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
Phase: NA
Conditions: Diabetes
Sponsor: Emory University

CGM OBSERVATIONAL VERSION 09.09.2019 
 
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IRB00107627 
NCT03832907 
 
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 
 
Principal Investigator: 
Guillermo E. Umpierrez, MD, CDE, FACP, FACE 
09.09.2019 
 
 
 
 

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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  
 
Principal Investigator: 
 
 
1Guillermo E. Umpierrez, MD, CDE, FACP, FACE 
Co-Investigators: 
1Georgia Davis, MD (Co-PI)  
1Alexandra Migdal, MD (Co-PI) 
1Rodolfo Galindo, MD  
1Maya Fayfman, MD 
1Francisco Pasquel, MD, MPH 
 
 
1Saumeth Cardona, MD 
1Priyathama Vellanki, MD 
2Limin Peng, PhD 
 
Institution: 
1Division of Endocrinology, Department of Medicine, Emory University School of Medicine 
2School of Public Health, Emory University, Atlanta, Georgia 
 
Short Title: Dexcom G6 Observational Study 
Correspondence: 
  
 
Guillermo E. Umpierrez, MD, CDE, FACE, FACP 
 
 
Professor of Medicine 
 
 
Director Clinical Research, Center of Diabetes & Metabolism 
Emory University 
Director, Diabetes & Endocrinology 
Grady Health System 
Atlanta, Georgia 
 
 

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I. 
RESEARCH OBJECTIVES AND SPECIFIC AIMS 
Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units 1,2. The 
annual incidence of diabetes as any listed diagnosis has more than doubled during the past 2 decades to a total 
of 7.2 million hospital discharges, for a total of 43.1 million hospital days among U.S. adults 3,4.  A large body 
of literature has shown a strong association between diabetes and increased mortality and morbidity 1,5-8. 
Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management 
approach of non-ICU patients with diabetes 9-11, as it has been shown to be effective in improving glycemic 
control and reducing hospital complications 12-14. However, hypoglycemia is a common adverse event of insulin 
therapy 15-18, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings 
14,19. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital 
complications, higher health care resource utilization, and hospital mortality 10,16,20-22.   
Bedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in 
the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to 
assess glycemic control and to adjust insulin therapy in the hospital 9,10,23. Continuous glucose monitoring 
(CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile 
during 24-hours compared to standard POC glucose testing 24,25. In a recent study of hospitalized patients with 
type 2 diabetes (T2D), we reported increased detection of both hypo- and hyperglycemic events with the use of 
CGM compare to the standard-of-care POC glucose testing. Patients were treated with basal-bolus regimen in 
conjunction with CGM use 24. More than 50% of the hypoglycemic events occurred between dinner and 
breakfast; suggesting that many of these episodes would be missed by standard POC testing. Schaupp et al 26 
reported that the number of nocturnal hypoglycemic episodes <3.9 mmol/L (70 mg/dl) was 15-fold higher, and 
the number of episodes >13.9 mmol/L (250 mg/dl) detected by CGM during night was 12.5-fold higher 24 
compared to capillary POC glucose testing in general medicine patients with type 2 diabetes treated with a basal 
bolus insulin regimen for ≥ 3 days.   
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 27,28.  Despite evidence supporting the use of CGM devices in hospitalized patients; clinical 
guidelines have been inconclusive in recommending the use of CGM in the hospital due to the lack of safety 
and efficacy outcome studies 27,29,30. In recent years, the improvement in the accuracy of CGM sensors, as well 
as lack of interference with acetaminophen 31 and need for calibration 32, suggest that CGM technology could 
replace the finger-stick blood glucose monitoring in insulin treated patients in the hospital. Accordingly, we 
propose a pragmatic evaluation of the Dexcom G6 CGM proving their accuracy and clinical effectiveness is 
needed, which may facilitate the widespread adoption of this technology in the hospital setting.   
We hypothesize that CGM will provide a more complete 24-hour assessment of glucose values during 
hospitalization and after hospital discharge improving detection of hypoglycemic and hyperglycemic events 
compared to POC glucose testing (standard of care) in patients with type 1 (T1D) and type 2 diabetes (T2D). 
B.        Specific Aims:   
Aim 1.  To determine differences in glycemic control, as measured by mean daily blood glucose and 
frequency of hypoglycemic and hyperglycemic events, between DexcomG6 CGM and POC BG testing in 
hospitalized patients with T1D and T2D treated with basal bolus insulin regimen.  
Hypothesis: Glucose monitoring by CGM will improve detection of clinically significant hypoglycemia (<54 
mg/dl) and severe hyperglycemia (>240 mg/dl) compared to standard POC testing in insulin-treated patients 
with T1D and T2D. 
Aim 2.  To determine differences in glycemic control and accuracy after hospital discharge between 
DexcomG6 CGM and POC BG testing in hospitalized patients with T1D and T2D. 

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Hypothesis: Glucose monitoring by CGM will improve detection of clinically significant hypoglycemia (<54 
mg/dl) and severe hyperglycemia (>240 mg/dl) compared to standard POC after hospital discharge in patients 
with T1D and T2D. 
 
II. 
BACKGROUND AND STATUS OF WORK IN THE FIELD. 
II.a.  Inpatient glycemic control in non-ICU setting.  Patients with diabetes have a three-fold greater chance 
of hospitalization compared to those without diabetes 33. The annual incidence of diabetes as any listed 
diagnosis has more than doubled during the past 2 decades to a total of 7.2 million hospital discharges for a total 
of 43.1 million hospital days among U.S. adults affected 3,4. Current guidelines recommend the use of 
intravenous insulin in the ICU and subcutaneous insulin regimens in non-ICU settings 10,34. Although effective 
in improving glycemic control and in reducing hospital complications 14,35, intensive insulin therapy results in 
frequent hypoglycemia, reported in 12% to 30% of patients 13,36,37. Thus, improving glycemic control while 
minimizing the rate of hypoglycemia is of major importance in the hospital, because both hyperglycemia and 
hypoglycemia have been shown to be independent risk factors of poor clinical outcome and mortality 1,38,39.  
II.b.  Transition Care from Hospital to Home. Hospital discharge represents a critical time for ensuring a safe 
transition to the outpatient setting and reducing the need for emergency department visits and re-hospitalization.  
Few studies have addressed the management of patients with diabetes after hospital discharge in insulin treated 
patients with T2D. In two recent randomized studies we assessed the efficacy of a hemoglobin A1c (HbA1c) 
based algorithm using glargine insulin for the management of patients with T2D 12. Patients were discharged on 
a combination of oral antidiabetic drugs (OADs) and glargine insulin at 50% of hospital dose if their HbA1c 
was < 9%. Patients with an HbA1c ≥ 9% were discharged on a combination of OAD and glargine insulin at 
80% of total daily hospital dose or on a basal bolus regimen with glargine and rapid-acting insulin analog before 
meals. The admission HbA1c on admission of 8.75% decreased to 7.9% and 7.35% after 4 and 12 weeks of 
hospital discharge. The rate of hypoglycemia was ~32% in patients treated with oral agents plus basal insulin 
and greater than 40% in patients treated with basal bolus insulin regimen. These RCT studies and previous 
retrospective studies highlight the importance of BG monitoring and cautious use of insulin after hospital 
discharge.   
II.c.  Use and limitations of CGM in non-ICU setting. Several studies have shown that the inpatient use of 
CGM is more effective in identifying trends toward hypoglycemia and hyperglycemia compared to standard 
POC glucose testing 24,25. 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 compare to the standard-of-care POC BG (23). 
There was no difference in mean daily blood glucose concentration between groups. CGM detected most 
hypoglycemic events, only one of which was detected on POC monitoring. More than 50% of the hypoglycemic 
events occurred between dinner and breakfast; suggesting that many of these episodes would be missed by 
standard POC testing. 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 (22). Significant limitations; however, are noted with the use of CGM 
in the hospital including 1) most studies used blinded CGM and therefore interventions to prevent impending 
hypoglycemia were not performed 25,26,40,41; 2) glucose values captured in the CGM device are not transmitted 
to the nursing station to allow providers to detect and treat impending hypoglycemia; 3) hypoglycemia alarms 
are only visible and audible at the bedside; 4) lack of studies using CGM to guide insulin therapy in patients 
with diabetes, with minimal data on T1D patients 42.  
We proposed a comprehensive research program to investigate the role of CGM (Dexcom G6 CGM) in the 
management of patients with diabetes in non-ICU setting receiving insulin treatment.  The Dexcom G6 hospital 
research program includes two studies:  
Study 1.  Assessment of glycemic control in hospitalized insulin-treated patients with T1D and T2D by 
capillary point-of-care testing and continuous glucose monitoring: Dexcom G6 Observational Study 

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Study 2.  Efficacy of Dexcom G6 continuous glucose monitoring in guiding insulin therapy in hospitalized 
patients with T1D and T2D: Dexcom G6 Hospital Intervention Trial.  
Study 1, the current proposal is a pilot, exploratory observational prospective study aiming to evaluate the 
feasibility of using the Dexcom G6 CGM in the hospital to obtain preliminary estimates on differences in 
glycemic control, as measured by mean daily blood glucose and frequency of hypoglycemic and hyperglycemic 
events, compared to capillary POC BG testing (standard of care) in hospitalized patients with T1D and T2D 
treated with basal bolus insulin regimen. Treatment interventions will be made based on the current standard-of-
care POC BG monitoring.  
Patients with T1D and T2D who are expected to be hospitalized for longer than 3 days will wear the CGM and 
undergo POC testing before meals and bedtime (standard of care) during the hospital stay and after hospital 
discharge for 10 days. Patients will wear a CGM in the current approved insertion site, the abdomen, and in the 
upper arm both during hospitalization and then for 10 days post-discharge. Patients and the research team will 
be blinded to the CGM glucose results during the study. Downloading of the sensors will be performed at the 
day of discharge and 10 days after hospital discharge.  
Study Diagram: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Dexcom G6 CGM is a commercially available factory-calibrated sensor system 32, thus there is no need 
for POC BG testing for sensor calibration. Clinical data for 7-day stability have reported excellent correlation 
with glucose values reported by laboratory and POC testing. Although the benefits of factory-calibrated CGM 
sensors include replacing the need for finger-stick blood glucose monitoring and providing the benefits of real-
time glucose values, its benefits and safety have not yet been proven in the hospital setting. It is important to 
mention potential limitations, including: the need for removing the sensor before MRI or diathermy treatment, 
and the potential interference in patients with severe dehydration.  
 
III. 
STUDY DESIGN AND METHODS 
Aim 1.  To determine differences in glycemic control, as measured by mean daily blood glucose and 
frequency of hypoglycemic and hyperglycemic events, between DexcomG6 CGM and POC BG testing in 
hospitalized patients with T1D and T2D treated with basal bolus insulin regimen.  
T1D and T2D, age >18 years, admission BG 140 – 400 mg/dl 
receiving basal bolus insulin regimen in non-ICU settings
Daily insulin dose adjustment 
following standard protocol
Hospital BG 
monitoring
POC testing 
AC and HS
Blinded 
CGM 
Post discharge BG 
monitoring (1 month)
POC testing 
AC and HS
Blinded 
CGM 

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Patients:  Patients with T1D and T2D will be included in this pilot, prospective observational study to 
determine differences in BG control by the Dexcom G6 CGM and POC testing before meals and bedtime 
(standard of care) during the hospital stay and after hospital discharge for 10 days. Two CGM devices will be 
inserted in all patients – one in the abdomen and one in the arm to also assess differences in BG readings 
between upper extremity and abdominal insertion sites. 
We will recruit a total of 100 male and female subjects >18 years with T1D and T2D treated with basal bolus 
insulin regimen. Due to the design of this study, there will be no run-in period.  Upon arrival to the emergency 
department or medical or general surgical wards, subjects will be screened.  Patients with a known history of 
T1D and T2D treated with insulin and expected to be hospitalized for longer than 3 days will be considered 
potential candidates for this study. Patients admitted with acute or chronic medical illnesses, emergency or 
elective surgical procedures and trauma will be included in the study. Patients anticipated to be admitted to ICU 
will be excluded from the study. 
Insulin treated patients will undergo BG monitoring by POC testing at bedside. A blinded Dexcom G6 will be 
place shortly after admission. Insulin therapy will be adjusted following POC readings (standard of care) 10,14,43.  
Information on CGM readings will be collected daily during the hospital stay using the Dexcom Studio software 
to download the Dexcom receiver data. During the study period patients and healthcare providers will be 
blinded to CGM readings.  
 
Primary and Secondary Research Outcomes: 
The primary aim is difference between POC testing (standard of care) and CGM in glycemic control (efficacy 
outcome) and hypoglycemic and hyperglycemic events (safety outcome) during hospitalization:  
1) Glycemic control, as measured by mean daily blood glucose and time in range (70-180 mg/dl)  
2) Clinical significant hypoglycemia (<54 mg/dl) and severe hyperglycemia (>240    mg/dl).  
 
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 hypoglycemic events (< 70 and 54 mg/dl)  
3. Duration or time in hypoglycemia (minutes) during the day and night 
4. Frequency and duration or time in hyperglycemia > 240 mg/dl  
5. Percentage of BG readings within target BG of 70 and 180 mg/dl  
6. Percentage of patients with greater than 5%-time below glucose target (<70 and 54 mg/dl)  
7. Percentage of patients with greater than 5%-time above glucose target (>180 and 240 mg/dl) 
8. Glycemic variability calculated by Standard Deviation, and MAGE 
9. Number of sensor removal for procedures/imaging, sensors failures, sensors dislodgments 
10. After discharge: time in range (TIR), frequency of and time in hypoglycemia (TIHypo), frequency of 
and time in hyperglycemia (TIHyper), glycemic variability (GV) 
11. Accuracy of Dexcom G6 CGM, as defined by overall MARD, as compared to the standard-of-care POC 
and daily morning laboratory glucose values  
12. Accuracy of Dexcom G6 CGM, as defined by ISO criteria (sensor values within 30/30%, 20/20%, 
15/15% for values < 70 mg/dl, 70-140 mg/dl, >140-180 mg/dl and > 180 mg/dl), compared to the 
standard-of-care POC BG 
13. Differences in accuracy between G6 CGM in the abdomen and upper arm insertion sites 
14. Percentage of values within Zone A, B, C of the Clarke Error Grid 
 
Inclusion Criteria: 
1. Males and females > 18 years admitted to a general medicine or surgical service.   
2. Known history of T1D or T2D receiving insulin therapy  

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3. Subjects must have a randomization BG between < 400 mg/dL without laboratory evidence of diabetic 
ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones). 
4. Patients with expected hospital length-of-stay of 3 or more days  
 
Exclusion Criteria:  
1. Patients with acute illness admitted to the ICU or expected to require admission to the ICU. 
2. Patients expected to require MRI procedures during hospitalization. 
3. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of 
the study. 
4. Female subjects who are pregnant or breast‑feeding at time of enrollment into the study. 
   
CGM Data Accuracy analysis:  
Interstitial glucose values collected by CGM will be paired with POC BG (closed values within a 5 min range). 
Two CGM devices will be inserted– one in the abdomen and one in the upper arm- to assess differences in BG 
readings between upper extremity and abdominal insertion sites. In addition, patients will undergo daily venous 
glucose values measured by the hospital laboratory.  Patients with > 2 days of sensor data, and with a minimum 
of 70% of CGM readings over used days will be included in the comparison analysis. A minimum of 
approximately 70% of possible CGM readings over used days appears to generate a report that enables optimal 
analysis and decision-making; standard reporting and visualization of CGM data are important 44,45. CGM 
metrics will include overall MARD and MAD, 30/30%, 20/20%, 10/10% for values < 70 mg/dl, 70-140 mg/dl, 
>140-180 mg/dl and > 180 mg/dl 45. A three way and direct head-to-head comparison of data from the 
abdomen, upper arm and POC BG will be compared. 
 
Primary Care Team (PCT) can continue to manage patients; if desired by PCT, research team can 
manage as follows: 
Recommended Basal Bolus Insulin Protocol.   
Patients will be treated with a basal bolus insulin regimen as previously reported 12,13.  The research team will 
follow the recommendations below to adjust insulin doses that target standard of care glycemic control goals.  
The primary care team will provide care concerning patients’ underlying medical or surgical conditions not 
related to diabetes management. 
 
TREATMENT PROTOCOL  
Patients Treated with Insulin Prior to Admission 
• Discontinue oral antidiabetic drugs on admission. 
• Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as 
basal bolus regimen with basal insulin (glargine, detemir or degludec) once daily plus rapid-acting 
insulin (lispro or aspart) before meals. 
• Half of TDD will be given as basal and half as rapid-acting insulin.   
• Basal insulin will be given once daily, at the same time of the day.   
• Rapid-acting insulin (lispro or aspart) will be given in three equally divided doses before each meal.  To 
prevent hypoglycemia, if a subject is not able to eat, rapid-acting insulin dose will be held. 
 
Insulin Naïve Patients Treated with Oral Agents or GLP1-RAs Prior to Admission 
• Discontinue oral antidiabetic drugs on admission. 
• Starting total daily insulin dose:  
▪ 0.4 U/Kg/day when randomization BG between 140-200 mg/dL 
▪ 0.5 U/Kg/day when randomization BG between 201-400 mg/dL   
▪ Reduce TDD to 0.3 units per kg in patients ≥ 70 years of age and/or with a eGFR < 60 ml/min. 
• Half of TDD will be given as basal insulin (glargine, detemir or degludec) once daily plus rapid-acting 
insulin (lispro or aspart) before meals.   

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• Basal insulin will be given once daily, at the same time of the day.   
• Rapid-acting insulin (lispro or aspart) will be given in three equally divided doses before each meal.  To 
prevent hypoglycemia, if a subject is not able to eat, rapid-acting insulin dose will be held. 
 
Basal Insulin adjustment.   
• Daily basal (glargine, detemir or degludec) insulin dose will be adjusted as follow:  
▪ If the fasting and pre-dinner BG is between 100 - 140 mg/dl in the absence of hypoglycemia the 
previous day: no change  
▪ If the fasting and pre-dinner BG is between 141 - 200 mg/dl in the absence of hypoglycemia: 
increase basal insulin by 10% every day  
▪ If the fasting and pre-dinner BG is between 201 - 280 mg/dl in the absence of hypoglycemia: 
increase basal insulin by 20% every day  
▪ If the fasting and pre-dinner BG is >281 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 20%.   
▪ If BG <40 mg/dL, the insulin TDD (basal and prandial) should be decreased by 30-40%.   
 
Supplemental insulin. Rapid-acting insulin will be administered following the “supplemental/correction 
insulin scale” protocol.   
• 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. 
• 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. 
• 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.   
**Check appropriate column and cross out other columns 
BG (mg/dL) 
        Insulin Sensitive                     Usual                    Insulin Resistant                                  
< 141 
                    No sliding scale (supplemental)insulin 
141 – 180 
2 
3 
4 
181 – 220 
3 
4 
6 
221 – 260 
4 
5 
8 
261 – 300 
5 
6 
10 
301 – 350 
6 
8 
12 
351 – 400 
7 
10 
14 
> 400 
8 
12 
16 
 
BEDTIME sliding scale: Supplemental Sliding Scale Insulin dose at bedtime starting at BG > 220 mg/dL 
  BG (mg/dL)          Insulin Sensitive                          Usual                    Insulin Resistant                                  
< 220 
                    No sliding scale (supplemental) insulin 
221 – 260 
1 
2 
4 
261 – 300 
2 
3 
5 
301 – 350 
3 
4 
6 
351 – 400 
4 
5 
7 
> 400 
5 
6 
8 
 
Hospital Diabetes Education.  

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1. Diabetes education if not received within 1 year of admission   
2. Use of glucose meters for home glucose self-monitoring 
3. Keeping BG records, and will receive a logbook to record glucose tests results 
4. Training on placement and care of CGM Dexcom G6 
5. Hypoglycemia prevention, recognition and management 
 
Aim 2.  To determine differences in glycemic control after hospital discharge between DexcomG6 CGM 
and POC BG testing in hospitalized patients with diabetes. 
During the hospital stay, patients will be instructed on CGM placement and care. The CGM system training 
sessions will be performed by a diabetes educator. The diabetes educator will educate patients on how CGM system 
differs from capillary SMBG, reinforcing the need for continued SMBG. Patients interested in participating in 
the study and willing to and able to use the CGM device will be recruited.  A new CGM (blinded) will be 
placed in the abdomen prior to discharge. Patients will be asked to return for a clinic visit ten days after 
discharge to review results of BG by home POC testing. Patients will be instructed to performed POC testing 
before meals and bedtime.  Patients with > 2 days of sensor data, and with a minimum of 70% of CGM readings 
over used days will be included in the comparison analysis.  
Recommendations for Insulin Discharge algorithm12:  
Patients will be discharged following a standard protocol taking in consideration preadmission treatment (oral 
agents or insulin) and HbA1c value on admission as previously reported 12.   
• Patients on oral agents prior to admission with an HbA1c between 7.5% and <10% will be discharged on 
oral agents plus basal insulin (NPH, glargine, detemir, degludec) at 50% of the daily hospital dose.  
• Patients on oral agents prior to admission with an admission A1C ≥ 10% will be discharged on their oral 
agents plus basal insulin at 80% of daily hospital dose.   
• Patients on oral agents plus basal insulin (NPH, glargine, detemir, degludec) prior to admission with an 
admission A1C between 7.5% and <10% will be discharged on their oral agents plus basal insulin at 
50% of daily hospital dose.   
• Patients on oral agents plus basal insulin (NPH, glargine, detemir, degludec) prior to admission with an 
admission A1C ≥ 10% will be discharged on their oral agents plus glargine U300 or glargine U100 at 
80% of daily hospital dose.   
• Patients treated with basal bolus regimen prior to admission will be discharged on 80% of their 
preadmission TDD with basal insulin once daily and rapid-acting insulin before meals.   
 
 
Follow-up Care: 
• New CGM (blinded) sensor will be placed  in the abdomen on the day of discharge. If primary care team 
is planning to discharge over the weekend: participants will get new blinded sensor on Friday evening 
prior to discharge. Patients will be asked to return to clinic 10 days after discharge (sooner or later 
depending on participant’s availability and schedule).   
• Duration of the outpatient study is 10 days. 
 
During follow up we will collect the following information:   
 
1. Glycemic control: 
a. Mean daily blood glucose by CGM and POC testing 
b. Time in range (70-180 mg/dl)  
c. Frequency of overall clinically significant hypoglycemia (<54 mg/dl) and severe hyperglycemia 
(>240 mg/dl).  
d. Nocturnal hypoglycemia < 70 mg/dl and < 54 mg/dl (between 22:00 and 06:00)  
e. Duration or time in hypoglycemic events (minutes) during the day and night 

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f. Frequency and duration or time in hyperglycemia > 240 mg/dl  
g. Percentage of BG readings within target BG of 70 and 180 mg/dl (time in range)  
h. Percentage of patients with greater than 5%-time below glucose target (<70 mg/dl) 
i. Percentage of patients with greater than 5%-time above glucose target (> 180 mg/dl) 
j. Glycemic variability calculated by Standard Deviation, and MAGE 
 
2. Diabetes treatment: 
a. Number of patients receiving insulin  
b. Insulin dosage (unit/day) 
c. Use of oral agents 
 
3. Clinical Outcome: 
a. Hospital readmissions 
b. Emergency room visits 
 
IV.  Statistical Methods  
The present study is one of two projects aimed to investigate the role of CGM (Dexcom G6 CGM) in the 
management of patients with diabetes in non-ICU setting receiving insulin treatment.  This observational and 
prospective study will explore the efficacy of CGM compared to standard POC glucose testing in assessing 
glucose control (efficacy) and hypoglycemic events (safety) in patients with type 1 and type 2 diabetes 
receiving insulin during admission and after hospital discharge. 
Statistical analyses will be conducted by Professor Limin Peng, PhD at the School of Public Health at Emory 
University.  We will report baseline characteristics by hospital service (medicine and surgery), diabetes type 
(T1D and T2D), and risk factors for hypoglycemia. The rates of incidence of hypoglycemia will be calculated 
based on the data obtained by CGM and POC. Comparisons will be made with the use of Wilcoxon tests (or 
Kruskal– Wallis tests) and Chi-square tests (or Fisher’s exact test) as appropriate. Multivariate linear regression 
will be conducted to assess the difference in continuous secondary outcomes between the two groups while 
other relevant covariates. To be eligible for analysis at least 70% of CGM values need to be available per day, 
with at least 2 eligible days of data per subject in each study arm (inpatient and outpatient). Glucose patterns 
will be analyzed based on the Ambulatory Glucose Profile, recently endorsed by an international expert as a 
standardized approach for CGM interpretation 44. Hospital glucose values after the first day of insulin treatment 
will be included in the analysis to allow us to have a full 24-hrs glucose profile and to avoid analyzing day-1 
CGM values which may have lower accuracy. For clinical accuracy, CGM and POC BG will be paired and will 
be plot in the Clarke Error Grid 46,47. Paired CGM and POC BG falling in the Zone A will be defined as 
“accurate”, and in Zone B as “acceptable”, with remaining values considered “not acceptable” if falling in Zone 
C, D, or E.  
A total of 105 (first five randomized subjects will not be included in the statistical analysis, instead, we will 
review any potential issues with recording/downloading data from their sensors to troubleshoot any possible 
problems with the software) insulin treated patients will be included in this prospective observational study.  
Based on previous studies by our unit, we anticipate that 80% of patients will complete the inpatient and 
ambulatory arms of the study 13,48. 
 
V.  Methods and Procedures Applied to Human Subjects: 
Potential Risk to Human Subjects 
Hypoglycemia. The risk of hypoglycemia in non-ICU patients treated with basal-bolus insulin is between 12%–
35% 14,19,37,49. In this analysis, 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 or IG < 40 mg/dL. 

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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. Other potential risks and drawbacks of using 
CGM described in the literature including unrealistic expectations, overly-aggressive correction of elevated 
glucose levels, and alerts and alarms won’t be an issue in this study because we will use blinded CGM. 
 
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, 
and c) women of reproductive age who are sexually active will undergo a urine pregnancy tests prior to 
participation in the study.  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 10% in the inpatient setting and ~20% in the outpatient (post-discharge) arm will 
experience one or more episodes of hypoglycemia.  To minimize the risk of hypoglycemia, the starting dose 
will be reduced in the basal bolus insulin regimen (TDD: 0.4 units per kg of body weight), in addition, in 
patients ≥ 70 years of age and/or eGFR < 60 ml/min the TTD will be further reduce to 0.3 units/kg.  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).  In addition, in patients treated with insulin at home, 
the TDD of insulin will be reduced by 20% on admission and the attending physician may further reduce insulin 
dose in the presence of severe hypoglycemia. 
Hypoglycemia will be treated with dextrose infusion.  Dextrose 50% solution will be given for glucose values < 
70 mg/dl.  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:  50 ml (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.  
Recruitment and Consent. 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.   
Potential Benefits to Human Subjects.  Subject participating in this trial will not receive any direct benefits 
during the hospital stay, since treatment decision will be made based on POC BG (standard of care). In the 
discharge follow up, investigators will analyze glucose profiles in a more detailed manner with potential for 
better treatment modifications in the future.   
Inclusion of children. No patients under the age of 18 will be recruited in this study. 
Confidentiality.  Informed consent will follow the procedure of Emory University Institutional Review Board.   
Every potential participant will be informed in writing and verbally with the important and key points of the 
study.   One of the investigators or research coordinators will obtain a witnessed informed consent prior to 
inclusion of a patient into the study.  Data collection records with personal identifiers will be stored in locked 
file cabinets.  Presentation of the study results at regional or scientific meetings or in publications will not 
identify subjects.  Access to research and confidential records will be limited to clinical investigators, 
coordinators and the IRB at Emory University. 
Payment for Participation.  Participation in this study is voluntary.  Patients will receive one hundred dollars 
($100.00) during the hospital stay and fifty dollars ($50.00) at the follow up visit 10 days after discharge. Total 

CGM OBSERVATIONAL VERSION 09.09.2019 
 
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compensation will be one hundred and fifty dollars ($150). Transportation to outpatient clinic visit will be 
arranged for those who need transportation. 
Financial Obligation.  No additional cost to patients or to the institution will be incurred for research purposes. 
Research studies will be performed at no cost to study subjects. CGM will be provided by the sponsor at no cost 
to participants.   
Research Injuries. If a patient is injured because of taking part in this study, Dr. Umpierrez and investigators, 
along with the medical facility will make medical care available to the patient at the patient’s own cost.  
Financial compensation for such things as lost wages, disability or discomfort due to an injury related to the 
study is not available.   
Financial Conflict of Interests.  None of the investigators in this study have any outside activities that may 
represent a conflict of interest.  None of the investigators have an economic interest in an outside entity, or act 
as officers, directors, employees or consultants with such an entity, whose financial interest may be affected by 
this research study. 
Informed Consent. 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.  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.  A signed 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.   
 
 
 

CGM OBSERVATIONAL VERSION 09.09.2019 
 
          13 
 
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