creatinine stable None

xx xxx xxx

xx xxx xxx

xxx xx xxx

xxx x x

xx xx

xx x xx

xxx x x GI sideeffects Treat hypo with glucose

Edema wt gain +++ Avoid with no salt diet & avoid NSAID Channel blocker, COX 2 inhibitors CHF 1%

wt gain ++/+

Nausea None Avoid by stop eating when feel full

Hypoglycemic risk when used alone Monitor for

None

+++

+ +/ +

None

None

None

Creatinine & Edema/ creatinine clearance Heart Failure OR NC NC OR NC

Hypoglycemia

Hypoglycemia Hypoglcemia Hypglocemia LFTs if use with if use with SU/insulin SU/insulin Decrease Neutral NC NC NC NC NC

Weight Lipids HDL LDL TG Insulin levels

both NC NC Decrease OR NC (less with glim.)

Decrease Glucosedependent rise Ideal

Decrease Glucosedependent rise Ideal

Elderly

AVOID if >70 years (because creatinine clearance) avoid Cr decrease <70 +

No special risks

Watch for Hypoglycemia

Watch for Hypoglycemia

No special risks (GI sideeffects may be benecial)

Preg risk in pts. with Polycystic Ovary Syndrome

Other Drug Information


Primary failure rate Cost ? long term complications 20% xx AGE products in vitro endothelial dysfunction 20% xxx endothelial dysfunction Preserve beta cell function. Only for Pio= advantageous for lipid prole 20% Xgeneric, XXbrand 20% xx xxx xxx No data xx

Appendix

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51

Bibliography
1. Byetta Prescribing Information. February 2007. www.byetta.com. Accessed March 2007. 2. Fineman MS, et al: Effect on glycemic control of exenatide (synthetic exendin-4) additive to existing metformin and/or sulfonylurea treatment in patients with type 2 diabetes. Diabetes Care 2003;26(8):23707. 3. FDA website. www.fda.gov/medwatch. Accessed June 2005. 4. Buse JB, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 2004;27(11):262835. 5. Triplitt CL, et al: Diabetes Mellitus. In Dipro J, et al(eds). Pharmacotherapy: Pathophysiologic approach. 6th ed. New York, NY: McGraw-Hill Companies. 2005;13331367 6. The American Association of Clinical Endocrinologists medical guidelines for the management of diabetes mellitus: The AACE system of intensive diabetes self-management 2002 update. Endocrine Practice 2002;8(Suppl. 1):4065. 7. American Diabetes Association. Diagnosis and classication of diabetes mellitus. Diabetes Care 2005;28(Suppl. 1):S37S42. 8. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2005;28(Suppl. 1):S4S36. 9. Poulsen MK, et al: The combined effect of triple therapy with rosiglitazone, metformin, and insulin aspart in type 2 diabetic patients. Diabetes Care 2003;26(12):32733279. 10. Dailey GE, et al: Glycemic control with glyburide/metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: a randomized, double-blind trial. Am J Med 2004;116:223229. 11. DeFronzo RA, et al: Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin treated patients with type 2 diabetes. Diabetes Care 2005;28(5):10921100. 12. Kendall DM, et al: Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005;28(5):10831091. 13. Klein S, et al: Weight management through lifestyle modication for the prevention and management of type 2 diabetes: rational and strategies. Diabetes Care 2004;27(8):20672073. 14. Chobanian AV, et al: Seventh Report of the Joint National Committee on prevention, detection, evaluation and treatment of high blood pressure. Hypertension 2003;42:12061252. 15. Heine RJ, et al: Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes. Annals of Internal Medicine 2005;143:559569. 16. Nathan DM, et al: Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2006;29(8)19631972.

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Appendix

American Diabetes Association Self-Assessment Program


Educational Critiques

IN ORDER TO MAXIMIZE YOUR LEARNING EXPERIENCE IT IS IMPORTANT THAT YOU DO NOT LOOK AT THE EDUCATIONAL CRITIQUES UNTIL AFTER YOU HAVE COMPLETED MARKING YOUR ANSWERS FOR THE MCQs ON THE ANSWER SHEET. DO NOT CHANGE THE ANSWERS MARKED ON YOUR ANSWER SHEET WHILE READING THE CRITIQUES. THE INTENT OF ADA-SAP IS LEARNING NEW KNOWLEDGE AND REINFORCING PREVIOUSLY LEARNED KNOWLEDGE. THERE IS NO PASS-FAIL SCORE.

MCQs Educational (Learning) Critiques

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53

Educational (Learning) Critiques Items 197


Item 1 True Answers A, C; False Answers B, D, E The ADA Guidelines recommend an A1C test at least 2 times a year in patients who are meeting treatment goals and who have stable glycemic control. This patient is more than 12 months past due for a follow-up A1C test. For her, the A1C test should be performed quarterly until her goal of 7% is achieved or as close to 6% without signicant hypoglycemia. A1C levels do not fully reect a change in glucose levels for approximately 3 months and, therefore, bimonthly measurement could be excessive and results in unnecessary additions of drugs or dose titrations. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 2 True Answers A, B, C, E; False Answer B Since this patient has not seen a physician for at least one year, she requires her annual dilated and comprehensive eye exam by an ophthalmologist or optometrist as well as a foot exam (ideally by a podiatrist) because she has developed loss of pain sensation in both feet. The ADA also recommends an annual test to assess urine albumin in all patients with type 2 diabetes starting at diagnosis. The preferred method of screening for microalbuminurea is a random spot collection for determination of a protein to creatinine ratio. A 24-hour or time collections are more burdensome and add little to prediction or accuracy. A spot urine for albumin only is less expensive but susceptible to false readings. Creatinine and calculated glomerular ltration rate (GFR) should also be determined annually using the MDRD equation or Cockroft-Gault equation. Tables 1 and 2 provide the denitions for abnormalities of albumin excretion and kidney disease. Medical nutritional therapy should be the cornerstone of treatment for patients with type 2 diabetes mellitus and is necessary for patients that are not achieving A1C targets. Referral to a dietition is part of the Standard of Care. Although this patient most likely has elevated liver enzymes due to hepatic steatosis, a liver ultrasound is not recommended unless she has more severe hepatic enzyme elevation or abnormal symptoms.
Table 1. Denitions of Abnormalities in Albumin Excretion Category Normal Microalbuminuria Macro (clinical)-albuminuria Spot collection (g/mg creatinine) 30 30299 300

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Educational (Learning) Critiques

Table 2. Stages of Chronic Kidney Disease GFR (ml/min per 1.73 m2 body surface area) 90 6089 3059 1529 15 or dialysis

Stage 1 2 3 4 5
* 1.

Description Kidney damage* with normal or increased GFR Kidney damage* with mildly decreased GFR Moderately decreased GFR Severely decreased GFR Kidney failure
Kidney damage dened as abnormalities on pathologic, urine, blood, or imaging tests.

Levey AS, et al: National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classication, and stratication. Ann Intern Med 2003;139:137147.

Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 3 True Answers A, D, E; False Answers B, C Carbohydrate intake monitoring is an important component of medical nutrition therapy for patients with type 2 diabetes mellitus. Effective strategies include carbohydrate counting, exchanges, or experience-based estimations. The use of the glycemic index and glycemic load may provide modest additional benets for glycemic control over that observed when total carbohydrates are considered alone. Saturated fat intake should be 7% of calories in the diet. Routine supplementation with antioxidants such as vitamins E and C and carotene or chromium supplementation are not advised because of lack of evidence of efcacy and concern related to long-term safety. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 4 True Answers A, B, C, D, E According to the ADA Guidelines, all of these medications/treatments would be recommended. Even though her LDL-C is 100 mg/dL (a goal of therapy), her non-HDL remains 130 mg/dL (a secondary goal of therapy if triglycerides are 200 mg/dL). In addition, the ADA Guidelines also recommend that statin therapy should be added to lifestyle therapy regardless of baseline lipid levels for patients with diabetes with cardiovascular disease (CVD) or without CVD who are the age of 40 and have one or more other CVD risk factors. Since this patient is over age 40, has a low HDL level and elevated blood pressure, and an ALT that is slightly above the upper limit of normal, a statin should be initiated to lower LDL-C level by 40% or more from the baseline level. In patients with type 2 diabetes and risk factors, a mild baseline elevation in LFT is not a reason for withholding a statin. She also has hypertension and, therefore, her blood pressure regimen should include either an ACE inhibitor or an angiotensin receptor blocker (ARB). If one class is not tolerated, the other should be substituted. Aspirin therapy (75162 mg/dL) as a primary prevention strategy is recommended in patients with type 2 diabetes mellitus over age 40 who have other risk factors. Patients with type 2 diabetes mellitus should have the inuenza vaccine annually and at least one lifetime pneumococcal vaccine should be administered. A one-time revaccination is recommended for individuals 65 years of age previously immunized when they were 65 years of age if the vaccine was administered 5 years ago. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Educational (Learning) Critiques

American Diabetes Association Self-Assessment Program

55

Item 5 True Answers A, B, C, D; False Answer E The ADA A1C goal is a minimum of 7%. The blood pressure goal is 130/80 mm Hg. Since she has renal impairment, consideration should be given to blood pressure goal of 120/80 mm Hg. The lipid goals over LDL 100 mg/dL (the primary target with statin) and the desirable levels for triglycerides is 150 mg/dL and HDL 40 mg/dL for men but 50 mg/dL for women. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 6 True Answers B, C, D, E; False Answer A Since her creatinine level is 1.5 mg/dL, metformin should be discontinued due to increased risk of developing lactic acidosis. Options B, C, D, and E are all potential considerations to improve her elevated A1C level but since she has renal impairment, there should be careful consideration of dosage adjustment for sitagliptin and exenatide because both drugs have signicant renal clearance. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 7 True Answers A, B, D; False Answers C, E Gembrozil will increase the AUC (area under the curve) by simvastatin and most often statins by 23 fold and, therefore, combination with a statin should be utilized cautiously and the statin dose should not exceed 10 mg for simvastatin and rosuvastatin as stated in the package insert. Gembrozil is also a cytochrome P4502C8 inhibitor in the major metabolic pathway for repaglinide and rosiglitazone and will, therefore, increase the hypoglycemic effect of these drugs. There have been case reports of gembrozil and repaglimide combination inducing severe hypoglycemia. Fenobrate does not increase the AUC for statins. Therefore, fenobrate has a much lower propensity to increase the risk of myopathy in combination with a statin and there are no dosage restrictions with statins, but the combination should still be used with caution. Fenobrate, more than gembrozil, can increase creatinine and homocysteine. The clinical relevance of this effect is unknown. Fenobrate is signicantly renally metabolized and, therefore, dosage adjustment is necessary in patients with severe renal impairment. Bibliography
1. Davidson MH. Statin/brate combination in patients with metabolic syndrome or diabetes: evaluating the risks of pharmacokinetic drug interactions. Expert Opin Drug Saf 2006;5:145156. 2. Davidson MH, et al: Safety considerations with brate therapy. Am J Cardiol 2007;19;99(6A):3C18C. 3. Davidson MH, et al: Safety of aggressive lipid management. J Am Coll Cardiol 2007;49:175362.

Item 8 True Answers A, C, D; False Answers B, E In patients with type 2 diabetes mellitus, hypertension and microalbuminurea, both ACE inhibitors and ARBs have been shown to delay the progression to microalbuminurea. However, the recent On Target Trial showed that both drugs (ACE and ARBs) used in combination were no better than each drug used alone on preventing CVD events. For patients with type 2 diabetes mellitus, the blood pressure goal is 130/80 mm Hg. This patient needs more aggressive blood pressure control especially in light of her renal impairment. Thiazide diuretics should be added to ACE or ARBs if needed to achieve blood pressure control with an estimated glomerular ltration rate (GFR) 50 ml/min per 1.73 m2, but in patients with GFR 50 ml/min per 1.73 m2, (such as this patient), a loop diuretic should be used instead. Reduction in protein intake is recommended for patients with diabetes and the earliest stages of chronic kidney disease. The ADA recommends continued monitoring of urine albumin excretion to assess both response to therapy and progression of disease.

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Educational (Learning) Critiques

Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 9 True Answers A, B; False Answers C, D, E Diabetes is the leading cause of blindness in the United States. Optimizing both glycemic control and blood pressure has been demonstrated to reduce the incidence and progression of retinopathy. The ADA recommends dilated eye exams by an ophthalmologist or optometrist at diagnosis and annually thereafter for patients with type 2 diabetes mellitus. The presence of retinopathy is not a contraindication to aspirin therapy for cardioprotection, as this therapy does not increase the risk of retinal hemorrhage. Two large trials, the Diabetic Retinopathy Study (DRS) and the Early Treatment Diabetes Retinopathy Study (ETDRS), provide strong support for the therapeutic benets of photocoagulation surgery. The DRS showed that panretinal photocoagulation surgery reduces the risk of severe vision loss from retinopathy from 15.9% in untreated eyes to 6.4% in treated eyes. Laser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with high risk proliferative diabetic retinopathy, clinically signicant macular edema, and in some cases of severe non-proliferative diabetic retinopathy. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 10 True Answers D, E; False Answers A, B, C Patients with diabetes should be screened annually for distal symmetric polyneuropathy (DPN) using tests such as pin-prick sensation, vibration perception with a tuning fork, 10 g monolament pressure at the distal planter aspect of both great toes and metatarsal joints, and assessment of ankle reexes. These tests, recommended annually, are 87% sensitive to diagnose neuropathy. Electrophysiological testing is rarely needed except in situations where clinical features are atypical. The rst step in management of patients with DPN should be to aim for stable and optimal glycemic control. Although controlled trial evidence is lacking, several observational studies suggest that neuropathic symptoms improve not only with optimization of control, but also with the avoidance of extreme blood glucose uctuations. Patients with painful DPN may benet from pharmacological treatment of their symptoms; many agents have efcacy conrmed in published randomized control trials, with several FDA-approved for the management of painful DPN. Refer patients who smoke, have loss of protective sensation and structural abnormalities, or have history of prior lower-extremity complications to foot care specialists for ongoing preventive care and life-long surveillance. Initial screening for peripheral arterial disease (PAD) should include a history for claudication and an assessment of the pedal pulses. A diagnostic ABI should be performed in any patient with symptoms of PAD. Due to the high estimated prevalence of PAD in patients with diabetes and the fact that many patients with PAD are asymptomatic, an ADA consensus statement on PAD suggested that a screening ABI be performed in patients older than 50 years of age and be considered in patients younger than 50 years who have other PAD risk factors (e.g., smoking, hypertension, hyperlipidemia, or duration of diabetes 10 years). Refer patients with signicant symptoms or a positive ABI for further vascular assessment, and consider exercise, medication, and surgical options. Diabetic autonomic neuropathy is also associated with genitourinary tract disturbances. In men, diabetic autonomic neuropathy may cause erectile dysfunction and/or retrograde ejaculation. Evaluation of bladder dysfunction should be performed for individuals with diabetes who have recurrent urinary tract infections, pyelonephritis, incontinence, or a palpable bladder. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Educational (Learning) Critiques

American Diabetes Association Self-Assessment Program

57

Items 1112

11) True Answers A, B, D, E; False Answer C 12) True Answers A, B, C, D; False Answer E The HEDIS 2008 NCQA guidelines are used to evaluate physician performance and are increasingly being utilized to institute pay for performance. The HEDIS 2008 NCQA guidelines are listed below: The percentage of patients 1875 years of age with diabetes (type 1 and type 2) who had each of the following: Hemoglobin A1C (HbA1C) testing. HbA1C poor control (9.0%). HbA1C good control (7.0%). Eye exam (retinal) performed. LDL-C screening. LDL-C control. Medical attention for nephropathy. Blood pressure control. Foot examination. Smoking status and cessation advice or treatment. Triglycerides 150 mg/dL and HDL 40 mg/dL are desirable levels recommended by the ADA but are not part of the HEDIS 2008 performance measures. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 13 True Answers A, B, C, D; False Answer E Insulin is a potential second line agent to treat hyperglycemia after metformin has failed to achieve goal A1C levels in patients with type 2 diabetes mellitus. Advantages include no dose limit, inexpensive, and improved lipid prole. Disadvantages are the injections, required monitoring, hypoglycemia, and weight gain. Insulin in combination with glitazones may increase the risk of uid retention. Insulin therapy has benecial effects on peripheral insulin sensitivity. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 14 True Answers A, B, D; False Answers C, E Thiazolidinediones (TZDs) or glitazones are also second line agents after metformin to improve hyperglycemia. Pioglitazone decreases triglyceride (TG) levels and raises HDL-C levels and therefore improves the lipid prole. Rosiglitazone does not decrease TG levels and raises HDL-C levels to a lesser degree than pioglitazone. Only rosiglitazone has a black box warning for increasing risk of MI, while both pioglitazone and rosiglitazone have a black box warning for increasing the risk of CHF. Both pioglitazone and rosiglitazone have been shown to increase the risk of fractures associated with trauma but not vertebral fractures. Both glitazones are mostly hepatically metabolized, and dosage adjustment in patients with renal impairment is not necessary. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

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American Diabetes Association Self-Assessment Program

Educational (Learning) Critiques

Item 15 True Answers A, B; False Answers C, D, E Sulfonylureas are the least expensive of the oral hypoglycemics and may be used second line after metformin but can cause weight gain and hypoglycemia. Sulfonylureas also appear to decrease -cell survival and have not been shown to reduce CV events. Dosage adjustment is necessary for patients with renal impairment. Bibliography
1. Summary of Revisions for the 2008 Clinical Practice Recommendations. Diabetes Care 2008;31:S3S54.

Item 16 Answer D This patient has limited options available given his comorbid conditions of congestive heart failure and renal insufciency. There is an increased risk of lactic acidosis in patients with both of these conditions (though there is a rare incidence overall). Creatinine levels of 1.5 mg/dL in men (1.4 mg/dL in women) is the recommended threshold above which metformin should be discontinued, given the reduced clearance of the medication. With the patient taking medications for heart failure, both metformin and pioglitazone would be inappropriate. The thiazolidinediones (TZDs) are contraindicated in patients with class III/IV NYHA heart failure. For those with NYHA class II heart failure, pioglitazone may be considered, but should be used with caution at low dose and increased gradually. The TZDs may increase uid retention and precipitate heart failure. Despite the risk of heart failure known, it remains unclear what the overall risk of cardiovascular-related death is. As the patient has an A1C level above goal (despite being on two additional oral agents prior to admission), additional therapy is needed beyond glyburide alone. The addition of insulin is the best option to assist the patient in reaching the recommended goal of 7.0%. With regard to continuing or discontinuing the sulfonylurea when starting insulin, there may be some debate. Bibliography
1. Riddle MC. Timely initiation of basal insulin. Am J Med 2004 Feb 2;116 Suppl 3A:3S9S. 2. Nathan DM, et al: Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2008 Jan;31(1):173175. 3. Lago RM, et al: Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Lancet 2007 Sep 29;370(9593):11291136. 4. Lincoff AM, et al: Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA 2007 Sep 12;298(10):11801188. 5. DePalo VA, et al: Lactic acidosis. Lactic acidosis associated with metformin use in treatment of type 2 diabetes mellitus. Geriatrics 2005 Nov;60(11):36, 3941. 6. Yki-Jrvinen H. Combination Therapies with Insulin in type 2 Diabetes. Diabetes Care 2001 Jan;24:758767. 7. Johnson JL, et al: Efcacy of insulin and sulfonylurea combination therapy in type II diabetes. A meta-analysis of the randomized placebo-controlled trials. Arch Intern Med 1996 Feb 12;156(3):259264.

Item 17 Answer D This patients blood glucose record and history indicate some hypoglycemia, especially in the middle of the night and early morning. To correct this, she needs a better balance of her scheduled insulin. Most patients take 50% of total daily insulin as basal insulin (glargine), and 50% in bolus form (aspart) before meals (Figure 1). However, this patient only receives 12 U total before meals (29% of total insulin). Possibly, her hypoglycemia, which also occurs during the day (per log) and during the night may be the result of too much glargine. A lower amount of glargine would be worth pursuing to quickly address this problem. Following this adjustment, further monitoring would be appropriate to establish new trends in glycemia. Then, the premeal aspart levels may be increased accordingly with a more appropriate basal/bolus insulin balance.

Educational (Learning) Critiques

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59

Breakfast Lunch 12 pm 6 am 10 8 2

Supper Bedtime 12 am 6 am 10 4 6 8 2 4

Breakfast Lunch 12 pm 6 am 10 8 2

Supper Bedtime 12 am 6 am 10 4 6 8 2 4

Insulin Effect

Lispro Lispro Lispro Glargine or Aspart or Aspart or Aspart

NPH or Lente Lispro Lispro NPH or Lente Lispro or Aspart or Aspart or Aspart

Figure 1. Examples of Physiologic Insulin Delivery Regimen


A. Once-daily glargine with lispro or aspart (shown in a ratio of 50:50) allows patients to skip meals or change mealtimes. Insulins lispro and aspart (rapid acting) are prandial insulins and glargine (long acting) is a basal insulin. This regimen is easier to use since it has true basal and prandial insulins. Dashed line indicates the effective duration of glargine continuing through the following day. Glargine achieves steady state at approximately 2 hours. B. Intermediate-acting neutral protamine Hagedorn (isophane insulin; NPH) and Lente (insulin zinc) are basal insulins. Rapid-acting lispro and aspart insulins are prandial insulins. This regimen (shown in a ratio of 50:50) is more difcult to adjust because NPH can act as both a basal and a prandial insulin. Dashed line indicates the effective duration of NPH or Lente continuing through the following day. Arrows indicate insulin injection. DeWitt DE, et al: Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientic review. JAMA May 7 2003;289(17):22542264.

Bibliography
1. DeWitt DE, et al: Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientic review. JAMA 2003 May 7;289(17):22542264. 2. Hirsch IB. Insulin analogues. N Engl J Med 2005 Jan 13;352(2):174183. 3. Devries JH, et al: Rening basal insulin therapy: what have we learned in the age of analogues? Diabetes Metab Res Rev 2007 Sep;23(6):441454. 4. Hirsch IB. A Real-World Approach to Insulin Therapy in Primary Care Practice. Clinical Diabetes 2005;23:7886.

Item 18 Answer B The A1C level in this patient is well above the typical goal in therapy (7.0%). While her mean pre-prandial glucose levels are not signicantly elevated, the postprandial levels are much more than the pre-meal values. The postprandial levels indicate substantial peaks from meals that basal insulin does not adequately address. The best change in therapy would be the addition of bolus insulin before meals to match these physiologic peaks in glucose levels. While this does require the addition of multiple injections per day, it would most likely result in the patient achieving desired goal in glycemic control if she remains adherent to her prescribed therapy. The addition of morning NPH insulin may provide a mid-afternoon peak, but would not assist in post-breakfast and post-dinner peaks in glucose levels. The addition of a second dose of glargine would increase insulin availability throughout the day, and while this may reduce postprandial glucose levels, it would likely reduce fasting levels further and increase the risk of hypoglycemia. This option, as well as the use of an alternative basal insulin (detemir), would not match the postprandial hyperglycemia as well in this situation. Increasing metformin would unlikely provide substantial benet to overall glycemic control; and her current dose is close to maximum therapy (2500 mg/day). Bibliography
1. Hirsch IB. A Real-World Approach to Insulin Therapy in Primary Care Practice. Clinical Diabetes 2005;23:7886. 2. OKeefe JH, et al: Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol 2007 Sep 1;100(5):899904. 3. Hirsch IB. Intensifying insulin therapy in patients with type 2 diabetes mellitus. Am J Med 2005 May;118 Suppl 5A:21S26S.

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Item 19 Answer A Individuals with A1C levels above goal but having fasting plasma glucose levels in the target range may be having signicant postprandial hyperglycemia. While there are no clear guidelines regarding the recommended measures for postprandial hyperglycemia, it is a very reasonable target of treatment for those with A1C levels at goal and fasting glucose levels in the target range. On one hand, there is great interest in improving therapy to aggressively reduce A1C levels to reduce the risk of diabetic complications. However, some clinicians are reluctant to do this given concerns for hypoglycemia. Unfortunately, the evidence remains unclear at this time regarding the true clinical impact of treating postprandial hyperglycemia. There is much epidemiologic evidence that shows associations between glucose levels two hours after an oral challenge and cardiovascular risk. This includes the Hoorn Study, the Honolulu Heart Study, the Chicago Heart Study, and the DECODE study (and evidence is supported by meta-analyses). There is also other supporting evidence that hyperglycemia during a myocardial infarction or stroke leads to a worse prognosis. However, there have been few studies evaluating the specic treatment of postprandial hyperglycemia, and many include surrogate markers for atherosclerosis. Data are lacking on long-term studies (especially randomized, controlled trials) that clearly demonstrate that effective treatment of postprandial hyperglycemia will reduce cardiovascular events and other outcomes without increasing mortality. Still, in the meantime, there are pathophysiological explanations for the potential impact of hyperglycemia on vascular disease. Studies show that hyperglycemia affects oxidative stress markers and endothelial function. Possibly, the combination of postprandial hyperglycemia and hyperlipidemia may represent a stronger risk factor together for cardiovascular disease than each independently. Bibliography
1. 2. 3. 4. 5. 6. 7. 8. Standards of medical care in diabetes2008. Diabetes Care 2008 Jan;31 Suppl 1:S1254. Ceriello A. Postprandial hyperglycemia and diabetes complications: is it time to treat? Diabetes 2005 Jan;54(1):17. Parkin CG, et al: Is Postprandial Glucose Control Important? Is It Practical In Primary Care Settings? Clinical Diabetes 2002;20(2):71. OKeefe JH, et al: Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol 2007 Sep 1;100(5):899904. de Vegt F, et al: Hyperglycaemia is associated with all-cause and cardiovascular mortality in the Hoorn population: the Hoorn Study. Diabetologia 1999 Aug;42(8):926931. Donahue RP, et al: Postchallenge glucose concentration and coronary heart disease in men of Japanese ancestry. Honolulu Heart Program. Diabetes 1987 Jun;36(6):689692. Lowe LP, et al: Diabetes, asymptomatic hyperglycemia, and 22-year mortality in black and white men. The Chicago Heart Association Detection Project in Industry Study. Diabetes Care 1997 Feb;20(2):163169. Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria. The DECODE study group. European Diabetes Epidemiology Group. Diabetes Epidemiology: Collaborative analysis of Diagnostic criteria in Europe. Lancet 1999 Aug 21;354(9179):617621.

Item 20 Answer C Hyperglycemia is common during acute illness and after major surgery. The hyperglycemia from these stressors has a negative impact on outcome after cardiac surgery. Randomized clinical trials have shown that intensive treatment of hyperglycemia in the surgical intensive care unit setting reduces morbidity and mortality. The clinical benet is present independent of whether the patient has a history of previously diagnosed diabetes or the severity and type of critical illness. Based on current evidence, it appears that the benet comes from metabolic control rather than insulin dose itself. For this reason, surgical intensive care units commonly treat hyperglycemia aggressively with IV insulin to keep glucose levels below 110 mg/dL. A sliding scale of regular insulin alone would not provide adequate glycemic control, and likely would increase hyper- and hypoglycemia during hospitalization. In fact, there is no evidence to support the use of sliding scale insulin therapy alone without long-acting insulin in the hospital setting. Next, daily basal insulin also would not provide adequate coverage to variability in glucose levels, and would only be adjusted once per day. Finally, oral agents and observation without treatment are not appropriate for this situation, particularly to reach an aggressive goal of blood glucose level less than 110 mg/dL.

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Bibliography
1. Van den Berghe GH. Role of intravenous insulin therapy in critically ill patients. Endocr Pract 2004 MarApr;10 Suppl 2:1720. 2. Van den Berghe GH, et al: Intensive insulin therapy in the critically ill patients. N Engl J Med 2001 Nov 8;345(19):13591367. 3. Ingels C, et al: Strict blood glucose control with insulin during intensive care after cardiac surgery: impact on 4-years survival, dependency on medical care, and quality-of-life. Eur Heart J 2006 Nov;27(22):27162724. 4. Clement S, et al: Management of diabetes and hyperglycemia in hospitals. Diabetes Care 2004 Feb;27(2):553591.

Item 21 Answer E The woman in this case has an average life expectancy of ve years or less with known cardiovascular disease and comorbid conditions, and consequently has a high risk of additional cardiac event. She has an elevated risk of hypoglycemia on a sulfonylurea. In general, those older (above age 80) and on more than 5 medications are at greater risk. She also has a history of falls, and factors such as depression, poor mobility, as well as others (orthostasis, dementia, visual disturbance, neuropathy, and polypharmacy) increase the risk of future falls. Based on all of these factors together, tight glycemic control (e.g., goal of A1C below 7) may not be desirable, where the risks could outweigh the benets. Based on guidelines from the American Geriatrics Society, a goal A1C of less than 8% may be reasonable to consider (thus, no change in therapy would be required). The other treatment options may place her at greater risk of hypoglycemia, where risks would outweigh the benets. In addition, she also has CHF class III that would preclude the use of pioglitazone. From the perspective of the practicing clinician, diabetes complications, duration of diabetes, individual functional status, and comorbid illnesses should all be considered in setting goals for glycemic therapy. In general, it is very appropriate for providers to discuss with patients and assess individually what goals in therapy may be, depending on patient life expectancy, burden of therapy, existing conditions, and patient preferences. Bibliography
1. Lee SJ, et al: Development and validation of a prognostic index for 4-year mortality in older adults. JAMA 2006 Feb 15;295(7):801808. 2. Olson DE, et al: Diabetes in older adults. Overview of AGS guidelines for the treatment of diabetes mellitus in geriatric populations. Geriatrics 2004 Apr;59(4):1824; quiz 25. 3. http://prweb.com/releases/ADA/ACCORD/prweb681794.htm. Accessed March 17, 2008. 4. Tinetti ME. Clinical practice. Preventing falls in elderly persons. N Engl J Med 2003 Jan 2;348(1):4249. 5. Shorr RI, et al: Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med 1997 Aug 1125;157(15):16811686. 6. Huang ES, et al: Self-reported goals of older patients with type 2 diabetes mellitus. J Am Geriatr Soc 2005 Feb;53(2):306311. 7. Huang ES, et al: The impact of functional status and comorbid illness on the expected benets of intensive glucose control in older diabetes patients. American Geriatrics Society Annual Scientic Meeting; 2007. 8. http://professional.diabetes.org/News_Display.aspx?CID=60642&TYP=9. Accessed March 17, 2008.

Item 22 Answer B Insulin therapy would be appropriate to reach this patients goal in glycemic management; however she has concerns of weight gain and alternative therapies are available to use. Exenatide, a glucagon-like peptide-1 mimetic, has multiple mechanisms for lowering glucose levels, including enhancement of insulin secretion, and is indicated with patients with type 2 diabetes who have -cell function remaining. The medication is approved for use with metformin and sulfonylureas and is under study for use with thiazolidinediones. Exenatide results in reduction of A1C level an average of 1%. It also has been shown to result in a small amount of weight loss. No studies have demonstrated long-term effects of this newer therapy. One study showed comparable efcacy with glargine insulin for those uncontrolled on metformin and sulfonylurea therapy; however, exenatide had greater withdrawal from the study (19.4% vs 9.7%) likely related to gastrointestinal side effects (57% of subjects on exenatide experienced nausea) (Figure 2).

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8.5 8.0 7.5 7.0 6.5 0.0 0 12 Weeks


244 249

Change in Body Weight, kg

Hemoglobin A1C Level, %

Exanatide group (n = 275) Insulin glargine group (n = 260)

Exanatide group (n = 275) Insulin glargine group (n = 260) 8.5 8.0 7.5 7.0 6.5 0.0 0 2 4
281 277 275 267 266 261

* * * * 12 Weeks
245 251

* 18
235 246

* 26
231 244

26
229 243

8
261 253

Exanatide group, n Insulin glargine group, n

275 260

Figure 2.
Time course for A1C level and body weight from week 0 to week 26 is shown for the exanatide group compared with the insulin glargine group; mean ( SE) is shown. Week 0 indicates baseline. Data are shown for intention-to-treat population. * P 0.0001 compared with insulin glargine measure at the same point. Heine RJ,et al: Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med Oct 18 2005;143(8):559569.

Maintaining medication therapy at the current level is not appropriate in this patient; a goal of A1C of 7.0% or less remains most appropriate to prevent long-term complications. Acarbose can be considered, but would reduce A1C level only slightly. Pioglitazone is a reasonable option; however, given concern for weight gain, this might not be as good a choice as exenatide. Finally, sibutramine has been shown to result in weight loss; however, it is unlikely to have the same benet in glycemic control. Other medications, such as orlistat and rimonabant, have been show to improve glycemic control in patients with diabetes, but implementation of these agents carries signicant risks of other side effects. Bibliography
1. Amori RE, et al: Efcacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA 2007 Jul 11;298(2):194206. 2. Jones MC. Therapies for diabetes: pramlintide and exenatide. Am Fam Physician 2007 Jun 15;75(12):18311835. 3. Heine RJ, et al: Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2005 Oct 18;143(8):559569. 4. Comi RJ. Treatment of type 2 diabetes mellitus: a weighty enigma. Ann Intern Med 2005 Med Oct 18;143(8):609610. 5. Rucker D, et al: Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ 2007 Dec 8;335(7631):11941199. 6. DeFronzo RA, et al: Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care 2005 May;28(5):10921100.

Items 2325 Answers 23 (C); 24 (C); 25 (B) This patient has been newly diagnosed with type 2 diabetes, and lifestyle modications including diet and exercise are necessary as they have clear benet. This is always an appropriate rst step in treating patients with type 2 diabetes. The referral to a dietitian is also appropriate. However, despite these measures, lifestyle interventions often fail to achieve metabolic goals. For this reason, it would be reasonable to also start metformin at this time, and not wait longer to evaluate the impact of lifestyle changes. It would also have been appropriate to start metformin three months prior upon diagnosis at the same time as the lifestyle intervention. Metformin, in the absence of contraindications, is superior to other oral agents as it is less expensive, well studied, has a low level of side effects, and may be less likely to cause hypoglycemia or weight gain. Metformin offers good potential improvement in A1C level (approximately 1.5%). In comparison with pramlintide, alpha-glucosidase inhibitors, and exenatide, metformin would most likely reduce A1C level the most as monotherapy (~1.5%; Table 3). Exenatide is FDA-approved for combination with sulfonylurea or metformin and may be considered as a second agent in the future. It would require twice daily regular injections. Insulin would also be effective in reducing blood glucose levels; however, an oral agent like metformin would remain the rst line agent to use in this situation.
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Table 3. Summary of Glucose-lowering Interventions as Monotherapy Interventions Step 1: Initial Lifestyle to decrease weight and increase activity Metformin 12 Low cost, many benets Fails for most in rst year Expected Decrease in A1C (%) Advantages Disadvantages

12

Weight neutral, inexpensive

GI side effects, rare lactic acidosis

Step 2: Additional therapy Insulin Sulfonylureas Thiazolidinediones (glitazones) 1.53.5 12 0.51.4 No dose limit, inexpensive, improved lipid prole Inexpensive Improved lipid prole Potential decreased risk of MI Injections, monitoring, hypoglycemia, weight gain Weight gain, hypoglycemia* Fluid retention, twofold increased risk of CHF, potential increased risk of MI, atherogenic lipid prole, weight gain, expensive Frequent GI side effects, three times/day dosing, expensive Injections, frequent GI side effects, expensive, little experience Three times/day dosing, expensive, hypoglycemia Injections, three times/day dosing, frequent GI side effects, expensive, little experience Little experience, expensive

Other drugs -Glucosidase inhibitors Exenatide Glinides Pramlintide Sitagliptin


*

0.50.8 0.51.0 11.5 0.51.0 0.50.8

Weight neutral Weight loss Short duration Weight loss Weight neutral

Severe hypoglycemia is relatively infrequent with sulfonylurea therapy. The longer-acting agents (e.g. chlorpropamide and glibenclamide [glyburide]) are more likely to cause hypoglycemia than glipizide, extended-release glipizide, glimepiride, or gliclazide. Pioglitazone. Rosiglitazone. Repaglinide is more effective at lowering A1C than nateglinide. GI Gastrointestinal. MI Myocardial infarction.

Nathan DM, et al. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care Jan 2008;31(1):173175.

The Diabetes Outcome Progression Trial (ADOPT) was a double blind, controlled trial of 4360 patients over approximately 5 years which compared thiazolidinediones with metformin and glyburide in terms of maintaining glycemic control. The cumulative incidence of monotherapy failure was 15% with rosiglitazone, 21% with metformin, and 34% with glyburide (Figure 3). Monotherapy failure was dened as fasting glucose of more than 180 mg/dL. The relative improvement from rosiglitazone may, in part, be due to slowing the rate of loss of -cell function. Rosiglitazone was associated with more weight gain and edema than the other agents, but with less gastrointestinal side effects than metformin and less hypoglycemia than with glyburide. In addition, those participants with a A1C level less than 7% was only 4% higher in the rosiglitazone group as compared with the metformin group (40% vs 36%), the difference being of questionable signicance. Overall, given side effects, cost, and evidence available, metformin remains the rst choice for many patients as the initial therapy upon diagnosis of type 2 diabetes.

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40 Cumulative Incidence of Monotherapy Failure (%) 30 20 10 0 0

Hazard Ratio (95% CI) Rosiglitazone vs metformin 0.68 (0.550.85); P 0.001 Rosiglitazone vs glyburide 0.37 (0.300.45); P 0.001

Glyburide

Metformin Rosiglitazone

Years

No. at Risk Rosiglitazone 1393 Metformin 1397 Glyburide 1337

1207 1205 1114

1078 1076 958

957 950 751

844 818 617

324 311 218

Figure 3. Kaplan-Meier Estimates of the Cumulative Incidence of Monotherapy Failure at 5 Years


Treatment was considered to have failed if a patient had a conrmed or adjudicated level of fasting plasma glucose of more than 180 mg per deciliter. Risk reduction is listed for comparisons of pairwise groups from a baseline covariate-adjusted Cox proportional-hazards model. Grays estimates of cumulative incidence adjusted for all deaths were smaller than KaplanMeier estimates of treatment failure: 10% in the rosiglitazone group, 15% in the metformin group, and 25% in the glyburide group. I bars indicate 95% CIs. Kahn SE, et al: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med Dec 7 2006;355(23):24272443.

Bibliography
1. Nathan DM, et al: Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2008 Jan;31(1):173175. 2. Kahn SE, et al: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006 Dec 7;355(23):24272443. 3. Nathan DM. Thiazolidinediones for initial treatment of type 2 diabetes? N Engl J Med 2006 Dec 7;355(23):24772480.

Item 26 Answer A Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is a new oral agent for the treatment of patients with type 2 diabetes. It increases levels of incretins, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) to reduce glucose levels. Studies have demonstrated efcacy of sitagliptin as monotherapy or in combination with metformin in lowering blood glucose. Markers of -cell function improved with sitagliptin therapy. In general, the medication is well tolerated, has a neutral effect on weight, and has a low risk of hypoglycemia or gastrointestinal side effects. Most of the studies have been less than one year in duration, and data are lacking on long-term effects on the prevention or delay of diabetes complications. Bibliography
1. Karasik A, et al: Sitagliptin, a DPP-4 inhibitor for the treatment of patients with type 2 diabetes: a review of recent clinical trials. Curr Med Res Opin 2008 Feb;24(2):489496. 2. Bonora E. Antidiabetic medications in overweight/obese patients with type 2 diabetes: drawbacks of current drugs and potential advantages of incretin-based treatment on body weight. Int J Clin Pract Suppl 2007 Aug;(154):1928. 3. Amori RE, et al: Efcacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA 2007 Jul 11;298(2):194206.

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Item 27 Answer C This patient has elevated fasting and postprandial glucose levels based on his detailed log. However, the postprandial levels are not far from goal, and the fasting levels are consistently elevated, and there is no evidence by history or log of hypoglycemia. To substantially improve the fasting glucose levels, the basal insulin dose should be increased. In general, the split between daily basal insulin and pre-meal very short-acting insulin is approximately 50%/50%. In this situation, the basal insulin constitutes 1/3 of the total daily insulin used, so it would be reasonable to increase. Increasing aspart insulin would improve postprandial levels; however, this is not as great a problem as the fasting levels in this situation. In general, lowering the amount of either type of insulin, in the absence of hypoglycemia, would worsen glycemic control and raise A1C levels. NPH insulin in the morning would improve afternoon glucose levels, but not improve the rest of the day substantially. Bibliography
1. Devries JH, et al: Rening basal insulin therapy: what have we learned in the age of analogues? Diabetes Metab Res Rev 2007 Sep;23(6):441454. 2. Hirsch IB. Intensifying insulin therapy in patients with type 2 diabetes mellitus. Am J Med 2005 May;118 Suppl 5A:21S26S.

Item 28 Answer B This patient has evidence consistent with non-alcoholic steatohepatitis (NASH). In general, weight loss is appropriate for this patient (approximately 12 kg/week is reasonable). Low-fat diets should be avoided, and may be associated with greater inammation of the liver. Instead, low glycemic index food (or the Mediterranean diet) has been recommended for patients with type 2 diabetes with non-alcoholic fatty liver disease. Various oral agents have been tested in patients with both type 2 diabetes and NASH. Oral medications that may improve insulin resistance may be preferable for this patient with NASH. Metformin may be a reasonable choice, but there would be an increased risk of lactic acidosis with renal insufciency (progressive liver disease may further increase this risk). As an alternative, pioglitazone, which also addresses insulin resistance, is a viable alternative. Some studies have shown improvement in ALT and liver histology with thiazolidinediones (TZDs). Still, it remains important to consider weight gain and to monitor transaminase levels after initiation of medication, especially given previous hepatotoxicity of troglitazone (withdrawn from the U.S. market). In addition, it should also be noted that the glitazones are associated with increased risk of uid retention, congestive heart failure exacerbation, and fractures in general. As for other therapeutic options, sulfonylureas could be used with patients with liver disease, though may be not be preferable to TZDs. Patients on sulfonylureas should be monitored closely for hypoglycemia. Those with more advanced liver disease may have reduced gluconeogenesis and ability to counteract hypoglycemia. Finally, insulin, while safe to use, should be reserved if oral agents have failed. It also would have greater risk of hypoglycemia and the dosage is frequently more challenging. Bibliography
1. Tolman KG, et al: Spectrum of liver disease in type 2 diabetes and management of patients with diabetes and liver disease. Diabetes Care 2007 Mar;30(3):734743. 2. Kang H, et al: Metabolic syndrome is associated with greater histologic severity, higher carbohydrate, and lower fat diet in patients with NAFLD. Am J Gastroenterol 2006 Oct;101(10):22472253. 3. Angelico F, et al: Drugs improving insulin resistance for non-alcoholic fatty liver disease and/or non-alcoholic steatohepatitis. Cochrane Database Syst Rev 2007(1):CD005166.

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Item 29 Answer D This patient has uncontrolled type 2 diabetes with A1C well above 7.0%. The addition of a thiazolidenedione would result in only a small expected improvement in A1C of approximately 1%, which would not likely result in reaching goal in therapy. Increasing metformin to 2500 mg (maximum daily dose) offers very limit benet over 2000 mg/day therapy. Repeating the A1C test and continuing therapy would only prolong his time having elevated glucose levels, and would contribute to clinical inertia (the problem where therapy is not intensied at an ofce visit when opportunity exists). He reports good adherence to his therapy, and there is no acute problem interfering with making a change in therapy. Instituting insulin therapy at this point is the best option. This patient has had type 2 diabetes for a signicant amount of time and may be having -cell failure (Figure 4). In the UKPDS study, 55% of newly diagnosed patients with type 2 diabetes allocated to treatment with sulfonylurea required insulin to maintain glycemic control during six years following diagnosis. In addition, early intensive insulin therapy offers benets beyond glycemic control, including preservation of -cell function. With a possible loss in -cell function and difference of 2.2% above goal, exenatide would unlikely help him reach his glycemic goal, and would not mitigate the need for insulin injection therapy.
100 -cell Function (%)
PPBG

75
FBG

50 T2DM phase III IGT 0 -12 -10 -6 -2 0 2 6 10 14 Years From Diagnosis Postprandial T2DM hyperglycemia diagnosis T2DM phase II

25

Figure 4.
Progressive -cell failure from 0 to 6 years from diagnosis represents data from the UKPDS group population and was determined by the homeostatic assessment model. These data were extrapolated both forward and backward in time. PPBG = postprandial blood glucose; FBG = fasting blood glucose; T2DM = type 2 diabetes mellitus; IGT = impaired glucose tolerance. Garg SK, et al: Practical Strategies for Introducing Insulin Therapy in 2006. Supplement to the Journal of Family Practice. April, 2006.

Bibliography
1. Garg SK, et al: Practical Strategies for Introducing Insulin Therapy in 2006. Supplement to the Journal of Family Practice. April, 2006. 2. Lebovitz HE. Insulin secretagogues: old and new. Diabetes Reviews 1999;7:139153. 3. Nathan DM, et al: Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2006 Aug;29(8):19631972.

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Item 30 Answer B In the pregnant patient with type 2 diabetes, insulin remains the best choice of therapy to provide intensive glycemic control, especially in those unable to achieve target blood glucose levels with recommended diet and physical activity. It would have been optimal for this patient to have been on insulin, and with better glycemic control, prior to becoming pregnant. Tight glycemic control is necessary to reduce the risk of birth defects and fetal macrosomia and promote optimal health of both developing fetus and mother. NPH insulin plus multiple injections of a rapidly-acting analog is the best combination in that it includes better studied insulin formulations and is more likely to result in tightly controlled blood glucose levels. The long-acting insulins detemir and glargine are Category C in pregnancy. Lack of large randomized controlled trials remains a limitation. Also, daily premixed insulin 70/30 is not the optimal choice of therapy, as this option does not provide exibility in intensifying therapy to reach goals in blood glucose levels. Continuing either of the oral agents (glyburide or pioglitazone) is less desirable, especially as these agents coupled with glargine and detemir have not been studied in combination. It would seem that a glitazone might be desirable to address insulin resistance (especially during pregnancy). However, there are no clinical data available on its use in pregnancy; and, one study reported that rosiglitazone crossed the placenta in early human pregnancy at 1012 weeks. Finally, there is inadequate time available to monitor for improvement in glycemic control with additional nutritional therapy and increased physical activity. Immediate changes in therapy are necessary, especially given the A1C level well above goal. Bibliography
1. Kitzmiller JL, et al: Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes Care 2008 May; 31(5):106079.

Item 31 Answer A This patient has an A1C level above 7.0% (target). Her logbook reveals elevated postprandial blood glucose levels, which are most likely contributing to her overall suboptimal glycemic control and now elevated A1C level. The specic times of the day when postprandial glucose levels are elevated include 2 hours after breakfast and dinner. Repaglinide might be an appropriate option, to be taken before these two meals. The glinides are short-acting insulin secretagogues, similar to sulfonylureas, that promote endogenous insulin secretion and affect early insulin release. This medication would help reduce postprandial glucose levels most efciently, with low risk of hypoglycemia, and can match the patients unique postprandial needs. Increasing metformin to 1000 mg b.i.d. would unlikely improve blood glucose levels in a meaningful way, though it would help limit the number of medications she would need to take overall. However, additional metformin would not adequately lower postprandial glucose levels as much as the addition of the glinide (which would help increase insulin secretion). Also, while increasing time exercising may be helpful in general and could reduce insulin resistance, it is still preferable to intensify therapy immediately to avoid further clinical inertia (situation when providers are slow to react to needed changes in therapy). Certainly, increases in physical activity may be recommended in addition to medication changes. An alternative medication that may improve postprandial glucose levels would be fast-acting insulin, such as lispro or aspart. However, this would require instituting insulin injections which may not be necessary at this point. In addition, it increases the risk of hypoglycemia. The use of basal insulin (glargine or detemir) would be less desirable, as this would also impact fasting glucose levels and increase the risk of hypoglycemia. Bibliography
1. Gerich JE. Clinical signicance, pathogenesis, and management of postprandial hyperglycemia. Arch Intern Med 2003 Jun 9;163(11):13061316. 2. Ceriello A. Postprandial hyperglycemia and diabetes complications: is it time to treat? Diabetes 2005 Jan;54(1):17. 3. Parkin CG, et al: Is Postprandial Glucose Control Important? Is It Practical In Primary Care Settings? Clinical Diabetes 2002;20(2):71. 4. OKeefe JH, et al: Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol 2007 Sep 1;100(5):899904.

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Item 32 Answer C The patient is anticipating a heart catheterization with administration of contrast. This potentially would increase the risk of lactic acidosis. The morning of the procedure, the patient should hold metformin, and then he may be able to restart it 48 hours after the procedure if renal function remains stable. Intravenous uids are appropriate to maintain hydration in this situation. If surgery or additional procedures are subsequently planned, the metformin should remain held. Note that metformin should be held if his renal function deteriorates further (metformin is contraindicated with creatinine level above 1.5 mg/dL in men and 1.4 mg/dL in women, with stage 4 chronic kidney disease also being a contraindication based on estimated GFR). It is important to consider risk factors for lactic acidosis when using metformin particularly in the hospital, where patients may experience hypoperfusion, increased renal failure, and hypoxia. Yet, despite these concerns, metformin is relatively safe when appropriately prescribed. A Cochrane Review found no evidence from prospective comparative trials or observational cohort studies that metformin is associated with increased risk of lactic acidosis, compared to other oral agents for treatment of type 2 diabetes when prescribed under similar study conditions accounting for contraindications. Discontinuing pioglitazone is not necessary, as this medication is not associated with hypoglycemia (with a patient fasting for the procedure). Other therapies, such as insulin or sulfonylureas, may need to be modied if they are being utilized in a similar situation. Bibliography
1. Shaw JS, et al: Establishing pragmatic estimated GFR thresholds to guide metformin prescribing. Diabet Med 2007 Oct;24(10):11601163. 2. Salpeter S, et al: Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev 2006(1):CD002967.

Items 3337

Answers 33 (A); 34 (B); 35 (D); 36 (E); 37 (C)


Diagnosis Lifestyle Intervention + Metformin No A1C 7% Yesa Add Glitazoneb (No hypoglycemia) Yesa No A1C 7% Yesa

Add Basal Insulin (Most effective) No A1C 7% Yesa No

Add Sulfonylurea (Least expensive) A1C 7%

Intensify Insulin No A1C

Add Glitazone b,c 7% Yesa

Add Basal Insulin No A1C

Add Sulfonylureac 7% Yesa

Add Basal or Intensify Insulin Intensive Insulin + Metformin +/- Glitazoneb Figure 5. Algorithm for the Metabolic Management of Type 2 Diabetes. Reinforce Lifestyle Intervention at Every Visit.
a b c Check A1C every 3 months until 7% and then at least every 6 months. Associated with increased risk of uid retention, CHF, and fractures. Rosiglitazone, but probably not pioglitazone, may be associated with an increased risk of myocardial infarction. Although three oral agents can be used, initiation and intensication of insulin therapy is preferred based on effectiveness and lower expense.

Nathan DM, et al: Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care Jan 2008;31(1):173175.

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33. Patients newly diagnosed with type 2 diabetes should receive lifestyle interventions to modify diet, increase physical activity, and promote weight loss. Small changes in weight loss (as low as 4 kg) will improve hyperglycemia. However, there is limited success with such lifestyle programs, usually due to failure to lose weight (or weight regain) or progressive disease. For these reasons, metformin is currently recommended as initial therapy at the same time lifestyle modications are instituted. Metformin should be titrated over 12 months as tolerated. In addition, metformin may result in modest weight loss, in contrast to many other therapies that result in weight gain (especially sulfonylureas and insulin). 34. The patient has an elevated A1C level above goal (7%) and further change in therapy is appropriate. In this situation, with cost being a potential concern, starting a sulfonylurea may be preferable to a thiazolidinedione. While the risk of hypoglycemia is introduced, severe episodes (those requiring need for assistance) tend to occur less often, especially in his age group. Other oral medications, such as the glinides (e.g., repaglinide), could be considered as an alternative if hypoglycemia was a signicant concern, depending on cost and availability. It would be less desirable to start insulin injections at this point, especially basal insulin given likely postprandial alterations. 35. The patient clearly has hyperglycemia that requires further therapy. Despite her age, she appears to have good functional status without diabetes-related complications. It is appropriate to target an A1C level of 7.0%. Pioglitazone could be added; however, this would unlikely reduce her A1C level to her target goal. Instead, daily basal insulin should be instituted, and then insulin may be intensied as necessary. 36. This patient has a history of Alzheimer disease for six years, and given his age and life expectancy and comorbid conditions, a higher target A1C level may be appropriate (such as 8.0% or less). Pioglitazone would not be indicated due to congestive heart failure, and would not offer benet in place of rosiglitazone. Heart failure is also a relative contraindication for metformin given risk of lactic acidosis; however, a recent retrospective review of patients in Canada found less morbidity and mortality by those with congestive heart failure on metformin when compared with sulfonylureas. 37. Her level of glycemic control is not much higher than goal (7.0%). A glitazone might be most appropriate in this situation, with the benet of avoiding the risk of hypoglycemia, though it may take a month before becoming effective. Glipizide might cause less hypoglycemia than glyburide, but may not be the optimal choice if a glitazone may be utilized. Basal insulin would also increase the risk of hypoglycemia. Metformin is contraindicated with the level of renal failure she currently has given the risk of lactic acidosis. Bibliography
1. Nathan DM, et al: Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2008;31(1):173175. 2. Kabadi UM. Cost-effective management of hyperglycemia in patients with type 2 diabetes using oral agents. Manag Care 2004 Jul;13(7):4849, 5346, 5849. 3. Eurich DT, et al: Improved clinical outcomes associated with metformin in patients with diabetes and heart failure. Diabetes Care 2005 Oct;28(10):23452351.

Item 38 Answer B Both the fasting glucose level and A1C level are both elevated, and instituting basal insulin therapy (detemir or glargine) would be the best option at this point. One potential advantage of detemir over other insulin formulations is that it may be associated with less weight gain (especially when given once daily). When utilized, the dose of insulin can be increased to target fasting levels below approximately 120 mg/dL. Starting once daily NPH or premixed insulin also would likely be somewhat effective in reducing fasting and average glucose levels; though in the treat to target studies, glargine and detemir daily insulin resulted in less hypoglycemia. The other options, while possibly reducing glucose levels in combination therapy, are less desirable. Pioglitazone would not signi-

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cantly further reduce glucose levels unless metformin was continued (while the patient in this case had microalbuminuria, metformin may be continued in combination therapy with the current level of renal function). Pioglitazone potentially offers a positive impact on lipid proles, has anti-inammatory properties, and may improve endothelial function providing some advantage for those with higher coronary artery disease risk. Next, exenatide offers some benet by reducing weight in this obese person while modestly improving glycemic control. However, this would be more appropriate in someone with persistently elevated postprandial glucose levels. In addition, it requires residual -cell function that may not be present given the extended history of diabetes. Aspart insulin with meals would also target postprandial glucose but this requires multiple injections throughout the day. Bibliography
1. Stojanovska L, et al: The anti-atherogenic effects of thiazolidinediones. Curr Diabetes Rev 2007 Feb;3(1):6774. 2. Rosenstock J, et al: A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008 Mar;51(3):408416. 3. Meneghini LF, et al: Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab 2007 May;9(3):418427. 4. Hermansen K, et al: A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006 Jun;29(6):12691274. 5. Riddle MC, et al: The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003 Nov;26(11):30803086.

Items 3941 Answers 39 (B); 40 (A); 41 (D) The patient is at higher risk of hypoglycemia being of older age on a sulfonylurea. However, his prior glycemic control is notable for absence of hypoglycemia on stable medication therapy. Recently, he was started on a uoroquinolone, and it is most likely that this combination of uoroquinolone and sulfonylurea that increased his risk of severe hypoglycemia. Based on one study, gatioxacin has a much greater risk of hypoglycemia than other agents (including other uoroquinolones). The mechanism by which uoroquinolones increase the risk of hypoglycemia is unclear, and likely complex and multifactorial. As sulfonylureas are cleared by the kidneys, renal failure may lead to increased drug levels in the bloodstream. Providers must use sulfonylureas with caution in patients who may have chronic renal insufciency or are at risk of developing acute renal disease. This may be related to an acute illness, poor oral intake, and/or dehydration; though this was not described in the case scenario. Adrenal insufciency may also cause hypoglycemia; this could be a potential factor if the patient had been on long-standing prednisone for obstructive lung disease and then abruptly stopped. Appropriate management includes hospitalization since glyburide has a long half-life, and continuous infusion of dextrose solution with frequent glucose level monitoring. Solumedrol is not necessary as adrenal insufciency is less likely. Glucagon is appropriate for home therapy if patient has altered mental status and is unable to eat or drink anything when experiencing hypoglycemia, but unnecessary when intravenous access is available. Octreotide has been used successfully in select situations of sulfonylurea overdose when hypoglycemia is refractory to dextrose bolus/infusion. Typical risk factors for iatrogenic hypoglycemia are based on insulin excess (from injected or secreted sources). These include situations when: insulin dose is excessive, such as with intensive insulin regimens, exogenous glucose delivery is decreased (for example, missed meal or snack), endogenous glucose production is decreased (alcohol ingestion), glucose utilization is increased (exercise), sensitivity to insulin is increased (insulin sensitizer), or insulin clearance is decreased (renal insufciency). Longer history of diabetes and older age, degree of glycemic control, and history of prior hypoglycemia all further increase the risk of developing future hypoglycemia. Hypoglycemia unawareness is thought to be related to reduced neurogenic symptom response to low blood glucose levels. Neurogenic symptoms include adrenergic (tremulousness, palpitations) and cholinergic (sweating, hunger, and paresthesia) components. Exenatide, an incretin mimetic, is typically used with oral agents and not as monotherapy, with an expected decrease in A1C level of up to 1%. However, a study of monotherapy with exenatide and a report of exenatide overdose showed no evidence of severe hypoglycemia.

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Bibliography
1. 2. 3. 4. 5. 6. Bussing R, et al: Severe hypoglycemia from clarithromycin-sulfonylurea drug interaction. Diabetes Care 2002 Sep;25(9):16591661. Lin G, et al: Refractory hypoglycemia from ciprooxacin and glyburide interaction. J Toxicol Clin Toxicol 2004;42(3):295297. Park-Wyllie LY, et al: Outpatient gatioxacin therapy and dysglycemia in older adults. N Engl J Med 2006 Mar 30;354(13):13521361. Carr R, et al: Octreotide for sulfonylurea-induced hypoglycemia following overdose. Ann Pharmacother 2002 Nov;36(11):17271732. Cryer PE, et al: Hypoglycemia in diabetes. Diabetes Care 2003 Jun;26(6):19021912. Nelson P, et al: The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther 2007 Aug;9(4):317326. 7. Cohen V, et al: Acute exenatide (Byetta) poisoning was not associated with signicant hypoglycemia. Clin Toxicol (Phila) 2007 Aug 15:12.

Item 42 Answer B This patient has inadequately controlled blood glucose levels, A1C above goal (7.0%) and postprandial blood glucose in the 200300 mg/dL range. The patient is already taking three oral agents and basal insulin; the next appropriate step would be to add pre-prandial rapid-acting insulin three times a day, in addition to basal insulin. A basal/bolus insulin combination (50% in bolus form, 50% in basal form) would likely help the patient achieve his goals in glycemic control. Adding a second dose of basal insulin (glargine) would be less helpful, and may increase the risk of hypoglycemia, since the fasting blood glucose levels are closer to goal. With the addition of bolus insulin before meals, less glargine may be required each day as well. There is no consensus on whether to continue or discontinue sulfonylurea therapy while taking insulin. In this situation, someone with long-standing type 2 diabetes may have less -cell function, offering little contribution in terms of postprandial glucose control. Switching to repaglinide would offer limited relative benet. With the addition of pre-meal insulin, a secretatogue in general would not then be appropriate. Finally, increasing pioglitazone is unlikely to reduce A1C level to less than 7.0%. It also would contribute to lower extremity edema (current edema possibly arising from pioglitazone and/or amlodipine). Still, continuing insulin sensitizers is appropriate in combination with intensive insulin therapy. Bibliography
1. Hirsch IB. Intensifying insulin therapy in patients with type 2 diabetes mellitus. Am J Med 2005 May;118 Suppl 5A:21S26S. 2. Raskin P. Why insulin sensitizers but not secretagogues should be retained when initiating insulin in type 2 diabetes. Diabetes/Metabolism Research and Reviews 2008;24(1):313. 3. Hirsch IB. Insulin analogues. N Engl J Med 2005 Jan 13;352(2):174183. 4. Devries JH, et al: Rening basal insulin therapy: what have we learned in the age of analogues? Diabetes Metab Res Rev 2007 Sep;23(6):441454.

Item 43 Answer E Resistance training in combination with aerobic exercise will likely reduce blood glucose levels. As she has tried various aerobic exercises, the addition of strength training offers additional benet. In one study of 251 adults aged 3970 years with type 2 diabetes, the absolute change in A1C among participants receiving combined aerobic and resistance training was -0.51% lower than aerobic training only participants, and -0.38% lower than resistance training only participants. The pursuit of swimming or water aerobics may be preferable given her level of obesity and knee pain. Resistance exercises are safe and effective and may be complimentary to her current efforts. Some evidence suggests that home-based resistance training is less desirable than community-based programs due to adherence, equipment, and social support-related factors necessary for long-term improvement in glycemic control. Repetitive stretches or weight lifting should be done targeting multiple muscle groups in a graduated fashion, preferably after receiving professional instruction. Since she has met regularly with a dietitian and experienced success in weight loss, she may also succeed with exercise instruction and support.

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The addition of medications may help her achieve her glycemic goal of therapy, but is likely less preferable than exercise. A combined medication/exercise intervention may be offered, though this was not a choice given for this item. Pioglitazone may result in weight gain, though this would reduce blood glucose levels without risk of hypoglycemia. Exenatide may result in mild weight loss; however, she indicated her interest in avoidance of injections of insulin, so this may not be the best option at this point. A sulfonylurea may result in weight gain approximately 2 kg is common with initiation of therapy. It also introduces the risk of hypoglycemia which may result with further efforts at lifestyle change. Finally, increasing metformin from 2000 mg to 2500 mg (maximum) will have limited benet, and alone would not be superior to instituting resistance exercise. Bibliography
1. Sigal RJ, et al: Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. Ann Intern Med 2007 Sep 18;147(6):357369. 2. Dunstan DW, et al: Home-based resistance training is not sufcient to maintain improved glycemic control following supervised training in older individuals with type 2 diabetes. Diabetes Care 2005 Jan;28(1):39. 3. Dunstan DW, et al: Community center-based resistance training for the maintenance of glycemic control in adults with type 2 diabetes. Diabetes Care 2006 Dec;29(12):25862591. 4. Dunstan DW, et al: High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care 2002 Oct;25(10):17291736.

Item 44 Answer A There is increasing evidence that supports the use of intensive glucose control in hospitalized patients, especially those in critical care units. However, sliding scale of insulin protocols continues to be prevalent in use despite little evidence to support its use. Physicians continue to utilize sliding scale of insulin protocols as it is convenient to implement, simple to apply, and provides quick treatment in response to elevated glucose levels. It is widely accepted by nursing staff and covering physicians so that additional contact and communication is unnecessary to manage hyperglycemia. Some physicians may fear hypoglycemia and turn to sliding scale of insulin monotherapy or inadequately scheduled insulin treatment. The sliding scale of insulin, usually with short-acting but not long-acting insulin, has never been associated with improved clinical outcomes. A MEDLINE review found 52 publications between 19662003, none of which showing benet via improved glycemic control or positive clinical outcomes. In general, it is felt that this approach is more likely dangerous to employ. The sliding scale is a response to previous hyperglycemia experienced and does not take into account trends in glucose levels. This approach has been described as reactive and leads to more rapid changes in glucose levels, exacerbating hypoglycemia and hyperglycemia. Instead, a standard insulin order set that includes basal replacement insulin therapy and scheduled prandial, short-, or rapid-acting insulin therapy is more appropriate during hospitalizations. Bibliography
1. Queale WS, et al: Glycemic control and sliding scale insulin use in medical inpatients with diabetes mellitus. Arch Intern Med 1997 Mar 10;157(5):545552. 2. Umpierrez GE, et al: Sliding scale insulin use: myth or insanity? Am J Med 2007 Jul;120(7):563567. 3. Umpierrez GE, et al: Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care 2007 Sep;30(9):21812186. 4. Clement S, et al: Management of diabetes and hyperglycemia in hospitals. Diabetes Care 2004 Feb;27(2):553591.

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Items 4547 Answers 45 (B); 46 (C); 47 (A) The extended-release glipizide recordings had the highest average blood glucose levels (with only oral medication therapy without insulin) during the washout period (11.3 mean mol/L, Option [A]). Both NPH (Option [B]) and glargine (Option [C]) combination with glipizide participants had signicant improvement with lower glucose levels throughout the day. Compared with the NPH combination group, the pre-supper and bedtime group had decreased glucose levels in the glargine combination group. Also, the 3 a.m. glucose levels decreased less in the basal (glargine combination) group. Overall, there were fewer uctuations in glucose levels with glargine at bedtime. Of note, there were no episodes of severe hypoglycemia in either insulin treatment group. In general, glycemic control includes three measures to address: fasting plasma glucose, postprandial glucose, and A1C. However, there is interest in exploring glucose variability as this may also be an important consideration. In one study, glucose uctuations (based on mean amplitude glucose alterations) were found to be activators of oxidative stress in people with type 2 diabetes (including for those only on oral medication therapy). Continuous glucose monitoring may provide a means to assess this further for adults with type 2 diabetes, though its clinical utility in this population remains to be determined. In addition, continuous blood glucose data may help in patient education and feedback, and possibly help motivate patients to transition from oral medication to insulin sooner when glycemic goals have not been achieved. Bibliography
1. Muggeo M, et al: Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study. Diabetes Care 2000 Jan;23(1):4550. 2. Wang XL, et al: Evaluation of the superiority of insulin glargine as basal insulin replacement by continuous glucose monitoring system. Diabetes Res Clin Pract 2007 Apr;76(1):3036. 3. Monnier L, et al: Continuous glucose monitoring in patients with type 2 diabetes: Why? When? Whom? Diabetes Metab 2007 Sep;33(4):247252. 4. Monnier L, et al: Activation of oxidative stress by acute glucose uctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA 2006 Apr 12;295(14):16811687.

Item 48 Answer A Though one might encourage this patient to follow a better diet and exercise, often this advice is not followed and it delays care. Though it used to be appropriate to wait 3 months between interventions, therapeutic inertia, (the watch em disease of physicians), it is now preferable to make changes every 2 to 4 weeks after increasing a dose or adding a new drug. One may choose to wait for a longer period of time, but in most situations external life stresses do not dissipate quickly. This patient needs DSME and also help with life stresses. Threatening the start of insulin therapy in order to achieve better compliance with diet and exercise rarely works, and adds to the patients future fear of insulin therapy, so this is strongly discouraged. Exercise increase alone will rarely lower fasting blood glucose levels from the 180 mg/dL range. It is important when a patient is on a sulfonylurea to make sure unrecognized hypoglycemia does not develop overnight thus resulting in a rebound elevated fasting blood glucose level. Clinically, if there is certainty that this is not the case, treatment with insulin should be initiated. Bibliography
1. Cefalu WT. Pharmacotherapy for the Treatment of Patients with Type 2 Diabetes Mellitus: Rationale and Specic Agents. Clin Pharmacol Ther 2007 May;81(5). 2. Shah BR, et al: Clinical inertia in response to inadequate glycemic control: do specialists differ from primary care physicians? Diabetes Care 2005;28:600. 3. Tibaldi J, et al: Why, when and how to initiate insulin therapy in patients with type 2 diabetes. International J Clinical Practice 2007 April;61:633644.

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Items 4953 Answers 49 (C); 50 (A); 51 (E); 52 (B); 53 (D) When a patient with type 2 diabetes fails 3 or 4 non-insulin modalities, insulin therapy is recommended. When basal-bolus in insulin is being used to treat both fasting and postprandial elevated glucose, there are logical goal reasons to maintain several of the non-insulin modality treatments as one uses basal-bolus insulin therapy. Metformin has been shown to reduce AGE production. It may also result in lower doses of basal insulin required for control. Thiazolidinediones may preserve remaining -cell production as evidenced by the DREAM trial showing a slower need to start a second non-insulin therapy in patients with type 2 diabetes. Pioglitazone may have a possible (as yet unproven) cardiovascular benet as suggested by the proactive trial, the Chicago trial, and the Periscope trial. However, rosiglitazone has a black box warning given by the FDA for possibly increasing adverse cardiac outcomes especially in patients with ischemic CV disease, on nitrates, or insulin. The Canadian as well as European drug agencies also have released warnings for possible increased cardiovascular risk. Rosiglitazone also has an adverse lipid pattern of increased triglycerides, increased non-HDL-C, and increased LDL particle number. Thus, there is no logic to maintain rosiglitazone therapy, but it is quite reasonable to switch these patients to pioglitazone and maintain it when starting insulin therapy so as to get lipid benets, likely preservation of -cells, and reduction of insulin doses required (by increasing insulin sensitivity). Exenatide, an injectable incretin, has evidence in animals for preserving remaining -cells and possibly increasing production of new -cells. It decreases required doses of insulin and provides smoother control of postprandial glucose and has a side benet of weight loss. However, this would be off-label use of exenatide, as it is not approved in combination with insulin. Sitagliptin, a DPP-4 inhibitor, increases endogenous incretin levels and will have the same benets as exenatide, except for the weight loss. But the use of sitagliptin would be off-label, as it is not approved in combination with insulin. Acarbose does result in reduced postprandial glucose and thus smoother control by delaying glucose absorption by shifting absorption to distal small intestinal sites; however, tolerance and patient compliance of this drug is difcult given the diarrhea that often accompanies its use. Sulfonylureas can control postprandial glucose, but this can be accomplished quite well with bolus insulin therapy alone. Discontinuing sulfonylureas avoids an undue risk of postprandial hypoglycemia and further destruction of any residual -cells. Glinides can control postprandial glucose, but this can be accomplished quite well with bolus insulin therapy alone. Discontinuation avoids an undue risk of postprandial hypoglycemia. Bibliography
1. Riddle MC. The treat-to-target trial and related studies. Endocr Pract 2006;12 suppl 1:71. 2. Bergenstal RM. Treatment models from the international diabetes center: advancing from oral agents to insulin therapy in type 2 diabetes. Endocr Practice 2006;12 suppl 1:98. 3. DECODE Study Group. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med 2001;161:397405. 4. Goldberg RB, et al: For the GLAI Study Investigators. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care 2005;28:154754. 5. Deeg MA, et al: For the GLAI Study Investigators. Pioglitazone and rosiglitazone have different effects on serum lipoprotein particle concentrations and sizes in patients with type 2 diabetes and dyslipidemia. Diabetes Care 2007;30:245864. 6. Dormandy JA, et al: Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macro Vascular Events): a randomized, controlled trial. Lancet 2005;366:127989. 7. Wilcox R, et al: for the PROactive Investigators. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events 04). Stroke 2007;38:86573. 8. Erdmann E, et al: for the PROactive Investigators. The effect of pioglitazone on recurrent myocardial infarction in 2445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) study. J Am Coll Cardiol 2007;49:177280. 9. Mazzone T, et al: Effect of pioglitazone compared with glimepiride on carotid intimamedia thickness in type 2 diabetes: a randomized trial. JAMA 2006;296:257281.

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10. Nissen SE. Comparison of Pioglitazone vs Glimepiride on Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes The PERISCOPE Randomized Controlled Trial. JAMA 2008;299(13):15611573. 11. Riddle MC. Glycemic Management of Type 2 Diabetes: An Emerging Strategy with Oral Agents, Insulins, and Combinations, Endocrinol Metab Clin N Am 2005;34:7798.

Item 54 Answer C A normal subject secretes a small amount of insulin almost continuously for 24 hours. This is to prevent ketogenesis when fasting. In the face of the need to store exogenous food, glucose, and calories, the pancreas secretes, very precisely, extra insulin at the time of any p.o. intake. One can sometimes discern an increase in the small continuous amount of insulin roughly between 3 a.m. and 8 a.m. due to increased renal clearance of insulin during that time and increased insulin requirement associated with the normal cortisol diurnal variation, i.e., increased cortisol seen early in the morning. Traditional insulins used in the past in regard to basal insulin therapy had signicant peaks, certainly did not last 24 hours and thus do not look like the normal basal insulin secretion pattern in the normal subject. The traditional regular human insulin takes 1 to 2 hours to peak and can last at least 5 and 6 hours and sometimes longer. The fast analog insulins peak within 1 hour and last 3 to 4 hours mimicking much more closely the normal -cell response to mealtime intake. An insulin pump with the ability to continuously put out sparing amounts of basal insulin given as a continuous 2 infusion of a fast analog insulin combined with adjusting boluses of the fast analog insulin each time one eats, can mimic the normal human pattern of insulin secretion more closely than any other standard regimen that is available at the present time. Thus, ideal insulin therapy will attempt to mimic what a normal pancreas does, will be best achieved by basal insulinization that has minimal peaks even if given once or twice a day, will mimic the fast release and relatively short duration of bolus insulin with a meal that can be done best with an insulin pump and bolus fat-insulin analogs, and, most importantly, the combination of basal and bolus insulin can be adjusted to match the pharmacokinetics of the insulin one chooses to the lifestyle and nutritional source or eating pattern of the patient. In this regard, patterns of administration can mimic and deal with the normal increased insulin requirement between 3 and 8 a.m. (called the dawn effect) and can match mealtime patterns where people delay or miss meals, travel internationally, do shift work, wake up at different times weekends and weekdays. However, because of the slower peak and longer duration of regular human insulin in comparison to fast analog insulin, ideal insulin therapy will in the vast majority of situations not include regular human insulin. Bibliography
1. Dewitt DE, et al: Out-patient Insulin Therapy in Type 1 and Type 2 Diabetes Mellitus. JAMA 2003;289:2254. 2. Gough S. A review of human and analogue insulin trials. Diabetes Research and Clinical Practice 2007;77:115. 3. Mooradian AD, et al: Narrative Review: A Rational Approach to Starting Insulin Therapy. Ann Intern Med 2006 July 18;145(2):125134. 4. Bode. Incorporating Postprandial and Fasting Plasma Glucose into Clinical management Strategies Insulin 2008;3:17. 5. Raccah D. When basal insulin therapy in Type 2 Diabetes is not enough-what next? Diabetes Metabolism Res Rev 2007;23:257. 6. Rosenstock J, et al: A randomized 52 Week, Treat-To-Target Trial Comparing Insulin Detemir With Insulin Glargine When Administered As Add-On To Glucose Lowering Drugs In Insulin-Naive People With Type 2 Diabetes, Diabetologica 2008;51:408. 7. Devries JH, et al: Rening basal insulin therapy: what have we learned in the age of analogues? Diabetes Metab Res Rev 2007;23:441. 8. LeRoith D. Our evolving understanding of getting to goal using insulin in Type 2 Diabetes. Endo Metab Clinics 2007 Dec;suppl 2:9. 9. Tibaldi J, et al: Why, when and how to initiate insulin therapy in patients with type 2 diabetes. International J Clinical Practice 2007 April;61:633. 10. Hirsch IB, et al: A real-world approach to insulin therapy in primary care practice. Clin Diabetes 2005;23:7886. 11. Davis T, et al: Insulin therapy in type 2 diabetes. Med Clin N Am 2004;88:865895.

Item 55 Answer A Regular human insulin starts working in 30 minutes to 1 hour, peaks in 2 hours and can last up to 6 and even more hours. Since patients with normal gastric emptying will absorb calories faster than the peak effect of the regular human insulin, these patients will be subject to hyperglycemia in the rst 2 hours and, are subject to late (46 hours) postprandial hypoglycemia.
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Since patients with type 2 diabetes given fast analog insulin are responsive within 30 minutes, peak in one hour, and last 3 or a maximum 4 hours, thus more closely mimicking the normal gastric emptying and appearance of glucose in the blood stream, there is a better match of insulin to absorb the calories resulting in less 2-hour hyperglycemia and less 4 hour hypoglycemia compared to regular human insulin. As a result, area under the curve postprandial glycemic patterns are signicantly reduced with the use of fast analogs rather than with the use of regular insulin. Moreover, patients with regular insulin are often told to take their insulin at least 30 minutes prior to the meal to try to reduce the postprandial hyperglycemia. However, if they do not know how much they are going to eat and must therefore delay insulin until after eating, they further accentuate postprandial hyperglycemia and late postprandial hypoglycemia. However, patients using fast analogs, because it works so quickly can actually be given it immediately after eating when they see and can calculate how much carbohydrate they ate, and thus can calculate the right amount of fast analog insulin to match what they ate, again getting the best control of their postprandial glycemic patterns. Fast analog insulin does not address the issue of gastroparesis better than regular insulin. Patients who have gastroparesis due to diabetic autonomic neuropathy will have signicantly delayed gastric emptying, such that fast analog insulin in these patients is likely to cause immediate postprandial hypoglycemia as well as signicant absorption of calories because of delayed emptying of contents into the small intestine. The best treatment of signicant gastroparesis in these patients is with an insulin pump where boluses can actually be given as a square wave over several hours after eating. Bibliography
1. Leahy JL. In: Leahy JL, Cefalu WT, eds. Insulin Therapy New York, NY:Marcel Dekker, Inc;2002:87112. 2. Bolli GB, et al: Diabetologia 1999;42:11511167.

Item 56 Answer D Differences in the pharmacokinetics and dynamics of regular insulin vs fast analog insulin are often highlighted by problems and situations often seen in hospitalized patients. Thus, a patient may be given regular subcutaneous insulin at breakfast, be taken for a laboratory study, and have a signicant delay in lunch and, as such, because of the prolonged action of regular insulin, there is an increased risk of hypoglycemia. Because fast analog insulin effect has dissipated 3 to 4 hours after injection, a signicant delay in lunch has a markedly reduced risk of hypoglycemia vs patients treated with regular insulin in the same circumstances. Another situation is that patients who have hyperglycemia are often given correction factor doses of subcutaneous short-acting insulin (the old sliding scale).Typically house staff will order a dose of regular insulin, nursing staff will be uncomfortable as they see no signicant reduction 3 and 4 hours later. House staff will be asked and will administer another dose of regular insulin and similarly a third event will occur 3 or 4 hours after the second dose. Repeated administration of an insulin that lasts for 6 or longer hours can result in stacking effects of the recurrent regular insulin dosing and markedly increases the risk of hypoglycemia by the third or more dose of regular insulin. Use of the fast analog where usual effect is gone after 3 to 4 hours, minimizes the risk for hyperglycemia due to stacking. In the hospital, patients frequently have inconsistent p.o. intake. This may be the elderly with altered mental status and altered and varying appetite for other reasons e.g.: this may be somebody getting chemotherapy, etc. Again, regular insulin is usually given at least 30 minutes before meal and if usual doses are given and the patient eats less, they are highly likely to become hypoglycemic after eating. Fast analog insulins in patients who have inconsistent p.o. intake in a predictable fashion can have their preprandial insulin held, and after it is observed how many calories or grams of carbohydrate they actually do eat, the nurse/physician can adjust the dose of the fast analog to compensate for the reduced intake. However, regular and fast analog insulin when given IV have equal effects and thus, there is no advantage to one or the other in terms of hypoglycemia, which is the answer D.

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Bibliography
1. 2. 3. 4. Leahy JL. Insulin management of diabetic patients on general medical and surgical oors. Endocr Pract 2006;12 suppl 1:86. Thompson CL, et al: Hyperglycemia in the Hospital. Diabetes Spectrum 2005;18:20. Tomky D. Detection, prevention, and treatment of hypoglycemia in the hospital. Diabetes Spectrum 2005;8:39. Braithwaite S. Hospital Hypoglycemia: not only treatment but prevention. Endocr Pract 2004;10 suppl 2:89.

Item 57 Answer C The most important diagnosis that one must assume exists before one considers or even treats other possibilities to explain the increased intermittent fasting glucose in the presence of (new) basal insulin therapy is the possibility of middle of the night hypoglycemia with an a.m. rebound. When the glucose level goes too low overnight, most people do not wake up with it, but the brain tells the liver to make extra glucose and the fasting levels are elevated. Many patients and physicians are not aware of this and will keep on increasing the basal insulin dose and this can result in increased weight gain because one has to eat more to avoid hypoglycemia during the day. Patients might notice waking up in the morning with headache, having occasional nightmares, having bed sheets soaked with sweat, or waking up with a profound malaise, a hangover sensation without drinking alcohol. If it proceeds too far, seizures can occur in the middle of the night. About 80% of patients referred for insulin therapy actually have required reductions in their current insulin doses. Thus, the pattern of increasing insulin with increased weight and unusual morning symptoms should make a physician consider middle of the night hyperglycemia with a rebound as the most plausible explanation. Certainly, the patients deserve increased education to double check their injection technique, see the nutritionist to reinforce compliance with diet, and learn more about high glycemic index foods. The likelihood of the dawn effect as an explanation is quite small, (that is, the pattern where middle of the night numbers are good, but glucose is higher because of lack of ability of the patients own pancreas to produce extra insulin to prevent the increased insulin resistance that is apparent in some truly insulin-decient patients rst thing in the morning). Bibliography
1. Devries JH, et al: Rening basal insulin therapy: what have we learned in the age of analogues? Diabetes Metab Res Rev 2007;23:441454. 2. Cryer PE. Insulin therapy and hypoglycemia in type 2 diabetes. Insulin 2007;2:127.

Item 58 Answer A The most important therapeutic intervention for this patient is to reduce the patients glargine 10% to 20% from the last stable dose, which has been 26 U. So a dose of 22 to 23 U would be quite appropriate. It would certainly be appropriate to advise the patient to check 3 a.m. glucose levels whenever changing the glargine dose and certainly even periodically once every week or two, even when it is apparently perfectly stable. The patient should be instructed on the proper insulin injection and glucose monitoring techniques, and understanding of nutrition and high glycemic index foods.

Item 59 Answer B To get better control of postprandial glucose levels, the best therapy for glycemic control and reducing the risk of hyperglycemia, less weight gain, better lifestyle, or adaptation to different lifestyles would be the start of bolus fast analog insulin with each meal. However, the patient preferred not to take 4 injections a day and so a twice daily before breakfast and before dinner xed mixture of an intermediate acting insulin with fast analog was started. Premixed preparations are available as combinations of intermediate-acting with regular insulin, but given the advantages of fast analogs discussed above, the preference is to use an intermediate-acting insulin with the fast analog. It is certainly more convenient to use a premixed preparation than to self-mix NPH and the short-acting insulin, and it is much more accurate than mixing NPH and short-acting insulin in the same syringe. Premixed preparations do require the patient to eat the same amount of food at the same time each day to try to adapt to the peaks of the NPH insulin.
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So, he was started and titrated, i.e., 6 mixture of NPH and a fast analog before breakfast and before dinner, and he was advised to eat the same amount of food each day and to wake up at the same time each day to minimize hypo and hyperglycemia due to the peaks of the intermediate-action insulin component Bibliography
1. Raskin P. Can glycemic targets be achieved-in particular with two daily injections of a mix of intermediate and short-acting insulin? Endocr Pract 2006;12 supp 1:52.

Item 60 Answer C One of the most common reasons to use insulin pump therapy is that patients, typically type 1 patients or type 2 patients who are very insulin decient, i.e., type 1-1/2,might with even the best, appropriate adjustment of basal doses, have reasonable glucose levels at 3 a.m., but without hypoglycemia intervening, may have elevated glucose levels on awakening in the morning. This is called the dawn phenomenon. It is due to the increased insulin requirements rst thing in the morning, which is actually denable in normal subjects due to normal diurnal variation of cortisol as well as increased renal excretion of insulin early in the morning. Thus, the ability to adjust basal rates hour by hour, which is achievable with insulin pump therapy, but is impossible with MDI, can easily solve this phenomenon of the dawn phenomenon. MDI can deal with regular exercise by reducing bolus amounts prior to the meals that are taken before exercise. However, insulin pumps allow basal rates to be altered as well as boluses, especially under the more difcult situations of intermittent exercise, and thus make it easier than MDI to deal with intermittent exercise. Insulin pump therapy makes it easier to deal with variations in carbohydrate absorption that occur with some complex carbohydrate, higher fat meals, higher ber meals, and most especially with gastroparesis by taking advantage of being able to give boluses as square waves or dual square waves. Glycohemoglobin is likely to be better with insulin pump therapy than with MDI. However, if there is a pump malfunction, the patient is not receiving any basal insulin and thus, onset of diabetic ketoacidosis can quickly develop, especially if the patient is very insulin-decient or absolutely insulin-decient. This is markedly less likely to occur if the patient is taking the usual basal therapy and MDI regimens. Bibliography
1. Raskin, et al: Diabetes Care 2003;26(9):25982603. 2. Testa, et al: Diabetes 2001;50 suppl 2:1781. 3. Weissberg-Benchell J, et al: Insulin pump therapy: a meta-analysis. Diabetes Care 2003;26:10791087.

Items 6166 Answers 61 (A); 62 (B); 63 (E); 64 (D); 65 (D); 66 (C) Metformin reduces insulin resistance at the liver. Pioglitazone and rosiglitazone increase insulin sensitivity at muscle and fat. Xenical works only by decreasing the rate of glucose absorption from the gut; however, we do know that exenatide does slow down gastric emptying and delays absorption of glucose from the gut with meals. Both exenatide and sitagliptin reduce the paradoxical rise of glucagon seen in patients with type 2 diabetes. Both exenatide and sitagliptin in animal studies seem to increase insulin production with transplant medicines and steroids. These incretins increase insulin secretion of any remaining -cells in a glucose-dependent manner that means when the glucose returns to normal, there is no further extra increase in this insulin and so the risk of hypoglycemia is quite minimal. The secretagogues, sulfonylureas, and glinides increase some secretion of the remaining -cells, but they do this in a glucose-independent manner, so patients have a low blood glucose, e.g., 40 mg/dL. They will continue to secrete insulin as long as the drug is circulating in the blood stream.

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Bibliography
1. Dunning BE, et al: The Role of beta-Cell Dysregulation in Fasting and Postprandial Hyperglycemia in Type 2 Diabetes and Therapeutic Implications. Endocr Rev 28(3):253283. 2. Shefeld, et al: Safety and Efcacy of exenatide in combination with insulin in patients with Type 2 diabetes mellitus. Endocr Pract 2008;14:285. 3. Yoon. Exenatide added to insulin. ADA abstracts 2008 ADA meeting. 4. Inzucchi. New drugs for the treatment of diabetes: Incretin based therapy and beyond. Ciculation 2008;117:574.

Item 67 Answer B Lifestyle changes including weight loss and increased activity have both short- and long-term benets, if they can be maintained. In recognition that many times lifestyle changes cannot be maintained, metformin is recommended as the initial pharmacologic therapy (in the absence of contraindications) given its efcacy (usual absolute decrease in A1C of 1.5%), absence of weight gain or hypoglycemia and relatively low cost compared to the other agents listed. Bibliography
1. Nathan DM, et al: Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2006;29:19631972.

Item 68 Answer C Substitution of intermediate-acting insulins with long-acting insulins actually decreases the risk of hypoglycemia. A missed or delayed meal can cause an excess of insulin relative to plasma glucose, causing hypoglycemia. Elderly patients are at greater risk of hypoglycemia. Factors that may predispose them to hypoglycemia include polypharmacy, erratic nutrition, impaired renal or hepatic function, and medication noncompliance. Renal insufciency predisposes to hypoglycemia because of reduced renal clearance of insulin as well as medications such as sulfonylureas. Alcohol consumption is known to have a delayed hypoglycemic effect. Bibliography
1. Briscoe VJ, et al: Hypoglycemia in Type 1 and Type 2 Diabetes: Physiology, Pathophysiology, and Management. Clin Diabetes 2006;24:115121.

Item 69 Answer E The original Diabetes Control and Complications Trial (DCCT) was conducted in patients with type 1 diabetes between 1983 and 1993. With a mean follow-up of 6.5 years, 1422 patients completed the study with one half assigned to intensive therapy and the remainder to conventional therapy. The average A1C level was 7.4% in the intensive group versus 9.1% in the conventional group. Development of new retinopathy was decreased by 76% in the intensive treatment group compared to the conventional group and the progression of established retinopathy was deceased by 54% in the intensive group compared to the conventional group. Intensive treatment also decreased the occurrence of microalbuminuria by 39% and albuminuria by 54% as well as occurrence of clinical neuropathy by 60%. However, there was no signicant change in macrovascular events between the intensive and conventional groups at the end of the study although there was a trend towards improvement. The Epidemiology of Diabetes Interventions and Complications (EDIC) was an observational study that followed the DCCT cohort of patients, all of whom were encouraged to transition to intensive therapy at the end of the DCCT. After 11 years, glycemic control was comparable between the two groups; the mean A1C was 7.9% in the group that had been the intensive group during the DCCT and 7.8% in the group that had been the conventional group. Micro- and macroalbuminuria continued with increasing frequency in the previous conventional group versus the previous intensive group. At the end of 17 years of DCCT and EDIC, the risk of nonfatal MI, stroke, and death from cardiovascular disease was 57% lower in the previous intensive group compared to the previous conventional group. Intensive diabetes management for 6.5 years early in the course of disease was able to decrease the risk of cardiovascular events several years later and reinforces the belief that patients with type 1 diabetes benet from the implementation of intensive insulin therapy.
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Bibliography
1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329(14):97786. 2. Nathan DM, et al: Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353(25):264353. 3. ACP Journal Club. 2006 MayJun;144:63.

Item 70 Answer B There can be signicant overlap between diabetic ketoacidosis (DKA) and hyperglycemic state (HHS) clinically, but generally, patients with HHS are more profoundly dehydrated, have a signicantly higher plasma osmolality, a signicantly higher glucose level, and are not ketonemic. The treatment of both conditions is similar and includes aggressive hydration, intravenous insulin, and potassium and phosphate repletion with care not to correct the hyperosmolar state too quickly. In experienced centers, the mortality rate in patients with DKA has decreased over time and is currently less than 5%. The mortality rate for HHS remains at 11%. In the majority of cases mortality is not due to these metabolic complications, but to the underlying precipitating cause. Bibliography
1. Kitabchi AE, et al: Hyperglycemic Crises in Adult Patients With Diabetes: A consensus statement from the American Diabetes Association. Diabetes Care 2006;29:27392748.

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Item 71 Answer D Data from the Diabetes Prevention Program showed that intensive lifestyle modication with 7% reduction in initial body weight with healthy diet and physical activity of moderate intensity (i.e. brisk walking) for at least 150 minutes/week improved hyperglycemia and cardiovascular risk factors. A recent meta-analysis of studies involving exercise and glycemic control in diabetics showed that A1C improved on average by 0.66% with regular exercise without any change in weight. The large majority of patients will require additional medications over the course of their diabetes despite adequate lifestyle changes. Bibliography
1. The Diabetes Prevention Program Research Group. Impact of Intensive Lifestyle and Metformin Therapy on Cardiovascular Disease Risk Factors in the Diabetes Prevention Program. Diabetes Care 2005;28:888894. 2. Boule NG, et al: Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA 2001;286(10):12181227. 3. Nathan DM, et al: Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2006;29:19631972.

Item 72 Answer C Metformin should not be used given this patients renal insufciency. Exenatide would be a good option but would improve postprandial hyperglycemia more signicantly than fasting glucose levels. Either the addition of basal insulin or a thiazolidinedione would be appropriate after consideration and discussion of possible side effects. Bibliography
1. Nathan DM, et al: Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2006;29:19631972.

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Item 73 Answer E Factors that increase the risk of hypoglycemia with sulfonylureas include longer-acting formulations, renal or hepatic disease, missed meals or poor nutrition, and concomitant therapy with salicylates, and bric acid derivatives. The risk of hypoglycemia is not increased in overweight patients.
1. Riddle MC. Combined Therapy With Insulin Plus Oral Agents: Is There Any Advantage?: An argument in favor. Diabetes Care 2008;31:S125130S. 2. Bressler P, et al: Drugs and diabetes. Diabetes Reviews 1994;2:53.

Item 74 Answer B This patient has microalbuminuria, dened as urinary albumin to creatinine ratio between 30300 mg/g. His blood pressure is not at the current goal for all patients with type 2 diabetes of less than 130/80 mm Hg. The ADA guidelines for treatment of hypertension in diabetes recommend either an ACE-I or ARB as the rst line agent with subsequent addition of a thiazide diuretic if needed, with the recognition that most patients will require multiple agents to achieve control. Both ACE-Is and ARBs have been shown in multiple studies to slow development and progression of diabetic nephropathy, but one agent has not been clearly shown to be more effective than the other. Although there have been some preliminary trials that the combination of ACE-I and ARB may be effective, this combination is not routinely recommended. A recent study showed that over a ve-year follow-up period, intensive blood pressure control (approximately 128/75 mm Hg) in patients with type 2 diabetes slowed the progression to micro- and macroalbuminuria, decreased the progression of diabetic retinopathy, and also decreased the incidence of stroke. Bibliography
1. Hypertension Management in Adults With Diabetes. Diabetes Care 27:65S67S. 2. Executive Summary: Standards of Medical Care in Diabetes2008. Diabetes Care 31:S511S. 3. Schrier RW, et al: Effects of aggressive blood pressure control in normotensive type 2 diabetic patients on albuminuria, r etinopathy and strokes. Kidney Int 2002 Mar;61(3):108697.

Items 7576 Answers 75 (B); 76 (D) Weight loss improves hepatic steatosis. Nonalcoholic fatty liver disease (NAFLD) encompasses the entire spectrum from steatosis alone to steatohepatitis (nonalcoholic steatohepatitis or NASH) and cirrhosis. While once thought to be a benign process, NASH in patients with diabetes has been shown to have the propensity to progress to more severe inammation and to cirrhosis. The reason why some patients progress and others do not is not currently understood. By some estimates, diabetes is now the most common cause of liver disease in the U.S. In asymptomatic patients, the most common causes of elevations in liver transaminases are nonalcoholic fatty liver disease (NAFLD) and chronic hepatitis. The prevalence of NAFLD is estimated to approach almost 100% in obese patients with diabetes. There is an increased prevalence of hepatitis C in patients with diabetes compared to the general population. Patients with hepatitis C are at higher risk of developing diabetes compared to patients with hepatitis B. Statins appear to be safe and may even be hepatoprotective in patients with diabetes with liver disease. NAFLD can be diagnosed by ultrasound. The use of liver biopsy to diagnose nonalcoholic steatohepatitis is currently controversial given that there are currently no clear pharmacologic treatments that alter the natural history of the disease. Bibliography
1. Tolman KG, et al: Spectrum of Liver Disease in Type 2 Diabetes and Management of Patients With Diabetes and Liver Disease. Diabetes Care 2007;30:734743. 2. Chalasani N, et al: Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity. Gastroenterology 2004;126:12871292.

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Item 77 Answer C Hypertension, advanced age, co-administration with insulin and coronary artery disease are all risk factors for the development of heart failure in patients with type 2 diabetes treated with thiazolidinediones (TZDs). Other risk factors include history of heart failure or prior MI, left ventricular hypertrophy, long-standing diabetes (10 years), pre-existing edema or current treatment with loop diuretics. Additionally, the development of edema or weight gain on TZD therapy is a risk factor. Lastly, chronic renal failure (creatinine 2.0 mg/dL) appears to be associated with higher risk of development of heart failure in patients treated with TZDs. Bibliography
1 Nesto RW, et al: Thiazolidinedione Use, Fluid Retention, and Congestive Heart Failure: A consensus statement from the American Heart Association and American Diabetes Association. Diabetes Care 2004;27:256263. 2. Elasy TA, et al: Thiazolidinedione Use, Fluid Retention, and Congestive Heart Failure: a consensus statement from the American Heart Association and American Diabetes Association: Response to Nesto. Diabetes Care 2004;27:2096.

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Item 78 Answer A Several studies have established the independent association between diabetes and the incidence of heart failure, including the Cardiovascular Health Study and ALLHAT. Diabetes has also been identied as a risk factor for the progression and worse outcome in patients with heart failure. Not only is diabetes a risk factor for the development of heart failure, but heart failure has been identied as a risk factor for the development of insulin resistance and diabetes.

Item 79 Answer C Any patient with type 2 diabetes on a thiazolidinedione (TZD) and admitted with heart failure should have their TZD stopped. Metformin has recently been recognized as safe for patients with stable heart failure but should be stopped during an acute episode. Many argue that metformin should be discontinued in all hospitalized patients given the high risk of acute renal insufciency in this population. Sulfonylureas, especially long-acting formulations, have an increased risk of hypoglycemia in hospitalized patients who may be eating erratically. Insulin is recognized as the safest, most effective and most quick-acting treatment for hyperglycemia in hospitalized patients.

Item 80 Answer C Most of the oral hypoglycemic agents are safe for patients with type 2 diabetes with heart failure, except for metformin and thiazolidinediones (TZDs) which have relative contraindications in severe heart failure. Metformin seems to be safe in patients with mild heart failure, who are clinically stable, and is not associated with weight gain. In a patient such as this with mild heart failure, a TZD should be prescribed with caution and close clinical follow up. Additionally, regimens including insulin or TZD are likely to cause weight gain. Sulfonylureas also generally cause mild weight gain, although less than TZDs or insulin. Sitagliptin appears to be weight neutral. Exenatide is the only medication listed that may cause weight loss. As a caveat, neither sitagliptin nor exenatide has been studied specically in heart failure patients.

Item 81 Answer A Although there is an independent association between type 2 diabetes and heart failure, there are currently no prospective studies showing what range of A1C is benecial in these patients. At this time, patients with mild heart failure should be treated according to ADA guidelines to goal of less than 7%. There is some concern in patients with severe heart failure that lower A1C may be associated with higher mortality but this may be for several reasons beyond glycemic control and further studies are needed to make any recommendations in this population with severe heart failure.
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Bibliography
1. Masoudi FA, et al: Diabetes mellitus and heart failure: epidemiology, mechanisms, and pharmacotherapy. Am J of Cardiology 2007 Feb 99(4A):113B132B. 2. Gottdiener JS, et al: Predictors of congestive heart failure in the elderly: the Cardiovascular Health Study. J Am Coll Cardiol 2000;35:16281637. 3. Davis BR, et al: Role of diuretics in the prevention of heart failure: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Circulation 2006;113:22012210. 4. Das SR, et al: Effects of diabetes mellitus and ischemic heart disease on the progression from asymptomatic left ventricular dysfunction to symptomatic heart failure: a retrospective analysis from the Studies of Left Ventricular Dysfunction (SOLVD) prevention trial. Am Heart J 2004;148:883888. 5. Tenenbaum A, et al: Functional class in patients with heart failure is associated with the development of diabetes. Am J Med 2003;114:271275. 6. Eshaghian S, et al: An unexpected inverse relationship between HbA1C levels and mortality in patients with diabetes and advanced systolic heart failure [clinical investigation]. Am Heart J 2006;151:91. 7. Nathan DM, et al: Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: Update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2008;31:173175.

Item 82 Answer B There have been meta-analyses showing a 2-fold increase in the risk of uid retention and heart failure in patients with type 2 diabetes compared to similar patients on a regimen not containing thiazolidinedione.
1. Nathan DM, et al: Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: Update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2008;31:173175. 2. Lago RM, et al: Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a metaanalysis of randomized clinical trials. Lancet 2007;370:11291136. 3. Singh S, et al: Thiazolidinediones and heart failure: a teleoanalysis. Diabetes Care 2007;30:22482253.

Item 83 Answer A Thiazolidinedione (TZD) use has recently been linked to bone loss and increased risk for fracture, especially in women. However, the majority of these fractures were not at typical osteoporosis sites, rather they were in the distal upper arm (forearm and below) and lower limb (below the knee). TZD use is associated with a change in fat distribution from visceral to subcutaneous location. There is no increased risk of hypoglycemia with TZDs. TZDs are associated with weight gain when used in monotherapy but the weight gain can be even greater when used in combination with insulin. Bibliography
1. Schwartz AV, et al: Thiazolidinedione use and bone loss in older diabetic adults. J Clin Endocrinol Metab 2006;91:33493354. 2. Kahn SE, et al: ADOPT Study Group: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:24272443. 3. Nathan DM, et al: Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: Update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2008;31:173175.

Item 84 Answer E DPP-IV inhibitors are currently approved for use in monotherapy and in combination with metformin and pioglitazone. They were also recently approved for utilization with a sulfonylurea (glimepiride) or with metformin and sulfonylurea. The main caution is an increased risk of hypoglycemia when sitagliptin is used with glimepiride (12% in combination group vs 2% in placebo group).

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DPP-IV inhibitors are currently not approved for use in combination with the GLP-1 agonist exenatide. The premise upon which both of these treatments are based is that GLP-1 levels are low in patients with type 2 diabetes and restoration of normal or even supranormal GLP-1 levels are benecial. GLP-1 acts to improve hyperglycemia by increasing glucose-stimulated insulin secretion, suppressing inappropriate glucagon secretion and slowing gastric emptying. Currently, there is no evidence to show that DPP-IV inhibitors and GLP-1 agonist would have additive effects. Bibliography
1. Deacon CF. Incretin-based treatment of type 2 diabetes: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors. Diabetes, Obesity and Metabolism 2007;9:(s1)2331. 2. Hermansen K, et al: Efcacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes, Obesity and Metabolism 2007;9:733745.

Item 85 Answer B The highest risk of hypoglycemia is with a combination of exenatide at 10 mcg b.i.d. dose in combination with metformin and sulfonylurea. In the large initial trial with exenatide, the rate of hypoglycemia was 27.8% in the metformin + sulfonylurea group that received exenatide versus 12.6% in the group that received metformin + sulfonylurea with placebo. This is higher than the observed rate of hypoglycemia in the trial evaluating sitagliptin with glimepride, where the incidence of hypoglycemia was in the range of 12%. Bibliography
1. Hermansen K, et al: Efcacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes, Obesity and Metabolism 2007;9:733745. 2. Kendall DM, et al: Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea. Diabetes Care 2005;28:10831091.

Item 86 Answer A Exenatide is not recommended in patients with signicant renal insufciency (creatinine clearance less than 30 ml/min) or in patients with signicant gastroparesis (since it slows gastric emptying). Exenatide can cause weight loss but there was more weight loss in patients that were obese. There is no specic contraindication to its use in patients with normal weight. Currently, exenatide is believed to be safe in patients with mild hepatic dysfunction. Use of exenatide in patients already on insulin has not been studied but there is no contraindication. Bibliography
1. Kendall DM, et al: Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea. Diabetes Care 2005;28:10831091.

Item 87 Answer C Addition of sitagliptin to metformin monotherapy in patients with mean A1C of 8% decreased the A1C by an average of 0.65% in the initial study evaluating this combination. Meta-analysis showed an average A1C reduction of 0.74%. Bibliography
1. Charbonnel B, et al: Efcacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone. Diabetes Care 29:26382643. 2. Amori RE, et al: Efcacy and Safety of Incretin Therapy in Type 2 Diabetes: Systematic Review and Meta-analysis. JAMA 2007 July 11;298(2):194206.

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Item 88 Answer C In a study of 552 patients suboptimally controlled on metformin and sulfonylurea, the addition of either exenatide or glargine was able to reduce A1C in a similar range of 1.11%. The rates of symptomatic hypoglycemia were similar in both groups. GI side effects such as nausea, vomiting, and diarrhea were more likely in the exenatide group, especially nausea (by 7-fold). Patients started on exenatide lost an average of 2.3 kg at the end of 26 weeks compared to 1.8 kg weight gain with glargine. Glargine reduced fasting glucose more effectively while exenatide is more effective in reducing postprandial glucose. Bibliography
1. Heine RJ, et al: Exenatide versus Insulin Glargine in Patients with Suboptimally Controlled Type 2 Diabetes. Annals Internal Medicine 2005;143:559569.

Item 89 Answer C In an analysis of patients on exenatide in combination with metformin and/or sulfonylurea over 82 weeks, the average decrease in A1C was close to 1% with a progressive reduction in weight over time, averaging 3.54.4 kg at 82 weeks. About a quarter of patients had more signicant weight loss, in the neighborhood of 11.9 kg. Generally, those with the greatest weight loss had the greatest reduction in A1C. Bibliography
1. Blonde L, et al: Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes, Obesity and Metabolism 2006;8(4):436447

Item 90 Answer B Given her renal insufciency and recent hospitalization, she is clearly at increased risk for hypoglycemia with sulfonylurea treatment and this would not be a good choice for her. Given that her A1C is above the ADA goal of 7%, some treatment should be intitiated if she is optimized with diet and exercise. Metformin is contraindicated given her renal failure. Basal insulin is an option but with a fasting glucose in the low hundreds, this may again predispose her to hypoglycemia. Sitagliptin would be effective given that her A1C is only mildly elevated and it has the benet of no increased risk of hypoglycemia when used as monotherapy. Bibliography
1. Raz I, et al: Efcacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 2006;49(11):25642571.

Item 91 Answer B Pramlintide is currently approved for use in patients with type 1 and type 2 diabetes. It is a synthetic analog of amylin, a peptide normally produced by the pancreas. Effects of amylin include inhibition of glucagon secretion, delayed gastric emptying and increased satiety. It is injected prior to each meal as an adjunct to insulin treatment. Average reduction in A1C has been close to 0.6%. It has been associated with very mild weight loss, in the range of 1 to 1.4 kg. Bibliography
1. Hollander PA, et al: Pramlintide as an Adjunct to Insulin Therapy Improves Long-Term Glycemic and Weight Control in Patients With Type 2 Diabetes: A 1-year randomized controlled trial. Diabetes Care 26:784790. 2. Schmitz O, et al: Amylin Agonists: A Novel Approach in the Treatment of Diabetes. Diabetes 2004;53:S233238.

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Phone Please check which credit you intend to apply for: M.D. DO PA FP (AAFP credit) RN NP (AANP credit) RD RPh/Pharm.D. Other Health Care Professional What is your professional degree? (Check all that apply) M.D. M.D./Ph.D. M.D./MPH DO PA NP/ANP RPh/Pharm.D. Ph.D. RD Other Are you a Certied Diabetes Educator? Yes No
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eMail (requiredupon completion certicate will be emailed) Which term best describes the healthcare system where you practice? (Choose one) Health Maintenance Organization Fee-For-Service Hospital Government University Individual/Group Practice Association Approximately what percentage of your patients have diabetes? 15% 610% 1120% More than 20% Primarily what age group of people with diabetes do you treat? Younger than 18 1925 2645 Older than 46 How many years have you worked in your current profession? Less than 1 year 12 years 35 years 510 years More than 10 years What is your primary area of practice? (Check one) Adult Endocrinology Basic Science Dietetics Epidemiology Family Practice Geriatrics Internal Medicine Nephrology Nursing Obstetrics/Gynecology Opthalmology Pediatrics Pediatric Endocrinology Pharmacy Podiatry Psychology Public Health Other Your gender (Optional) Male Female Your age (Optional) 2534 3544 4554 5564 6574 Over 75 Your race/ethnicity (Optional) African American Asian Caucasian Hispanic/Latino Native American Pacic Islander Other

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Directions for Recording Answers


Use a black lead pencil (No. 2 or softer). Make each mark heavy enough to completely obliterate the letter within the oval. Marks should ll the oval completely. Erase clearly any answers you wish to change. Make no stray marks on this answer sheet.

True False Answer Sample


1
T F A A B B C C D D E E

Multiple Choice Answer Sample


Correct Marks
A B D E

Incorrect Marks
A B C D E

ADA-SAP 2 Answer Sheet


Section A
1
T F A A B B C C D D E E

Section B
11
T F A A B B C C D D E E

6
T F A A B B C C D D E E

16 A B C D E 17 A B C D E 18 A B C D E 19 A B C D E 20 A B C D E 21 A B C D E 22 A B C D E 23 A B C D E 24 A B C D E 25 A B C D E 26 A B C D E 27 A B C D E 28 A B C D E 29 A B C D E 30 A B C D E 31 A B C D E 32 A B C D E 33 A B C D E 34 A B C D E 35 A B C D E 36 A B C D E

37 A B C D E 38 A B C D E 39 A B C D E 40 A B C D E 41 A B C D E 42 A B C D E 43 A B C D E 44 A B C D E 45 A B C D E 46 A B C D E 47 A B C D E 48 A B C D E 49 A B C D E 50 A B C D E 51 A B C D E 52 A B C D E 53 A B C D E 54 A B C D E 55 A B C D E 56 A B C D E 57 A B C D E

58 A B C D E 59 A B C D E 60 A B C D E 61 A B C D E 62 A B C D E 63 A B C D E 64 A B C D E 65 A B C D E 66 A B C D E 67 A B C D E 68 A B C D E 69 A B C D E 70 A B C D E 71 A B C D E 72 A B C D E 73 A B C D E 74 A B C D E 75 A B C D E 76 A B C D E 77 A B C D E 78 A B C D E

79 A B C D E 80 A B C D E 81 A B C D E 82 A B C D E 83 A B C D E 84 A B C D E 85 A B C D E 86 A B C D E 87 A B C D E 88 A B C D E 89 A B C D E 90 A B C D E 91 A B C D E

2
T F A A B B C C D D E E

7
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12
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3
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8
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13
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4
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9
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14
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5
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10
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15
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2008 Professional Evaluation, Inc. All rights reserved.

Program Evaluation
Please complete this evaluation to receive your CME/CE credit.

1. After completing this activity, please rate your ability to: Interpret and utilize ADA Guidelines and Treatment Algorithms. A Outstanding B Above Average C Average
D Below Average E Poor

Incorporate combination therapy for management of patients with advanced type 2 diabetes and achieve A1C targets. A Outstanding B Above Average C Average D Below Average E Poor Utilize insulin for management of patients with acute hyperglycemia. A Outstanding B Above Average C Average Manage medication-induced hypoglycemia. A Outstanding B Above Average
C Average D Below Average E Poor

D Below Average

E Poor

Regulate secondary disorders in patients with severe hyperglycemia, such as those with chronic renal insufciency, congestive heart failure, and hepatic dysfunction. A Outstanding B Above Average C Average D Below Average E Poor 2. How many hours of CME/CE are you claiming? (Claim only the number of hours which you actually participated.) A 3 hours B 4 hours C 4.5 hours D 5 hours Please describe how this content did or did not meet these objectives.

ADA strives to present activities that are independent, balanced, objective, and scientically rigorous. Do you believe this activity met this objective? Please explain your response. Yes No

ADA strives to utilize educational formats that are appropriate and adequate to the content and method of delivery of the program and that are appropriately equipped for personal and educational needs. Do you believe ADA has met this objective? Please explain your response. Yes No

Educational Activity Elements


Place an X in the appropriate box to provide your feedback on the educational activity. Strongly Disagree The topic(s) were informative and relevant. The format was suitable for the content. The instructional materials were of high quality. The length of the course was appropriate for the material presented. Disagree Neutral Agree Strongly Agree Dont Know

2008 Professional Evaluation, Inc. All rights reserved.

89

Program Evaluation (continued)


Knowledge/Behavior Change
Place an X in the appropriate box to indicate if you will change your practice based on your participation in this educational activity. Strongly Disagree My understanding of the subject matter increased. I will incorporate what I have learned into my practice. I will change the way I interact with my patients. Disagree Neutral Agree Strongly Agree Dont Know

Personal Satisfaction
Place an X in the appropriate box to indicate your level of agreement with the following statements. Strongly Disagree My personal objectives were met. My professional development was enhanced. My expectations were met. I am encouraged to participate in future ADA education activities. List three components to take back to your practice. Carefully fold back and crease these four pages before removal from booklet. Disagree Neutral Agree Strongly Agree Dont Know

What topics would interest you for future clinical education programs?

Do you have any comments or suggestions you wish to make?

Completion of Answer Sheet & Program Evaluation Form


1. 2. 3. 4. Provide all your Personal/Practice information. Email address is required. Complete the Answer Sheet. Complete the Program Evaluation questions; and Add your signature, date and return to PEI in accompanying postage-paid envelope.

Signature

Date

90

2008 Professional Evaluation, Inc. All rights reserved.

Developed and Published by: Professional Evaluation, Inc. Developing Medical Specialty Board Category 1 CME Programs for Over Three Decades Professional Evaluation Inc. 4 Midland Avenue, Suite 105, Berwyn, PA 19312-1687 | www.proevalinc.com