Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
Phase: NA
Conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Sponsor: Scripps Whittier Diabetes Institute

 
 
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Scripps Digital Diabetes – Glucose as a Vital Sign  
A translational and transformational digital diabetes care program 
 
Managing type 1 and high risk type 2 diabetes in the hospital setting 
 
 
 
 
Study sites:   
 
Scripps Whittier Diabetes Institute and Scripps Health  
 
Principal Investigator:  
Athena Philis-Tsimikas, MD 
 
Sub-Investigators:  
Isabel Garcia, RN, MSN; Laura Talavera, RN, MSN, MPH; Remy 
Babanto, RN, MSN, CNS; Souling Chou, RN, MSN, CNS; Addie 
Fortmann, PhD;  Linda Nyagaya, DNP 
 
Sponsor:  
 
 
Scripps Whittier Diabetes Institute 
 
Version:  
 
 
January 9th, 2020 
 
 
 
Scripps Whittier Diabetes Institute and Scripps Health 
9894 Genesee Ave, Suite 300 
La Jolla, CA 92037 
Telephone-858-626-4645 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Protocol Synopsis 
 
 

 
 
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Title: 
 
 
Scripps Digital Diabetes – Glucose as a Vital Sign 
Managing type 1 and high risk type 2 diabetes in the hospital 
setting 
 
Study sites:   
 
 
Scripps Whittier Diabetes Institute and all Scripps Health 
hospitals 
 
Sponsor:  
 
 
 
Scripps Whittier Diabetes Institute  
 
Investigational Device: 
 
Dexcom G6, Investigation Use Only (IUO) Continuous 
Glucose Monitoring (CGM) System (the “IUO CGM”)  
Pilot Study Design and Sample 
Size:  
Pilot 
Type 1 observational study – 5 patients 
Type 2 randomized study – 56 patients 
 
Pilot Expected Completion Date:  
5 months from 1st patient enrolled 
 
 
Study Design and Sample Size 
(randomization based on statistical 
analysis): 
 
 
Type 1 observational study – 100 patients 
Type 2 randomized study – 404 patients, Subset using 
Dexcom G6, n=110 patients for full evaluation and analysis. 
 
Expected Completion Date: 
 
 
5 years from 1st patient enrolled 
 
 
Purpose: 
 
This program will provide patients with type 1 and high risk type 2 diabetes the safest 
hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their 
glucose parameters in real-time similar to other continuously monitored vital signs.  The CGM 
will inform a team of health professionals who will monitor the patients’ progress, communicate 
recommendations, and be available for discussion when recommended targets are not achieved.  
Health teams will utilize sensor results in addition to existing electronic medical records data to 
evaluate progress and manage care. 
 

 
 
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Inclusion Criteria: 
 
1. 18 years of age and above 
2. One of the following: 
a. Diagnosed with diabetes type 1 OR 
b. Diagnosed with diabetes type 2, requiring insulin during this hospitalization, and any 
of the following: 
I. 
HbA1c > 8%  
II. 
Point-of-care blood glucose (POC) > 180 mg/dL at admission.  
III. 
Point-of-care blood glucose tests (POC) > 200 mg/dL or chemistry glucose 
>200 mg/dl on at least three different time points within the last 24 hours, before 
consenting.  
c. English or Spanish speaker.  
 
Exclusion Criteria: 
 
1. Pregnant  
2. Patient in ICU and with insulin drip (participants in ICU not on the insulin drip are allowed) 
3. Known allergy to adhesives 
4. Anticipated CT/MRI/diathermy procedure within 24 hours from admission (patients with 
a planned operation within 24 hours from admission may be included in the study before 
the operation – see Sensor Insertion/Transmitter Connection section of the protocol). 
5. Current participation in any medication or device research study 
6. Have any condition that in the opinion of the Principal Investigator is deemed 
contraindicated for study participation 
 
 
Overview: 
 
All patients with type 1 or type 2 diabetes who meet study criteria will be invited to participate in 
the study.  All patients included in the study will be followed by an advanced practice diabetes 
nurse (APN) for glucose management during their hospitalization.  All patients included in the 
study will receive a CGM.  Patients with type 2 diabetes will be randomized to control (blinded 
CGM glucose values) or intervention (CGM blood glucose values will be used to aid with glucose 
management during the hospitalization).  In addition, a research only supplemental order set will 
be implemented for all study participants.  The order set focuses on any glucose point of care test 
that is between 70-79 mg/dL at any time or ≥ 201 mg/dl  at night, between 9pm and 4am (21:00-
04:00). (Appendix B).  The goal is to prevent hypoglycemia and hyperglycemia for all study 
patients.   The advanced practice diabetes nurse will work with the physician in charge of the 
patient’s care as well as the patient’s care team.   

 
 
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Patients with type 1 diabetes:   
 
Patients with type 1 diabetes will receive a CGM.  The CGM device will be placed for the length 
of the patient’s stay with sensor changes at 240 hours (10 days) post insertion or as needed.  
Calibrations are not required for the IUO CGM and will not be performed routinely.  
The CGM device will be kept unblinded, which means that the data can be viewed at the patient’s 
bedside.  Monitoring devices will be set to alarm if rate of change is trending towards 
hypoglycemia with a value of ≤ 90 mg/dL or trending towards severe hyperglycemia with a value 
of ≥ 250 mg/dL.  Wireless communication will allow for assigned personnel to view CGM values 
at real time and also be alerted by alarms set by specifications above.  Nursing staff assigned to 
the patient will then conduct POC testing.  If the initial POC testing value after alarm is 70-79 
mg/dL then the patient will receive 15 gm glucose gel with follow up POC testing per APN 
recommendations, based on supplemental order set (PFO).  Below 70mg/dl, patients are treated 
based on established hypoglycemia standing orders. If the initial POC testing value after alarm is 
≥ 201 mg/dL then insulin adjustments will be individualized based on the patient’s clinical 
scenario. Patients receive supplemental insulin for hyperglycemia only if POC testing ≥ 201mg/dl 
is between 9pm and 4am (21:00-04:00) and they have not received any additional insulin for the 
past three hours.   Thereafter, follow up POC testing will continue according to APN 
recommendations.   In addition, insulin adjustment algorithms will be used by the APN after CGM 
and POCT values ongoing daily review and communication with the physician and care team, to 
maintain glucose levels within goal.  Communication between glucose management team, nursing 
staff and monitoring physician may take place more often if trends towards hypoglycemia or 
hyperglycemia are visible.   
 
CGM data will automatically be uploaded to a commercially available, web-based service 
(Dexcom ClarityTM Diabetes Management Software) using the Scripps’ wifi connection. This 
system enables research staff to review historical CGM data and also provides summary reports, 
including average glucose and patterns of high and low glucose.  
 
POC glucose values, HbA1c level at admission and usual care laboratory glucose values will be 
collected as well. A follow-up questionnaire will take place within 7 days from discharge 
(including discharge date) to assess any adverse events and to obtain patient satisfaction data 
regarding his/her hospital stay and use of the CGM device. 
 
For data analysis, the percentage of patient-days with average glucose within 70-180 mg/dL will 
be compared to historical baseline data. 
 
 
 
 
 

 
 
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Patients with type 2 diabetes:    
 
All type 2 patients enrolled will receive the CGM device, but patients will be randomized to control 
(CGM glucose values are blinded to APN, care team and researchers) or intervention (CGM blood 
glucose values will be used to aid with glucose management during the hospitalization).    CGM 
data will be compared between both groups during data analysis.  CGM data will be blinded for 
all type 2 patients.  This means that data will not be viewed at the patient’s bedside, but will be 
reviewed remotely by research staff for the intervention group.  In short, the CGM device will be 
placed for the length of the patient’s stay with sensor changes at 240 hours (10 days) post insertion 
or as needed.  Calibrations are not required for the IUO CGM and will not be performed routinely. 
 
For the intervention group, monitoring devices will be set to alarm remotely if rate of change is 
trending towards hypoglycemia with a value of ≤ 90 mg/dL or trending towards severe 
hyperglycemia with a value of > 250 mg/dL. Wireless communication will allow for assigned 
personnel to view CGM values at real time and also be alerted by alarms set by specifications 
above.  Nursing staff assigned to the patient will then conduct POC testing.  If the initial POC 
testing value after alarm is 70-79 mg/dL then the patient will receive 15 gm glucose gel with follow 
up POC testing per APN recommendations, based on supplemental order set (PFO).  Below 
70mg/dl, patients are treated based on established hypoglycemia standing orders. If the initial POC 
testing value after alarm is ≥ 201 mg/dL then insulin is administered in accordance with 
supplemental research order set. Patients receive supplemental insulin for hyperglycemia only if 
POC testing ≥201 mg/dl is between 9pm and 4am (21:00-04:00) and they have not received any 
additional insulin for the past three hours.   In addition, APNs will recommend insulin adjustments 
based on daily review of CGM trends and POCT values. Communication between glucose 
management team, nursing staff and monitoring physician may take place more often if trends 
towards hypoglycemia or hyperglycemia are visible. 
 
CGM data will automatically be uploaded to a commercially available, web-based service 
(Dexcom ClarityTM Diabetes Management Software) using the Scripps’ wifi connection. This 
system enables research staff to review historical CGM data and also provides summary reports, 
including average glucose and patterns of high and low glucose.  
 
POC glucose values, HbA1c level at admission and usual care laboratory glucose values will be 
collected for both control and intervention groups.  A follow-up questionnaire will take place 
within 7 days from discharge (including discharge date) for both groups to assess any adverse 
events, patient satisfaction with hospital stay and patient satisfaction regarding the use of the CGM 
device.   
 
Patients who are randomized to the control group may still benefit from study participation as the 
research only supplemental order set will be used for this group as well with the goal of preventing 

 
 
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hypo and hyperglycemia.  The control group may also benefit from the daily visits from the 
research staff as diabetes education would be provided for all. 
 
For data analysis, the percentage of patient-days with average glucose within 70-180 mg/dL will 
be compared between both groups. 
 
 
Study Aims: 
 
Aim 1 (observational):  To compare the percentage of patient-days with average glucose in the 
target range (70-250 mg/dL) among patients with type 1 diabetes receiving CGM versus historical 
baseline data. 
 
Aim 2:  To compare the percentage of readings in the target range (70-250 mg/dL) among patients 
with type 2 diabetes randomized to control versus intervention. 
 
Aim 3:  To examine the acceptability and feasibility of using CGM in the hospital environment 
from patient (type 1 and type 2 diabetes) and provider perspectives. 
 
Aim 4 (exploratory): To compare rates of hypoglycemia (<70 and < 54 mg/dL) and hyperglycemia 
(>180mg/dL, >250 and 300 mg/dL) among patients with type 1 diabetes receiving CGM versus 
historical baseline data. 
 
Aim 5 (secondary/exploratory):  To compare rates of hypoglycemia (<70 and < 54mg/dL) and 
hyperglycemia (>250 and 300 mg/dL) among patients with type 2 randomized to control versus 
intervention. 
 
 
Statistical Analysis Plan (SAP); see full plan in Appendix C: 
 
All patients with type 1 diabetes will receive CGM (CGM data used for glucose management).  
This is an observational aspect of the study with no further analysis.  
 
See SAP in Appendix C for plan for type 2 diabetes analysis. 
 
 
 

 
 
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Protocol 
 
 
 

 
 
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Background 
People with type 1 diabetes make up a small portion of hospital admissions annually but when 
hospitalized with critical medical conditions blood glucose values can fluctuate dramatically, 
quickly putting patients at risk for complications of hyperglycemia and severe hypoglycemia (1-
10).  People with type 2 diabetes who use insulin or are at high risk of complications with 
uncontrolled hyperglycemia are also at increased risk in the hospital setting.  A study by Mendez 
et al. indicated that glucose variability in non-critically ill patients in the hospital setting was 
associated with longer length of stay and increased number of deaths over a 90 day period (11).  
Optimally, in an acute care setting blood glucose monitoring should occur continuously, similar to 
other vital signs such as heart rate, heart rhythm, oxygen levels and blood pressure.  Hyper and 
hypo-glycemia can be prevented by ongoing monitoring of trends and changes in blood glucose 
values and immediate intervention when values rise above or fall below the target ranges.  
Moreover, unwanted complications related to fluctuations in blood glucose will be prevented with 
frequent monitoring and management that maintains normoglycemia.   
There are several continuous glucose monitoring (CGM) devices available in the ambulatory care 
setting that allow rapid, real-time monitoring of patients’ subcutaneous interstitial fluid glucose 
values and provide a warning system to people with diabetes that glucose values may be or will 
likely be entering dangerous levels.  Currently there are no subcutaneous CGM devices approved 
for use in the United States for a hospital environment.  These devices offer an accurate display of 
glucose values and trends with high and low alarms.  Additionally, a new app allows wireless 
transmission of glucose values to a central location for monitoring.  This is similar to the telemetry 
units found in hospitals that monitor ongoing heart rate and rhythm.  Studies using similar devices 
in acute care environments in Europe and South America have demonstrated clinical and economic 
success by maintaining glucose control within target ranges and improving health cost outcomes 
by decreasing staff time required for point of care monitoring and shortening length of hospital 
stay.  (12-14) 
 
 
Specific Aims 
We hypothesize that instituting the broad use of subcutaneous CGM with wireless transmission to 
an advanced practice diabetes team for high risk patients with type 1and type 2 diabetes will result 
in improved well-managed glucose days, fewer episodes of severe hyper- and hypoglycemia, and 
improved patient satisfaction.  We propose using existing subcutaneous CGM technology to 
monitor rapid, real-time glucose values in patients admitted to a Scripps hospital to determine the 
effectiveness of maintaining normoglycemia and reducing rates of hyper- and hypoglycemia and 
to evaluate patient and provider satisfaction with using this device in a hospital environment.  All 
patients included in the study will be followed by an advanced practice diabetes nurse for glucose 
management during their hospitalization.  All patients included in the study will receive a CGM.  
Patients with type 2 diabetes will be randomized to control (blinded CGM glucose values to APN, 

 
 
10 of 37 
care team and researchers) or intervention (CGM blood glucose values will be used to aid with 
glucose management during the hospitalization).  In addition, a research only supplemental order 
set will be implemented for all study participants.  The order set focuses on any glucose point of 
care test that is between 70-79 mg/dL at any time or ≥ 201 mg/dl  at night, between 9pm and 4am 
(21:00-04:00). The goal is to prevent hypoglycemia and hyperglycemia for all study patients.   The 
advanced practice diabetes nurse will work with the physician in charge of the patient’s care as 
well as the patient’s care team.  Historical baseline data for type 1 diabetes patients will be used 
as comparison for Aim 1 and Aim 4 below.  Historical baseline data is defined as patients with 
type 1 diabetes admitted to a Scripps hospital within 24 months before first patient enrolled. 
 
Aim 1 (observational):  To compare the percentage of patient-days with average glucose in the 
target range (70-250 mg/dL) among patients with type 1 diabetes receiving CGM versus historical 
baseline data. 
 
Aim 2:  To compare the percentage of readings in the target range (70-250 mg/dL) among patients 
with type 2 diabetes randomized to control versus intervention. 
 
Aim 3:  To examine the acceptability and feasibility of using CGM in the hospital environment 
from patient (type 1 and type 2 diabetes) and provider perspectives. 
 
Aim 4 (exploratory): To compare rates of hypoglycemia (<70 and < 54 mg/dL) and hyperglycemia 
(>180mg/dL, >250 and 300 mg/dL) among patients with type 1 diabetes receiving CGM versus 
historical baseline data. 
 
Aim 5 (secondary/exploratory):  To compare rates of hypoglycemia (<70 and < 54 mg/dL) and 
hyperglycemia (>250 and 300 mg/dL) among patients with type 2 randomized to control versus 
intervention. 
 
Secondary analyses will examine additional parameters derived from CGM data (e.g., measures 
of central tendency, variability indicators, time spent within/outside target ranges). 
 
 
Study sites 
Although type 1 diabetes is not always well documented in the hospital environment we estimate 
that there are 1000-1500 admissions per year with type 1 diabetes to the Scripps hospitals 
countywide.  Scripps has four licensed hospitals at five locations throughout San Diego County 
which range from the border of Mexico with Scripps Mercy Chula Vista to south of Camp 
Pendleton with Scripps Memorial Encinitas.  There are three additional central and coastal 
locations with Scripps Mercy San Diego, Scripps Memorial La Jolla and Scripps Green.  The 
hospitals serve a diverse ethnic and socioeconomic population of patients with type 1 and type 2 

 
 
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diabetes.  In 2012, there were 412 admissions for diabetic ketoacidosis, a life threatening condition 
which occurs almost exclusively in type 1 diabetes.  In the same year, there were 12,000 
admissions for patients with type 2 diabetes.  The ability to monitor blood glucose continuously in 
high risk diabetes patient populations would allow safer and more rapid resolution of 
hyperglycemia while preventing adverse events of hypoglycemia. 
 
Patients with type 1 diabetes will be recruited at any Scripps hospital site (main sites will be La 
Jolla, Mercy San Diego, Green and Chula Vista as staffing permits).  Patients with type 2 diabetes 
will be recruited mainly at Scripps Mercy Chula Vista and Scripps Mercy San Diego where their 
mean length of stay is 7 days within the Medical/Surgical units.  Patients may also be recruited at 
other Scripps hospital sites. 
 
 
Inclusion Criteria: 
 
1. 18 years of age and above 
2. One of the following: 
a. Diagnosed with diabetes type 1 OR 
b. Diagnosed with diabetes type 2, requiring insulin during this hospitalization, and any 
of the following: 
I. 
HbA1c > 8%  
II. 
Point-of-care blood glucose (POC) > 180 mg/dL at admission 
III. 
Point-of-care blood glucose tests (POC)> 200 mg/dl or chemistry glucose  >200 
mg/dL on at least three different time points within the last 24 hours, before 
consenting. 
3. English or Spanish speaker  
 
 
Exclusion Criteria: 
 
1. Pregnant  
2. Patient in ICU and with insulin drip (participants in ICU not on the insulin drip are allowed) 
3.  Known allergy to adhesives 
4. Anticipated CT/MRI/diathermy procedure within 24 hours from admission (patients with 
a planned operation within 24 hours from admission may be included in the study post 
operation – see Sensor Insertion/Transmitter Connection section of the protocol). 
5. Current participation in any medication or device research study 
6. Have any condition that in the opinion of the Principal Investigator is deemed 
contraindicated for study participation 
 

 
 
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Study Design 
We will conduct a study to test the feasibility and utility of providing CGM monitoring devices to 
each of the Scripps hospitals for use when patients aged 18 and above with type 1 or high risk type 
2 diabetes are admitted to the general wards or step-down units over a 2 year time period.  Patients 
with type 1 or type 2 diabetes will be identified at the time of admission by the emergency 
department, admitting nurse or attending physician. Patients with diabetes type 1 or 2 will undergo 
chart review to determine if they meet study inclusion/exclusion criteria.  Scripps staff will be 
trained to notify the hospital glucose management team for all admissions of type 1 or type 2 
diabetes. 
 
All patients included in the study will be followed by an advanced practice diabetes nurse for 
glucose management during their hospitalization.  The advanced practice diabetes nurse will work 
with the physician in charge of the patient’s care as well as the patient’s care team.    
 
Licensed clinical staff will perform daily evaluation of CGM insertion site. Research staff will be 
available to respond to any questions patient and/or hospital staff may have concerning study and 
CGM.  
 
Patients with type 1 diabetes:   
 
Patients with type 1 diabetes will receive a CGM.  The CGM device will be placed for the length 
of the patient’s stay with sensor changes at 240 hours (10 days) post insertion or as needed.  
Calibrations are not required for the IUO CGM and will not be performed routinely. 
The CGM device will be kept unblinded, which means that the data can be viewed at the patient’s 
bedside.  Monitoring devices will be set to alarm if rate of change is trending towards 
hypoglycemia with a value of ≤ 90 mg/dL or trending towards severe hyperglycemia with a value 
of ≥ 250 mg/dL.  Wireless communication will allow for assigned personnel to view CGM values 
at real time and also be alerted by alarms set by specifications above.  Nursing staff assigned to 
the patient will then conduct POC testing.  If the initial POC testing value after alarm is 70-79 
mg/dL then the patient will receive 15 gm glucose gel with follow up POC testing per APN 
recommendations, based on supplemental order set (PFO).  Below 70mg/dl, patients are treated 
based on established hypoglycemia standing orders. If the initial POC testing value after alarm is 
≥ 201 mg/dL then insulin adjustments will be individualized based on the patient’s clinical 
scenario. Patients receive supplemental insulin for hyperglycemia only if POC testing ≥ 201mg/dl 
is between 9pm and 4am (21:00-04:00) and they have not received any additional insulin for the 
past three hours..  Thereafter, follow up POC testing will continue according to APN 
recommendations.   In addition, insulin adjustment algorithms will be used by the APN after CGM 
and POCT values ongoing daily review and communication with the physician and care team, to 
maintain glucose levels within goal.  Communication between glucose management team, nursing 

 
 
13 of 37 
staff and monitoring physician may take place more often if trends towards hypoglycemia or 
hyperglycemia are visible. 
 
If a patient arrives to the hospital with a CGM device, it will be discontinued and a new study 
sensor, transmitter and CGM device will be used. 
 
CGM data will automatically be uploaded to a commercially available, web-based service 
(Dexcom ClarityTM Diabetes Management Software) using the Scripps’ wifi connection. This 
system enables research staff to review historical CGM data and also provides summary reports, 
including average glucose and patterns of high and low glucose.  
 
POC glucose values, HbA1c level at admission and usual care laboratory glucose values will be 
collected as well.  A follow-up questionnaire will take place within 7 days from discharge 
(including discharge date) to assess any adverse events and to obtain patient satisfaction data 
regarding his/her hospital stay and use of the CGM device. 
 
For data analysis, the percentage of patient-days with average glucose within 70-180 mg/dL will 
be compared to historical baseline data where available. 
 
 
Patients with type 2 diabetes:    
 
 All type 2 patients enrolled will receive the CGM device, but patients will be randomized to 
control (CGM glucose values are blinded to APN, care team and researchers) or intervention 
(CGM blood glucose values will be used to aid with glucose management during the 
hospitalization).    CGM data will be compared between both groups during data analysis.  CGM 
data will be blinded for all type 2 patients.  This means that data will not be viewed at the patient’s 
bedside, but will be reviewed remotely by research staff for the intervention group.  In short, the 
CGM device will be placed for the length of the patient’s stay with sensor changes at 240 hours 
(10 days) post insertion or as needed.  Calibrations are not required for the IUO CGM and will not 
be performed routinely. 
 
For the intervention group, monitoring devices will be set to alarm remotely if rate of change is 
trending towards hypoglycemia with a value of ≤ 90 mg/dL or trending towards severe 
hyperglycemia with a value of ≥ 250 mg/dL.  Wireless communication will allow for assigned 
personnel to view CGM values at real time and also be alerted by alarms set by specifications 
above.  Nursing staff assigned to the patient will then conduct POC testing.  If the initial POC 
testing value after alarm is 70-79 mg/dL then the patient will receive 15 gm glucose gel with follow 
up POC testing per APN recommendations, based on supplemental order set (PFO).  Below 
70mg/dl, patients are treated based on established hypoglycemia standing orders. If the initial POC 

 
 
14 of 37 
testing value after alarm is ≥201 mg/dL then insulin adjustments will be individualized based on 
the patient’s clinical scenario. Patients receive supplemental insulin for hyperglycemia only if POC 
testing ≥201mg/dl is between 9pm and 4am (21:00-04:00) and they have not received any 
additional insulin for the past three hours.. Thereafter, follow up POC testing will continue 
according to APN recommendations.   In addition, insulin adjustment algorithms will be used by 
the APN after CGM and POCT values ongoing daily review and communication with the 
physician and care team, to maintain glucose levels within goal.  Communication between glucose 
management team, nursing staff and monitoring physician may take place more often if trends 
towards hypoglycemia or hyperglycemia are visible. 
 
CGM data will automatically be uploaded to a commercially available, web-based service 
(Dexcom ClarityTM Diabetes Management Software) using the Scripps’ wifi connection. This 
system enables research staff to review historical CGM data and also provides summary reports, 
including average glucose and patterns of high and low glucose.  
 
POC glucose values, HbA1c level at admission and usual care laboratory glucose values will be 
collected for both control and intervention groups.  A follow-up questionnaire will take place 
within 7 days from discharge (including discharge date) for both groups to assess any adverse 
events, patient satisfaction with hospital stay and patient satisfaction regarding the use of the CGM 
device.   
 
Patients who are randomized to the control group may still benefit from study participation as the 
research only supplemental order set will be used for this group as well with the goal of preventing 
hypo and hyperglycemia.  The control group may also benefit from the daily visits from the 
research staff as diabetes education would be provided for all. 
 
For data analysis, the percentage of patient-days with average glucose within 70-180 mg/dL will 
be compared between both groups. 
 
 
 
 
 
 
 
Section intentionally left blank 

 
 
15 of 37 
Materials and Methods 
Device overview (POCT equipment) 
 
Used hospital wide.  Any POC test done for study purposes only (per CGM alarms) will be coded 
separately for easier access for study data purposes.  This equipment is calibrated on a daily basis 
and will not function if a calibration has not taken place within the last 24 hrs.    
Device overview (Sensor applicator/Sensor)  
 
 
  
 
Dexcom G6 IUO CGM Sensor 
The applicator is molded so that insertion of 
the needle occurs at a 45 degree angle. The 
applicator includes a built-in sensor. Sensor 
insertion occurs in one step, by pressing 
button. The sensor pod remains on the skin 
with the sensor probe (platinum/silver wire) 
below the skin.   

 
 
16 of 37 
 
Device overview 
[Information from IUO CGM Investigator Brochure] 
Transmitter 
The transmitter is designed to continuously measure the electrochemical signal produced by the 
sensor probe. It can be re-used for multiple sessions. The transmitter is worn over the sensor and 
secured within the transmitter holder after the sensor is deployed by the auto-applicator.  
The transmitter is programmed with a specific Identification Number (ID) which must be entered 
into the mobile app to establish a secure Bluetooth wireless communication between the devices, 
and allow for the following features to be available: display of real-time glucose information; 
glucose-related alerts or alarms; indicators of “failsafe” mechanisms that the sensor cannot provide 
meaningful glucose information, such as signal loss, the end of the sensor session, and ability to 
connect to Dexcom Share Service or Dexcom CLARITYTM Diabetes Management Software.  
 
Once the glucose monitoring session is initiated, the transmitter does not require calibration 
entries.  
 
 
 
 
Mobile Application 
Mobile app (on Phone) communicates with the transmitter via Bluetooth and displays glucose 
information in real-time. The IUO CGM System requires a two-hour warm up period after which 
it will display data once every five minutes for up to ten days.  
 
Transmitter 

 
 
17 of 37 
The mobile application has a menu setting for glucose related alerts and alarms. High and low 
glucose alerts can be set to warn against glucose excursions. The mobile application also provides 
a low glucose alarm set at 55 mg/dL. In addition to glucose excursions, additional alerts can be 
configured, including predictive alerts (Action Alert) for warning users of impending low glucose 
of 55 mg/dL, signal loss, the end of the sensor session, or the need to calibrate. 
 
In addition to displaying real time glucose data and alerts to users, the mobile app provides 
connectivity to the Dexcom Share Service offering the ability to share their CGM data wirelessly 
with up to five individuals. Once the Share feature in the mobile app is activated, the mobile device 
transfers glucose readings to the Dexcom Share Cloud using either Wi-Fi or a cellular data plan. 
The sensor glucose readings are then sent from the Dexcom Share Cloud to the mobile device of 
the Follower, the person remotely monitoring the user’s glucose, via Wi-Fi or cellular data. 
 
Sharer and Follower equipment 
The Dexcom IUO CGM transmitter can directly transmit blood glucose readings to compatible 
phones. A phone will therefore be placed at patient’s bedside. Phones will have multiple functions: 
receive blood sugar values, upload these values automatically (via wifi) to ClarityTM, store blood 
sugar values for up to 30 days (for the event that wifi connection is temporarily lost) and lastly can 
send values to selected followers.    
 
Type 2 Patients: These patients are blinded to their blood glucose readings. Phone will be stored 
in a box at bedside. Depending on whether patient is in intervention or control group, phone will 
accordingly transmit data to selected followers or not.  
 
Type 1 patients: These patients can see their blood glucose readings. Phone will be given to them 
while in study, in order to see their blood sugar values.  
 
A compatible device (Android, iPhone or iPad) will be used by the follower (assigned research 
staff and/or telemetry unit) to view all CGM data. 
 
 
Security of equipment 
 
The phone will remain at the participant’s bedside until discharge.  The CGM Share Direct allows 
for mobility and will follow the patient as able, as an extension to the IV pole.  The equipment will 
be enclosed in a secured container that will allow access from study staff as needed.  
 
CGM data will automatically be uploaded to a commercially available, web-based service 
(Dexcom ClarityTM Diabetes Management Software) using the Scripps’ wifi connection. This 

 
 
18 of 37 
system enables research staff to review historical CGM data and also provides summary reports, 
including average glucose and patterns of high and low glucose.  
 
The Dexcom Studio application as well as IBM SPSS (a statistical package) will be used for data 
analysis. 
 
 
Cleaning of Devices 
The sensor applicator as well as the sensor itself are disposable after each use.    The transmitter, 
phone and share station will be transferred to other study participants after thorough cleaning and 
disinfecting between patients (following Scripps wide cleaning/disinfecting instructions 
[applicable to POC equipment as well] Appendix A).  As part of this study we will be applying 
the same transferability between patients as with the Professional System following thorough 
cleaning and disinfecting steps. 
 
Study Procedures 
Informed Consent 
The consent form provided will be available in English and Spanish (consent forms will be 
translated by certified translators).  The research staff, which includes the research nurse, diabetes 
educator or diabetes advance practice nurse, fluent in Spanish and English, will conduct the 
consenting process in the participants’ preferred language.  The research staff will ensure that 
participants understand all information provided, answer participants’ questions and concerns, and 
inform them that their participation is completely voluntary and will in no way affect their 
relationship with Scripps Health.  The research staff will provide participants a copy of their signed 
form.  A participant will not be excluded if illiterate or if he/she has visual problems (this may 
include recent procedures to the eye/s, which is a common finding for patients with advanced 
diabetes disease).  A participant will not be included if legally blind at both eyes or if primary 
reading ability is thru braille.  A witness line will be used for a third person to sign (the person 
must be fluent in English or Spanish, the language of the participant).  As above, the research staff 
will ensure that the witness as well, understands all information provided.   
All research staff has completed the CITI Human Subjects Training and under the direction of the 
nurse research coordinator, have also received extensive training on obtaining study consent.  They 
will review all sections of the consent form and ensure that the potential participant comprehends 
the information provided and is capable of making an informed choice to participate.  Consent 
forms will be stored in locked cabinets at the Scripps Whittier Diabetes Institute, separate from all 

 
 
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other study data to ensure the confidentiality of any information that participants disclose.  Consent 
forms will be kept for six years at which point they will be shredded.  
 
Screening and Enrollment: 
Patients with type 1 or type 2 diabetes will be identified during their hospitalization by Research 
staff, by using the daily hospital reports of abnormal blood sugars for all hospitalized patients.   
Patients with diabetes type 1 or 2 will undergo chart review to determine if they meet study 
inclusion/exclusion criteria.   
Once a patient is determined to meet study criteria, the physician in charge of the care of the patient 
while hospitalized, will be contacted to approve patient inclusion in the study.  If patient and 
physician are in agreement, the consent process will proceed. 
A patient can only participate once in the event of multiple hospitalizations.    
A screening list will be kept of all patients who are approached for study participation.  These lists 
will be kept until the end of study enrollment period.    
 
 
Post screening procedures: After consent signing and before sensor insertion 
The following post screening procedures will take place within 7 days before sensor insertion.  
These procedures include: Collection of medical/diabetes history, vital signs, height, weight, 
HbA1c, hematocrit.  The following post screening procedure will take place within 72 hrs before 
sensor insertion: Pregnancy test and evaluation of sensor insertion area (integumentary system at 
abdomen,). 
All these procedures are part of the usual hospital procedures for patient care.  No post screening 
procedures will be done solely for study purposes.   All data from these procedures will be kept 
for study purposes. 
 
Sensor Insertion/Transmitter Connection: 
Once a patient has met all inclusion/exclusion criteria, signed consent, and completed the post 
screening procedures, he/she will have a sensor placed (see Device overview section above).  The 
placement of the sensor will be done by the diabetes research nurse, the RN diabetes educator or 
the diabetes advance practice nurse (RN or RD). 

 
 
20 of 37 
Basic metabolic panel values will be collected +/- 24 hours before sensor insertion.  These values 
are part of usual patient care.  Any diabetes medications, acetaminophen and steroid use within 
the last 24 hours before sensor insertion will be documented as well as pre-insertion vital signs.  
The insertion site will be cleaned with alcohol swabs, the sensor will be placed and subsequently 
the transmitter will be connected for communication of data to the phone.  The phone will be 
maintained up to a maximum of 20 feet away for the patient.  
If the patient is to have a surgical procedure and the patient has been consented, then solely the 
sensor can be placed.  The initial accuracy of CGM data is based on the length of time the sensor 
is in place and the CGM data has been shown to increase in accuracy with continued sensor wear.  
After the surgical procedure, the transmitter will be connected for communication of data to the 
receiver. 
Sensor and transmitter will be removed before any CT, MRI or surgery. After procedure is 
complete, a new sensor can be placed if patient agrees.  
 
Glucose Management  
An Inpatient Glycemic Management Advanced Practice Registered Nurse Standardized Procedure 
(APN-S) will be followed (Appendix B: supplemental order set for subcutaneous insulin or PFO).  
The standardized procedure uses specific guidelines for the management of patients with diabetes 
within the hospital setting. The target goal for in-hospital blood glucose values are pre-prandial 
BG of 100-140 mg/dL and random BG less than 180 mg/dL.   
Per PFO, if the initial POC testing value after alarm is 70-79 mg/dL then the patient will receive 
15 gm glucose gel with follow up POC testing within 15 minutes.  If the initial POC testing value 
after alarm is ≥ 201 mg/dL anytime between 9pm (21:00) and 4am (04:00), and the patient has not 
received any insulin over the past three (3) hours, then patient will receive supplemental insulin 
dose, which is based on patient’s current order of correction insulin. Communication will be 
ongoing between the advanced practice diabetes team, physician in charge of the patient’s care as 
well as the patient’s care team. 
 
For Type 1 patients or Type 2 patients randomized in Intervention group,  , CGM data will be used 
by APN to evaluate BG control of the patient every 24 hrs and/or earlier based on alarm CGM 
settings and rates of change arrows.  The CGM device will be set to alarm if rate of change is 
trending towards hypoglycemia with a value of ≤ 90 mg/dL (arrow being shown will be       , which 
means that if BG continues falling at this rate, BG could decrease up to 30 mg/dL in 15 minutes) 
or trending towards severe hyperglycemia with a value of ≥ 250 mg/dL (arrow being shown will 
be       , which means that if BG continues rising at this rate, BG could increase up to 30 mg/dL in 

 
 
21 of 37 
15 minutes).  Trend arrows (rising, rapidly rising and falling and rapidly falling), will be taken into 
consideration looking at the whole patient picture, including nutritional intake and timing of 
meals/medications.  When CGM alarms, “Followers” (which may include research staff and/or 
tele tech staff) will alert nursing staff assigned to the patient to conduct POC testing and treat 
patient accordingly per Research (PFO) or Hospital protocol (whichever applies).  
 For Type 2 patients randomized to the Control group, blood glucose values from CGM are not 
visible by APN or tele tech staff. PFO will still apply during any time patient gets a POC from 
bedside RN per standard hospital procedures.  
 
Sensor Removal: 
The sensor will be removed before hospital discharge, at day 10 post insertion, if the sensor fails 
for any reason or if the patient is to undergo a CT or MRI procedure.  The sensor may also be 
removed at the discretion of the Principal Investigator.  If the patient is to continue hospitalization, 
then a new sensor will be inserted.  Once a sensor is removed, the insertion site will be examined 
for any inflammation/bleeding. 
 
Follow-up: 
A follow-up questionnaire will take place within 7 days from discharge (including discharge date) 
to assess any adverse events and to obtain patient satisfaction data regarding his/her hospital stay 
and use of the CGM device. 
Provider satisfaction data will also be gathered (via focus group or questionnaire) after study 
patients have been discharged.   
 
Measurements and Analysis 
Clinical measures:  Clinical measures that will be collected will include HbA1c on admission and 
at any time post admission while the patient is hospitalized, point of care glucose values conducted 
with the hospital based glucose meters (a minimum of four times a day) and CGM downloaded 
data.  The reason for admission and patient medical history will be collected from the patient 
records. 
Any change in insulin dosing per APN and/or physician will be collected. 
Medications:  All diabetes medication, steroids and acetaminophen use will be recorded. 

 
 
22 of 37 
Behavioral measures: Patient satisfaction surveys will be collected just prior to discharge and/or 
one week post discharge to assess the experience with the hospital based CGM device and glucose 
management.  Post discharge 2 patient focus groups will be convened with a minimum of 5 patients 
in each group to assess patients experience and recommendations after participating in the pilot.  
Two additional focus groups will be convened with providers that include staff nurses, hospitalists 
and advanced practice nurses from the glucose management team to gather level of satisfaction 
and recommendations based on their experience.   
 
Data analysis: (See Appendix C for Statistical Analysis Plan) 
 
Potential Risks 
The procedure of insertion and retraction of the needle and the sensor placement itself may cause 
redness, edema, and/or bruising at the site of insertion.  Local infection at insertion site, erythema, 
inflammation, bleeding, or hematoma are also possible.  The frequency of these last events is very 
low.   
Once the sensor is removed, irritation at the site may be present.  This may be due to the adhesive 
(MARSI or Medical Adhesive Related Skin Injuries).  This reaction should resolve within a few 
days to a week.  Patients may experience itching at the area which is normal as part of the healing 
process.  These possible expected risks will be assessed with the 1 week f/u call.  
There is a remote chance that the sensor or introducer needle could break if insertion is performed 
improperly. A minor procedure similar to removing a splinter may be required to retrieve the 
fragment. To minimize the risk associated with this procedure, only trained personnel will perform 
the insertion of the sensor.  
Rarely participants may develop an allergic reaction to any component of the sensor and/or 
transmitter.  This is similar to allergies that occur due to medical tape.  If this occurs, then the 
device will be withdrawn and the patient will be discontinued from participation.     
Fingersticks are part of regular patient care.  An increased number of fingersticks may take place 
if the CGM values are not within goal or if there are downward or upward rate of change arrows.  
Fingersticks may cause pain and/or a bruise. 
Hypoglycemia and/or hyperglycemia may occur during the course of the study.  Hypoglycemia 
may be associated with reduced cognitive, diaphoresis, tachycardia, coma and seizure.  Symptoms 
of hyperglycemia may be associated with thirst, glycosuria, ketoacidosis, and hyperosmolar coma.  
The risk of these complications is an inherent risk of having diabetes. Close follow-up during 
patient participation will minimize these risks.   

 
 
23 of 37 
Patient blood glucose information will be viewed by specific Scripps staff.  The creation of 
Dexcom share accounts will be established by Scripps research staff.  No patient information will 
be entered within the apps.  All info will be coded.    
All research staff will complete human subjects’ research training prior to their involvement.  
There are no other known risks.  
All data collected are for research purposes only and findings will be presented only in aggregate 
form. No identifiable information on individuals will be used in reports or manuscripts. To ensure 
confidentiality, data will be kept in locked files when not in use and will be properly stored at the 
Scripps Whittier Diabetes Institute. Participants will be assigned identification numbers for data 
management and data will be identified only by these numbers. A master list of identification 
numbers, names, and contact information will be kept separate from data in a locked file cabinet 
at the Scripps Whittier Diabetes and/or in a secure file.  This list will never be stored with the 
participants’ data, and will be accessible only to the investigators and trained project assistants. 
Study records will be stored in the clinical trials office at Scripps Whittier Diabetes Institute.   
 
Potential Benefits 
The anticipated potential benefit in joining the study includes improved glucose management 
during hospitalization with decreased incidence of hypo and hyperglycemic events.  The patient 
may also learn more about self-diabetes management while participating in the study.  However, 
there is no guarantee that participants will incur any personal benefit from participating in the 
study. The information learned from this study may help improve the way diabetes is managed 
within a hospital setting. 
 
Adverse Events (AE): 
Overview of rating severity and relationship of AE to Study Device:  An adverse event is an 
event that was not present when the patient was consented.  The event can be an acute event, like 
cough or cold symptoms or worsening of symptoms (in this case an example would be recurrent 
MI after the patient was admitted for an MI).  For study purposes, adverse events will be collected 
in relation to CGM device use.  Serious adverse event can include a significant medical event (ie. 
severe hypoglycemia, etc). 
PI or sub-I will determine the relationship of the AE to CGM use and/or APN-S as not related, 
possibly related or probably related.  Information regarding action taken (none, CGM interrupted, 
CGM discontinued, or none, APN-S interrupted, APN-S discontinued) will also be collected.  
Severity (mild, moderate, severe) and outcome (resolved, resolved with sequelae, ongoing, death) 

 
 
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will also be assessed.  Information regarding the use of a medication for the AE will also be 
collected.  
Adverse Device Effect (ADE):  May include redness, bruising, etc.  May also include malfunction 
of the sensor, transmitter, phone or Dexcom share.  AE charting will be done as above. 
Serious Adverse Device Effect (SADE):  If the PI or sub-I find the ADE to be serious, then the 
event will go under SADE.  AE charting will be done as above. 
Serious Unexpected Adverse Device Event (SUADE): If the PI or sub-I find the ADE to be 
serious and unexpected, then the event will go under SUADE.  AE charting will be done as above. 
Serious Adverse Event (SAE):  Any event of severe hypoglycemia (an episode requiring 
assistance of another person to actively administer carbohydrate, glucagon, or take other corrective 
actions) will be collected.  Any significant medical event will also be collected. 
 
 
 
Confidentiality Procedures 
Data to be published or made public will not contain any identifying information.  Demographic 
information will be seen only by the research staff and individuals managing the patient health 
during hospitalization.  The participants will be assigned an identifying number, instead of their 
names, to ensure their privacy.  All data will be transported in locked boxes to the clinical research 
office at Scripps Whittier Diabetes Institute, where these items and the rest of the study files will 
be stored in a locked office. The study researchers and their research team, sponsoring agency, 
government research agencies, and the Scripps IRB are the only ones allowed access to any 
information from this study.  The documents obtained in relation to and during the study will be 
held for 7 years after study completion.  Data that may be entered in databases will be kept in 
Scripps encrypted computer systems.  All data will be de-identified for analyses.  If data is to be 
transferred to any of the facilities specified above, it will be de-identifiable data. 
 
Costs to Subjects 
Participants will not incur any cost for participation. 
 
Compensation 

 
 
25 of 37 
Participants will not receive any compensation as part of study participation. 
 
 
 
 
 
 
 
 
 
 
 
Timeline 
Study implementation 
steps 
- 3 
months 
0 
months 
0 – 5 
months 
0 - 60 
months 
60 
60 – 70 
months 
Obtain CGM Share 
Direct devices, sensors 
and transmitters 
x 
 
 
 
 
 
Train hospital glucose 
management teams and 
telemetry monitoring 
teams in device 
placement and protocol 
x 
 
 
 
 
 
Introduce devices and 
protocol to hospital RN 
and MD staff 
x 
 
 
 
 
 
Begin patient enrollment, 
consenting and data 
safety and monitoring 
(each hospital enrollment 
may start at different 
times) 
 
x 
 
 
 
 

 
 
26 of 37 
Pilot enrollment and data 
gathering 
 
 
x 
 
 
 
Ongoing data safety and 
monitoring review 
 
 
 
x 
 
 
Patient enrollment ends 
 
 
 
 
x 
 
Data compilation from 
the electronic data 
warehouse 
 
 
 
x 
 
 
Data analysis 
 
 
 
x 
 
x 
Patient and provider 
focus groups 
 
 
 
x 
 
x 
Final report & 
Dissemination of results 
 
 
 
 
 
x 
 
 

 
 
27 of 37 
References 
1. Qual. Safe Health Care. 2008, Dec;17 (6): 464-8.- Health systems are integrating 
approaches to care to improve quality and financial goals 
2. Kavanagh & McCowen. N Engl J Med 2010;363:2540-2546-National hospital glycemic 
practice guidelines are available yet most clinical staff are not familiar with methods 
recommended to safely achieve glucose targets2 
3. Umpierrez, J. Clinical Endo. Metab. 2012 Jan;97(1):16-38-Dys-glycemia is a common and 
costly event 
4. Diabetes Care vol. 35, sup.1, Jan. 2012. p. S45- Dys-glycemia is a common and costly 
event 
5. Arch Intern Med. 2009;169(5):438-446-Hyperglycemia and Poor Outcomes Following 
Myocardial Infarction 
6. Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE: Hyperglycemia: 
an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J 
Clin Endocrinol Metab 87:978–982, 2002. 
7. Van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M et al. 
Intensive Insulin Therapy in Critically Ill Patients. N Engl J Med 2001; 345 (19):1359-67. 
8. Malmberg K. Prospective Randomized Study of Intensive Insulin Treatment on Long Term 
Survival After Acute Myocardial Infarction in Patients with Diabetes Mellitus. DIGAMI 
(diabetes mellitus, insulin glucose infusion in myocardial infarction) study group. BMJ 
1997; 314: 1512-5. 
9. Krinsley JS. Association between Hyperglycemia and Increased Hospital Mortality in a 
Heterogeneous Population of Critically Ill Patients. Mayo Clin Proceed 2003; 78:1471-8. 
10. Pomposelli et.al, J Parenter Enteral Nutr. 1998;22:77-81- Early postoperative glucose 
control predicts nosocomial infection rate in diabetic patients 
11. Mendez C, Tanenberg R, Mok K, Calles-Escandon J, Ata A, Umpierrez, G.  Increased 
Glycemic Variability is Independently Associated with Length of Stay and Mortality in 
Non-Critically Ill Hospitalized Patients.  Diabetes Care.  Published Online ahead of print 
Oct 29, 2013 
12. EASD OP57. 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.  A.M. Gomez, G.E. Umpierrez, P. Aschner, F. Herrera, O. Muñoz; 
Endocrinology, Hospital Universitario San Ignacio, Bogota, Colombia, Endocrinology, 

 
 
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Emory University School Of Medicine, Atlanta, GA, USA. Tuesday, Sep 24, 2013, 3:30 
PM - 3:45 PM 
13. EASD OP59-The safety and efficacy of a subcutaneous continuous glucose monitoring 
system compared to point of care measurement in critically ill patients: a randomised 
controlled trial.  D.T. Boom, S. Rijkenberg, S. Kreder, M.K. Sechterberger, P.H.J. van der 
Voort; Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands, Internal 
Medicine, Academic Medical Centre Amsterdam, Amsterdam, Netherlands.  Tuesday, Sep 
24, 2013, 4:00 PM - 4:15 PM 
14. EASD OP60- Continuous glucose monitoring at the intensive care unit: nursing workload 
reduction and cost-benefit analysis. M.K. Sechterberger, J.H. DeVries, P.H.J. van der 
Voort;  Internal Medicine, Academic Medical Centre, Amsterdam, Netherlands, Intensive 
Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands. Tuesday, Sep 24, 2013, 4:15 
PM - 4:30 PM 
15. Dexcom Investigator’s brochure for Dexcom Investigational Use Only  Continuous 
Glucose Monitoring (IUO CGM) System, 2018  
 
 

 
 
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Appendix A 
 
 
 

 
 
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Appendix B 
 
 
 
 

 
 
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Appendix C 
 
 

 
 
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Statistical Analysis Plan 
Statistical analysis was conducted in a subset of N=110 participants with T2D using Dexcom G6 
and N=47 participants with T1D using Dexcom G6.  
Baseline demographics will be determined to describe the population of patients served over the 
five year time period.  For both type 1 and type 2 patients, glucose data will be analyzed for 
percentage of CGM values in the target range (70-250 mg/dl), rates of hypoglycemia (<70 mg/dL) 
and rates of hyperglycemia (>250 and 300 mg/dL). IBM SPSS Statistics v24 will be used to 
calculate individual and group rates for the specified outcomes; group means will be compared 
using ANCOVA procedures that incorporate relevant covariates (e.g., age, gender, length of stay).  
 
Sample Size 
IBM SPSS Sample Power 3 was used to calculate the projected sample size needed in patients 
with type 2 diabetes to detect a 4.2% absolute difference (5% relative difference) between groups 
for the diabetes type 2 primary outcome [Aim 2] (i.e., % of CGM readings in the target range of 
70-250 mg/dL). The comparison/baseline effect size was estimated at 85.4% based on pilot data 
in the target population, resulting in a target outcome of 89.6% based on the above-stated 
difference between groups. With a sample size of N=110 and alpha of .05, power will be 0.80 to 
detect this effect size, thus indicating adequate statistical power for our diabetes type 2 primary 
aim (Aim 2). This sample size will also provide sufficient power to examine secondary 
outcomes, percentage of values < 70 and >300 mg/dL; the between-group comparison of 
percentage of values < 250 mg/dL will remain purely exploratory.  
 
Analyses 
Of the early participants enrolled, Dexcom G4 and G5 CGM devices were used.  Pilot analyses 
of TIR were conducted and reported as preliminary outcomes. A full evaluation and analyses 
were conducted on a subset of the total enrolled participants who were placed on Dexcom G6 
devices.   
Analyses of T2D Subgroup: 
A total of 110 adults ≥18 years old, Spanish or English speaking, with type 2 diabetes (T2D) and 
three POC or serum values >200 mg/dL in the last 24 h, requiring subcutaneous insulin, were 
admitted to a non–intensive care unit (ICU) floor at Scripps Mercy Hospital (San Diego, CA) 
and enrolled in an RCT for ≥18 h. Pregnancy, intravenous insulin, adhesive allergy, anticipated 
computed tomography/MRI/diathermy procedures in next 24 h, or any condition deemed 
contraindicated were reasons for exclusion. The Scripps Health Institutional Review Board (San 
Diego, CA) approved the study.  

 
 
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After informed consent, enrollment, and randomization, a Dexcom G6 was placed by a research 
assistant or nurse. Blinded CGM data were used for evaluation only in usual care (UC) (standard 
POC testing protocol;n= 53). Data in the RT-CGM group (n= 57) were wirelessly transmitted 
from a bedside smartphone to secure Health Insurance Portability and Accountability Act–
compliant, monitoring platforms: Dexcom FOLLOW and CLARITY. To target a hospital time in 
range (TIR) of 70–250 mg/dL, hospital telemetry monitored RT-CGM data in FOLLOW on an 
iPad and notified nursing of hyperglycemia (>250 mg/dL, 9:00 p.m.–4:00 a.m.) and trends 
toward hypoglycemia (<90 mg/dL, 24 h/day) for rapid treatment per protocol (Real-Time 
Adjustments. Of note, because CGM was not U.S. Food and Drug Administration–approved for 
hospital use, confirmatory POC testing was conducted before treatment, and RT-CGM 
participants were still monitored via the hospital’s standard POC protocol (∼4 times/day). All 
previous antihyperglycemic agents were discontinued, and participants were placed on the 
hospital subcutaneous insulin protocol to standardize glucose management across groups. A 
diabetes advanced practice nurse conducted the POC review for all participants and remotely 
monitored CGM trends in CLARITY and collaborated with hospitalists to make standardized 
algorithm-based insulin adjustments using trends noted to optimize therapy in the RT-CGM only 
(Daily Adjustments). 
Baseline characteristics were examined to evaluate randomization using χ2,t, and Mann-Whitney 
tests. Restricted maximum likelihood was used in a linear effects model to evaluate concordance 
between CGM and POC values. Participant-level CGM metrics included CGM duration, glucose 
mean, SD, and coefficient of variation, and percentage of TIR (70–180, 70–200, 70–250 mg/dL) 
and time in hyperglycemia (>250, 300 mg/dL) and hypoglycemia (<70, 54 mg/dL). Outcomes 
were tested in unadjusted linear regression models with group as a fixed effect, unless otherwise 
specified. Results reported in the text are regression coefficients (β) for the group effect and 
represent expected mean differences between RT-CGM (coded 1) and UC (coded 0). 
Hypoglycemic events (≥20 min <54 or 70 mg/dL) were descriptively analyzed to document the 
number of participants with one or more event and the number/participant and event duration. 
All analyses were conducted in R 3.5.3 software. 
 
Analyses of T1D Observational Subgroup: 
Continuous glucose monitoring as SOC data are entered in Research Electronic Data Capture 
(REDCap). Patient data are obtained via the EMR through an automated data acquisition 
platform built into Snowflake Data Cloud (Snowflake Inc, Bozeman MT). Continuous glucose 
monitoring data for each encounter are downloaded via Dexcom CLARITY. 
Data are presented for type 1 diabetes (T1D). Data are presented descriptively. Categorical data 
are described as frequencies/percentages, and continuous data as means and standard deviations, 
or medians and interquartile ranges (IQRs), if skewed. Encounter-level CGM metrics included 
CGM duration, glucose mean and standard deviation, coefficient of variation, and several TIR, 

 
 
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time-above-range, and time-below-range metrics, as well as hypoglycemic events (as previously 
described). The POCT/CGM concordance was calculated using encounter-level and overall 
mean absolute relative differences (MARDs) and is displayed via a Clarke Error Grid (CEG) 
using the “ega” package in R. Comorbidity data were reported based on International 
Classification of Diseases (ICD) code classification using the “comorbidity” package in R. 
All data processing and analyses were conducted in R v. 4.0.3.