JAMDA xxx (2015) 1e8

JAMDA
journal homepage: www.jamda.com

Original Study

Sliding Scale Insulin vs Basal-Bolus Insulin Therapy in Long-Term

Care: A 21-Day Randomized Controlled Trial Comparing Efcacy,
Safety and Feasibility
Thiruvinvamalai S. Dharmarajan MD, MACP, AGSF a, *, Dheeraj Mahajan MD, CMD b, c, d, e,
Annie Zambrano PA-C b, c, d, e, Bikash Agarwal MD, CMD, FACP f,
Rachel Fischer DNP f, Zahra Sheikh MD, MPH g, Anna Skokowska-Lebelt MD h,
Meenakshi Patel MD, FACP, MMM, CMD i, j, Rebecca Wester MD k,
Naga P. Madireddy MD l, Naushira Pandya MD, CMD, FACP m, Florence T. Baralatei MD n,
Jackie Vance RN o, Edward P. Norkus PhD, FACN a
a
Monteore Medical Center (Wakeeld Campus), Bronx, NY
b
Lakeview Nursing and Rehabilitation Center, Chicago, IL
c
Carlton at the Lake, Chicago, IL
d
Cedar Pointe Rehab and Nursing, Cicero, IL
e
Presence Villa Scalabrini Nursing and Rehabilitation Center, Northlake, IL
f
Life Care Nursing Home, Michigan City, IN
g
Beaumont Rehabilitation and Skilled Nursing Center at Worcester, Worcester, MA
h
Beth Abraham Health Services, Bronx, NY
i
Bethany Village, Dayton, OH
j
Trinity Community Nursing Home, Beavercreek, OH
k
Nebraska Skilled Nursing and Rehabilitation Center, Omaha, NE
l
Koester Pavilion, Troy, OH
m
St. Johns Care Center, Sunrise, FL
n
Heritage Healthcare of Macon, Macon, GA
o
American Medical Directors Association Foundation, Columbia, MD

a b s t r a c t

Keywords:
Insulin therapy for type 2 diabetes in long
term care
sliding scale insulin therapy
basal-bolus insulin therapy
efcacy and safety of basal-bolus insulin
therapy in long-term care
Introduction: Sliding scale insulin (SSI) therapy remains a common means of insulin therapy in long-term
care (LTC) for the management of type 2 diabetes mellitus, despite current recommendations not sup-
portive of the form of therapy today. Lack of randomized trial data on the efcacy and safety of basal-
bolus insulin (B-BI) therapy in nursing home residents may have precluded this form of insulin
administration in the LTC setting. Our study is a comparison of the efcacy of SSI (control) and B-BI
(intervention) therapies during a 21-day intervention trial in older nursing home residents.
Methods: Fourteen LTC facilities in the US participated; 110 residents with type 2 diabetes volunteered to
participate; 35 failed inclusion criteria, 75 signed informed written consent, and 11 were discharged to
home/hospital or withdrew consent; data from 64 participants are reported. Recent fasting blood glucose
(FBG), hemoglobin A1c, and chemistries were obtained. Four glucose readings (prior to breakfast, lunch,
dinner, and bedtime), oral antiglycemic drug, and insulin doses and changes, and all adverse events/
serious adverse events, both those related to glucose control [hypoglycemic (<70 mg/dL) and hyper-
glycemic (>200 mg/dL) episodes] and those unrelated, were recorded daily. Patients were randomized to
either remain on SSI or be shifted to the B-BI group.
Results: Nursing home residents 80
8 (standard deviation) years, 66% female participated; Control and
Intervention participants had similar age, gender, race distributions, comorbidity, and 3-day average
pretrial FBG levels (all P > .05). At study end, B-BI volunteers had signicantly lower 3-day average FBG

Annual Meeting of the American Geriatrics Society in Washington, DC,

Study was sponsored by the AMDA Foundation, supported by a grant from
May15-17, 2015.
Sano (LANTU_R_05927).
* Address correspondence to Thiruvinvamalai S. Dharmarajan MD, MACP, AGSF,
The authors declare no conicts of interest.
Department of Medicine, Monteore Medical Center (Wakeeld Campus), 600 East
This work was presented, in part, at the Annual Meeting of the American
233rd Street, Bronx, NY 10466.
Medical Directors Annual Meeting in Louisville, KY, March 19-22, 2015 and at the
E-mail address: dharmarajants@yahoo.com (T.S. Dharmarajan).

http://dx.doi.org/10.1016/j.jamda.2015.08.015
1525-8610/ 2015 AMDA e The Society for Post-Acute and Long-Term Care Medicine.
2 T.S. Dharmarajan et al. / JAMDA xxx (2015) 1e8

levels vs pretrial (P .0231) while SSI participants had no change in 3-day average FBG (P > .05). During
the trial, participants from both groups had similar rates of hypoglycemia, hyperglycemia, other adverse
events, and hospitalizations (serious adverse events) unrelated to glucose control (all P > .05).
Conclusions: B-BI therapy produced signicantly lower average FBG levels after 21 days compared with
SSI therapy; both groups had similar rates of hypo- and hyperglycemia. Switching to B-BI therapy is
feasible, safe, and effective in the LTC setting.
2015 AMDA e The Society for Post-Acute and Long-Term Care Medicine.

The prevalence of diabetes in long-term care (LTC) is hard to
estimate, largely because of inconsistent reporting methodology.1 The
United States National Nursing Home Survey reported a prevalence of
24.2% for diabetes in 2004, estimating 363,000 nursing home resi-
dents with diabetes.2 Diabetes, itself, is an independent predictor of
nursing home admission and hospitalization1; having large numbers
of diabetic residents in LTC poses additional health care issues. Insulin
therapy is an option to manage type 2 diabetes in conjunction with or
without other agents.3 Reduction in hyperglycemia and avoidance of
hypoglycemia are desired goals in diabetes care. Management stra-
tegies include setting individualized targets suited to patient charac-
teristics, comorbidity, life expectancy, and specic socioeconomic
contexts.4
Advances in insulin therapy such as the use of basal insulin with
insulin analogs have helped improve glycemic control.4 Basal insulin is
simple to administer with low injection frequency and good patient
tolerability.5 Physiologically, in individuals without diabetes, basal
insulin is continuously released by the pancreas in low amounts to
maintain normal plasma glucose; in individuals with diabetes, basal
insulin analogs have been shown to provide a relatively at time-
action prole mirroring that of basal insulin.5
Sliding scale insulin (SSI) regimens involve administering insulin
following demonstrated elevations of blood glucose, rather than
promoting fewer glucose excursions. A newer approach, basal-bolus
insulin (B-BI) therapy, was introduced and comparisons of the 2 ap-
proaches followed.6 B-BI therapy is considered a physiologic approach
as it mimics pancreatic release of insulin to provide steady regulation
of blood sugar both in fasting and post prandial states. Although B-BI
therapy is considered safe, little data exist that specically compares
SSI and B-BI in the management of type 2 diabetes in terms of safety
and efcacy, particularly in the LTC setting.7 Presently, SSI therapy
continues in LTC, despite major societies and organizations failing to
endorse its continued long-term use.7 In addition, some view the
extensive use of SSI to be associated with patient morbidity and
question its continued use.8,9
The paucity of data from randomized trials in LTC to support the
efcacy and safety of B-BI therapy are barriers to a transition from SSI
to B-BI therapy in nursing home residents. A recent review suggested
that B-BI use in inpatient and outpatient settings is associated with
decreased hospitalizations, decreased length of stay, lower health care
costs, reduced hyper- and hypoglycemic episodes, and improved
outcomes.10 An earlier prospective, randomized trial in 130 hospital-
ized patients with type 2 diabetes, suggested that B-BI therapy ach-
ieves superior glucose control compared with SSI therapy.11
The use of the basal insulin analog, glargine, as a component of B-BI
therapy has been determined safe in clinical practice12 in the young
and old13; the addition of insulin aspart (or other analogs) provides a
bolus or prandial component to provide glucose control similar to
human insulin.14 Prandial insulin use provides a favorable effect on
postprandial glucose values.15
Still, a shift to B-BI from SSI in the LTC setting is perceived by some
as risky and, without established protocols to guide the safe transition
to B-BI therapy, SSI remains the therapy of choice in LTC. SSI permits
greater uctuations of blood glucose, doing little to improve overall
glycemic control; sustained hyperglycemia has the potential to impair
cognition, impede wound healing, predispose to falls, and cause
multiorgan damage.16 Frailty and signicant comorbidities are asso-
ciations in older patients with type 2 diabetes, rendering their man-
agement a daunting task.17,18 The aforementioned suggested that B-BI
therapy may be safe and provide better glucose control in residents
with diabetes in LTC. The AMDA Foundation requested that we
conduct a study to compare the efcacy and safety of SSI vs B-BI using
a randomized design in older nursing home residents.
Methods
An algorithmic approach was used to examine the safety and
benets of basal (and basal bolus, as necessary) insulin in nursing
home residents with type 2 diabetes who were older than 64 years.
The algorithmic tool is available for preview in the e-version site of the
manuscript. This design compared the safety and efcacy using SSI
monotherapy (control group) vs B-BI therapy (intervention group)
during 21 days of study. The American Diabetes Association denition
criteria for diabetes using hemoglobin A1C (HbA1C) equal to or greater
than 6.5% or a fasting blood glucose (FBG) equal to or greater than
126 mg/dL or a 2-hour glucose equal to or greater than 200 mg/dL
were used.19 A roadmap algorithm used a conversion tool to provide a
means to accurately calculate daily basal insulin dose (plus prandial
doses, as needed) to reduce the patients 24-hour glucose variability
and to provide data to explore our primary objective, [ie, to compare
average FBG levels at the end of the trial period and determine if
differences resulted due to the treatment (SSI vs B-BI)]. The secondary
objective was a reduction in glucose variability, demonstrated by a
reduction in hyperglycemia (glucose greater than 200 mg/dL) and/or
hypoglycemia (glucose less than 70 mg/dL) episodes during the
21 days of observation that followed an initial screening day (study
duration 22 days). Approval for this study was obtained from a
central institutional review board (New England institutional review
board, NEIRB # 11-382: 2011-02) prior to study initiation. Physicians
from 14 LTC sites participated.
Participants included male and female nursing home residents
with a diagnosis of type 2 diabetes on an SSI regime (dened as daily
use of sliding scale with or without other antidiabetic agents
excluding glucagon-like peptide-1 agonists) at screening. Study
enrollment required residents to have a fasting mean blood glucose
greater than 150 mg/dL and/or an HbA1C of 7.0% or greater. All par-
ticipants or their legal authorized representative, if cognitively
impaired, provided a written informed consent.
Immunosuppressed residents and those receiving medications or
radiotherapy that compromise the immune system, residents on
dialysis, those in hospice care, and residents unlikely to remain at their
LTC site for the entire study duration. Residents who required hospi-
talization were withdrawn from the study but were eligible to re-
enroll upon return to the facility.
Eligibility was determined by each site investigator (SI) during an
initial screening visit. At this time, the patients medical history was
reviewed followed by a physical examination. As part of the eligibility
requirement, demographics, presence of type 2 diabetes, medications
used, diabetes control, CKD, dementia, and other comorbidity were
factored; recent labs (including FBG and HbA1c levels) were obtained.
 T.S. Dharmarajan et al. / JAMDA xxx (2015) 1e8
In addition, all adverse events (AEs) and serious adverse events (SAEs)
that had occurred within the prior 3 months were recorded. This in-
formation was entered into a Standardized Enrollment Data Collection
Tool that was used by all SIs. Once the SI identied a patient as study
eligible, the AMDA Central Coordinating Site (CCS) was informed and
randomized the subject into either the intervention (B-BI) or control
(remaining on SSI) group.
For participants put into the intervention (B-BI) arm, the facility
staff and the residents attending physician or Primary Care Provider
(PCP) were notied of a change from the current SSI regimen. For
these residents, all oral antidiabetic agents were discontinued during
the 24 hours immediately prior to beginning the 21-day trial, and
patients were maintained on insulin alone. Patients in the interven-
tion arm had the option to be on basal or basal/bolus therapy, based on
individual needs. An algorithm conversion tool was provided to the SIs
to facilitate understanding and implementation of the protocol for
conversion of SSI to B-BI therapy in intervention patients. For partic-
ipants placed into the control group, their current glycemic control
medications (SSI) were continued (Figure 1).
A total of 110 potential people were recruited and screened at 14
different LTC sites and randomized (n 55 per arm) to receive either
SSI or B-BI regimens. Our initial data analysis identied a number of
enrolled participants who had incomplete data, required hospitali-
zation, or withdrew their consent. Our nal analysis was completed on
the remaining 64 participants (27 SSI and 37 B-BI participants).
Four blood sugar readings (within 60 minutes prior to breakfast,
lunch, dinner, and bedtime) were collected daily. All hypoglycemia
and hyperglycemia episodes (<70 and >200 mg/dL, respectively), all
other AEs/SAEs unrelated to glucose control, and all changes in anti-
diabetic drugs including dosing changes for concomitant medications
were monitored and recorded. Blood sugar readings during the initial
3 days of the trial were averaged and used to establish each volun-
teers baseline blood sugar values and baseline insulin needs. As the
trial proceeded, the daily blood sugar readings were factored for al-
terations in the insulin regimen based on the algorithm guidelines.
Blood sugar readings during the nal 3 days of the trial were again
averaged and used to establish each volunteers end-of-trial blood
sugar values.
Results
Table 1 presents data collected at the initial screening of study
participants. As shown, participants in both the SSI and B-BI arms had
comparable baseline characteristics. They were similar in age, gender
distribution, racial make-up, and serious known comorbidity. Their
body weight, body mass index and Brief Interview for Mental Status
(BIMS) scores also were comparable, as were their most recent FBG
and HbA1c readings. Lastly, all participants met the criteria estab-
lished for study inclusion. The data indicate that the randomized 27
SSI and 37 B-BI participants were appropriately identied during the
initial screening for study inclusion.
The studys main objective, to determine if 21 days of B-BI therapy
improved FBG levels, is examined in Table 2. The 3-day mean FBG
(pre-breakfast) levels collected during 2 time intervals, trial days 1e3
and 19e21, from both SSI and B-BI participants were compared. Data
described in Table 2 show that participants maintained on the SSI
regimen (controls) had no signicant change in their pre-breakfast
FBG levels by trial end 19e21 (P > .05) whereas volunteers who
were randomized from their SSI regimen to the B-BI regime at the
start of the trial showed a signicant decrease in their pre-breakfast
FBG levels by end of the trial period (P .0036).
Table 3 presents ndings for 2 additional study objectives by
comparing hypoglycemia episodes (all, only night, and only day epi-
sodes) and all hyperglycemia episodes that occurred during the
numerous glucose monitoring (4/day) during the trial. Hypoglycemia
3
and hyperglycemia rates (episodes/total BS collected  100) were then
compared between groups. Hypoglycemia episodes rarely occurred
during the 21 days of observation. On average, total hypoglycemia
episodes occurred in less than 1% of the monitored glucose readings in
both SSI and B-BI participants (P > .05). When examined separately as
day-occurring and night-occurring hypoglycemia, data from both
groups also were similar (P > .05) with night episodes occurring less
than 0.5% of the time and day episodes occurring less than 0.2% of the
time. In contrast, hyperglycemia episodes occurred much more
frequently and observed at more than one-third of the total glucose
monitoring intervals. But again, similar rates hyperglycemia occurred
between the 2 groups of study participants (P > .05).
Table 3 describes 1 type of AE (either hypoglycemia or hypergly-
cemia episodes) that occurred during the trial. Relatively few other
types of AEs or SAEs, unrelated to glucose control, were recorded in
volunteers who completed the trial. Table 4 lists these other AEs and
SAEs events. The recorded AEs were deemed minor whereas the SAEs
required hospitalization. For each event that occurred, the primary
care provider and SI deemed them as unrelated to the glycemic control
measures used in this study.
Discussion
Current Standards for Insulin Therapy of Type 2 Diabetes
AMDAs Clinical Practice Guideline (CPG) on Diabetes Management
calls for individualized care plans and goals for medical treatment,
including oral therapy and insulin.18 The CPG mentions that although
SSI is widely used in hospitals and LTC facilities, its routine and pro-
longed use is generally not recommended as a primary treatment.18
Further, it states that SSI is a reactive way of treating hyperglycemia
and that SSI does not reduce glucose uctuations or effectively meet
physiological needs.18 The guideline acknowledges that no standard-
ized protocols (for insulin use) exist for LTC1; and that SSI is frequently
ordered for short-term use yet remains in effect indenitely even
though this widespread practice increases demands on nursing time
for glucose monitoring and may negatively impact the residents
quality of life.1 Finally, the CPG recommends that although the use of
SSI may be acceptable for short periods in newly recognized diabetes
when insulin needs are unknown, that any patient on SSI be re-
evaluated within 1 week and converted to xed daily doses.1,18
A consensus report published in the Journal of the American
Geriatric Society also comments on the excessive reliance on SSI
therapy in LTC, recommending that SSI use alone for chronic glycemic
management be discouraged in LTC facilities.20 The 2012 American
Geriatrics Society Updated Beers Criteria for inappropriate medication
use in older adults explicitly state that SSI should be avoided (strong
recommendation) because of the higher risk of hypoglycemia without
improvement in hyperglycemia management, regardless of setting.21
An editorial predicts (based on Centers for Disease Control and Pre-
vention data) that 1 in 3 people could have diabetes in the US by 2050
and that treatment should be individualized to minimize iatrogenic
hypoglycemia, warranting the need for physicians and other health
care professionals to implement evidence-based approaches.22 The
same journal issue also recommends the need to initiate insulin
therapy with basal insulin (and subsequent prandial insulin).23
Nevertheless, SSI use persists in LTC and US hospitals despite a lack
of evidence of its superiority after decades of use; the call to optimize
insulin use in LTC is not new.24
Concepts Behind SSI and B-BI Therapy
Insulin therapy choice is based on blood glucose proles, with the
intent to improve fasting and round-the- clock hyperglycemia while
avoiding hypoglycemia. The prescription of insulin is a dynamic
4 T.S. Dharmarajan et al. / JAMDA xxx (2015) 1e8

Fig. 1. Algorithm Tool for Conversion of Sliding Scale Insulin to Basal / Basal-Bolus Insulin therapy.
 T.S. Dharmarajan et al. / JAMDA xxx (2015) 1e8 5

Fig. 1. Continued.

process to be adjusted individually.25 One approach, SSI, represents a
reactive treatment in that insulin is provided only after hyperglycemia
has occurred. Typically, SSI regimen involves measuring blood glucose
before meals and at bedtime, or on a 6-hour schedule, and does not
consider basal insulin needs, instead only reacting to glucose elevation
control. SSI therapy does not prevent hyperglycemia26; its use is
inappropriate as a monotherapy for hyperglycemia.
Another approach, scheduled administration of subcutaneous in-
sulin with basal, prandial, and correction components, is a proactive
and preferred approach to achieve and maintain glycemic control. The
basal method provides a low rate of insulin dosing over 24 hours
regardless of meal intake while the addition of rapid acting insulin
before meals addresses the tendency toward postprandial hypergly-
cemia. Elevations in blood sugar, should they occur after food intake,
are corrected by as needed supplementation with bolus insulin prior
to meals (ie, correctional dose insulin). These insulin boluses are
calculated to mimic the natural effect of insulin release because of
elevated blood sugar following food. Newer basal insulins also are
associated with lower risk of hypoglycemia than neutral protamine
hagedorn insulin and the strategy of adding a xed prandial insulin
dose before 1 or more meals (termed basal/bolus) yields acceptable
glucose control.27 Utilization of the basal, correction, and prandial
components of insulin therapy attempts to achieve, as near as normal,
an individualized physiological insulin prole. Thus, B-BI therapy
6 T.S. Dharmarajan et al. / JAMDA xxx (2015) 1e8

Table 1 Table 3
Demographics and Pretrial Eligibility Parameters Episodes of Hypo- and Hyperglycemia Episodes by Study Group

Study Groups Study Groups

Variable Control (SSI) Intervention P Value Variable Control (SSI) Intervention (B-BI) P Value
(n 27) (B-BI) (n 27) (n 37)
(n 37) Overall rate* of hypoglycemia 0.9
2.5 0.4
1.1 >.05y
Age (years) 79
9 80
8 >.05* (BS < 70 mg/dL)
Gender (%male/% female) 33 m/67 f 34 m/66 f >.05y Night ratez of hypoglycemia 0.5
1.7 0.1
0.5 >.05y
Race distribution (BS < 70 mg/dL)
White (%) 75.0 60.0 Day ratez of hypoglycemia 0.2
0.5 0.1
0.3 >.05y
African American (%) 20.8 23.3 (BS < 70 mg/dL)
Hispanic (%) 0.0 13.3 Overall rate* of hyperglycemia 38.0
25.1 39.1
23.0 >.05y
Asian (%) 4.2 3.3 all >.05y (BS > 200 mg/dL)
BIMS score (total computed) 10.7
3.6 11.4
3.1 >.05*
BS, blood samples.
Weight (lbs) 202
53 189
55 >.05*
*Overall rate was calculated as [# of episodes during trial/total BS collected
BMI (kg/m2) 33.9
10.4 30.9
9.4 >.05*
(4/day  21 days) measured  100].
Inclusion criteria y
Data are presented as means
standard deviation, and comparisons were made
Most recent FBG (mg/dL) 194
44 208
50 >.05y
using Student t-tests.
Most recent HbA1c (%) 7.6
0.9 8.2
1.4 >.05y z
Night and day rates used the same overall rate calculation except that
Exclusion criteria
night only values collected after bedtime until breakfast and day only values
ESRD (%) 0 0 (n.d.)z
collected from breakfast until bedtime.
Immunosuppressed (%) 0 0 (n.d.)z
Hospice care (%) 0 0 (n.d.)z
Anticipated discharge <22 days (%) 0 0 (n.d.)z
Serious comorbidity history (#) 8.7
3.9 8.4
2.4 >.05* diabetic residents with complex problems.28 One survey of residents
Active serious comorbidity (#) 7.0
3.2 7.5
2.3 >.05* with type 2 diabetes in 13 nursing homes observed that SSI was used
ESRD, end-stage renal disease; FBG, fasting blood glucose; n.d., not done. in 58% of these residents and that only 15% of the homes had treat-
Data presented as means
standard deviation or percentages (%). ment algorithms to manage diabetes mellitus.29 Another, a retro-
*Comparisons made using Student t-test. spective chart review of 2096 older residents, conrmed that SSI alone
y
Comparisons made using c2 analysis.
z or as supplemental therapy was used in 74% of cases.30 Still another, a
Statistical comparison not done.
longitudinal observational study of 9804 nursing home residents with
diabetes, revealed that the majority of residents initiated on insulin
provides for a constant release of insulin over 24 hours for glucose were given SSI, and 83% remained of SSI until study end. In addition,
control, and addition of rapid-acting insulins provides the necessary one-third of those not started on SSI were later switched to SSI.31
cover for meal-related glucose spikes. One-half of the calculated total Overall 73.8% of the 9804 residents received SSI therapy, creating a
daily dose of subcutaneous insulin needed is given as a long-acting burden associated with the need for continual nger-stick glucose
insulin (basal dose), and the other one-half is divided over 3 meals testing, requiring a mean of 19.9 nger sticks per week of which 12.5
daily (bolus dosing). The addition of a correctional insulin dose, as were not followed by insulin administration.32
needed, provides the nal insulin daily adjustment.26 In settings A 2013 report demonstrated that switching patients with type 2
where there is uncertainty about the patients ability to eat, the bolus diabetes from other regimens to B-BI was possible and safe.33 Another
dose is often withheld until the meal is ingested. in 2015, found that 26% of older LTC residents with type 2 diabetes
Importantly, residents in LTC differ substantially from patients in were provided aggressive SSI regimen and 31% given conservative SSI
hospital and community settings in terms of their comorbidity, life therapy. Those on aggressive SSI therapy more often developed hy-
expectancy, and nutritional status, and accordingly, their diabetes poglycemic episodes and overall, hypoglycemic events were 2.65
management strategies can differ. times greater on SSI compared with non-SSI therapy.34 In our study,
hypoglycemia events were infrequent and recorded only 23 times (14
during the night and 9 during the day) from over 3800 blood samples
Studies on SSI and B-BI Therapies collected, at an overall rate of less than 1% of the time during the trial
(Table 2). In addition, blood sugar values below 50 mg/dL occurred
Present data on insulin use in LTC residents with type 2 diabetes is only 5 times (5/23 hypoglycemia episodes).
meager with great variation in treatment regimen indicating a need A large analysis of 53 randomized controlled trials involving
for data from new randomized, prospective trials.7,10 Of 440 trials 32,689 patients suggested that for any HbA1c target, B-BI regimens
investigating treatments for type 2 diabetes, 65.7% excluded older with insulin analogs produce the best results.35 Other, non-LTC studies
adults, and only 1.4% were designed to study the elderly28; the age also have conrmed the value of B-BI therapy. In 1 study, 4998
exclusion appears higher than that reported for other age-related
diseases, limiting the value of ndings when treating older LTC
Table 4
AEs and SAEs Unrelated to Glucose Control
Table 2
Three-Day Average FBG Comparisons at Beginning and End of Trial Study Groups

Variable Control (SSI) Intervention (B-BI)

Study Groups
(n 27) (n 37)
Variables Control (SSI) Intervention (B-BI) AEs (# of AEs*) 3 recordedy 5 recordedz
(n 27) (n 37) SAEs (# of SAEx) none recorded 1 recordedk
Ave. FBS, day 1-3 (mg/dL) 157
50 179
63
None of these events were deemed related to the patients insulin therapy.
Ave. FBS, day 19-21 (mg/dL) 142
59 150
36
*Those AEs unrelated to glucose control.
P value >.05* .0036* y
One urinary tract infection, 1 feeding tube insertion site redness, and 1 skin tear
FBG, fasting blood glucose. occurred.
z
*Data presented as means
standard deviation and the beginning vs end of trial Three skin tears and 2 lacerations occurred.
comparisons were made using paired t-tests. x
Those SAEs unrelated to glucose control and k1 fall w/fracture occurred.
 T.S. Dharmarajan et al. / JAMDA xxx (2015) 1e8
patients were followed for 6 months and use of insulin glargine as a
basal-bolus regimen resulted in a reduction in hypoglycemic events
and improved metabolic control evidenced by lower HbA1c, FBG, and
6-point blood glucose prole along with greater patient and physician
satisfaction.12 A comparison of B-BI and SSI treatment in a tertiary
teaching hospital suggested B-BI to be effective, safe, and superior to
SSI therapy.36 Still another found that individuals with type 2 diabetes
with severe and acute hyperglycemia were better managed with
better glycemic control using B-BI compared with SSI therapy.5
Our study demonstrated that transition from SSI to B-BI in LTC is
feasible, safe, and smooth, and that no serious adverse event occurred
because of the shift from SSI to B-BI therapy. All 37 patients in the B-BI
arm received basal insulin. In addition, most participants received pre-
meal bolus dosing and correctional dosing at various times during the
trial. However, the study objectives were not to determine the doses of
basal or the frequency of bolus insulin administration. The purpose of
this study was to examine the feasibility of switching, and the safety
and efcacy of the 2 approaches. The barriers were largely related to
the recruitment of volunteers and obtaining an informed written
consent, rather than maintaining residents on B-BI therapy. In a real
life situation, we expect the transition would be easier as the protocol
and CPG could be tailored to the setting and individual. While only 1
analog insulin (glargine) was used as the basal treatment in our study,
it is quite conceivable that similar results may be obtained from other
similarly acting analog insulins.
Study Limitations
Initial recruitment of volunteers was more difcult than antici-
pated, largely because the number of patients with intact cognition
(BIMS score >8) and type 2 diabetes on SSI in LTC was limited. This
prompted a protocol revision to add cognitively impaired participants
with a BIMS score <8. A few centers expressing a desire to participate
had just begun to use B-BI therapy precluding recruitment of partic-
ipants. This information may help better design future studies in LTC.
Although the study collected volunteers from a widespread
geographical area, it recruited only 110 candidates, and many were
unable to complete the study for reasons identied above. In the end,
data were analyzed from 64 residents who completed the study. Still,
we showed a signicant improvement in FBG levels in older residents
with type 2 diabetes following a switch from SSI to B-BI therapy over
only 21 days. We were unable to determine a drop in HbA1c because
of the short trial duration. Our ndings suggest that the same study
protocol for longer duration may also have decreased the HbA1c
levels. In summary, larger scale studies with similar protocols, over
longer periods, appear warranted.37
Challenges and Future Directions
Diabetes is common in nursing homes and is associated with
much comorbidity and risk of poor glucose control. A major concern
is the high use of SSI regimens as the sole means of glucose con-
trol,38 yet, the practice has persisted largely because of tradition
rather than science.34 Our study demonstrated that a safe transition
from SSI to B-BI is possible in long-term care. The next step is to
educate LTC care providers on the benets of B-BI as the preferred
form of therapy. Education could be offered by AMDA through a
systematic approach. Analysis of trends and practices suggests that
many health care providers lack condence in using insulin regi-
mens more complex than long-acting insulin alone, which further
emphasizes the importance of education.39 Our study algorithm tool
developed by the AMDA Foundation may be tailored to needs of LTC
in the future.
The transition from SSI to B-BI also may become part of a quality of
care and performance improvement project, similar to that used in the
7
proper use of an indwelling urinary catheter. A buy-in by nursing,
nutritionists, pharmacists, nurse practitioners, physicians, and facility
administrators would be necessary to enable successful transition to
B-BI. Pharmacists could help by educating staff in the optimal use of
insulin therapies.40 In addition, an interdisciplinary team approach is
more likely to be successful.41 Barriers related to the patients reluc-
tance to accept insulin therapy must be addressed.
The effects of morbidity in residents with type 2 diabetes calls for
an interprofessional team approach to manage the complexities and to
ensure success.20,42 In addition to the burden of polypharmacy, dia-
betic residents in LTC manifest limited life expectancy, cognitive
impairment, a predisposition to falls and fractures, functional limita-
tions, nutritional issues, and renal, visual, and hearing impairment.
Thus, insulin therapy must be individualized to avoid wide glucose
excursions, while maintaining quality of life.20,43 The individual care
plan must provide staff training to enable an understanding of the
specicities of care for frail residents with diabetes.44 Patient-
physician discussions are paramount and must always include other
measures such as diet and physical activity as keys to glycemic control.
Besides limiting SSI therapy, life style must be addressed; exercise is a
vital component, preferably after meals where possible.45 Current
guideline approaches along with life style interventions are the
foundation of diabetes care.46 In the future, patch pumps (already in
use in certain settings) may help deliver basal and bolus doses sub-
cutaneously in those requiring multiple daily injections of insulin.47
The introduction of B-BI computerized glycemic control protocols
and its barriers will offer challenges in the future.48 Finally, as 1 author
stated regarding SSI will the false idol nally fall?.49
Conclusions
This study demonstrated the efcacy of B-BI therapy for glycemic
control in older LTC residents with type 2 diabetes. B-BI therapy
provided better blood sugar control than SSI as demonstrated by a
signicant decrease in fasting blood sugar levels at 21 days in B-BI
participants. Individuals with type 2 diabetes maintained on SSI
therapy and those switched to B-BI had similar rates of hypoglycemia
and hyperglycemia, and other AEs and SAEs unrelated to glucose
control. Switching to B-BI therapy appears to be effective, safe, and
feasible in residents with type 2 diabetes in the LTC setting.
References
1. American Medical Directors Association Diabetes Management in the Long-
Term Care Setting. Clinical Practice Guideline. Columbia, MD: AMDA; 2008.
revised 2010.
2. Jones AL, Dwyer LL, Bercovitz AR, Strahan GW. The National Nursing Home
Survey: 2004 overview. National Center for Health Statistics. Vital Health Stat
2009;13:67.
3. Sorli C. Insulin therapy in type 2 diabetes: A reection on the state of the art
today, and the potential journey yet to come. Am J Med 2014;127:S1eS2.
4. Moghissi E, King AB. Individualizing insulin therapy in the management of type
2 diabetes. Am J Med 2014;127:S3eS10.
5. Huri HZ, Permalu V, Vethakkan SR. Sliding-scale versus basal-bolus insulin in
the management of severe or acute hyperglycemia in type 2 diabetes patients:
A retrospective study. PLoS One 2014;9:e106505.
6. Niswender KD. Basal insulin: Physiology, pharmacology and clinical implica-
tions. Postgrad Med 2011;123:17e26.
7. Van Brunt K, Curtis B, Brooks K, et al. Insulin use in long term care settings for
patients with type 2 diabetes mellitus: A systematic review of the literature.
J Am Med Dir Assoc 2013;14:809e816.
8. Browning LA, Dumo P. Sliding scale insulin: An antiquated approach to gly-
cemic control in hospitalized patients. Am J Health Syst Pharm 2004;61915:
1611e1614.
9. Hirsch JB. Sliding scale insulindTime to stop sliding. JAMA 2009;310:213e214.
10. Jackson B, Grubbs L. Basal-bolus insulin therapy and glycemic control in adult
patients with type 2 diabetes: A review of the literature. J Am Assoc Nurse
Pract 2014;26:348e352.
11. Umpierrez GE, Smiley D, Zisman A, et al. Randomized study of basal-bolus
insulin therapy in the inpatient management of patients with type 2 dia-
betes (RABBIT 2 Trial). Diabetes Care 2007;30:2181e2186.
8 T.S. Dharmarajan et al. / JAMDA xxx (2015) 1e8
12. Zdarska DJ, Broz J, Krivska B, et al. Basal insulin glargine using a basal-bolus
regiment in a common, clinical practice: Observational, noninterventional,
multicenter, national project LINDA (Lantus in daily practice- safety and ef-
cacy in basal bolus regimen). Vnitr Lek 2014;60:712e719.
13. Pandya N, DiGenio A, Gao L, Patel M. Efcacy and safety of insulin glargine
compared to other interventions in younger and older adults: A pooled anal-
ysis of nine open-label. Randomized controlled trials in patients with type 2
diabetes. Drugs Aging 2013;30:429e438.
14. Heller S, Bode B, Koziovski P, Svendsen AL. Meta-analysis of insulin aspart
versus regular human insulin used in a basal-bolus regimen for the treatment
of diabetes mellitus. J Diabetes 2013;5:482e491.
15. Ampudia-Blasco FJ, Rossetti P, Ascaso JF. Basal plus basal-bolus approach in
type 2 diabetes. Diabetes Technol Ther 2011;13:S75eS83.
16. Stratton IM, Adler AI, Neil HAW, et al. Association of glycemia with macro-
vascular and microvascular complications of type 2 diabetes (UKPDS 35):
Prospective observational study. BMJ 2000;321:405e412.
17. Kalyani RR, Tian J, Xue Q-L, et al. Hyperglycemia and incidence of frailty and
lower extremity mobility limitations in older women. J Am Geriatr Soc 2012;
60:1701e1707.
18. American Medical Directors Association Diabetes Management in the Post-
Acute and Long-Term Care Setting Clinical Practice Guideline. Columbia, MD:
AMDA; 2015.
19. Standards of Medical Care in Diabetese2014. American Diabetes Association
Position Statement. Diabetes Care 2014;37:S14eS80.
20. Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults: A consensus
report. J Am Geriatr Soc 2012;60:2342e2356.
21. Fick D, Semla T, Beizer J, et al. American Geriatrics Society updated Beers
criteria for potentially inappropriate medication use in older adults. The
American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am
Geriatr Soc 2012;60:616e631.
22. Seaquist ER. Addressing the burden of diabetes. JAMA 2014;311:2267e2268.
23. Wallia A, Molitch ME. Insulin therapy for type 2 diabetes mellitus. JAMA 2014;
311:2315e2325.
24. Haas LB. Optimizing insulin use in type 2 diabetes: Role of basal and prandial
insulin in long-term care facilities. J Am Med Dir Assoc 2007;8:502e510.
25. Mooradian AD. Special considerations with insulin therapy in older adults with
diabetes mellitus. Drugs Aging 2011;28:429e438.
26. Nau KC, Lorenzetti RC, Cucuzzella M, et al. Glycemic control in hospitalized
patients not in intensive care: Beyond sliding scale insulin. Am Fam Physician
2010;81:1130e1135.
27. Medeghini LF. Insulin therapy for type 2 diabetes. Endocrine 2013;43:
529e534.
28. Cruz-Jentoft AJ, Carpena-Ruiz M, Montero-Errasquin B, et al. Exclusion of older
adults from ongoing trials about type 2 diabetes mellitus. J Am Geriatr Soc
2013;61:734e738.
29. Feldman SM, Rosen R, DeStasio J. Status of diabetes management in the nursing
home setting in 2008: A retrospective chart review and epidemiology study of
diabetic nursing home residents and nursing home initiatives in diabetes
management. J Am Med Dir Assoc 2009;10:354e360.
30. Pandya N, Wei W, Kilpatrick BS, et al. Too many ngersticks for nothing? A
study of sliding scale insulin use among elderly nursing home residents with
type 2 diabetes. J Am Geriatr Soc 2012;60:S126.
31. Pandya N, Thompson S, Sambamoorthi U. The prevalence and persistence of
sliding scale insulin use among newly admitted elderly nursing home residents
with diabetes mellitus. J Am Med Dir Assoc 2008;9:663e669.
32. Pandya N, Wei W, Meyers JL, et al. Burden of sliding scale insulin use in elderly
long-term care residents with type 2 diabetes mellitus. J Am Geriatr Soc 2013;
61:2103e2110.
33. Vinagre I, Sanchez-Hernandez J, Sanchez-Quesada JL, et al. Switching to basal-
bolus insulin therapy is effective and safe in long-term type 2 diabetes patients
inadequately controlled with other insulin regimens. Endocrinol Nutr 2013;60:
249e253.
34. Lopez S, Pekmezaris R, Sinvani L, et al. Sliding scale insulin and hypoglycemia
in long-term care. Ann Longterm Care 2015;23:37e40.
35. Giugliano D, Maiorino MI, Bellasatella G, et al. Multiple HBA1c targets and
insulin analogues in type 2 diabetes: A systematic review. J Diabetes 2011;25:
275e281.
36. Roberts GW, Aguilar-Loza N, Esterman A, et al. Basal-bolus insulin versus
sliding-scale insulin for inpatient glycaemic control: A clinical practice com-
parison. Med J Aust 2012;196:266e269.
37. Pollom RD. Optimizing inpatient glycemic control with basal-bolus insulin
therapy. Hosp Pract (1995) 2010;38:98e107.
38. Migdal A, Yarandi SS, Smiley D, Umpierrez GE. Update on diabetes in
the elderly and in nursing home residents. J Am Med Dir Assoc 2011;12:
627e632.
39. Williamson C, Glauser TA, Burton BS, et al. Health care provider management of
patient with type 2 diabetes. Analysis of trends in attitudes and practices.
Postgrad Med 2014;126:145e160.
40. Garza H. Minimizing the risk of hypoglycemia in older adults: A focus on long-
term care. Consult Pharm 2009;24:18e24.
41. Timko A, Anderson J, Sabar R, et al. A successful interdisciplinary team
approach to improving HbA1c values and reducing sliding scale usage
in residents at a long-term care facility. J Am Med Dir Assoc 2014;15:
B13eB14.
42. Ferrer A, Padros G, Formiga F, et al. Diabetes mellitus: Prevalence and effect of
morbidities in the oldest old. The Ocabaix Study. J Am Geriatr Soc 2012;60:
462e467.
43. Ligthelm RJ, Kaiser M, Vora J, Yale J. Insulin use in elderly adults: Risk of
hypoglycemia and strategies for care. J Am Geriatr Soc 2012;60:
1564e1570.
44. Benetes A, Novella J, Guerci B, et al. Pragmatic diabetes management in nursing
homes: Individual care plan. J Am Med Dir Assoc 2013;14:791e800.
45. Sinclair A, Morley JE. How to manage diabetes mellitus in older persons in the
21st century: Applying these principles to long term diabetes care. J Am Med
Dir Assoc 2013;14:777e780.
46. Yacoub TG. Application of clinical judgment and guidelines to achieving gly-
cemic goals in type 2 diabetes: Focus on pharmacologic therapy. Postgrad Med
2014;126:95e106.
47. Simon AC, Devries JH. The future of basal insulin supplementation. Diabetes
Technol Ther 2011;13:S103eS108.
48. Wei NJ, Wexier DJ. Basal-bolus insulin protocols enter the computer age. Curr
Diab Rep 2012;12:119e126.
49. Cheung NW, Chipps DR. Sliding scale insulin: Will the false idol nally fall?
Intern Med J 2010;40:662e664.