Randomized Controlled Trial To Assess the Benefits of Dexcom Continuous Glucose Monitoring With Glucose Telemetry System for the Management of Diabetes in Long-term Care Setting: The CGM-GTS in Long-term Care
Phase: NA
Conditions: Diabetes, Diabetes Mellitus, Type 2
Sponsor: Emory University

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
PROTOCOL TITLE: Randomized Controlled Trial To assess the Benefits of Dexcom Continuous 
Glucose Monitoring with Glucose telemetry System for the Management of Diabetes in Long-
term Care Setting:  The CGM-GTS in Long-term care 
 
NCT Number: NCT04818242 
 
Protocol Date: March 22, 2021 
 
Principal Investigator: 
 
 
1Guillermo E. Umpierrez, MD, CDE, FACP, FACE 
Co-Investigators: 
1Thaer Idrees, MD 
2Theodore Johnson, MD, Monica D. Gavaller 
1Iris Castro, MD, MPH, Francisco Pasquel, MD, MPH, Rodolfo J. Galindo, MD,  
Priyathama Vellanki, Georgia M. Davis, Maya Fayfman, MD; Alexandra Migdal, 
MD; Saumeth Cardona, MD, MPH 
3Limin Peng, PhD 
Institution: 
1Division of Endocrinology, Department of Medicine, Emory University School of Medicine 
2Division of Geriatrics and Internal Medicine, and 3School of Public Health, Emory University, 
Atlanta, Georgia 
3School of Public Health 
Short Title: Dexcom CGM in Long-term care 
 
Funding Source: Dexcom, Inc 
 
 
 
 

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Table of Contents 
1. 
Study Summary ........................................................................................................................ 3 
2. 
Objectives ................................................................................................................................ 4 
3. 
Background .............................................................................................................................. 4 
4. 
Study Endpoints ..................................................................................................................... 10 
5. 
Study Intervention/Investigational Agent ............................................................................. 11 
6. 
Procedures Involved .............................................................................................................. 12 
7. 
Data and Specimen Banking .................................................................................................. 14 
8. 
Sharing of Results with Participants ...................................................................................... 14 
9. 
Study Timelines ...................................................................................................................... 14 
10. 
Inclusion and Exclusion Criteria ......................................................................................... 14 
11. 
Vulnerable Populations ...................................................................................................... 15 
12. 
Local Number of Participants............................................................................................. 15 
13. 
Recruitment Methods ........................................................................................................ 15 
14. 
Withdrawal of Participants ................................................................................................ 16 
15. 
Risks to Participants ........................................................................................................... 16 
16. 
Potential Benefits to Participants ...................................................................................... 17 
17. 
Compensation to Participants ........................................................................................... 17 
18. 
Data Management and Confidentiality ............................................................................. 17 
19. 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................... 19 
20. 
Provisions to Protect the Privacy Interests of Participants ............................................... 20 
21. 
Economic Burden to Participants ...................................................................................... 20 
22. 
Consent Process ................................................................................................................. 21 
23. 
Setting ................................................................................................................................ 22 
24. 
Resources Available ........................................................................................................... 22 
25. 
Multi-Site Research when Emory is the Lead Site ................ Error! Bookmark not defined. 
26. 
References ......................................................................................................................... 22 
 
 
 
 
 

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1. Study Summary 
Study Title 
Randomized Controlled Trial To assess the Benefits of 
Dexcom Continuous Glucose Monitoring with Glucose 
telemetry System for the Management of Diabetes in 
Long-term Care Setting:  The CGM-GTS in Long-term 
care 
Study Design 
Randomized Controlled Trial 
Primary Objective 
To compare differences in frequency of hypoglycemia 
(<70 mg/dl) and glycemic control (time in range [TIR] 
80-180 mg/dl) between the Dexcom CGM with 
Glucose Telemetry System (CGM-GTS) compared to a 
standard of care protocol, in residents with T2D 
treated with insulin and/or insulin-secretagogues, in 
subacute and long-term skilled nursing care facilities. 
 
Secondary Objective(s) 
Determine differences in clinical outcomes (number of 
complications, ER visits and need for hospital re-
admissions), and health care utilization between the 
use of real-time Dexcom CGM Glucose Telemetry 
System (CGM-GTS) compared to a standard of care in 
patients with T2D in subacute and long-term skilled 
nursing care facilities.   
Research 
Intervention(s)/Interactions 
POC testing or to real time Dexcom CGM with GTS for 
up to 60 days of admission.  
Study Population 
Adult residents with T2D in subacute and long-term 
skilled nursing care facilities treated residents with 
T2D treated with insulin and/or insulin-secretagogues. 
Sample Size 
100 
Study Duration for 
individual participants 
Length of admission to subacute and long-term skilled 
nursing care facilities or up to 60 days (whichever 
comes sooner) 
Study Specific 
Abbreviations/ Definitions  
T2DM: Type 2 Diabetes Mellitus 
OADs: oral antidiabetic medications 
CGM: continuous glucose monitor  
GTS: glucose telemetry system  
LTC: Long Term Care 
SSI: Sliding Scale Insulin 
Funding Source (if any) 
Dexcom, Inc. 

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2. Objectives 
Diabetes is common in patients in subacute and long-term skilled nursing care facilities.  Most 
patients with T2D are treated with insulin alone or in combination with oral antidiabetic agents, 
with reported high rate of iatrogenic hypoglycemia 12,13. The rate of hypoglycemia in 
sulfonylureas and insulin treated patients is reported ~ 30-40%, and the development of 
hypoglycemia has been associated with greater resource utilization and higher emergency 
room and hospital transfers compared to residents without hypoglycemia 44. The use of CGM 
has been shown superior to POC testing (standard of care) in detecting both hypo- and hyper- 
glycemic events 21. The use of CGM with glucose telemetry system (CGM-GTS) with alarm 
reduces the frequency and time in hypoglycemia compared in insulin treated patients with T2D 
compared to POC.  We propose to conduct a RCT to compare the efficacy of CGM-GTS in 
reducing hypoglycemia in high risk population with T2D treated with insulin and/or insulin-
secretagogues in subacute and long-term skilled nursing care facilities 
 
3. Background 
Prevalence of diabetes in older adults and subacute and long-term skilled nursing care 
facilities.  The prevalence of diabetes increases with age, and it is estimated that more than 
20% of older adults aged 65-75 years and 40% of adults >80years of age have diabetes29,30. The 
prevalence of diabetes in older adults is expected to increase due to longer life expectancy and 
improve care of the population30,31. The estimated prevalence of diabetes in subacute and long-
term skilled nursing care facilities is reported to be ~ 20% to 34%1, and in parallel to the 
increasing geriatric population, the number of LTC admissions is expected to rise31.  
 
Diabetes treatment in LTC facilities.  The goals of diabetes care in older adults and in patients 
in subacute and long-term skilled nursing care facilities include control of hyperglycemia and its 
symptoms, prevention and treatment of diabetic complications, and maintenance or 
improvement of general health status. Studies in hospitalized patients with diabetes have 
shown that improvement in glucose control can reduce complications and are cost savings7,18,32; 
however, no prospective studies have determined the impact of improving glucose control on 
clinical outcome in subacute and long-term skilled nursing care facilities (LTC). The 
management of diabetes in LTC residents is similar to that recommended for ambulatory 
patients with diabetes33,34; however, several factors complicate the management of 
hyperglycemia in this population8. LTC residents tend to be older and to have higher rates of 
comorbidities associated with aging such as functional disability, hypertension, coronary artery 
disease, cerebrovascular events, depression, cognitive impairment, urinary incontinence, and 
higher risk of falls.  In addition, they often experience changes in nutritional intake, which 
increase the risk of hypoglycemia5-8. 
Current guidelines and position statements on diabetes management in older adults 35-38 are 
based on consensus opinions or from extrapolations from studies involving middle-aged 
patients with diabetes. The American Diabetes Association guidelines recommend that older 
adults who are functional, cognitively intact, and have longer life expectancy should receive 
diabetes care with goals similar to those   developed for younger adults 36. In these subjects, a 

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HbA1c level <7.5%, a fasting glucose between 90-130 mg/dl, and a random glucose <180 mg/dl 
is recommended. Less intensive goals are recommended for patients with advanced 
complications, life-limiting comorbid illness, or cognitive impairment. Other organizations 
including the American Geriatric Society, European Diabetes Working Party for Older People 
guidelines, International Association of Gerontology and Geriatrics, the European Diabetes 
Working Party for Older People recommend a target HbA1c of <7.5% for patients without major 
comorbidities while a higher target of 7.6-8.5% is proposed for frail patients with high risk of 
hypoglycemia35,39-44. These guidelines highlight the importance of improved glucose control and 
avoidance of side effects and hypoglycemia, as they are associated with increased risk of 
complications and mortality in patients with diabetes40-44.  
Diabetes drug utilization in subacute and long-term skilled nursing care facilities (LTC).  There 
are twelve antidiabetic drugs with different mechanisms of action to treat patients with T2D45. 
Metformin is recommended as first choice OAD agent for the management of patients with 
T2D36,46; however, it may cause anorexia, nausea, diarrhea, weight loss, and lactic acidosis in 
patients with impaired renal function47,48.  Insulin secretagogues are effective in reducing 
glucose levels, but are associated with high risk of hypoglycemia49. Thiazolidinediones improve 
insulin sensitivity but frequently cause weight gain, edema, osteopenia and are contraindicated 
in subjects with heart failure49,50͘dŚĞɲ-glucosidase inhibitors delay carbohydrates absorption, 
but are associated with a high rate of GI side effects48. DPP4-inhibitors are promising agents in 
the elderly because they stimulate insulin secretion in a glucose-dependent fashion, thus not 
causing hypoglycemia when used as monotherapy or in combination with metformin therapy51-
53.  
Insulin therapy is widely recommended for diabetes management in LTC residents 54,55.  Recent 
reports indicate that prescribing pattern in patients with diabetes in LTC facilities is shifting 
towards insulin, accounting for nearly 68% of new drug starts 56. Clinical guidelines recommend 
initiating insulin when oral agents fail or are contraindicated, and when random BG levels are 
>180 mg/dL54,55. These guidelines favor the use of basal bolus insulin regimens over sliding scale 
regular insulin57-59. The basal bolus insulin has been shown to improve glycemic control 60-62 and 
to reduce hospital complications in patients with T2D62; however, insulin administration 
approach is associated with high risk of hypoglycemia (see preliminary results). 
Glucose monitoring in subacute and long-term care settings: Capillary point of care (POC) and 
CGM glucose testing.  Bedside capillary POC glucose monitoring is the standard of care to 
assess glycemic control in the hospital and in LTC facilities 17-19. POC testing is usually performed 
before meals and at bedtime. CGM measures interstitial glucose every 5-15 minutes, thus 
provides a more complete glycemic profile during 24-hours than POC testing. Several 
randomized trials have shown that CGM systems facilitate and improve diabetes care in insulin-
treated ambulatory patients 63-65, as well as in hospitalized patients 21,23,66-69.  In a recent study 
of hospitalized patients with T2D, we reported increased detection of both hypo- and hyper- 
glycemic events with the use of CGM compared to the standard-of-care POC BG testing 21. 
More than 50% of the hypoglycemic events occurred between dinner and breakfast; suggesting 
that these episodes would be missed by standard POC testing. In addition, a prospective 

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hospital study in insulin treated patients with T2D by our group reported that 45% of 
hypoglycemic events were asymptomatic 70.  In multivariate analysis, male gender (OR 2.08, 
95% CI 1.13 to 3.83, p=0.02) and age >65 years (OR 4.01, 95% CI 1.62 to 9.92, p=0.02) were 
independent predictors of asymptomatic hypoglycemia. A recent panel of experts in inpatient 
diabetes care reported that CGM could more effectively identify trends toward hypoglycemia 
and hyperglycemia, allowing for better and safer management of patients with inpatient 
hyperglycemia 71,72.   
Recent reports indicate that CGM data can be transmitted to the nursing station by way of 
automatic downloading into a monitor at the nursing station. A recently published study 
evaluated whether the Dexcom CGM using a “Glucose Telemetry System” can decrease 
hypoglycemia in the general wards/non-ICU setting92. The study included insulin treated 
patients with T2D at high risk for hypoglycemia. Participants were randomized to either the 
“Glucose Telemetry System” (intervention group) or to POC BG testing (control group). For 
patients in the “Glucose Telemetry System” nurses were instructed to proceed with 
hypoglycemia prevention actions if the low glucose alerts were activated (set at <85 mg/dl). 
Participants in the control group were placed on “blinded” CGM systems which were only used 
to collect glucometrics data. Overall, the subjects in the CGM-GTS experienced fewer events of 
hypoglycemia (<70 mg/dL), clinically significant hypoglycemia (<54 mg/dL) compared to the 
POC BG group. The outcomes of the intervention versus control groups for these two levels of 
hypoglycemia were, respectively, 0.67 versus 1.69 events/ patient, p =0.024 (< 70 mg/dl) and 
0.08 versus 0.75 events/patient, p =0.003 (< 54 mg/dl). In addition, there was a reduction in 
percentage of time in hypoglycemic range <70 mg/dl and <54 mg/dl in the GTS compared to 
POC group (0.40%, versus 1.88%, p =0.002 and 0.05%, versus 0.82%, p =0.017). In the current 
research proposal, we will use the Dexcom G6 CGM with GTS and alarm set up at 85 mg/dL to 
prevent hypoglycemia.  
Significance and Innovation. 
Significance.  Two previous RCTs in the subacute and LTC facilities comparing oral agents and 
basal insulin reported similar improvement in glycemic control, but high rates of hypoglycemia 
in patients treated with basal insulin  12,13. The rate of hypoglycemia in insulin and sulfonylureas 
treated patients was 30-40%.  Patients with hypoglycemia required greater resource utilization 
and higher emergency room and hospital transfers compared to residents without 
hypoglycemia 44. The high rate of insulin-associated hypoglycemia is worrisome, as recent 
population studies have suggested that diabetes prescribing in LTC is shifting towards insulin, 
accounting for ~half of patients with T2D 44 and nearly 68% of new drug starts 56.  Capillary POC 
glucose testing is the standard of care for glucose monitoring in the hospital and LTC facilities.  
Our group and others have shown that POC misses about 40% of hypoglycemia cases, 
particularly at night (REF). Increased detection of both hypo- and hyper- glycemic events have 
reported with the use of CGM compare to the POC BG 21. In addition, we recently reported that 
CGM-GTS with alarm can successfully reduce the frequency and time in hypoglycemia 
compared in insulin treated patients with T2D compared to POC (REF).  We anticipate that by 
Reducing hypoglycemia in subacute and long-term skilled nursing care facilities may reduce the 
rate of complications, ER visits and need for hospital readmissions. 

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Innovation.  We propose the first RCT to assess the impact of glucose control and hypoglycemia 
reduction with the use of real time CGM with an alarm system to prevent hypoglycemia and 
facilitate the care of insulin and non-insulin treated patients with T2D in subacute and long-
term skilled nursing care facilities. The results of this study have great potential to impact and 
facilitate care and to change current clinical guidelines in the management of older adults with 
diabetes in subacute and LTC facilities. 
 
PRELIMINARY RESULTS: 
Diabetes and Clinical Outcome in LTC Residents 44.  In a retrospective study, we analyzed the 
quality of diabetes care, glycemic control, and clinical outcome in 1,409 subjects admitted to 3 
community LTC facilities in Atlanta. The prevalence of diabetes was 34.2%. On admission, 
patients with diabetes were sliding scale regular insulin (25%), OADs (5%), insulin (34%), or with 
combination of OADs and insulin (26%). Patients with diabetes had higher number of 
complications and required more emergency room and hospital transfers. A total of 42% of 
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reported in 45% on OADs (mostly sulfonylurea plus SSI), or insulin therapy. Patients with 
hypoglycemia had a longer length of stay, higher emergency room or 
hospital transfers (44% vs. 30%; p=0.004) and higher mortality (18% 
vs. 10%, p=0.015).  These results indicate that diabetes is common in 
LTC and is associated with higher resource utilization and 
complications, and that hypoglycemia is associated with increased 
rates of emergency room care and hospitalization, length of stay, and 
mortality44.  
Comparing of Oral Antidiabetic Agents and Basal Insulin in LTC 
Residents with T2D 12. In a prospective study we recruited 150 
patients from 2 university-affiliated facilities with BG > 180 mg/dl or 
A1C >7.5%, treated with diet and/or with stable dose of OADs or 
glargine (starting at 0.1 U/kg/day), were randomized to continue OAD 
plus sliding scale insulin or to basal insulin glargine starting at 0.1 
U/kg/day plus SSI for up to 6 months (Fig 1). There were no 
differences in daily glucose or with the A1C at 3 months or at 6 
months or in the number of patients with hypoglycemia (basal 28% 
vs. control 31%, p=0.37). The results of this study indicated similar 
improvement in glycemic control, without differences in mean daily BG, hypoglycemia with 
basal insulin or with OADs and SSI supplements. It was also evident that 1/3 od treated with 
OADs and insulin experienced hypoglycemia indicating the need for safer regimens.  
Fig 1-Oral agents vs. Basal Insulin in LTC 

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DPP4-inhibitors vs Basal insulin in LTC (Linagliptin-LTC Trial)13.  A 6-
month open-label pilot randomized controlled trial compared the 
efficacy and safety of a DPP4-i (linagliptin) and basal insulin in 
subacute and LTC residents with T2D admitted to 3 institutions 
affiliated with Emory University. A total of 140 residents with T2D 
treated with oral antidiabetic agents or low-dose insulin (0.1 U/kg/d), 
with fasting BG>180 mg/dL and/or HbA1c >7.5% were randomized to 
linagliptin 5 mg day or glargine at a starting dose of 0.1 U/kg/d. 
Baseline antidiabetic therapy, except metformin, was discontinued on 
trial entry. BG was measured before meals and both groups received 
supplemental rapid-acting insulin before meals for BG > 200 mg/dL. 
As shown in Figure 4, treatment with linagliptin resulted in no 
significant differences in mean daily BG, but resulted in fewer mild 
hypoglycemic events <70 mg/dL (3% vs. 37%, P <0.001), and a non-
significant trend towards lower risk of BG <54 mg/dL (0% vs 7%, 
p=0.06). There were no significant between-group differences in 
length of stay, complications, emergency department visits, or 
hospitalizations. These results suggested that DPP4-inhibiors are 
effective and represent an alternative to insulin therapy in many LTC 
residents with T2D. 
Continuous glucose monitoring (CGM) in the hospital setting.  Our 
research team have reported on 3 RCTs comparing the accuracy of 
using of CGM and capillary point of care (POC) glucose testing in 
insulin treated patients with T2D 21,24,73,74.  Increased detection of 
both hypo- and hyper-glycemic events with the use of CGM compared 
to POC testing was found. More than 50% of the hypoglycemic occurred 
at night; suggesting that many of these episodes would be missed by 
standard POC testing.  In a recent study 24, we compared the 
performance of the FreeStyle Libre Pro CGM and POC glucose testing 
among insulin-treated hospitalized patients with T2D. The mean daily 
glucose was higher by POC testing, and proportions of patients with BG 
<70 mg/dl and <54 mg/dl by POC BG were lower compared to CGM, all 
p<0.001 (Fig 3).  The overall mean absolute relative difference (MARD), 
the statistical measure of accuracy used as the standard in glucose 
monitoring to represent performance, was 14.8%, ranging between11.4 to 16.7% for glucoses 
between 70 and 250 mg/dl and the Error Grid analysis showed 98.0% of glucose pairs within 
Zones A and B.   
In Figure 4, we present the accuracy of the Dexcom G6 CGM compared to POC testing in 218 
consecutive insulin-treated general medicine (n= 192) and surgery (n= 26) patients with T1D (n= 
9) and T2D (n=209). The mean age was 61 r12 years, HbA1c 9.07r2.2%, admission BG 224r2 
mg/dl, with 47% of patients with eGFR < 60 ml/min, length of stay, median 5.0 (4.0, 10.0) days.  
The Overall mean absolute relative difference (MARD) was 12.692 and median ARD of 10.048 
Fig 2- Linagliptin vs Basal Insulin in 
Fig 3. Hypoglycemia by POC and CGM 

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during the hospital stay and with 98.6% of matched pair readings within Error Grid within Zones 
A and B (Figure 4).   
Real Time CGM with Glucose 
telemetry System.  We have 
conducted several clinical studies 
with GTS to transmit CGM data to 
the nursing station. A recently 
published study evaluated whether 
the Dexcom CGM using a “Glucose 
Telemetry System” can decrease 
hypoglycemia in the general 
wards/non-ICU setting92. This 
report is the first interventional RCT study of CGM to improve outcomes in the non-ICU setting. 
The study included patients with T2DM, who were at high risk for hypoglycemia. Participants 
were randomized to either the “Glucose Telemetry System” (intervention group) or to POC BG 
testing (control group). For patients in the “Glucose Telemetry System” nurses were instructed 
to proceed with hypoglycemia prevention actions if the low glucose alerts were activated (set 
at <85 mg/dl). Participants in the control group were placed on “blinded” CGM systems which 
were only used to collect glucometrics data. Overall, the subjects in the CGM-GTS experienced 
fewer events of hypoglycemia (<70 mg/dL), clinically significant hypoglycemia (<54 mg/dL) 
compared to the POC BG group. The outcomes of the intervention versus control groups for 
these two levels of hypoglycemia were, respectively, 0.67 versus 1.69 events/ patient, p =0.024 
(< 70 mg/dl) and 0.08 versus 0.75 events/patient, p =0.003 (< 54 mg/dl). In addition, there was 
a reduction in percentage of time in hypoglycemic range <70 mg/dl and <54 mg/dl in the 
glucose telemetry system group compared to POC group (0.40%, versus 1.88%, p =0.002 and 
0.05%, versus 0.82%, p =0.017).  
Summary of Preliminary Data:  The result of studies demonstrates that hypoglycemia is 
common in insulin and non-insulin treated patients admitted to subacute and LTC facilities. 
Most of these episodes are missed when using capillary POC testing, with CGM providing a 
more complete assessment of glycemic status, detecting episodes of diurnal and nocturnal 
hypoglycemia compared to POC testing. The accuracy of Dexcom G6 is excellent and used 
together with GTS, reduces the frequency and time in hypoglycemia. The proposed RCT have 
great potential to impact and facilitate care of patients with diabetes in subacute and long-term 
LTC facilities, and might change current clinical guidelines in the management of patients with 
diabetes in subacute and long-term skilled nursing care facilities. 

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4. Study Endpoints 
Diabetes is highly prevalent among adults admitted to subacute and long-term skilled nursing 
care facilities (LTC) 1-4. Management of diabetes in these LTC facilities is challenging due to 
number of older adults with high prevalence of comorbidities, functional disability and altered 
nutritional intake, which increase the risk of hypoglycemia5-8.   
Clinical guidelines from professional organizations 9-11 recommend the use of subcutaneous 
insulin, as the preferred therapy for glycemic control for most patients with type 2 diabetes 
(T2D) in LTC facilities. Although effective in improving glycemic control, observational and 
prospective randomized studies have reported rates of hypoglycemia between 30-37% with 
insulin administration in LTC residents with T2D 12,13.  The high frequency of hypoglycemia is 
of great concern, as it has been associated with cardiac complications, emergency room visits, 
hospital admissions and mortality 14-16.   
Bedside capillary point-of-care (POC) glucose monitoring is the standard of care to assess 
glycemic control in the in LTC facilities 17-19. POC testing is recommend by national guidelines 
before meals and at bedtime. This approach provides limited evaluation of glycemic excursions 
and to miss nocturnal hypoglycemia 20-23. Continuous glucose monitoring (CGM) measures 
interstitial glucose every 5-15 minutes, thus providing a more comprehensive 24-hours 
glycemic profile assessment than POC testing.  
Recent studies from our group and others in hospitalized patients with T2D have reported 
increased detection of both hypo- and hyperglycemic events with the use of CGM compared to 
POC BG testing 21,23-25.  We also reported that the hospital use of the Glucose Telemetry 
System with Bluetooth technology allows CGM glucose values to be transmitted from the 
patient’s bedside to a central monitoring device in the nursing station, reducing the frequency 
of hypoglycemia in insulin treated patients with T2D 26,27.  More recently, in collaboration 
with the University of Maryland, reported significant reduction in the rate of hospital 
hypoglycemia in insulin treated medicine and surgery patients with T2D using the glucose 
telemetry system with real-time CGM 28.  In addition, the use of Dexcom G6 CGM in insulin-
treated patients revealed great accuracy, with 98.6% of reading within Clarke error Grid A and B 
(unpublished data, see preliminary results section).  Thus, our experience in the hospital 
supports the use of the use of CGM for the management of patients with diabetes and 
prevention of hypoglycemia.  However, we do not know if this experience can be extrapolated 
to individuals in long-term skilled nursing facilities.  Therefore, in-depth analyses of glycemic 
control and potential benefit of RT-CGM in real-world is needed to determine whether the 
CGM-GTS can improve glycemic control and prevent hypoglycemia in vulnerable population of 
adult patients admitted to LTC facilities.   
The primary aim is difference between POC testing and CGM-GTS in the frequency of 
hypoglycemia (safety outcome) and glycemic control (efficacy outcome) during admission.  
1) Hypoglycemia <70 mg/dl and clinically significant hypoglycemia <54 mg/dl (safety 
outcome) 
2) Glycemic control, as measured by time in range (TIR) between 80-180 mg/dl (efficacy 
outcome)  

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Secondary outcomes include differences between groups in any of the following measures:  
1. Nocturnal hypoglycemia < 70 mg/dl and < 54 mg/dl (between 22:00 and 06:00)  
2. Number of hypoglycemia events (< 70 and 54 mg/dl)  
3. Time in hypoglycemia (<70 mg/dl) and hyperglycemia (>240 mg/dl) 
4. Number of prolonged hypoglycemia > 1 and 2 hours by CGM 
5. Frequency and time of hypoglycemic during the day and night  
6. Frequency and duration or time on hyperglycemia > 240 mg/dl  
7. Percentage of BG readings within target BG of 70 and 180 mg/dl  
8. Glycemic variability calculated by standard deviation and MAGE 
9. Number of sensor removal for procedures/imaging, sensors failures, sensors 
dislodgments 
 
5. Study Intervention/Investigational Agent 
We propose to conduct a randomized controlled trial to determine whether compared 
to standard of care using capillary POC testing, the use of Dexcom CGM with Glucose 
Telemetry System (CGM-GTS) with hypoglycemia alarm will facilitate diabetes treatment 
and reduce the risk of hypoglycemia in insulin and non-insulin treated patients with T2D 
in LTC facilities.  
Dexcom CGM- Glucose 
Telemetry System CGM-GTS).  
The system will include 3 main 
devices, i) DEXCOM G6 CGM 
device (sensor, transmitter, ii) 
a smart phone, and iii) a tablet 
computer located at the 
nursing station. As a first step 
glucose values obtained from 
the CGM sensor will be sent to 
the CGM transmitter by 
Bluetooth technology and DEXCOM Share2 software application to a smart phone that serves 
as an intermediate-transmitting (routing) device. The study phone will be locked in a safe box 
located in the patient’s room. With the help of commercial internet wireless network, glucose 
values from the smart phone will be transmitted wirelessly to a table computer (I-Pad) using 
the DEXCOM Follow application [https://www.dexcom.com/apps].  
 
 
 
 
 
 
 
 

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6. Procedures Involved 
Residents with T2D in subacute and long-term skilled nursing care facilities treated with insulin 
and/or insulin-secretagogues will be randomized to a standard of care group with POC testing 
or to real time Dexcom CGM with GTS for up to 60 days of admission. 
Patients in the standard of care group will wear a 
blinded CGM and receive POC testing before meals 
and bedtime, with providers adjusting oral agents or 
insulin dose based on POC results. Patients in the 
intervention CGM group will have a single daily 
fasting POC testing and will wear a real-time Dexcom 
G6 with GTS, and providers will adjust oral or insulin 
therapy based on CGM-GTS profile information. 
Nursing staff and primary care will receive education 
on the CGM technology by our research team. 
Education efforts will include general information on 
the technology, how and when to remove or replace 
CGM sensors and transmitters, and the hypoglycemia 
prevention protocol. Treatment of hypoglycemia 
(POC <70 mg/dl) will be similar in both groups 
following a standard hospital protocol.  
CGM alarm settings, and prevention of hypoglycemia protocol. Hypoglycemia alarm will be set 
to < 85 mg/dl (for prevention for low blood glucose levels). Nursing staff will be instructed to 
provide 15 grams of carbohydrates in response to a hypoglycemia alarm.  For control group 
(blinded CGM) CGM alarms are turned off, however if the POC is found to be between <80 
mg/dl by POC, 15 grams of carbohydrates will be given as a preventive measurement for 
hypoglycemia (standard of care). 
The hyperglycemia alarm will be set at 300 mg/dl. If this occurs, the nursing staff will assess 
clinical status and perform a POC glucose testing to confirm glucose values.  If BG > 300 mg/dl, 
nursing staff will communicate the high glucose value to the primary care team. 
Diabetes Management Protocol
We will recruit and randomize males and females with a known history of T2D treated with oral 
antidiabetic agents, short- and long-acting GLP1-RA or insulin therapy. Glycemic target during 
admission is to maintain BG between 80-180 during the day, while avoiding hypoglycemia < 70 
mg/dl. 
Patients treated with oral antidiabetic agents.  Dose of antidiabetic agents will be continued 
after randomization unless there is contraindication (i.e., eGFR < 30 mil/ml for patients on 
metformin and SGLT2; pioglitazone and heart failure, history of pancreatitis for DPP4-I or GLP1-
RA), or sulfonylurea (eGFR < 30 ml/min or history of severe hypoglycemia).  patients will receive 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
supplemental/correction insulin for BG >200 mg/dL per sliding-scale. The attending physician 
could adjust oral medications at his/her discretion in the presence of severe glycemic 
excursions.  
Recommended Insulin staring dose for insulin naïve patients.  If primary care opts to start 
insulin therapy, the recommended dose of basal insulin is 0.1 unit/kg, given at the same time 
every day.  Dose of oral agents may be continued, but sulfonylurea agents should be reduced 
by half or stopped to prevent hypoglycemia. 
Patients T2D Treated with Insulin. Subjects treated with insulin will continue to receive their 
total daily dose (TDD) and insulin formulation after randomization. Glycemic target during 
admission is to maintain BG between 80-180 during the day, while avoiding hypoglycemia < 70 
mg/dl. 
The attending physician could adjust total daily insulin dose following the suggested insulin 
adjustment protocol: 

Basal Insulin adjustment.   
x Daily basal (glargine, detemir or degludec) insulin dose will be adjusted as follow:  
 If the fasting and pre-dinner BG is between 100 - 180 mg/dl in the absence of hypoglycemia 
the previous day: no change  
 If the fasting and pre-dinner BG is between 181 - 250 mg/dl in the absence of hypoglycemia: 
increase basal insulin by 10% every day  
 If the fasting and pre-dinner BG is between 251 - 350 mg/dl in the absence of hypoglycemia: 
increase basal insulin by 20% every day  
 If the fasting and pre-dinner BG is > 350 mg/dl in the absence of hypoglycemia the previous 
day: increase basal insulin (glargine) dose by 30% every day  
 If the fasting and pre-dinner BG is between 70 - 99 mg/dl in the absence of hypoglycemia: 
decrease TDD (basal and prandial) insulin dose by 10% every day  
 If BG <70 mg/dL, the insulin TDD (basal and prandial) should be decreased by 30%.   
 If BG <40 mg/dL, the insulin TDD (basal and prandial) should be decreased by 40-50%.   
 
 
Supplemental insulin. Rapid-acting insulin will be administered following the 
“supplemental/correction insulin scale” protocol followed by the facility.    
x If a patient is able and expected to eat most of his/her meals, supplemental insulin will be 
administered before meals and at bedtime following the “usual” dose of the insulin scale 
protocol. 
x If a patient is not able to eat, supplemental insulin will be administered every 6 hours 
following the “sensitive” dose of the supplemental insulin scale protocol.\ 
x Table indicates number of units to be added to scheduled insulin dose.   
BEFORE MEAL, Supplemental Sliding Scale Insulin (number of units) - Add to scheduled 
insulin dose.  

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
BG (mg/dL) 
 
< 200 
Do not give extra insulin  
201-300 
Give extra 2 units regular insulin   
301-400 
Give extra 4 units regular insulin   
401-450 
Give extra 6 units regular insulin   
> 450 
Call NP, PA, or MD 
7. Data and Specimen Banking  
Not applicable 
8. Sharing of Results with Participants 
 
The result of instant blood sugar will be shared with patients, nurses and health care providers 
immediately at LTC. However, the final results of the study and its finding will not be shared 
with participants. 
9. Study Timelines 
The duration of an individual participant’s participation in the study will be equal the 
length of admission to subacute and long-term skilled nursing care facilities (LTC) or up 
to sixty (60) days, whichever comes sooner. 
10.Inclusion and Exclusion Criteria 
Coordinators will screen for potential participants from the electronic medical record. 
Subjects will be provided with sufficient information on the practice of glucose 
monitoring before providing written consent. The process of obtaining informed 
consent will follow the standard procedures of Emory University. This protocol will be 
submitted for approval by the Emory IRB. 
Inclusion Criteria: 
1. Males and females admitted to subacute and long-term skilled nursing care facilities  
2. Known history of T2D treated with insulin (glargine, detemir, degludec, NPH, premixed 
insulin) or sliding scale regular insulin) or insulin secretagogues (sulfonylureas, repaglinide, 
nateglinide) with or without additional oral antidiabetic agents (alpha-glucosidase 
inhibitors, thiazolidinedione, SGLT2- inhibitors, DPP4-inhibitors), short- and long-acting 
GLP1-RA (exenatide, liraglutide, dulaglutide, semaglutide)  
3. Patients with an expected LTC length-of-stay > 1 week 
 
Exclusion Criteria:  
1. Patients expected to require MRI procedures during admission. 
2. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal 
hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca 
(massive peripheral edema). 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
3. Female subjects who are pregnant or breast-feeding at time of enrollment into the study. 
 
Inclusion of children: No patients under the age of 18 will be recruited in this study. 
 
11.Vulnerable Populations: 
Prisoners, pregnant women, neonates will not be included in the study. Nursing home residents 
with diabetes have higher rates of serious comorbidities and have greater activity of daily living 
dependencies than other residents without diabetes. The present study aims to determine if 
CGM -GTS will benefit the management and reduce the risk of hypoglycemia of LTC patients with 
T2DM. Research staff will ask the primary care team about the resident’s cognitive status and ask 
if they are able to consent. If the primary team deems the patient is not able to give informed 
consent then we will approach the legal representative (durable power of attorney for health 
care, court appointed guardian for health care decisions, spouse, or adult child).  
 
12.Local Number of Participants 
The total number of participants to be accrued locally is 100. 
 
13.Recruitment Methods 
Coordinators will screen for potential participants from the electronic medical record. 
Once a potential research candidate is identified, the investigators and/or research 
coordinators will discuss the research protocol with the provider (doctor, nurse, or 
house staff) taking care of the SAR/LTC resident and request permission to include 
him/her in the trial. If the primary provider agrees to include the resident in the trial, 
then he/she will be invited to participate in the study. Subjects will be approached by 
phone or in their facility room to find out their interested. If the potential candidate is 
interested, they will be provided with sufficient information on the practice of glucose 
monitoring before providing written consent.  If the primary team deems the resident is 
not able to give informed consent then we will approach the legal representative 
(durable power of attorney for health care, court appointed guardian for health care 
decisions, spouse, or adult child) by phone. In this case, a verbal consent will be 
obtained, and a full copy of the consent will be provided by email or regular mail. The 
process of obtaining informed consent will follow the standard procedures of Emory 
University. This protocol will be submitted for approval by the Emory IRB. 
Participation in this study is voluntary. Participants will receive one hundred dollars 
($100.00) during the LTC stay. Total compensation will be one hundred dollars ($100).  
 
 
 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
14.Withdrawal of Participants 
Participants may withdraw from the study if they decided to. They also will have the right to 
request that any data was collected to be removed by contacting  members of the research 
team.  
 
15.Risks to Participants 
Potential Risk to Human Subjects
Hypoglycemia. The risk of hypoglycemia in patients treated with insulin regimens is between 
12%–35% 61,62,79,80. In this study, hypoglycemia is defined as a BG or IG < 70 mg/dL. Clinical 
significant hypoglycemia is defined as BG or IG < 54 mg/dl. Severe hypoglycemia is defined as 
BG < 40 mg/dL. 
Use of CGM. No major risks are expected with the use of the CGM device. Pain and bleeding 
with insertion is minimal. Skin irritation may occur in those sensitive to adhesives.  
Protection against Risks 
We will follow safeguards to minimize the risk to our subjects: a) we will carefully monitor 
capillary BG at the bedside using a hand-held glucose meter, b) only experienced nurses/or 
phlebotomist will draw blood samples.  To prevent significant clinical events, no patients with 
history of significant liver, renal impairment or cardiac failure will be recruited in this study.   
We expect that approximately 20-30% in insulin and sulfonylurea treated patients will 
experience one or more episodes of hypoglycemia.  To minimize the risk of hypoglycemia, the 
starting dose will be adjusted following a protocol that has been shown effective on insulin 
adjustment.  To avoid hypoglycemia, the total daily dose of insulin will be decreased by 10% for 
BG between 70-99 mg/dl and by 20% after each episode of hypoglycemia (BG < 70 mg/dl).  
CGM – alarms and hypoglycemia protocol.  We will use a Dexcom CGM device with a modified 
transmitter able to store and transmit glucose data to different devices including a 
notebook/IPAD or computer desk located at the nursing station. The use of hypoglycemia alarm 
set at 85 mg/dl will alert nursing staff and providers that a patient maybe at risk of 
hypoglycemia.  If this occurs, the nursing staff will meet patient in the room to assess clinical 
status and signs/symptoms of hypoglycemia and will perform a POC glucose testing to confirm 
glucose values.  In addition, a carbohydrate load of 15 grams will be provided to patients as per 
hospital protocol to avoid hypoglycemia. 
Hyperglycemia alarm will be set at 300 mg/dl to alert the nursing staff and providers of the risk 
of clinically significant hyperglycemic complication.  If this occurs, the nursing staff will meet 
patient in the room to assess clinical status and will perform a POC glucose testing to confirm 
glucose values.  If BG > 300 mg/dl, nursing staff will communicate this high glucose value to the 
primary care team. The primary care team will review patient record and insulin administration 
prior to determining need for additional corrective rapid-acting insulin. If patient has received 
corrective insulin within the past 2 hours, additional correction will not be given, and the blood 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
sugar will be re-checked in 1 hour.  If the glucose value continues to rise with a rise indicated by 
CGM trend arrow, then additional corrective insulin will be given at that time. 
Hypoglycemia management:  If the patient is awake, 25 ml (1/2 amp) will be given IV or oral 
juice/snack (crackers) as per protocol.  If the patient is not awake:  50ml (1 amp) will be given 
STAT.  Blood glucose levels will be repeated in 15 minutes and dextrose administration will be 
repeated as needed for values < 70 mg/dl.   
Insertion of the CGM sensor will be performed per manufacturer instructions, and 
following an aseptic technique. After insertion of the sensors, providers will ensure 
proper hemostasis is achieved. Sensors will be removed if prolonged bleeding or severe 
pain occurs. 
16.Potential Benefits to Participants 
Subject participating in the standard group will not receive any direct benefits during the LTC 
stay, since treatment decision will be made based on POC BG (standard of care).  Patients in the 
intervention group of CGM-GTS will also have a POC in the morning, but will benefit of 24/7 
glucose monitoring to assess glycemic control.  In addition, CGM with alarm may reduce the risk 
of hypoglycemia. 
 
17.Compensation to Participants 
Participants will receive one hundred dollars ($100.00) during the LTC stay. Total compensation 
will be one hundred dollars ($100). Compensation will be provided via ClinCard. 
18.Data Management and Confidentiality 
In order to assure each subject’s confidentiality, data collected under this protocol will be 
coded and stored in a secure locked file cabinet with access limited to those directly related to 
the conduct of this study. Electronic versions of these data will be stored on a limited access, 
password protected, secure server with coded patient identifiers. Study participants will be 
assigned a code number that will be linked to their name. Only study personal will have access 
to the linked name-code key. 
 
Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The Principal investigator and other study 
personnel will not use data or PHI for any purpose other than conduction of the study. All PHI 
used will be de-identified and coded by the Principal investigator or designee. The code will be 
kept in a password protected computer file. PHI will be disclosed when required for audit by 
regulatory agency. 
Information from medical records and from the procedures, interviews and tests that are part of 
this research will be collected. The personal information will be kept private and confidential. 
Absolute confidentiality cannot be guaranteed. Personal information may be disclosed if required 
by law. The results of this study may be shown at meetings or published in journals to inform 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
other doctors and health professionals. Subject identity will be kept private in any publication or 
presentation about the study. People and organizations that may inspect and/or copy research 
records to assure the quality of the data and to analyze the data include:  
x Medical staff who are directly or indirectly involved in patients’ care related to this 
research; 
x People who oversee or evaluate research and care activities at Emory University  
x People from agencies and organizations that perform independent accreditation and 
oversight of research; 
R Emory offices that are part of the Human Research Participant Protection 
Program and those that are involved in study administration and billing.  These 
include the Emory IRB, the Emory Research and Healthcare Compliance Offices, 
and the Emory Office for Clinical Research  
R Government agencies that regulate the research 
R Public health agencies 
R Research monitors and reviewer 
R Accreditation agencies 
Data management and statistical analysis: 
The present aims of this RCT is to investigate whether the Dexcom G6 CGM with Glucose 
Telemetry System (CGM-GTS) with hypoglycemia alarm may reduce the risk of hypoglycemia < 
70 mg/dl (safety outcome) and improve glycemic control as measured by the percent of time in 
range (TIR) 70-180 mg/dl (efficacy end-point) in patients with T2D in subacute and long-term 
skilled nursing care facilities. Patients in the standard of care group will wear a blinded CGM 
and receive POC testing before meals and bedtime, with providers adjusting oral agents or 
insulin dose based on POC results. Patients in the intervention CGM group will have a single 
daily fasting POC testing and will wear a real-time Dexcom G6 with GTS, and providers will 
adjust oral or insulin therapy based on CGM-GTS profile information.  Professor Limin Peng, 
PhD at the School of Public Health at Emory University will conduct statistical analyses.   
For the safety endpoint, we will first compare the proportions of patients who have at least one 
episode of hypoglycemia by POC and by CGM. We will first perform nonparametric 
comparisons of the rate of hypoglycemia based on a two-sided Chi-square test (or Fisher’s exact 
test in the presence of low incidence rates), followed by the Cochran-Mantel-Haenszel test, 
which adjusts for the potential center effect. Then we will perform univariate Poisson 
regression (or Negative Binomial regression) to assess whether there is any difference in the 
number of clinically significant hypoglycemia events between the two treatment groups. We 
will further conduct multivariate Logistic regression, Poisson regression (or Negative Binomial 
regression) to estimate the difference in the rate and frequency of hypoglycemia while 
adjusting for potential confounders. A glucose value < 70 mg/dl is considered as hypoglycemia 
requiring a nurse-driven response; thus, a BG <70 mg/dl will be used for sample size calculation. 
Data from Singh et al75 a reduction of hypoglycemia was reported comparing the CGM/GTS 
system than POC (Sign et al 2020) per patient (0.67 episodes per patient, 95% CI 0.34-1.30 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
versus 1.69 episodes per patient, 95% CI 1.11-2.58, p= 0.024) 28. Based on the results of the 
recent glargine U100 vs U300 study using CGM monitoring in the hospital, 56% had CGM BG 
readings <70 mg/dl (vs 14% with POC testing-standard of care), it is reasonable to assume 60% 
of resident on LTC facilities will experience one or more BG < 70 mg/dl by CGM.   If we assume 
that 35% in the standard of care group will have at least one BG <70 mg/dl (based on linagliptin 
LTC study) 76, using one-sided, two-sample t-tests, we require we will need 70 patients per 
group to achieve 80% power.   
Hypoglycemia incidence, Rate in the
CGM intervention group 
30% 
35% 
40% 
45% 
50% 
 Estimated sample size (N/group) for 80% 
power  
 49 
  
 70 
 107 
 186 
 407 
For the efficacy endpoint, we will compare mean daily glucose levels measured by CGM or POC, 
and percent TIR measured by CGM between treatment groups by nonparametric Wilcoxon-
tests or two-sample t-tests, and by multivariate linear regression, which adjusts for other 
potential confounders such as age, gender, BMI, center, and admission HbA1c. A logarithm 
transformation may be employed to make the data better conform to the normality 
assumption. When conducting multivariate regression analyses, we will apply standard variable 
selection and model checking procedures to decide the final model. Stepwise, backward, or 
forward model selection strategy will be adopted to determine the variables to be included in 
the final model. Standard diagnostic and model checking procedures, such as deviance residual 
plot and Hosmer- Lemeshow test, will be applied to examine the fit of the developed models. 
To show non-inferiority between POC and CGM in terms of glycemic control, we set the 
equivalence margin of 18 mg/dl (1 mosm/l), from a view that a difference <18 mg/dl is usually 
not considered as clinically significant 60,61,77. Based on the results from our recent CGM trials 
28,78, it is reasonable to assume the standard deviation of mean daily BG is bounded above by 45 
mg/dl. Assuming the true BG difference between the treatment groups is zero, and using one-
sided, two-sample t-tests, we require 70 subjects for each treatment group to achieve 80% 
power.  
 
19.Provisions to Monitor the Data to Ensure the Safety of Participants 
 
Baseline and daily information will be entered by the study coordinators into data collection 
paper forms and into an electronic database (REDCap) provided by the Emory Research 
Information Technology Department. Baseline data will include demographics/history form 
(subject gender, age, ethnicity, type of treatment and comorbid conditions, body weight, BMI, 
laboratory results).  Daily information will be collected on treatment, nutrition, blood glucose 
and laboratory values, complications and adverse events (hypoglycemia). The safety of 
interventions and treatments associated with this protocol will be under continuous review by 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
the investigative team. All adverse events will be reviewed bi-weekly in a multidisciplinary 
format that will involve review by a physician, and other members of the research team. All 
Serious Adverse Events will be reviewed within the applicable guidelines and submitted to the 
IRB and other appropriate regulatory bodies governing this study. 
In addition, we have implemented protection against risks approaches as above to minimize the 
risk to our subjects. 
 
Stopping Rules: We plan to perform interim analysis on the primary endpoint every 6 months 
and/or when half of the subjects have been randomized. The trial will be stopped if there is 
evidence beyond a reasonable doubt of a difference in the rate of death and hospital 
complications (two-sided alpha level, <0.01) between the treatment groups.  
Plans for transmission of temporary or permanent suspension actions: 
Any actions that mandate temporary or permanent suspension of study will be transmitted to 
the Emory IRB, and, if appropriate, to the FDA. 
 
The frequency of protocol review will be: every 6 months.   
 
The PI will forward reports of safety reviews within 15 days of the meeting to the Emory IRB. 
 
See full Data safety monitoring plan in the attachment labeled Data Safety Monitoring Plan 
A Data Safety Monitoring Board or Safety Officer has been designated for this study.   
 
David Reyes, MD 
 
 
 
       David C. Ziemer, MD, MPH 
Department of Medicine/Endocrinology 
      Department of Medicine/Endocrinology 
 
 
 
20.Provisions to Protect the Privacy Interests of Participants 
All participant data will be kept confidential and de-identified. Access to research will be limited 
to clinical investigators, research coordinators, and the IRB at Emory University. Clinical data 
will be stored in a secure web-based database that requires password access. 
 
21.Economic Burden to Participants 
There will be not economic burden on participants. 
 
 
 
 
 
 

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
22.Consent Process 
After identification of eligible patients, these individuals will be provided basic information 
regarding the study and, if interested, they will then be screened by research staff using the 
inclusion/exclusion criteria delineated elsewhere in this protocol. Research staff will approach 
participants by phone to find out their possible interest in the study. If participants agree, the 
research staff will meet with them in their room to explain the study procedures in person. The 
consent form, potential risks and benefits, and the rights of research participants will be 
explained to the participant by the investigators or research coordinator. Individuals will be 
asked if they have any questions, and research staff will answer these questions. The principal 
investigator will also be available to answer questions that participants may have during the 
consent procedure or during the time a participant is enrolled in the study. The consent form 
will be completed in accordance with the IRB guidelines of Emory University. Residents will be 
informed that participation in the study is voluntary and there are other forms of treatment 
available to control their blood glucose levels. They will be given time to ask any questions they 
have about the study. They will also be informed that their care will not be affected if they 
choose not to participate. Consent process will take place in residents’ room. In the event 
where primary care team deems that the resident not able to give informed consent, research 
coordinator will approach their LAR by phone.  
A copy of the consent form will be provided to the participant and a copy will be placed in the 
file that is maintained for each participant in the study office. A copy of the consent will be sent 
via email or by mail when the LAR has provided verbal consent or requests a full copy prior to 
providing consent for their relative.  
Adults who speak any of the following languages (English, Russian, Spanish and Arabic) 
will be approached for participation in the study.   
Cognitively Impaired Adults and Adults Unable to Consent   
Long-term care residents with diabetes have higher rates of serious comorbidities and 
have greater activity of daily living dependencies than residents without diabetes. The 
present study aims to determine if CGM -GTS will benefit the management and reduce 
the risk of hypoglycemia in long-term care residents with T2DM. Research staff will ask 
the primary care team about the resident’s cognitive status and ask if they are able to 
consent. If the primary team deems the patient is not able to give informed consent 
then we will approach the legal representative (durable power of attorney for health 
care, court appointed guardian for health care decisions, spouse, or adult child). During 
the progress of the study the primary team will be monitoring the cognitive status of the 
participant. In the instance that the patient has a legal representative, the study 
procedures will be described to them. The resident’s legal representative will be 
approached by phone to inform the study activities, benefits, and risks. They will be 
given time to ask any questions they have about the study and the opportunity to 
discuss with the potential enrollee as well. The legal guardian will be informed that the 
study is voluntary and that care of their relative will not be affected if they choose not 
to participate.  

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Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
23.Setting 
Identification and recruitment of patients will occur in Grady (Crestview Health and 
Rehabilitation Center) and Emory affiliated subacute rehab and skilled nursing facilities which 
include: Budd Terrace Nursing Home and A.G. Rhodes Wesley Woods. 
 
24.Resources Available 
Potential subjects will be identified by their treating physicians and referred to the 
researchers. Residents' private and identifiable information will not be shared prior to 
receiving permission from the resident to do so. All residents with history of diabetes 
will be considered for participation. The research team and/or the research 
coordinators will also review resident's medical records and laboratory tests to identify 
potential candidates. Once identified, the investigators and/or research coordinators 
will discuss the protocol with the attending physician taking care of the resident and 
request permission to include him/her in the trial. If the primary physician agrees to 
include the resident in the trial, then the resident will be invited to participate in the 
study. Potential candidates will be informed that there are other forms for glucose 
monitoring available to manage their diabetes. Long-term care residents will be 
instructed both verbally and in the written informed consent form that their 
participation in the study is entirely voluntary and that they can withdraw at any time, 
which will in no way compromise or alter the usual care that they would otherwise 
receive. They will also be given the phone numbers of the PI, IRB chair and Grady official 
to whom they can address any questions or concerns. 
 
25.References 
 
1. 
Mooradian AD, Osterweil D, Petrasek D, Morley JE. Diabetes mellitus in elderly nursing 
home patients. A survey of clinical characteristics and management. J Am Geriatr Soc. 
1988;36(5):391-396. 
2. 
Funnell MM, Herman WH. Diabetes care policies and practices in Michigan nursing 
homes, 1991. Diabetes Care. 1995;18(6):862-866. 
3. 
Hauner H, Kurnaz AA, Haastert B, Groschopp C, Feldhoff KH. Undiagnosed diabetes 
mellitus and metabolic control assessed by HbA(1c) among residents of nursing homes. 
Experimental and clinical endocrinology & diabetes : official journal, German Society of 
Endocrinology [and] German Diabetes Association. 2001;109(6):326-329. 
4. 
Travis SS, Buchanan RJ, Wang S, Kim M. Analyses of nursing home residents with 
diabetes at admission. J Am Med Dir Assoc. 2004;5(5):320-327. 
5. 
Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for 
adverse drug events in older Americans. The New England journal of medicine. 
2011;365(21):2002-2012. 
6. 
Ben-Ami H, Nagachandran P, Mendelson A, Edoute Y. Drug-induced hypoglycemic coma 
in 102 diabetic patients. Arch Intern Med. 1999;159(3):281-284. 

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7. 
Shorr RI, Ray WA, Daugherty JR, Griffin MR. Incidence and risk factors for serious 
hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med. 
1997;157(15):1681-1686. 
8. 
McNabney MK, Pandya N, Iwuagwu C, et al. Differences in diabetes management of 
nursing home patients based on functional and cognitive status. Journal of the American 
Medical Directors Association. 2005;6(6):375-382. 
9. 
Moghissi ES, Korytkowski MT, DiNardo M, et al. American Association of Clinical 
Endocrinologists and American Diabetes Association consensus statement on inpatient 
glycemic control. Diabetes Care. 2009;32(6):1119-1131. 
10. 
Schnipper JL, Magee M, Larsen K, Inzucchi SE, Maynard G. Society of Hospital Medicine 
Glycemic Control Task Force summary: practical recommendations for assessing the 
impact of glycemic control efforts. J Hosp Med. 2008;3(5 Suppl):66-75. 
11. 
Seley JJ, D’Hondt N, Longo R, et al. Position Statement: Inpatient Glycemic Control. 
Diabetes Educator 2009;35(Suppl 3):65-69. 
12. 
Pasquel FJ, Powell W, Peng L, et al. A randomized controlled trial comparing treatment 
with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term 
care facilities. BMJ Open Diabetes Res Care. 2015;3(1):e000104. 
13. 
Umpierrez Gea. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) 
and Basal Insulin (Glargine) in Patients with Type 2 Diabetes in Long-Term Care and 
Skilled Nursing Facilities: Linagliptin-LTC Trial. . JAMDA. 2018. 
14. 
Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. 
Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general 
ward. Diabetes Care. 2009;32(7):1153-1157. 
15. 
Akirov A, Grossman A, Shochat T, Shimon I. Mortality Among Hospitalized Patients With 
Hypoglycemia: Insulin Related and Noninsulin Related. J Clin Endocrinol Metab. 
2017;102(2):416-424. 
16. 
Rajendran R, Rayman G. Serious harm from inpatient hypoglycaemia: a survey of 
hospitals in the UK. Diabet Med. 2014;31(10):1218-1221. 
17. 
Munshi MN, Florez H, Huang ES, et al. Management of Diabetes in Long-term Care and 
Skilled Nursing Facilities: A Position Statement of the American Diabetes Association. 
Diabetes Care. 2016;39(2):308-318. 
18. 
Migdal A, Yarandi SS, Smiley D, Umpierrez GE. Update on diabetes in the elderly and in 
nursing home residents. Journal of the American Medical Directors Association. 
2011;12(9):627-632 e622. 
19. 
American Diabetes A. 11. Older Adults. Diabetes Care. 2017;40(Suppl 1):S99-S104. 
20. 
Maynard G, Umpierrez G. Introduction: Overview of efforts and lessons learned. J Hosp 
Med. 2008;3(5 Suppl):1-5. 
21. 
Gomez AM, Umpierrez GE. Continuous Glucose Monitoring in Insulin-Treated Patients in 
Non-ICU Settings. J Diabetes Sci Technol. 2014;8(5):930-936. 
22. 
Galindo RJ, Davis GM, Fayfman M, et al. Comparison of Efficacy and Safety of Glargine 
and Detemir Insulin in the Management of Inpatient Hyperglycemia and Diabetes. 
Endocr Pract. 2017;23(9):1059-1066. 

Protocol Title:  The CGM-GTS in Long-term care  
 
Page 24 of 27 
 
Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
23. 
Schaupp L, Donsa K, Neubauer KM, et al. Taking a Closer Look--Continuous Glucose 
Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under 
Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015;17(9):611-618. 
24. 
Gallindo R, Migdal AL, Davis GM, Urrutia MA. Albury B, Zambrano C, Vellanki P, Pasquel 
FJ, Fayfman M, Peng L, Umpierrez GE.  . Performance and Efficacy Evaluation of the 
Freestyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System and Point-of-
Care Capillary Glucose Testing in Hospitalized Patients with Type 2 Diabetes (T2D) 
Treated with Basal-Bolus Insulin Regimen. Diabetes Care. 2020. 
25. 
Pasquel FJ, Lansang MC, Khowaja A, et al. A Randomized Controlled Trial Comparing 
Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and 
Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial. Diabetes Care. 
2020;43(6):1242-1248. 
26. 
Spanakis EK, Levitt DL, Siddiqui T, et al. The Effect of Continuous Glucose Monitoring in 
Preventing Inpatient Hypoglycemia in General Wards: The Glucose Telemetry System. J 
Diabetes Sci Technol. 2018;12(1):20-25. 
27. 
Spanakis I et.all.  Reducing inpatient hypoglycemia in the general wards using real-time 
CGM- the Glucose Telemetry system: A randomized clinical trial. Diabetes Care ip. 
28. 
Singh LG, Levitt DL, Satyarengga M, et al. Continuous Glucose Monitoring in General 
Wards for Prevention of Hypoglycemia: Results From the Glucose Telemetry System 
Pilot Study. J Diabetes Sci Technol. 2020;14(4):783-790. 
29. 
Kamel HK, Rodriguez-Saldana J, Flaherty JH, Miller DK. Diabetes mellitus among ethnic 
seniors: contrasts with diabetes in whites. Clin Geriatr Med. 1999;15(2):265-278. 
30. 
Morley JE. An overview of diabetes mellitus in older persons. Clin Geriatr Med. 
1999;15(2):211-224. 
31. 
Boyle JP, Honeycutt AA, Narayan KM, et al. Projection of diabetes burden through 2050: 
impact of changing demography and disease prevalence in the U.S. Diabetes Care. 
2001;24(11):1936-1940. 
32. 
Holt RM, Schwartz FL, Shubrook JH. Diabetes care in extended-care facilities: 
appropriate intensity of care? Diabetes Care. 2007;30(6):1454-1458. 
33. 
Haas L. Management of diabetes mellitus medications in the nursing home. Drugs & 
aging. 2005;22(3):209-218. 
34. 
Edge JA, Matthews DR, Dunger DB. Failure of current insulin regimes to meet the 
overnight requirements of adolescents with insulin-dependent diabetes. Diabetes Res. 
1990;15(3):109-112. 
35. 
Sinclair AJ, Paolisso G, Castro M, Bourdel-Marchasson I, Gadsby R, Rodriguez Manas L. 
European Diabetes Working Party for Older People 2011 clinical guidelines for type 2 
diabetes mellitus. Executive summary. Diabetes & metabolism. 2011;37 Suppl 3:S27-38. 
36. 
Standards of medical care in diabetes--2013. Diabetes Care. 2013;36 Suppl 1:S11-66. 
37. 
Zarowitz BJ, Stefanacci R, Hollenack K, O'Shea T. The application of evidence-based 
principles of care in older persons (issue 1): management of osteoporosis. Journal of the 
American Medical Directors Association. 2006;7(2):102-108. 
38. 
Association AMD. Diabetes Management in the Long Term Care Setting. Columbia, 
MD2007. 

Protocol Title:  The CGM-GTS in Long-term care  
 
Page 25 of 27 
 
Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
39. 
Sinclair AJ. Good clinical practice guidelines for care home residents with diabetes: an 
executive summary. Diabetic medicine : a journal of the British Diabetic Association. 
2011;28(7):772-777. 
40. 
Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 
diabetes. The New England journal of medicine. 2008;358(24):2545-2559. 
41. 
Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in 
veterans with type 2 diabetes. The New England journal of medicine. 2009;360(2):129-
139. 
42. 
Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular 
outcomes in patients with type 2 diabetes. The New England journal of medicine. 
2008;358(24):2560-2572. 
43. 
Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. Effect of intensive glucose 
lowering treatment on all cause mortality, cardiovascular death, and microvascular 
events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ. 
2011;343:d4169. 
44. 
Newton CA, Adeel A, Sadeghi-Yarandi S, et al. Prevalence, Quality of Care and 
Complications in Long-Term Care Residents with Diabetes: A Multicenter Observational 
Study. JAMDA. 2013. 
45. 
American Diabetes A. Standards of Medical Care in Diabetes-2017 Abridged for Primary 
Care Providers. Clin Diabetes. 2017;35(1):5-26. 
46. 
Garber AJ, Abrahamson MJ, Barzilay JI, et al. American association of clinical 
endocrinologists' comprehensive diabetes management algorithm 2013 consensus 
statement - executive summary. Endocr Pract. 2013;19(3):536-557. 
47. 
Ong CR, Molyneaux LM, Constantino MI, Twigg SM, Yue DK. Long-term efficacy of 
metformin therapy in nonobese individuals with type 2 diabetes. Diabetes Care. 
2006;29(11):2361-2364. 
48. 
Bloomgarden ZT. Approaches to treatment of type 2 diabetes. Diabetes Care. 
2008;31(8):1697-1703. 
49. 
Nyenwe EA, Jerkins TW, Umpierrez GE, Kitabchi AE. Management of type 2 diabetes: 
evolving strategies for the treatment of patients with type 2 diabetes. Metabolism. 
2011;60(1):1-23. 
50. 
Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: 
a meta-analysis. JAMA : the journal of the American Medical Association. 
2007;298(10):1189-1195. 
51. 
Umpierrez GE, Meneghini L. Reshaping Diabetes Care: The Fundamental Role of DPP-4 
Inhibitors and GLP-1 Receptor Agonists in Clinical Practice. Endocr Pract. 2013:1-37. 
52. 
Lovshin JA, Drucker DJ. Incretin-based therapies for type 2 diabetes mellitus. Nat Rev 
Endocrinol. 2009;5(5):262-269. 
53. 
Barnett AH, O'Hare P. Cardiovascular benefits of incretins. BMJ. 2013;347:f4382. 
54. 
Summary of revisions for the 2009 Clinical Practice Recommendations. Diabetes Care. 
2009;32 Suppl 1:S3-5. 
55. 
American Medical Directors Association. Diabetes management in the long-term care 
setting: Clinical practice guideline. Columbia MA, 2008. 

Protocol Title:  The CGM-GTS in Long-term care  
 
Page 26 of 27 
 
Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
56. 
Zullo AR, Dore DD, Daiello L, et al. National Trends in Treatment Initiation for Nursing 
Home Residents With Diabetes Mellitus, 2008 to 2010. Journal of the American Medical 
Directors Association. 2016;17(7):602-608. 
57. 
Inzucchi SE. Clinical practice. Management of hyperglycemia in the hospital setting. N 
Engl J Med. 2006;355(18):1903-1911. 
58. 
Clement S, Braithwaite SS, Magee MF, et al. Management of diabetes and 
hyperglycemia in hospitals. Diabetes Care. 2004;27(2):553-597. 
59. 
Draznin B, Gilden J, Golden SH, et al. Pathways to quality inpatient management of 
hyperglycemia and diabetes: a call to action. Diabetes Care. 2013;36(7):1807-1814. 
60. 
Umpierrez GE, Smiley D, Zisman A, 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;30(9):2181-2186. 
61. 
Umpierrez GE, Hor T, Smiley D, et al. Comparison of inpatient insulin regimens with 
detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients 
with type 2 diabetes. J Clin Endocrinol Metab. 2009;94(2):564-569. 
62. 
Umpierrez GE, Smiley D, Jacobs S, et al. Randomized study of basal-bolus insulin therapy 
in the inpatient management of patients with type 2 diabetes undergoing general 
surgery (RABBIT 2 surgery). Diabetes Care. 2011;34(2):256-261. 
63. 
Chico A, Vidal-Rios P, Subira M, Novials A. The continuous glucose monitoring system is 
useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 
diabetes but is not better than frequent capillary glucose measurements for improving 
metabolic control. Diabetes Care. 2003;26(4):1153-1157. 
64. 
Grunberger G, Handelsman Y, Bloomgarden ZT, et al. American Association of Clinical 
Endocrinologists and American College of Endocrinology 2018 Position Statement on 
Integration of Insulin Pumps and Continuous Glucose Monitoring in Patients with 
Diabetes Mellitus. Endocr Pract. 2018;24(3):302-308. 
65. 
Vigersky R, Shrivastav M. Role of continuous glucose monitoring for type 2 in diabetes 
management and research. Journal of diabetes and its complications. 2017;31(1):280-
287. 
66. 
Rodriguez LM, Knight RJ, Heptulla RA. Continuous glucose monitoring in subjects after 
simultaneous pancreas-kidney and kidney-alone transplantation. Diabetes Technol Ther. 
2010;12(5):347-351. 
67. 
Gomez AM, Umpierrez GE, Munoz OM, et al. Continuous Glucose Monitoring Versus 
Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes 
Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin 
Regimen. Journal of diabetes science and technology. 2015;10(2):325-329. 
68. 
Gu W, Liu Y, Chen Y, et al. Multicentre randomized controlled trial with sensor-
augmented pump vs multiple daily injections in hospitalized patients with type 2 
diabetes in China: Time to reach target glucose. Diabetes Metab. 2017;43(4):359-363. 
69. 
Burt MG, Roberts GW, Aguilar-Loza NR, Stranks SN. Brief report: Comparison of 
continuous glucose monitoring and finger-prick blood glucose levels in hospitalized 
patients administered basal-bolus insulin. Diabetes Technol Ther. 2013;15(3):241-245. 

Protocol Title:  The CGM-GTS in Long-term care  
 
Page 27 of 27 
 
Protocol Version: Version 2, March 22, 2021 
IRB Form BIO 08102020 
70. 
Cardona S, Gomez PC, Vellanki P, et al. Clinical characteristics and outcomes of 
symptomatic and asymptomatic hypoglycemia in hospitalized patients with diabetes. 
BMJ Open Diabetes Res Care. 2018;6(1):e000607. 
71. 
Wallia A, Umpierrez GE, Rushakoff RJ, et al. Consensus Statement on Inpatient Use of 
Continuous Glucose Monitoring. J Diabetes Sci Technol. 2017;11(5):1036-1044. 
72. 
Krinsley JS, Chase JG, Gunst J, et al. Continuous glucose monitoring in the ICU: clinical 
considerations and consensus. Crit Care. 2017;21(1):197. 
73. 
Gomez AM, Umpierrez GE, Aschner P, Herrera F, Muñoz O, Rubio C. Comparison of 
inpatient glycaemic control by continuous glucose monitoring (CGM) and capillary point-
of-care (POC) testing in general medicine patients with type 2 diabetes. . Diabetologia 
2013;56(Suppl 1):S1-S566. 
74. 
Umpierrez GE DG, Galindo R, Fayfman M, Pasqeul FJ, Vellanki P, Migdal A, Peng L. 
Inpatient and post-hospital discharge assessment of glycemic control by capillary point-
of-care glucose testing and by continuous glucose monitoring in insulin-treated patients 
with type 1 and type 2 diabetes: Dexcom G6 Observational Study ADA Scientific 
Meeting, Abstract. 2020. 
75. 
Singh LG, Satyarengga M, Marcano I, et al. Reducing Inpatient Hypoglycemia in the 
General Wards Using Real-Time Continuous Glucose Monitoring: The Glucose Telemetry 
System, a Randomized Clinical Trial. Diabetes Care. 2020. 
76. 
Umpierrez GE, Cardona S, Chachkhiani D, et al. A Randomized Controlled Study 
Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With 
Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. J 
Am Med Dir Assoc. 2018;19(5):399-404 e393. 
77. 
Umpierrez GE, Smiley D, Jacobs S, et al. RAndomized Study of Basal Bolus Insulin 
Therapy in the Inpatient Management of Patients with Type 2 Diabetes Undergoing 
General Surgery (RABBIT Surgery). Diabetes Care. 2011;34(2):256-261. 
78. 
Galindo RJ, Migdal AL, Davis GM, et al. Comparison of the FreeStyle Libre Pro Flash 
Continuous Glucose Monitoring (CGM) System and Point-of-Care Capillary Glucose 
Testing (POC) in Hospitalized Patients With Type 2 Diabetes (T2D) Treated With Basal-
Bolus Insulin Regimen. Diabetes Care. 2020. 
79. 
Umpierrez GE. Basal versus sliding-scale regular insulin in hospitalized patients with 
hyperglycemia during enteral nutrition therapy. Diabetes Care. 2009;32(4):751-753. 
80. 
Queale WS, Seidler AJ, Brancati FL. Glycemic control and sliding scale insulin use in 
medical inpatients with diabetes mellitus. Arch Intern Med. 1997;157(5):545-552.