Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
Phase: NA
Conditions: Diabetes, Diabetes Mellitus, Glucose, High Blood, Glucose, Low Blood
Sponsor: Baylor Research Institute

15 Nov 2022 
Continuous Glucose Monitoring of Hospitalized Patients with Diabetes:  
A Pilot Study to Establish Evidence 
Principal Investigator: Tresa McNeal, MD – Division Director, Inpatient Medicine for Baylor 
Scott & White Medical Center - Temple, Baylor Scott & White Health 
Clinical Team Members: 
Keith Cryar, MD – BSWH Senior Staff Endocrinologist (Sub-PI) 
Srikanth Gogineni, MD – BSWH Senior Staff Hospitalist Physician (Sub-PI) 
Research Team Members: 
Alan Stevens, PhD – Director, Center for Applied Health Research (Sub-PI) 
Jason Ettlinger – Manager, Center for Applied Health Research 
Jinmyoung Cho, PhD – Assistant Investigator, Center for Applied Health Research (Sub-PI) 
Jennifer Thomas – VP, Baylor Scott & White Research Institute 
FDA IDE #: G190136  
NCT #: NCT04230694 

08 Jun 2022 
Background and Significance 
About 25-30% of the hospitalized patients have diabetes mellitus(1). Maintaining target glucose levels of 
patients with diabetes is critical to both acute and chronic effects of Type 1 and Type 2 diabetes. Inpatient 
glycemic variability has shown to have worse patient outcomes (2). Negative inpatient outcomes include 
increased risk of infection, worsening infection, poor wound healing, acute delirium, and increased length 
of stay for those with hyperglycemia. Hypoglycemia occurs frequently in hospitalized patients contributing 
to a higher mortality rate (OR 1.07)(3). Inpatient hypoglycemic episodes are predominantly asymptomatic 
due to decreased hypoglycemic awareness as well as impaired cognition due to acute illness or 
medications(4). These inpatient risks of poorly controlled glucose levels have shown increased 90-day 
mortality (2) and decreased overall well-being post hospitalization. 
The hospitalization of persons with diabetes mellitus increases the risk of uncontrolled glucose levels for 
a number of reasons related to both the patient and care provided by the hospital. Patient related factors 
that present challenges are the patient’s underlying illness, steroid use, renal function, NPO status, and 
erratic eating schedule due to being away from the room for tests. Most importantly, changes associated 
with self-monitoring and control by the patient in the home setting to one of limited self-care while in the 
hospital also contributes to poor glycemic control. 
Processes for glucose maintenance in the hospital are challenged by hospital staffing patterns which often 
engage numerous healthcare providers in the overall care of the patient. Thus, glucose control shifts from 
one of self-management by the patient to one in which unique care providers are responsible for planning 
and providing meals, checking blood sugar levels and, if needed, administering insulin. The identified risk 
to poor glucose control during an inpatient stay requires a system level care delivery innovation that 
addresses challenges presented by both patient and care delivery characteristics. 
Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients 
with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients 
has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose 
control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been 
found to be helpful for reducing hypoglycemia in some studies while less so in others, however, these studies 
were performed with earlier generation glucose monitoring devices(5). ICU studies have confirmed accuracy 
of CGM measurements compared with capillary glucose even in settings with use of vasopressors and large-
volume resuscitation. A limited number of studies have evaluated glycemic outcomes in the inpatient non-
ICU setting. Studies of non-ICU patients (6-10) are limited by very small sample size, short study duration, 
and use of older CGM devices. There is, therefore, a critical need to systematically investigate the use of 
CGM in the inpatient care of patients with diabetes mellitus who are receiving care in a hospital setting that 
is typical of inpatient care. We propose a randomized clinical trial (RCT) to investigate the efficacy of CGM 
in the management of glucose levels by clinical staff of two hospital units in Baylor Scott & White Medical 
Center in Temple, Texas, a flagship hospital of the Baylor Scott & White Health system. The RCT will serve 
as a pilot study designed to demonstrate the feasibility of using CGM in an inpatient setting. Findings from 
the study will allow the research team to determine the effect of CGM in managing episodes of hypoglycemia 
and hyperglycemia during a typical inpatient stay as well as maintaining glucose readings within the target 
range as much as possible. 
The Project Team and Study Feasibility 
This innovative study is based on a partnership between a national leader in CGM, the clinical staff of a 

08 Jun 2022 
large hospital and the research unit embedded within the inpatient setting. Dr. McNeal, Project Director, 
has assembled clinical and research teams to lead the implementation of the proposed study. The clinical 
team, led by Dr. T. McNeal, is composed of experts in endocrinology, inpatient medicine and nursing. The 
research team is led by Dr. Alan Stevens with support from staff of the BSW Research Institute, Center 
for Applied Health Research and Clinical Trials groups. The research team has worked with the clinical 
team to design the proposed study. The clinical team has worked with the clinical support personnel from 
Dexcom, a leader in the industry of CGM, to secure access to the Dexcom G6 CGM and Dexcom G6 PRO 
devices. Both the devices are disposable products with an easy-to-use applicator and the Dexcom G6 has 
the possibility of remote glucose telemetry monitoring. Measurements detected by this sensor are also less 
affected by acetaminophen than prior sensors were when most other inpatient CGM studies were 
conducted. Thus, it appears that this device addresses both patient and care delivery challenges that were 
identified above. EHR data suggests that the two selected inpatient units have a history of providing care 
to a large number of patients with diabetes. Data provided by BSWH’s Center for Applied Health Research 
(CAHR) show that in 2017 there were over 2000 admissions of patients with diabetes to Baylor Scott & 
White Medical Center - Temple who received insulin during their stay. These data suggest that the hospital 
has enough medical patients capable for conducing the study described below. 
Study 1: A Pilot Randomized Clinical Trial of CGM 
AIM   
1) Test the health impact of CGM of inpatients as defined by rates of hypo- and hyperglycemia and the 
derivative of time in appropriate glucose range. Forty (40) patients will be randomized 1:1 into one of 
two groups. In the treatment group, patients will receive a Dexcom G6 device and the clinical staff 
(i.e., nursing and medical staff assigned to the patient’s care) will be trained to use readings from the 
Dexcom G6 for the management of the patient’s glucose levels below 100. In the control group, 
patients will receive a Dexcom G6 PRO device, but the clinical staff (i.e., nursing and medical staff 
assigned to the patient’s care) will not have access to the readings and will provide usual care (four 
glucose checks per 24 hours and use of insulin or other diabetic agent ordered by the admitting and 
rounding providers to determine glucose management). 
a. Hypothesis 1: Patients in the treatment group will experience fewer episodes of hypoglycemia as  
compared to patients in the control group as measured by the Dexcom device readings. 
b. Hypothesis 2: Patients in the treatment group will experience less frequent hyperglycemia events 
as compared to patients in the control condition as measured by the Dexcom device readings. 
Approach 
Subject Recruitment & Enrollment Plan: Non-surgical, non-ICU patients with diabetes admitted to 
BSWMC-Temple who meet the inclusion/exclusion criteria delineated below will be approached for 
enrollment within 24 hours of admission. Screening and enrollment will be conducted by a research nurse 
or a Clinical Research Coordinator with consents signed for those wanting to participate. 
Inclusion Criteria: 
 Patients with Type 1 and Type 2 diabetes. 
 Subjects 18 years of age or older with diabetes. 
 Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day) 
 Subjects with expected hospital length-of-stay of 2 or more days. 

08 Jun 2022 
 Subjects willing to wear CGM device.  
 
Exclusion Criteria: 
 Female subjects who are pregnant or lactating at the time of enrollment into the study. Females 
with childbearing potential will be queried about the possibility of pregnancy and a serum 
pregnancy test will be performed. 
 Subjects with greater than 4gm use of Tylenol/24 hr. 
 Surgical patients or patients with pre-planned surgery during the study. 
 Subjects with acute illness admitted to the ICU or expected to require admission to the ICU. 
 Patients who may potentially require IV insulin. 
 Patients with skin lesions, severe psoriasis, burns, tattoos, scarring, redness, infection or edema 
at the application sites that could interfere with device placement or the accuracy of interstitial 
glucose measurements. 
 Patient with a known allergy to medical grade adhesive or isopropyl alcohol used to disinfect 
skin. 
 Patients who have had organ transplant. 
 Hematocrit outside specification of the study-assigned blood glucose meter (hematocrit ≤ 30% or 
≥ 55%). 
 Patients with any severe medical conditions such as end-stage renal disease on dialysis, status 
post renal transplantation, end-stage liver disease with diffuse anasarca, heart failure on inotropic 
support, Ejection Fraction (EF) < 15 % or pulmonary disease requiring Non-Invasive Positive 
Pressure Ventilation (NIPPV) or severe sepsis. 
 Any condition for which, in the opinion of the investigators, it would not be in the best interest of 
the participant. 
 Legally protected subjects (under judicial protection, guardianship, or supervision), persons 
deprived of their liberty, mental or language barriers rendering the subject unable to understand 
the nature, scope and possible consequences of the study. 
 Subjects with active substance abuse. 
 Subjects with infaust prognosis. 
Monitoring for Adverse Events and Serious Adverse Events: The Principal Investigator is 
responsible to report all SAE’s (serious adverse events) involving participants regardless of whether 
expected, unexpected, associated, or not associated. SAE’s have to be reported to the Institutional 
Review Board (IRB) with a detailed narrative report within 10 working days after learning of the event. 
If an SAE is unexpected and definitely or probably related, immediately report to the IRB upon learning 
of the event (within three business days). All unanticipated adverse device events occurring during the 
investigation should be reported as soon as possible, no later than 10 business days. All anticipated 
adverse events will be tracked and will be assessed for frequency. If there is an increase in the number 
of anticipated adverse events, these events will be reported to the IRB in real time and at the continuing 
review. The principal investigator will be responsible for determining when these will be reported to the 
IRB. 
Reportable Adverse Events 

08 Jun 2022 
For this protocol, a reportable adverse event includes any untoward medical occurrence that meets one 
of the following criteria: 
1. A Serious Adverse Event 
2. An Adverse Device Effect 
3. An Adverse Event occurring in association with a study procedure 
4. Hypoglycemia meeting the definition of severe hypoglycemia as defined below 
5. Diabetic ketoacidosis (DKA) as defined below (#4) or in the absence of DKA, a 
hyperglycemic or ketosis event meeting the criteria defined below 
Relationship of Adverse Event to Study Device 
The study investigator will assess the relationship of any adverse event to be related or unrelated by 
determining if there is a reasonable possibility that the adverse event may have been caused by the study 
device. 
To ensure consistency of adverse event causality assessments, investigators should apply the following 
general guideline when determining whether an adverse event is related: 
 Yes. There is a plausible temporal relationship between the onset of the adverse event and the 
study intervention, and the adverse event cannot be readily explained by the participant’s 
clinical state, intercurrent illness, or concomitant therapies; and/or the adverse event follows a 
known pattern of response to the study intervention; and/or the adverse event abates or resolves 
upon discontinuation of the study intervention or dose reduction and, if applicable, reappears 
upon re-challenge. 
 No. Evidence exists that the adverse event has an etiology other than the study intervention 
(e.g., preexisting medical condition, underlying disease, intercurrent illness, or concomitant 
medication); and/or the adverse event has no plausible temporal relationship to study 
intervention. 
Intensity of Adverse Event 
The intensity of an adverse event will be rated on a three-point scale: (1) mild, (2) moderate, or (3) 
severe. It is emphasized that the term severe is a measure of intensity; thus, a severe adverse event is not 
necessarily serious. For example, itching for several days may be rated as severe, but may not be 
clinically serious. 
 MILD: Usually transient, requires no special treatment, and does not interfere with the 
participant’s daily activities. 
 MODERATE: Usually causes a low level of inconvenience or concern to the 
participant and may interfere with daily activities but is usually ameliorated by simple 
therapeutic measures. 
 SEVERE: Interrupts a participant’s usual daily activities and generally requires 
systemic therapy or other treatment. 
Reportable Device Issues 
 All unexpected adverse device events, (UADEs), ADEs, device complaints, 
and device malfunctions will be reported irrespective of whether an adverse 
event occurred. 
Criteria for Discontinuation of Individual Participants: 

08 Jun 2022 
Subjects can decide to discontinue entirely from the study at any time for any reason. This is 
documented as withdrawal of consent. Subjects can also be discontinued from the study or 
discontinued from the study treatment due to Investigator or Sponsor decision as detailed below. 
1. Withdrawal of consent. 
2. At the Investigator’s discretion in certain situations such as lack of compliance or serious 
adverse event. (A single severe hypoglycemic event resulting in seizure or LOC or DKA). 
3. 2 or more hypoglycemic events based on CGM readings that do not correlate with standard 
finger stick blood glucose monitor readings. 
4. One DKA event or one episode of hyperglycemic, hyperosmolar nonketotic syndrome (HHNS). 
5. Skin infection at the site of device insertion that occurs after placement of the device. 
6. Transfer of the patient to the ICU or deterioration of medical condition that in the judgment of 
the principal investigator carries an unacceptable risk for the participant. 
7. Skin irritation at the site of device insertion prompting the patient to request removal of the device. 
Criteria for stopping the overall study: 
1. The IRB will have the responsibility of determining if the overall study should be stopped. Each 
participant withdrawal (except withdrawal of consent) will be reported to the IRB within 3 days. 
2. If an investigational device malfunction results in an SAE and the issue cannot be corrected by 
a modification to the system or a component of the system or adjustment to protocol 
procedures, the study will be stopped. 
3. In the case of unanticipated adverse device effects (UADEs) related to a severe adverse 
event, the study will be stopped while the severe adverse event is evaluated and a root cause 
is determined by the Sponsor. 
Randomization: 
Patients that meet enrollment eligibility and consent to participate in the RCT will be randomized 1:1 
to one of two groups, treatment or control using Research Electronic Data Capture (REDCap). 
Randomization will be performed by assigning computerized random numbers. Computerized random 
numbers will be generated by statistical software. 
Application of the Dexcom Devices: 
Following randomization, the clinical nurse researcher will return to the patient’s bedside to apply the 
Dexcom G6 or Dexcom G6 PRO sensor and transmitter. The sensor can be placed on the upper arm or 
abdomen. Those in the treatment group will then link the transmitter to the receiver. All clinical nurse 
researchers assigned to this project will be trained on the application of the device according to Dexcom 
protocol. The clinical nurse researcher will calibrate the device according to Dexcom protocol. 
In some cases, patients will experience care procedures that require the device to be temporarily or 
permanently removed. If a patient requires a CT, the device will remain in place. If a patient requires an 
MRI as part of routine evaluation during hospitalization, the CGM device will be removed prior to 
imaging and a new one will be placed within twelve hours of the patient returning to their patient room 
on the nursing floor. 
Dexcom sensors may be worn up to 10 days. The sensor will only be replaced if it is not providing 
appropriate readings or as noted above. 

08 Jun 2022 
Standing Order for All Patients Enrolled in the Study: 
Attending and/or consulting physicians will be responsible for writing orders for finger stick glucose 
measurements on all patients per standard care whether they are in the treatment or control group. Insulin 
orders will be determined by the patients’ home medication history and current clinical status. To avoid 
investigator bias, orders written by the attending will not be adjusted by the study team with the exception 
of standing orders for nurse response to CGM readings as detailed below for those patients randomized to 
the treatment group. Standing orders for blood sugars <100 will allow for administration of glucose 
replacement in the treatment group based on Dexcom G6 reading. 
CGM informed Clinical Care (Treatment Group): 
Glucose management of patients in the treatment group will be guided by readings from the Dexcom G6. 
The Dexcom device will provide interstitial fluid glucose measurements at five-minute intervals used to 
construct a graph for trending CGM levels as well as an approximate rate of change. Threshold alarm for 
hypoglycemia will be set with CGM glucose values < 100 mg/dL and system alarm for CGM glucose 
value < 55 mg/dL. The alarms will be incorporated into the decision protocol for treatment of low blood 
glucose levels to achieve the stated goal of improved glycemic control and decreased rates of 
hypoglycemia within the hospital setting. 
This requires a detailed protocol of how the devices is to be used in the RCT and that all clinical staff 
assigned to the patient be trained to follow the protocol (i.e., staff must be trained to use CGM as a patient 
care tool). 
The Dexcom G6 protocol includes the following: 
1) The treatment group will have the data displayed with alarms set for glucose measurements of  
A. Threshold alarm CGM glucose < 100 mg/dL 
B. The urgent low soon alert, indicated by 2 downward arrows on the device reading. (Blood sugar 
of 55 mg/dL in less than 20 minutes) 
C. Urgent low system alarm set at CGM glucose < 55 mg/dL. 
2) Definition of target range is CGM glucose 100 -180 mg/dL 
3) Definition of hypoglycemia is CGM glucose < 70 mg/dL (2 consecutive CGM readings below 
threshold) 
4) Definition of hyperglycemia is CGM glucose > 300 mg/dL (2 consecutive CGM readings above 
threshold) 
5) Definition of Severe hypoglycemia (see below) 
Severe Hypoglycemia: the event required assistance of another person due to altered 
consciousness, and required another person to actively administer carbohydrate, glucagon, or 
other resuscitative actions. This means that the subject was impaired cognitively to the point that 
he/she was unable to treat himself/herself, was unable to verbalize his/her needs, was incoherent, 
disoriented, and/or combative, or experienced seizure or coma. These episodes may be 
associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose 
measurements are not available during such an event, neurological recovery attributable to 
the restoration of plasma glucose to normal is considered sufficient evidence that the event 
was induced by a low plasma glucose concentration. 

 
08 Jun 2022 
Definition of severe hyperglycemia/DKA: 
Hyperglycemic events are classified as severe hyperglycemia or DKA if the following are 
present: 
 
Symptoms such as polyuria, polydipsia, nausea, or vomiting; 
 
Serum ketones > 1.0 mmol/L or large/moderate urine ketones; 
 Either arterial blood pH < 7.30 or venous pH < 7.24 or serum bicarbonate < 15; 
and treatment provided in a health care facility 
Research Blood Glucose Protocol will be followed at all times. 
Research Blood Glucose Protocol:  
i. If CGM > 180 mg/dL, patient will receive usual care based on attending physician or advanced 
practice professional orders based on readings from AC and HS finger stick blood glucose 
readings. In other words, CGM readings will not be used for management of glucose levels > 
180 mg/dL. Physicians and Advanced Practice Professionals (APPs – includes nurse 
practitioners or physician assistants) will be educated on the fact that, to prevent the risk of 
insulin stacking, CGM glucose values should not be used to bolus insulin or dose insulin. 
Elevated CGM readings > 180 mg/dL should not be relayed to on-call physicians or APPs by 
nursing staff. Pharmacy personnel will also be educated to not use CGM readings for dosing of 
insulin in order to prevent insulin stacking. 
ii. If CGM 100-180 mg/dL with arrow direction 
: continue usual care 
iii. If CGM 100-180 mg/dL with arrow direction 
: Recheck CGM in 1 hour; continue 
usual care 
iv. If CGM 100-180 mg/dL with arrow direction 
: Recheck CGM in 30 min; continue usual 
care 
v. If CGM 100-180 mg/dL with arrow direction 
(double arrow down): Recheck CGM in 15 
min; continue usual care 
vi. If CGM between 70-100 mg/dL and arrow direction 
or 
: continue usual care 
vii. If CGM between 70-100 mg/dL and arrow direction 
(horizontal) 
Recheck CGM in 30 min and follow research blood glucose protocol 
viii. 
If CGM between 70-100 mg/dL and arrow 
Recheck CGM in 15 min and follow research blood glucose protocol 
ix. If CGM between 70-100 mg/dL and arrow direction
(1 arrow down)
Administer one of the following options and recheck CGM device 15 minutes after intervention 
and follow research blood glucose protocol again: 
1. 2 oz. (60 ml) juice 
2. 2 glucose tablets 
3. 1/2 tube glucose gel 
: 

08 Jun 2022 
4. 12.5 ml D50W IV 
x. If CGM between 70-100 mg/dL and arrow direction 
(2 arrows down) 
Administer one of the following options and recheck CGM device 15 minutes after intervention 
and follow research blood glucose protocol again: 
1. 4 oz. (120 ml) juice 
2. 4 glucose tablets 
3. 1 tube glucose gel 
4. 25 ml D50W IV 
xi. If CGM < 70 mg/dL: confirm with finger stick blood glucose and initiate standard of care per 
hospital hypoglycemia protocol per hospital policy. Resume CGM study research blood glucose 
protocol after two hours. 
Additional standing orders in the Dexcom G6 protocol:  
a. Protocol will not encompass changes in basal, pre-meal, or corrective factor insulin ordered by 
the attending physician. 
b. Provide 24-hour CGM printout of glucose monitoring on morning rounds to the physicians 
caring for patients in the treatment group for their consideration in adjusting the scheduled 
basal/bolus insulin based on the CGM pattern. Information will also be provided regarding any 
interventions that were provided to the patient as a result of the research glucose protocol 
during the prior 24 hours. 
c. Review 24-hour CGM printout with patient in the treatment group to outline the effect of food, 
insulin and any exercise that may have occurred during the past 24 hours on glycemic control. 
Usual Care for Glucose Control (Control Group): Patients assigned to the control group and 
wearing the Dexcom G6 PRO, will receive usual care as ordered by their attending physician. That 
means, the patient’s glucose management will be based on reading from the blood glucose test that are 
conducted within a 24-hour period, and orders for glucose management will be determined by the 
attending physician. 
Outcome Measures: Impact of CGM on key patient health indicators will be tracked during the enrolled 
patient’s inpatient stay for up to 10 days. Number of events or amount of time will be calculated in 
consideration by the total time while the patient is hospitalized with an active Dexcom device (i.e., total 
time in which the Dexcom device is in use will serve at the denominator). Patients with less than 48 hours 
of Dexcom device reading will be excluded from outcome data analyses. Key outcomes abstracted from the 
Dexcom device will include: 
1) Episodes of hypoglycemia (two consecutive CGM reading above or below threshold) 
2) Episodes of hyperglycemia (two consecutive CGM reading above or below threshold) 
3) Episodes of severe hypoglycemia 
4) Episodes of severe hyperglycemia/DKA 
5) Total time spent in the target range of 100-180 
6) Number of times that CGM readings would change management of hypoglycemia compared to 
standard care 

08 Jun 2022 
Other outcome measures to be collected include:  
1) Questionnaires regarding perceptions of use of CGM devices in the inpatient setting to be completed 
by nurses and physicians 
2) Questionnaires about the anticipated experience and actual experience of wearing a CGM device by 
the patient. To be administrated by a clinical research nurse or research Clinical Research Coordinator 
immediately prior to application of the device and immediately after removal of the final device 
applied (i.e., immediately prior to discharge) 
3) Length of stay 
4) The Diabetes Treatment satisfaction questionnaire–change (DTSQc) at completion of Dexcom data 
collection (11) 
Other variables to be collected and entered in the data analyses include:  
1) Patient demographics 
2) Medical history 
3) Admitting diagnosis 
4) Information about home diabetic regimen 
5) Most recent hemoglobin A1c found in EHR 
6) Length of time since diagnosis of diabetes 
7) Any skin irritation at the site of monitor device insertion 
Data Analysis: The proposed inpatient health indicators related to glucose management will serve as the 
study’s primary outcomes. The primary outcome measures, number of hypoglycemic events and time in 
the target range, will be compared between two groups using t-test. Non-parametric test (such as 
Wilcoxon-Mann-Whitney test) will also be used to examine unadjusted differences in the events between 
two groups if the distributional assumption of outcome measures does not meet the normality assumption. 
Other compounding variables such as patient demographics, admitting diagnosis, HbA1c will be adjusted 
where applicable. Statistical analyses will be conducted using SAS 9.2. 
Other outcome measures on patient and provider’s experience and perception of using CGM device and 
Diabetes Treatment Satisfaction Questionnaire-change (DTSQc) also will be analyzed. (See survey 
questions as stand-alone documents). 
Anticipated Challenges: The study team composed of clinical staff and research members is well 
prepared to carry out the proposed research. There are, however, potential challenges to completing the 
proposed research. The team is aware of these challenges and will be prepared to address challenges if 
they emerge. Potential challenges include: 
 1. Potential adverse effects of the device 
a) Skin irritation, infections, bleeding etc. 
b) Inaccurate sensor value 
c) Error in entering the calibration code from the sensor that would require manual calibration 
d) Patient annoyance due to device alarms 
 2. Clinical staff adherence to protocol 
a) Nursing staff on the units will be trained in using Dexcom G6 readings for treatment group 
patients. Specific components that will be addressed include: 

08 Jun 2022 
 During 2 hr warm up nursing staff will use finger stick blood glucose for dosing decisions. 
 In situations when the CGM is not showing a number value or arrow, a finger stick blood 
glucose reading should be obtained. 
 If patient symptoms do not correlate with CGM glucose values or if symptoms are 
indicative of hypoglycemia or hyperglycemia, a reading from the blood glucose meter 
will be obtained. 
 Patients and caregivers should avoid the use of skin care products coming into contact 
with the Dexcom G6 device. 
 Patients, caregivers, and nurses should be aware that the transmitter and display device 
should be kept within 20 feet with no obstacles like walls or metal separating the patient 
location from the device location. 
 Patients who receive Tylenol, over the recommended dose of 1000 mg/6 hrs will require 
a finger stick blood glucose . 
b) Attending physician on the units will be trained in using Dexcom G6 readings for treatment 
group patients 
3. Recording of CGM data for data analyses 
4. Removal and replacement of CGM sensor to accommodate patients receiving MRI. 
If, as we assume, CGM is found to be a feasible practice for hospitalized patients, the team is prepared to 
move CGM into a practice innovation on the two units that participated in the pilot RCT. This will require 
further development of the RCT protocols into practice guidelines and ongoing training and monitoring of 
clinical staff implementation of CGM. 
Anticipated benefits: 
1. Treatment group 
a. Improved glucose control in the target range of 100-180 mg/dL 
b. Decreased severe hypoglycemic events 
c. Decreased severe hyperglycemic events 
d. Improved understanding of the trend of glucose readings over a 24-hour period and how 
these readings are affected by food, glucose, activity and stress 
2. Control group 
a. Realization of the patient’s personal contribution to possibly improve medical practices for  
the larger population of inpatient patients with diabetes 
b. Being allowed the experience of wearing a CGM device which may allow them to 
determine their personal interest in the use of such a device as an outpatient 
Human Subjects: 
Risks: The equipment used in magnetic resonance imaging (MRI), or high-frequency electrical heat 
(diathermy) treatment can potentially damage the Dexcom devices and produce inaccurate readings or 
prevent alerts, as a result. Therefore, subjects cannot wear the Dexcom devices (sensor, transmitter, receiver, 
or smart device) during those procedures. Subject in this study who need these procedures will have their 
CGM device removed prior to the test and replaced within twelve hours thereafter. There is potentially 
unknown risk to anyone who is pregnant, on dialysis, or critically ill, 

08 Jun 2022 
as it is unknown how different conditions or medications used by these populations affect performance of 
the Dexcom sensor. These populations are not included in this study. There is a risk of potential infection at 
insertion site if the site is not clean and completely dry. There is the potential of scarring or skin irritation if 
using the same insertion site too often. There is a risk of inaccurate reading of the Dexcom devices due to 
taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults). There is a 
risk that your personal information may be released outside of the study. Federal Privacy Regulations provide 
safeguards for privacy, security, and authorized access of your records. 
Benefits: There is no monetary compensation to subjects in this study. The results of this study will provide 
generalizable data in regard to the care of hospitalized patients with diabetes with the use of continuous 
glucose monitoring (CGM) devices versus without the use of the CGM device. The knowledge and insight 
gained from this study will potentially change what is currently the standard of care for patients who require 
glucose monitoring. 
Confidentiality: Participation in this study is voluntary. A potential subject’s refusal to participate will not 
affect patient care. Proper precautions are in place to maintain a subject’s confidentiality including limiting 
access to data to only key study personnel of the study and securing data via password-protected devices, 
locked filing cabinets, behind locked offices. 
Informed Consent: Participants of this study will sign an IRB approved consent form. Trained and 
knowledgeable key study personnel (KSP) of the study will obtain informed consent. 
Conflict of Interest Disclosure(s): All KSP will complete conflicts of interest disclosure. At this time, there 
are no identifiable conflicts to disclose. 
Data Retention and/or Data Destruction Plan: All paper data related to the study will be stored securely in 
a locked file cabinet in a secured room. Any digital data files will be stored in a password protected BSWH 
maintained network. Access to data will be restricted to listed key study personnel only. Data abstracted 
for this study will be retained for study recordkeeping purposes and research compliance until the 
completion of the study. Once the study is closed, research related documents will be stored at the Dallas 
research Storage facility for an indefinite amount of time. 
Subject Withdrawal: 
Subjects may choose to withdraw from the study at any time prior to the conclusion of the study. Patients 
with less 48 hours of Dexcom device readings will be excluded from outcome data analyses. 
Reporting adverse events or other significant events: Adverse events will be reported to the IRB 
accordingly and promptly. 
Data collection: 
Data will be collected for evaluation purposes and reported only in aggregate. Dexcom data will be 
compared to historical quality data reports of hypoglycemic events and hyperglycemic events on glucose 
management. Below is a list of variables that will be collected: 

08 Jun 2022 
Table 1: Data Collection Variables 
  
Variable
Source
Demographics
MRN
EPIC 
Name (first, last) 
EPIC 
DOB
EPIC
Gender
EPIC 
Race
EPIC
Ethnicity 
EPIC 
Clinical Outcomes
Admitting Diagnosis
EPIC 
Most recent hemoglobin A1C
EPIC
Length of Stay 
EPIC
Episodes of hypoglycemic events
Dexcom
Episodes of hyperglycemic events
Dexcom 
Total time spent in the target range of 100-180 
Dexcom 
# of times that readings would change management of hypo or hyperglycemia 
compared to standard care 
  
Glycated hemoglobin levels 
EPIC 
Survey 
Duration of diabetes
Patient Survey
Information about home diabetic regimen
Patient Survey 
Perceptions of device use in inpatient setting (comfort with device, preference of 
finger stick vs. device, feel safer, CGM perceive to prevent hypo/hyperglycemia, 
CGM assist in staying in a more desirable glucose range, etc.)
Patient Survey 
Anticipated experience and actual experience of wearing device (barriers, benefits)
Patient Survey
Patient satisfaction with their diabetes care in the hospital (knowledge of diabetes 
from clinical team, presentation of care, etc.) 
Patient Survey 
Clinician feedback (problems encountered with device, preference of having all 
patients with diabetes/insulin 
therapy to 
be 
on CGM, 
comfort with 
protocol/intervention, self-efficacy etc.). 
Clinical Staff  
Survey 
 
Data Collection Details 
REDCap is a web-based application for building and managing online surveys and databases. While 
REDCap can be used to collect virtually any type of data (including 21 CFR Part 11, FISMA, and 
HIPAA-compliant environments), it is specifically geared to support online or offline data capture for 
research studies and operations. 
Baylor Scott & White Health (BSWH) joined REDCap consortium and received REDCap source code 
for local installation in 2014. The web server and database server are two separate servers and are in 
Baylor Scott & White Health (BSWH) data centers located securely as required by institutional policy. 
Each user has their own account, and their user account will only have access to REDCap projects that 
they themselves have created or to projects to which other users have granted them access. REDCap 
implements authentication to validate the identity of end-users that log in to the system. REDCap has a 
built-in audit trail that automatically logs all user activity and logs all pages viewed by every user, 
including contextual information (e.g. the project or record being accessed). Whether the activity be 

08 Jun 2022 
entering data, exporting data, modifying a field, running a report, or add/modifying a user, among a 
plethora of other activities, REDCap logs all actions. 
REDCap allows users to export any and all data from their REDCap projects, supposing they have been 
given full data export privileges. 
REDCap stores its data and all system and project information in various relational database tables 
(i.e. utilizing foreign keys and indexes) within a single MySQL database, which is an open source 
RDBMS (relational database management system). All data captured in REDCap is stored on BSWH 
servers. Therefore, all project data is stored and hosted here at BSWH institution, and no project data 
is ever transmitted at any time by REDCap from that BSWH to another institution or organization. 
Only key study personnel will have access to this information. Any PHI collected during this study will 
be minimal for the needs of this study and will only be accessed by KSP assigned to this study. PHI 
records will be obtained using the password protected EHR system of Baylor Scott & White Health. 
Data Protection & Confidentiality: * Data will be maintained after the conclusion of the study for six 
years, after which the data will be removed from REDCap by the PI. 
Data Analysis 
Descriptive statistics (mean, standard deviations, percentage) will be used to summarize the characteristics 
(age, gender, race, and ethnicity) of participating patients and clinical outcomes. Exploratory analyses will 
also 
be 
performed 
to 
assess 
relationship 
between 
patient’s 
characteristics 
and 
experiences/perceptions/satisfaction of using devices collected from survey. Results of data analysis will 
be reported at aggregate level to improve management of diabetes patients. 
Budget  
Attached 
Timeline for Proposed Study 
Study Timeline 
  
Months 
1
2
3
4
5
6 7 
8 9 10 11 12
Study Activities 
  
  
  
  
  
  
  
  
  
  
  
  
Revision of RCT protocols for IRB and 
FDA approval.
  
  
  
  
  
  
  
  
  
  
  
  
Training clinical staff 
  
  
  
  
  
  
  
  
  
  
  
  
Patient enrollment 
  
  
  
  
  
  
  
  
  
  
  
  
Data collection and analysis 
  
  
  
  
  
  
  
  
  
  
  
  
Report preparation 
  
  
  
  
  
  
  
  
  
  
  
  

08 Jun 2022 
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