Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Sponsor: Korey Hood

 
Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes 
Version 1.3 (Version that Received FDA Approval) 
December 22, 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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CHAPTER 1: INTRODUCTION 
 
1.1.  Purpose 
  
The primary objective of this pilot project is to examine the impact of continuous glucose monitoring (CGM) on 
families with newly diagnosed children with type 1 diabetes (T1D). This randomized clinical trial compares newly 
diagnosed T1D youth who are started on CGM (the intervention group) versus those who are not (the control 
group). We will examine group differences over a 6-month period (Phase 1) on two sets of outcomes. The first set 
of outcomes includes psychosocial variables such as parents’ diabetes-related distress, hypoglycemic concerns, 
broad markers of parent stress, anxiety and sleep quality, and health-related quality of life. In this set of 
psychosocial outcomes, health-related quality of life is the identified primary endpoint. The second set of outcomes 
includes glycemic variables such as time spent in range, hemoglobin A1c, and C-peptide. In this set of glycemic 
outcomes, time spent in target range is the identified primary endpoint. After the initial comparison of intervention 
to control across the first six months after diagnosis, we will conduct a longitudinal follow-up (Phase 2) of glycemic 
and psychosocial variables for an additional 18 months. 
 
1.2.  Background 
1.2.1.  Current landscape of type 1 diabetes management.  Type 1 diabetes management is complex and demanding.  
The T1D regimen requires frequent blood glucose monitoring, precise timing and dosing of insulin administration, 
and consideration of dietary intake and physical activity. Each individual task by itself is demanding, but the 
integration of them all adds a high degree of complexity. Achieving optimal diabetes control remains elusive for 
many families with children with T1D 1,2.   
 
1.2.2.  Current approaches to diabetes treatment in newly diagnosed youth.  There is some variability with 
treatment approaches in the United States. However, most diabetes centers base their standards of care on the 
Clinical Practice Guidelines published annually by the American Diabetes Association in Diabetes Care. That is the 
case for both clinical sites in this study. A general framework of diabetes care initiated at diagnosis of type 1 
diabetes is depicted in Figure 1 using a swim lane diagram. While this is specific to care delivered at Stanford, this 
is the same approach to care delivered at the Barbara Davis Center. 
 
 
 

 
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Figure 1. New Onset Flow Chart 
 
 
The diabetes clinics at Stanford and Barbara Davis Center both initiate treatment with multiple daily injections of 
rapid acting insulin analogs and 1-2 injections per day of long acting insulin (glargine or detemir). At both sites, 
basal-bolus regimens are the first line of insulin treatment and frequent monitoring (over the phone or email) and 
face-to-face visits with the clinical care team will help to fine-tune dosages. Parents and youth (typically starting at 
age 10) are taught procedures for injecting insulin as well as time periods to check blood sugar to understand 
insulin action. They are discouraged from administering rapid acting insulin unless three hours have passed (i.e., 
avoid insulin stacking). In addition to nutrition therapy via carbohydrate counting, families are recommended to 
do 6-10 fingersticks per day to monitor blood sugars. Substantial education is provided through additional 
materials including Understanding Diabetes (known to many as the Pink Panther book) written by Drs. Peter Chase 
and David Maahs at the Barbara Davis Center. The 13th edition of this book is given to new onset families and also 
accessible online at the Barbara Davis Center website (www.barbaradaviscenter.org) under online books. Both 
sites give this book to new onset families. In addition, supplemental education handouts are typically provided as 
well by the diabetes education. As an example, the supplemental education materials from the Stanford site are 
included in the Appendix.  
 
With CGM and insulin pump use becoming more common, more families are interested in adding these 
technologies to the treatment regimen sooner. Many providers do not start using CGM or insulin pumps until at 
least 3-6 months after diagnosis and previous wisdom was to wait until at least 12 months from diagnosis to move 
to the insulin pump. Even if a family with experience in treating type 1 diabetes (such as a parent or sibling with 

 
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T1D), insurance may reject coverage for insulin pumps and CGM prior to 6 months of T1D diagnosis. Research data 
on the initiation of CGM use soon after diagnosis would be helpful to update and possibly improve on the treatment 
of newly diagnosed youth with T1D.  
 
1.2.3. Evidence of safety and efficacy of CGM.  Recent data suggest that youth with T1D using CGM can achieve 
lower hemoglobin A1c values and experience fewer hypoglycemic events than non-CGM-using youth 3,4. 
Even with relatively older and less reliable CGM systems, parents of youth with T1D often reported relatively high 
levels of satisfaction. However, little else is known about parents’ responses to CGM. We do know that parents of 
youth with T1D are often highly distressed at diagnosis and over the course of many years, partly due to their 
sense of powerlessness in the face of often wild swings in their child’s mood and glucose levels as well as their 
fears and worries concerning the ever present danger of hypoglycemia 5-7. A goal of this project is to better 
understand whether the introduction of CGM in youth with T1D at diagnosis might allay parents’ fears, more 
broadly ease their sense of diabetes-related distress and foreboding, and impact glycemic variables measured 
during the first year of T1D. 
 
1.3.  Preliminary studies  
We have extensive experience using sensors, pumps, and new technology. Both the Stanford and University of 
Colorado groups participated in the NIH sponsored metabolic control at the onset of diabetes study where newly-
diagnosed children received three days of closed-loop therapy within a week of diagnosis and then were 
maintained on sensor augmented pump therapy for one year 8. Stanford and University of Colorado were two of 
the three centers conducting the predictive low glucose suspend (PLGS) in-home studies 9 and have worked 
together on DirecNet studies and the JDRF randomized clinical trial of CGM, as well as full day and night closed-
loop studies using automated delivery systems.  
 
All of the investigators involved in these studies have extensive experience in continuous glucose monitoring and 
artificial pancreas development.  Our study groups have worked well together since the onset of the  NIH-funded 
Diabetes Research in Children Network (DirecNet).  Since 2001 DirecNet has conducted numerous protocols 
involving CGM in which both centers participated in equally.  Both centers also were leaders in the JDRF-funded 
CGM Randomized Clinical Trial (RCT) comparing CGM to standard care 10. Dr. Buckingham was the PI at Stanford 
on the STAR-1 randomized trial of continuous glucose monitoring 11. Drs. Chase and Slover at the University of 
Colorado were major participants in the STAR-3 trial of sensor augmented pumps.  Dr. David Maahs was the PI for 
the recent treat-to-range studies at the University of Colorado. As part of these studies, we all have gained 
extensive experience using the Medtronic Paradigm REAL-Time Insulin Pump and CGM System.   
 
The Metabolic Control study (IDE G080204) was an NIH-sponsored study to determine if tight glucose control 
beginning within the first week of diagnosis of diabetes will be of benefit in maintaining endogenous insulin 
production. We have over 700 hours of experience using this system at Stanford, and two of the centers doing this 
study (Stanford and University of Colorado) have amassed over 1,400 hours of inpatient data without any severe 
adverse events.  
 
In a recent pilot study conducted at Stanford, Barbara Davis Center, and Indiana University (PIs Buckingham & 
Hood) called Using Behavioral Supports for Diabetes Devices in Young Children with Type 1 Diabetes, 17 families 
with a child under the age of 6 with type 1 diabetes were enrolled. All participants were on CGM and as part of 
assessment procedures, parents completed food, insulin, and meter blood glucose logs (7 days pre-intervention 
and 7 days post-intervention). On those logs, 8 noted they were using non-adjunctive CGM data to make diabetes 
treatment decisions. Logging of this information was not required as part of the study and it is not known if the 9 
participants who did not indicate so had used non-adjunctive CGM data to make treatment decisions. The age 
range of the 8 participants who had indicated non-adjunctive CGM use at the time of enrollment was 2 to 5 years. 
Duration of diabetes was between 1.08 and 4.67 years (mean 2.25, SD 1.13 years). Frequency of CGM use prior to 
study enrollment ranged from 7 to 30 days per month (mean 26 days, SD 8.39 days). Over 90% were using the 
Dexcom G4 system, some with active Share remote monitoring. 

 
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In sum, our research teams have a great deal of experience utilizing diabetes devices and technologies, including 
CGM, in young people with T1Dand we have collaborated extensively in the past. 
 
 

 
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CHAPTER 2: STUDY PROTOCOL 
 
2.1.  Synopsis of study protocol 
 
This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on CGM (the 
intervention group) versus those who are not (the control group). We will examine group differences over a 6-
month period (Phase 1) on two sets of outcomes: psychosocial variables and glycemic variables. After the initial 
comparison of intervention to control across the first six months after diagnosis, we will conduct a longitudinal 
follow-up (Phase 2) of glycemic and psychosocial variables for an additional 18 months. The CGM system used in 
this study is the Dexcom G5 System with the Share function (FDA Approved). An IDE will be obtained to use this 
system in a non-adjunctive manner. Participants will complete Phase 1 in six months. Phase 2 includes 3 more 
assessments conducted every six months until participants are two years post-diagnosis. 
 
2.2.  Study Procedures 
 
Participants will be recruited at two centers: Stanford University and the Barbara Davis Center for Diabetes, 
University of Colorado. Participants will be enrolled while inpatient or within 1 month of diagnosis. Based on data 
over the past year, we anticipate at least 15 new diagnoses each month at these two centers, with at least 10 in the 
eligible age range. Once identified, study staff will approach potential participants to explain the study, determine 
eligibility, and obtain informed consent. Once enrolled in the study, participants will be randomized. We will 
randomize at a 2:1 ratio, intervention to control. We will also stratify by age group to ensure equal representation 
of ages across groups. The age groups (in years) are 2-6, 7-11, and 12-17. To ensure safety in the youngest group, 
recruitment of participants in the age 2-6 years group will not begin until we have at least 2 weeks of non-
adjunctive CGM use data in at least 3 participants aged 7-17 years. Data will be reviewed by the DSMB on these 3 
participants and if deemed safe by the DSMB, we will start enrolling participants in the youngest age group. 
 
2.3.  Study Groups 
 
There are two groups in this pilot study: intervention and control. After randomization, participants in the 
intervention group (CGM) will receive standardized education about CGM and its use. This session can take up to 
120 minutes and will focus largely on adjunctive use and other foundational aspects of education about CGM use. 
After a two-week period of adjunctive use, families will receive another training (up to 120 minutes) that will 
reinforce some of the content on CGM use and introduce and train on non-adjunctive use of the Dexcom G5 system. 
The procedures for non-adjunctive use are detailed below in section 2.5. and families will be informed that they 
have the freedom to check and rely on blood glucose via fingerstick any time the child or parent notices a potential 
discrepancy between CGM and fingerstick values. Families will be given handouts that contain information in 
sections 2.5. Families will also be provided with accuracy tables 3-D, 11-B, and 12-B from the Dexcom manual and 
will be instructed on the accuracy of sensor values at different readings. This information, along with all that is 
given as handouts to study participants, will also be given to the healthcare team. A person trained in delivering 
education about CGM will deliver the education about CGM use and will insert the first sensor at the first training. 
This individual will be available to assist with questions from participating families. In addition, Dexcom 
representatives are available to the family for technical questions or issues with the system, just like the access any 
Dexcom user has. Families randomized to the intervention group will be required to actively use CGM for 6 months. 
After six months, they can continue or discontinue use of CGM. If they decide to continue, the study team will work 
with the diabetes care team to assist them with obtaining CGM via the standard clinic and insurance procedures. 
 
Families randomized to the control group will receive usual care for T1D and take part in blinded CGM one week 
per month. Blinded CGM use entails insertion of a Dexcom sensor and calibration of the system using blood glucose 
meter values at system start up, every 12 hours thereafter, and any time the system requests a calibration value. At 
six months, they will receive training and supplies for the next six months to start non-adjunctive use of CGM. They 
will receive the exact training, education, and monitoring delivered to the intervention group and described earlier 
in this section. At 12 months, if they decide to continue to use CGM, the study team will work with the diabetes care 
team to assist them with obtaining supplies via the standard clinic and insurance procedures. 

 
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2.4.  Rationale for non-adjunctive use of CGM in this study 
 
The use of CGM in newly diagnosed youth with T1D offers a unique opportunity to teach diabetes management in 
the manner that is expected to be more common in several years. Increasingly, individuals with T1D who use CGM 
make treatment decisions based on the information obtained from CGM instead of fingerstick glucose values done 
by blood glucose meters. Further, as the safety and accuracy of these CGM systems has improved and can actually 
surpass the accuracy of many meters, more treatment decisions are made in a non-adjunctive manner. 
 
The Dexcom G5 System with Share is FDA approved and this Dexcom system and all other CGM systems approved 
by the FDA are indicated for use as adjunctive devices. The Dexcom G5 Mobile system is approved via a CE mark 
for non-adjunctive use and can be used as the primary source of glucose information for diabetes management. In 
other words, information about glucose levels provided by CGM can be used to make diabetes treatment decisions. 
Thus, there are trends toward non-adjunctive use of CGM in both patient populations and from industry. This study 
will provide data on non-adjunctive use and provides a unique group to test this in – individuals who do not have 
working knowledge of adjunctive use or blood glucose meter treatment decisions. 
 
2.5.  Procedures for non-adjunctive Use of CGM 
 
Participants in this study will be taught to use CGM in a non-adjunctive manner that is consistent with the language 
included in Dexcom’s CE mark. Participants – youth with T1D and their caregivers – will be taught the following in 
their initial education session with CDE and will be provided with this information in a handout. Of note, 
participating families are able to seek out other devices (e.g., insulin pump) and start them during the course of the 
study. We will track this information, but neither encourage or discourage use. The study-specific CGM education 
and informational handout will be provided by the research team. The study team (CDE in particular) will review 
the following guidelines and note that alert and alarm settings on the CGM system should be set in consultation 
with the diabetes care team. 
 
Instructions for non-adjunctive CGM use with Dexcom G5 Share 
 
1. If your glucose alerts and readings from your Dexcom G5 do not match your symptoms or expectations, use 
a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. 
 
2. Discuss with a  healthcare provider on your study team  how you should use the information displayed on 
the Dexcom G5 to help manage your diabetes. 
 
3. Taking medications with acetaminophen while wearing the Dexcom G5 may lead to inaccurate glucose 
readings generated by the Dexcom G5. The level of inaccuracy depends on the amount of acetaminophen 
active in your body and is different for each person.  Do not rely on CGM data produced by the Dexcom G5 if 
you have recently taken acetaminophen. Keep in mind that some cold medicines contain acetaminophen. If 
you are not sure if your medication contains acetaminophen, contact your health care provider before 
taking the medication. 
 
4. If your Dexcom G5 does not display a sensor glucose reading or if you are getting inconsistent readings, use 
a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. 
 
5. Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do not match your 
symptoms or expectations, you should obtain a fingerstick blood glucose value from your blood glucose 

 
7 
 
meter to make diabetes treatment decisions or seek immediate medical attention. 
 
6. Calibrate the Dexcom G5 at least once every 12 hours. The Dexcom G5 needs to be calibrated in order to 
provide accurate readings. Do not use the Dexcom G5 for diabetes treatment decisions unless you have 
followed the prompts from the device and calibrated every 12 hours after the initial calibration.  
 
7. Make diabetes treatment decisions based on the combination of the sensor glucose reading, trend arrow, 
trend graph, and/or actionable alerts generated by the Dexcom G5. If you plan to administer insulin for a 
sensor glucose reading over 300 mg/dl, you should be conservative with dosing and possibly double-check 
sensor value with fingerstick blood glucose before administering a correction dose. 
 
8. If your sensor glucose is below 40 mg/dl, you get a “LOW” on your display device. You may have very low 
blood sugar requiring immediate treatment based on your health care professional’s guidance.  To be safe, 
treat first. After treating, make sure your glucose is very low by doing a fingerstick for a BG measurement. 
 
9. If your sensor glucose is above 400 mg/dl, you get a “HIGH” on your display device. You may have very high 
blood sugar requiring immediate treatment based on your health care professional’s guidance. To be safe, 
first make sure your glucose is very high and do a fingerstick for a BG measurement. Treat based on your 
BG measurement. 
 
There are three keys when making decisions based on your Dexcom G5. Without all three, you won’t have all the 
needed information to make a correct treatment decision. 
 
To help you remember the three key pieces, think of TAG: 
 
T-Trend: Trend Dots 
 
Make sure trend graph has three back-to-back readings within the last 15 minutes 
 
A-Arrow: Trend Arrow 
 
Your trend arrow telling you the speed and direction of your glucose 
 
G-Glucose: Sensor Glucose Readings 
 
If you do not have TAG do not make any treatment decisions using your Dexcom G5 
 
Possible Scenarios to use TAG: 
 
Scenario 1:  You have consistent trend dots for the past hour (T), the arrow is to the right 
 (A), and the glucose 
reading is 243 mg/dl. In this situation, you first consider whether you need to administer a correction insulin dose 
because you have consistent information and a flat arrow to the right showing steady sensor values. In this 
situation, you would check to see if any rapid acting insulin has been administered in the past 3 hours. If so, you 
will wait until the three hours is up and then re-assess using TAG. If it has been 3 hours or longer since the last 
rapid acting insulin injection (or bolus), you will plug the sensor value in to the equation you came up with your 
clinical care team and decide on the appropriate insulin dose. 
 

 
8 
 
Scenario 2:  You do not have all three pieces of information for TAG and want to administer insulin. In this case, 
you will resort back to blood glucose readings and make treatment decision based on rules provided by your 
clinical care team. 
 
Scenario 3:  You have consistent trend dots for at least the past 15 minutes (T) and your glucose reading is 174 
mg/dl (G). Your trend arrow is straight down 
  (A). Before administering insulin or taking fast-acting 
carbohydrates, you should “watch and wait” for 15 minutes and re-assess TAG at that time. Do not administer 
insulin until you no longer have a down arrow. Possibly treat with fast-acting carbohydrates if sensor value 
approaches your low threshold or the arrow is still going straight down. 
 
 
 

 
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Table 1. Possible actions based on sensor glucose reading and trend arrows 
 
Screen 
Possible actions based on sensor glucose reading’s trend arrows 
Arrows 
Low Glucose 
High Glucose 
Target Glucose 
 
No arrows/no sensor 
glucose readings. 
  
Use BG meter, not Dexcom 
G5, to make treatment 
decision. 
No arrows/no sensor 
glucose readings. 
  
Use BG meter, not 
Dexcom G5, to make 
treatment decision. 
No arrows/no sensor 
glucose readings. 
Use BG meter, not 
Dexcom G5, to make 
treatment decision. 
 
May need to eat a snack or 
a fast acting 
carbohydrate. 
May adjust insulin to 
correct a high sensor 
glucose reading to reach 
target range. 
  
Do not take multiple 
insulin doses too close 
together in time. 
  
Think about your trend 
graph and recent 
Alarm/Alerts. 
Based on last meal or 
insulin dose, may need 
to take insulin or eat a 
snack to stay within 
target. 
  
Do not take multiple 
insulin doses too close 
together in time. 
 
Watch and wait. 
May adjust insulin to 
correct a high sensor 
glucose reading to reach 
target range. 
  
Do not take multiple 
insulin doses too close 
together in time. 
  
Think about your trend 
graph and recent 
Alarm/Alerts. 
Based on last meal or 
insulin dose, may need 
to take insulin to stay 
within target. 
  
Do not take multiple 
insulin doses too close 
together in time. 
 
Watch and wait. 
Make sure you did not 
over treat for a low. 
May adjust insulin to 
correct a high sensor 
glucose reading to reach 
target range. 
  
Do not take multiple 
insulin doses too close 
together in time. 
  
Think about your trend 
graph and recent 
Alarm/Alerts. 
If not with a recent meal 
or snack, may take 
insulin to stay within 
target range. 
 
Watch and wait. 
Make sure you did not 
over treat for a low. 
May adjust insulin to 
correct a high sensor 
glucose reading to reach 
target range. 
  
Do not take multiple 
insulin doses too close 
May need to take insulin 
to stay within target. 
  
Do not take multiple 
insulin doses too close 
together in time. 

 
10 
 
together in time. 
  
Think about your trend 
graph and recent 
Alarm/Alerts. 
 
May need to eat a snack or 
fast acting carbohydrate. 
  
Was last insulin dose too 
high or activity too 
strenuous? 
Based on last insulin 
dose or activity, may 
need to watch and wait 
to reach your target 
range. 
  
Think about your trend 
graph and recent 
Alarm/Alerts. 
May need to eat a snack 
or fast acting 
carbohydrate. 
 
May need to eat a snack or 
fast acting carbohydrate. 
  
Was last insulin dose too 
high or activity too 
strenuous? 
Based on last insulin 
dose or activity, may 
need to watch and wait 
to reach your target 
range. 
  
Think about your trend 
graph and recent 
Alarm/Alerts. 
May need to eat a snack 
or fast acting 
carbohydrate. 
 
 
May need to eat a snack or 
fast acting carbohydrate. 
  
Was last insulin dose too 
high or activity too 
strenuous? 
Based on last insulin 
dose or activity, may 
need to watch and wait 
to reach your target 
range. 
  
Think about your trend 
graph and recent 
Alarm/Alerts. 
May need to eat a snack 
or fast acting 
carbohydrate. 
 
 
 
2.6. Coordination of Study Procedures with Clinical Care 
 
All study participants will receive clinical care by staff in their respective diabetes centers. Staff at both sites 
include pediatric endocrinologists, nurses, nurse practitioners, certified diabetes educators, social workers, 
psychologists, and dietitians. As noted and depicted earlier in section 1.2.2., care for newly diagnosed youth with 
type 1 diabetes and their families includes frequent contact, extensive education, and materials and guides 
provided to all families. Clinical care teams will teach families who enroll in this study about insulin administration, 
nutrition therapy (e.g., carbohydrate counting), and blood glucose monitoring. If families start on an insulin pump 
during the course of the study, that will be coordinated by the clinical care team and study staff will not be part of 
that decision making or training. In sum, care for new onset type 1 diabetes will be delivered by the clinical care 
team and this care is consistent with clinical practice guidelines and clinician expertise. 
 
The study staff has the primary role of initiating CGM (at the start of the study with intervention participants and 
after six months with control participants) and training participants on non-adjunctive use. Clinical care staff will 
be informed about which of their clinic patients are study participants and which are actively engaged in non-
adjunctive use of CGM. The clinical care team will also be provided with the educational materials given to study 
participants. The clinical care team will be informed about use of Dexcom software so that they may review study 

 
11 
 
participant CGM data. Further, the following scenarios may be encountered and if they occur, they will be reported 
to the clinical care team: 
• 
Upon review of CGM, more than 5% of values fall below the threshold for hypoglycemia (<60 mg/dl). 
• 
Upon review of blood glucose meter downloads (all participants), more than 10% of values fall below the 
threshold for hypoglycemia (<60 mg/dl). 
• 
Any evidence of insulin stacking reported by participants to study staff or apparent on a download (if 
download includes any insulin administration details). 
2.7. Study Visits and Measurements   
 
Study visits for both groups will occur at baseline, 13 weeks, and 26 weeks post randomization in Phase 1. Baseline 
is the date they complete the first assessment, which will have to be within the first month since diagnosis of T1D. 
These visits should be within ±2 weeks of the scheduled visit and will typically be done before or after a scheduled 
diabetes center outpatient visit. All participants receive these 3 comprehensive assessments.  
 
After the initial six-months of the study, we will obtain data from participants at 12, 18, and 24 months post-
diagnosis (Phase 2). We will conduct these assessments to examine changes over time in glycemic and 
psychosocial variables.  
 
Assessment components are included in Table 2 for Parents and Table 3 for Youth. 
 
 
 

 
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Table 2. Assessment battery for Parents 
 
Measure 
Construct Measured / Relevant Points 
Number of Items / 
Time to Complete 
Psychosocial Outcomes 
Parents’ Diabetes 
Distress 
The Problem Areas in Diabetes, Pediatric 
version (PAID-P).  The PAID-P is a validated 
tool used to assess parental burden related to 
diabetes management. 
The Parent Diabetes Distress Scale (PDDS).  
This is a validated tool to assess how diabetes 
care impacts on parents’ quality of life.   
20 items. 5-10 
minutes to complete. 
 
6 items, 2 – 3 minutes 
to complete. 
Parents’ Psychological 
Distress 
The PHQ-9 and the State-Trait Anxiety 
Inventory will be used to assess depressive and 
anxiety symptoms. These symptoms represent 
the general construct of psychological distress. 
9 items on PHQ-9 (5 
minutes) and 40 items 
on STAI (10 minutes) 
Parents’ Sleep Quality 
An abbreviated version of the Pittsburgh Sleep 
quality Index, a validated tool for assessing 
self-reported sleep quantity and quality, will be 
developed for this project.   
7 items, 2 – 3 minutes 
to complete.   
Parents’ Hypoglycemic 
Fear 
The Hypoglycemic Fear Survey-Parents (HFS-
P) is a validated tool to assess parents’ anxiety 
and behavior concerning possible 
hypoglycemia.   
25 items, 5 – 10 
minutes to complete 
Parents’ Hypoglycemic 
Confidence 
A new version of the Hypoglycemic Confidence 
Questionnaire, modified for use by parents, 
will be developed for this project.   
7 items, 2 – 3 minutes 
to complete 
Health-related quality of 
life 
Parents will complete the generic version of 
the Pediatric Quality of Life Inventory 
(PedsQL) to provide a report of their 
perception of the child’s quality of life. This 
cuts across social, emotional, academic, and 
health domains. 
25 items. 5-10 
minutes to complete. 
Satisfaction with 
Diabetes Technology 
We will use our CGM Satisfaction Scale from 
JDRF and DirecNet studies (developed by Tim 
Wysocki, PhD).  
 
 
The Glucose Monitoring System Satisfaction 
Survey (GMSS-T1D) is a validated tool used to 
assess treatment satisfaction with glucose 
monitoring devices and its impact on quality of 
life and other patient-reported outcomes. 
43 items. 5-10 
minutes to complete. 
 
 
 
15 items. 5-10 
minutes to complete. 

 
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Use and Comfort with 
Technology 
Objective questions documenting the 
frequency of use and types of technologies 
used. Both general (e.g., smartphone) and 
diabetes-specific (e.g., trend program). 
20 items. 5 minutes to 
complete. 
Demographic and 
Family Data 
Parents will complete a questionnaire on the 
family’s structure, racial and ethnic 
background, indicators of socioeconomic 
status, insurance status (public vs. private), 
and other essential characteristics. 
5 minutes  
Behavioral Outcomes 
Diabetes management 
behaviors 
Blood glucose monitoring frequency (by meter 
download); adherence to injections/pump 
boluses;  
Download (no time 
burden for 
participants) 
Health care utilization 
Number of visits and calls to the diabetes care 
team 
Tracking by interview 
(10 minutes to 
complete) 
Placement of sensor 
Parents will log placement of sensor based on 
Dexcom manual table on page 75. A quadrants 
on the front abdomen and B locations on back 
of body will be noted. 
 
 
 
Table 3. Assessment Battery for Youth 
 
Measure 
Construct Measured / Relevant Points 
Number of Items / 
Time to Complete 
Psychosocial Outcomes 
Diabetes Distress 
The Problem Areas in Diabetes (PAID) – 
Teen, Diabetes Burden is a measure of 
diabetes-specific burden. Items focus on 
degree to which diabetes impacts areas of 
everyday functioning. Strong correlations 
with clinical outcomes. 
 
The Diabetes Distress Scale (DDS) is a gold 
standard measure for understanding 
distress symptoms related to diabetes.  
26 items. 7 minutes 
to complete.  
 
 
 
 
17 items. 5 minutes 
to complete.  
Psychological Distress 
The Center for Epidemiologic Studies – 
Depression (CES-D) is a widely used 
measure to assess psychological distress 
20 items. 5 minutes 
to complete. 

 
14 
 
and depression. 
Health-Related Quality 
of Life 
The Child Health Utility-9D (CHU-9D) is a 
pediatric generic preference based 
measure of health-related quality of life. 
 
The Pediatric Quality of Life Inventory 
(PedsQL) Diabetes module measures 
diabetes-specific health-realted quality of 
life. 
9 items. 5 minutes to 
complete.  
 
 
28 items. 5 minutes 
to complete. 
 
Hypoglycemic 
Confidence 
This 8 item survey has questions about the 
level of confidence that hypoglycemia can 
be addressed in different situations. 
8 items. 3-4 minutes. 
Health Literacy 
The Diabetes Numeracy Test is a widely 
used measure of diabetes numeracy. This 
diabetes-specific measure has been shown 
to be linked with health outcomes and 
health literacy.  
15 items. 5 minutes 
to complete.  
Cognition (Attention, 
Executive Functioning, 
Processing Speed) 
The NIH Toolbox offers standardized, 
validated assessments. Three modules are 
self-administered:  
 
The Flanker Inhibitory Control and 
Attention Test measures both a 
participant’s attention and inhibitory 
control. 
 
 The Dimensional Change Card Sort Test is 
a measure of cognitive flexibility. 
 
The Pattern Comparison Processing Speed 
Test measures speed of processing.  
 
 
 
 
3 minutes to 
complete. 
 
 
4 minutes to 
complete. 
 
3 minutes to 
complete. 
Satisfaction with 
Diabetes Technology 
We will use our CGM Satisfaction Scale 
from JDRF and DirecNet studies 
(developed by Tim Wysocki, PhD).  
 
The Glucose Monitoring System 
Satisfaction Survey (GMSS-T1D) is a 
validated tool used to assess treatment 
satisfaction with glucose monitoring 
devices and its impact on quality of life and 
other patient-reported outcomes. 
 
43 items. 5-10 
minutes to complete. 
 
 
15 items. 5-10 
minutes to complete.  

 
15 
 
 
Use of and Comfort 
with Technology 
Objective questions documenting the 
frequency of use and types of technologies 
used. Both general (e.g., smartphone) and 
diabetes-specific (e.g., trend program).  
20 items. 5 minutes 
to complete.  
Behavioral Outcomes 
Diabetes Management 
Behaviors 
The Diabetes Self Management Profile 
(DSMP) – Self Report is a validated tool 
used to assess daily diabetes management 
tasks including frequency of blood glucose 
monitoring, carbohydrate counting, and 
insulin administration. 
24 items. 7 minutes 
to complete. 
Health Outcomes 
HbA1c measurement  
Participants will provide a small 
fingerstick sample of blood (capillary) 
during their routine clinic visit. This will 
be done using the DCA in clinic or local 
CTRU. 
Gold standard 
measure of glycemic 
control 
Glycemic excursion 
measures 
Time in range (70 to 150 mg/dL); percent 
below 70 and 60 mg/dL as indicators of 
hypoglycemia, and above 150 and 250 
mg/dL as indicators of hyperglycemia; 
additional indices of variability including 
standard deviation will also be calculated 
 
C-peptide 
Fasting C-peptide collected at 0, 13, 52, 
and 104 weeks 
4 blood draws over 
24 months 
 
In addition, parents will be asked to complete a brief online survey (< 10 minutes) at the following intervals since 
randomization – 4, 8, 18, and 22 weeks. These online surveys will consist of the Diabetes Distress Scale (3 items), 
PHQ-9 (9 items), and the short form of the STAI (10 items). Additional questionnaires will be administered at study 
conclusion to ascertain CGM satisfaction (both perceived benefits and barriers), overall usability issues, and 
amount of time the device was used. All surveys can be completed online via RedCap. Families will receive a $40 
gift card for each assessment they complete. Participants 11-17 years of age will be asked to complete child/teen 
versions of several surveys. These include psychological distress, fear of hypoglycemia, and quality of life. They will 
not complete the phone call assessments. We will provide a $25 gift card to teens at each assessment. 
 
The following table highlights the planned timeline for study visits. 
Visit Number: 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Study Time: 
0 
4w 
8w 
13w 
18w 
22w 
26w 
52w 
78w 
104w 
History (medical and 
demographic) 
X 
 
 
 
 
 
 
 
 
 
Training on use of CGM 
(intervention only) 
X 
 
 
 
 
 
 
 
 
 
Adverse Events such as 
severe hypoglycemia 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 

 
16 
 
CGM downloads 
 
 
 
X 
 
 
X 
X 
X 
X 
Meter and CSII 
downloads (if 
applicable) 
 
 
 
X 
 
 
X 
X 
X 
X 
Training on use of CGM 
(control only) 
 
 
 
 
 
 
X 
 
 
 
Local HbA1c 
X 
 
 
X 
 
 
X 
X 
X 
X 
Fasting C-peptide 
X 
 
 
X 
 
 
 
X 
 
X 
Full Psychosocial 
Questionnaires 
X 
 
 
X 
 
 
X 
X 
X 
X 
Brief Online 
Psychosocial Survey 
 
X 
X 
 
X 
X 
 
 
 
 
 
In addition, participating families will be contacted once weekly for the first four weeks, and once every four weeks 
after to remind to upload Dexcom receiver via Dexcom Clarity website and software. The study team will provide 
technical assistance if required to upload the Dexcom receiver data. 
 
2.8 Study population 
 
The patient population is children with type 1 diabetes and their parents. Parents (18 years and older) will provide 
informed consent for their own participation and parental permission for their child to participate. Youth 11 years 
of age and older will provide assent for their own participation. In order to have at least 60 subjects complete the 
protocol, we will enroll  up to 75 youth with newly diagnosed T1D and randomize them to either the intervention 
(CGM, n=50) or control group (no CGM, n=25). 
 
2.8.1.  Eligibility criteria 
 
To be eligible for the study, a child must meet the following criteria: 
 
1. Diagnosis of type 1 diabetes according to ADA diagnostic criteria 
2. Time since diagnosis of no longer than one month  
3. Age between 2 and 17 years   
4. Parental consent (and assent from the child where applicable) to participate in the study  
5. No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in 
this clinical trial. 
 
To be eligible for the study, a parent must meet the following criteria: 
 
1. Parent or legal guardian of a child with type 1 diabetes meeting the “child” criteria outlined above 
2. Age of 18.0 years or older 
3. Parent comprehends written English 
4. Parent understands the study protocol and signs the informed consent document 
 
 
2.8.2.  Exclusion criteria 
 
The presence of any of the following is an exclusion for the study: 
 
1. Child has a medical disorder that in the judgment of the investigator will interfere with completion of any 
aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may 
hinder sensor application). 

 
17 
 
2. Child has a neurologic disorder that in the judgment of the investigator will affect completion of the 
protocol 
3. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would 
be a contraindication to participation in the study 
4. Child is unable to completely avoid acetaminophen for duration of study  
 
2.9. Data Analysis Plan 
Our team has extensive experience in database design and implementation, use of web-based assessment, 
data management, and data analysis. We will utilize the RedCap survey system to format all measures in to 
electronic form for completion online or in-person via computer or iPads. Data collected from participants will be 
housed on the RedCap server, which is encrypted and HIPAA-compliant, with secure access for unique study IDs 
assigned to each participant. RedCap survey data is then ready for download by study staff and will be imported to 
SAS 9.3 for data cleaning and analysis.  
First, we will document uptake of the study with a review of descriptive statistics for all relevant metrics 
(e.g., recruitment rate, proportion enrolled relative to patient population) as well as indicators of the acceptance of 
randomization and overall intervention components (i.e., is there variability in retention and satisfaction between 
treatment arms?). When needed, data will be displayed graphically using spaghetti plots for individual as well as 
grouped data.  
Second, in order to determine the preliminary efficacy of the intervention condition (CGM) compared to the 
control condition (standard care), linear mixed effects models will be used. A model will be run for each of the 
main endpoints, psychosocial distress and glycemic indices. The testable covariate in both cases will be treatment 
status (intervention or control). Linear mixed effects models were deemed most appropriate for these analyses 
due to the continuous nature of the variables, the longitudinal nature of the design, and our interest in testing 
within-individual change over time. PROC MIXED in SAS will be used for the linear modeling.  
In general, if missing data are realized, these linear models allow for data that are missing at random to be 
handled appropriately by incorporating relevant variables in the statistical model. We will also assess the degree of 
non-ignorable missingness present through investigating and reporting the impact of sensitivity analyses (e.g., 
pattern mixture models8) that allow for plausible non-ignorable missing data patterns on the model results. 
A total of 60 participants with newly diagnosed T1D will be enrolled. This sample size is based on our 
projections of ease in recruiting in the two clinical centers across the study time frame, the pilot nature of the 
proposed research, and sufficient sample size to project effect sizes for the larger efficacy trial. We are mindful of 
caution raised by biostatisticians in underestimating sample size for pilot clinical trials9 and thus have been 
conservative in our estimates. The estimate of 60 participants is predicated upon a longitudinal two-group test of 
significance with 4 time points, an effect size of 1σ on psychological distress and glycemic indices, up to 10% 
attrition at follow-up, and 80% power. Recognizing that estimates from small samples are imprecise, we will 
cautiously use summary measures from the pilot study to help determine the appropriate sample size for a larger 
trial, including effect sizes and the standard deviations of continuous outcome measures.  
 
2.10.  Expected duration of study participation 
 
Duration of study participation is expected to be 2 years.  
 

 
18 
 
CHAPTER 3: ADVERSE EVENT REPORTING AND SAFETY MONITORING 
 
3.1.  Overview of Safety Monitoring 
 
Study procedures are in place to monitor safety of participants and reduce risk for adverse events. These 
procedures come in two forms: those conducted by the study staff and conveyed to study participants, and those 
conducted by the study staff and conveyed to their diabetes care team. All participants will have glucose data 
reviewed at planned intervals and based on pre-determined cut points to determine safety. 
 
All participants, intervention and control, will have their glucose data reviewed weekly by study staff for the first 
month of study participation. All participants in the intervention group will have their CGM data reviewed daily in 
their first week of non-adjunctive CGM use (week 3 of the study). Those on CGM will be monitored via Dexcom 
Clarity download and those using only meters (control group) will be done via meter download (or review of faxed 
or emailed logbooks if family is not able to download meter at home). After the first month, this occurs once 
monthly, starting on week 6 of the study,for the remaining 5 months. The control group also wears a blinded CGM 
for one week each month and this data will be reviewed as well. We are examining these reports for adverse events 
and the potential of adverse events (e.g., hypoglycemia). When the control group starts use of CGM non-
adjunctively (month 7), they will follow the same pattern of data review that the intervention group did. 
 
3.2. Definition of Adverse Event 
 
Reportable adverse events in this study include any untoward medical occurrence that meets criteria for a serious 
adverse event or any medical occurrence (expected or unexpected) in a study participant that is study or device-
related.  
 
Hypoglycemic events are recorded as adverse events if 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 his or herself, was unable to verbalize his or 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.   
 
On each daily download (week 1 of non-adjunctive CGM use) and weekly download and review (within the first 
month), we will also document the percent time spent at or below 60 mg/dL. If this value is greater than or equal 
to 5% (>1.2 hours per day), we will notify the participant’s caregiver and diabetes care provider in order to 
prevent future hypoglycemia. These criteria will also apply to the CGM data obtained from monthly blinded CGM 
use in the control group. 
 
Hyperglycemic events are recorded as adverse events if the event involved diabetic ketoacidosis (DKA), as defined 
by the DCCT, and had all of the following:  
 
⋅ 
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     
 
 
Skin irritation from sensor wear will be recorded in specific sections of the case report forms.  An adverse event 
form is only completed if skin irritation is severe.   
 

 
19 
 
Distress or discomfort experienced by participants as they complete surveys is not considered an adverse event. 
However, we have trained psychologists on staff who will be available to address any distress or discomfort and 
initiate referrals if requested. 
 
 
3.2.  Recording of adverse events 
 
Throughout the course of this study, all efforts will be made to remain alert to possible adverse events or untoward 
findings.  The first concern will be the safety of the participant, and appropriate medical intervention will be made. 
 
The investigator will elicit reports of adverse events from the participant at each visit and phone call and complete 
all adverse event forms online. The medical monitor will review each adverse event form to verify required coding 
and reporting.      
 
The study investigator will assess whether an adverse event is related or unrelated to the study by determining if 
there is a reasonable possibility that the adverse event may have been caused by the study device or by study 
procedures.    
 
The intensity of adverse events 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.   
 
Adverse events that continue after the participant’s discontinuation or completion of the study will be followed 
until their medical outcome is determined or until no further change in the condition is expected.   
 
3.3.  Reporting serious or unexpected device-related adverse events 
 
A serious adverse event is any untoward occurrence that: 
⋅ 
Results in death 
⋅ 
Is life-threatening; (a non life-threatening event which, had it been more severe, might have become 
life-threatening, is not necessarily considered a serious adverse event) 
⋅ 
Requires inpatient hospitalization or prolongation of existing hospitalization 
⋅ 
Results in significant disability/incapacity  
⋅ 
Is a congenital anomaly/birth defect 
 
3.4.  Unanticipated adverse device event  
 
An unanticipated adverse device event is defined as an adverse event caused by, or associated with, a device, if that 
effect or problem was not previously identified in nature, severity, or degree of incidence. 
 
Serious or unexpected adverse events must be reported to the coordinating center immediately via completion of 
the online serious adverse event form. 
 
The principal investigator will notify all participating investigators of any adverse device event that is both serious 
and unexpected.  Notification will be made within 10 days after the PI becomes aware of the event.  Such events 
will be reported to the FDA according to regulatory requirements. 
 
Each principal investigator is responsible for informing his/her IRB of serious study-related adverse events and 
abiding by any other reporting requirements specific to their IRB. 
 

 
20 
 
3.5.  Data and safety monitoring board  
 
An independent Data and Safety Monitoring Board will be informed of all serious adverse events and any 
unanticipated adverse device events that occur during the study and will review compiled adverse event data at 
the completion of the study.   
  
3.6.  Potential risks and side effects 
 
Loss of confidentiality is a potential risk, and is protected by the safeguards discussed above. Hypoglycemia, 
hyperglycemia, and ketone formation are always a risk in subjects with type 1 diabetes. Subjects will be closely 
monitored for this.  When wearing CGM sensors there are risks of skin rashes, allergic reactions to tape, infections 
at the insertion site, or small pieces of the sensor breaking off or remaining under the skin. These risks will be 
monitored, but study staff will not oversee insertions, tracking of sensor information, and other diabetes device 
information. 
 
3.6.1.   Lancing risks 
 
A small drop of blood will be obtained by finger stick to measure blood glucose and HbA1c. This is a standard 
method to obtain blood for routine hospital laboratory tests. Pain is common at the time of lancing. In about 1 in 10 
cases, a small amount of bleeding under the skin will produce a bruise. A small scar may persist for several weeks. 
The risk of local infection is less than 1 in 1000. We recommend children with diabetes check their blood sugar at 
least 4 times daily. This should not be a significant contributor to risks in this study as finger lancing is part of the 
usual care for people with diabetes. 
 
 
3.6.2.  Sensor site risks 
 
Whenever the skin is broken there is the possibility of an infection. CGM sensors are inserted under the skin. There 
may be bleeding where the sensor is inserted, which can cause bruising. CGM site infections occur very 
infrequently, but, if an infection was to occur, oral and/or topical antibiotics can be used. The risk of skin problems 
could be greater if a sensor is left in longer than recommended. Participants will be carefully instructed about 
proper use of sensors.  
 
3.7.  Risk of hypoglycemia 
 
There is always a risk of hypoglycemia for patients with insulin-dependent diabetes. The frequency of 
hypoglycemia during this study is not expected to be greater than the risk incurred during daily living. If severe 
hypoglycemia occurs, it is readily treated with either oral glucose or glucagon injection. To minimize the risk of 
hypoglycemia due to “stacking” insulin doses, study participants will be instructed in their initial education (face-
to-face and in educational materials) not to take rapid acting insulin injections to correct hyperglycemia more than 
once every 3 hours. Further, the low glucose alert on the Dexcom G5 system will be set at 70 mg/dl for all 
participants on CGM.   
 
3.8.  Risk of hyperglycemia 
 
Hyperglycemia and ketonemia can occur if insulin delivery is attenuated or suspended for an extended period. This 
is a risk of type 1 diabetes that is not expected to be greater during the study period than it is during daily living. If 
severe hyperglycemia occurs, participants will be advised to treat with insulin therapy or to seek medical attention 
from the child’s diabetes care team.    
 
3.9.  Other risks 
 

 
21 
 
Subjects may develop skin irritation or allergic reactions to the adhesives used to secure the CGM. If these 
reactions occur, different adhesives (such as with IV 3000, Tegaderm, etc.) will be tried, sites will be rotated 
frequently, and a mild topical steroid cream or other medication may be required. 
 
Data downloaded from the CGM and the home glucose meter will be collected for the study as measures of diabetes 
self-management behaviors.  Some people may be uncomfortable with the researchers' having such detailed 
information about their daily diabetes habits. 
 
Psychological and human factors testing and focus groups may make study participants uncomfortable. Subjects 
are free to withdraw from the study at any time. A psychologist or a health care professional will be available to 
help them with their stress or anxieties.   
 
3.10.  Adequacy of protection against risks 
 
3.10.1.  Recruitment and informed consent 
 
All minorities will be encouraged to participate.  Economically and educationally disadvantaged people, parents 
who are employed at the clinical center (Stanford or the University of Colorado) will be eligible to enroll their child 
in this study if they meet all the study criteria. Subjects will be recruited from our clinics, chart review, and IRB 
approved patient recruitment lists. We will also use IRB approved recruitment materials to post the study on 
clinicaltrials.gov and the local universities’ research and department websites. Participants may self-select to join 
the research by responding to advertisements on social media. These posts will provide contact information for the 
research staff at each site. We will not interact with potential participants or enrolled participants through these 
media. We will actively work to prevent harm to all subjects enrolled in the study. We will work to avoid coercion 
by allowing equal enrollment opportunities for employees, as well as non-university affiliated subjects. We will 
ensure that all families are informed that their participation is voluntary, that they will receive no ill treatment 
should they decide to not participate, and that they will receive no special advantages, aside from those mentioned 
in the "benefits" section of the consent, for participating in the study.  
 
Participation will be voluntary and all participants must provide consent prior to inclusion in this research 
study.  The primary investigator at each of the participating clinical sites, or one of their designees, will explain the 
nature, purpose, expected duration, and risks of study participation to each eligible family.  The primary 
investigator at each site, or one of their designees, will also obtain consent and authorization for the release of 
personal information.  
 
For children < 18 years of age we will follow the federal guideline 21 CFR 50.52 for clinical investigations involving 
greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable 
knowledge about the subjects’ disorder or condition. In accordance with federal guideline 21 CFR 50.55 we will 
require that the permission of two parents is required, unless one parent is deceased, unknown, incompetent, not 
reasonably available, or only one parent has legal responsibility for the care and custody of the child.  After 
speaking with the subject and their parent and/or legal guardian, questions will be answered about the study, and 
the participant and/or parent and/or legal guardian will be asked to explain what they understand about the study 
in order to assess the autonomy of the subject and caregiver and their comprehension of the explanations 
provided.  A copy of the consent form will be provided to the adult subjects or parent or guardian of subjects < 18 
years of age, and a copy will be placed in the subject’s medical file at the participating institution.  
  
3.10.2.  Protections against risk  
All protocols and consent documents will be approved by the local IRB at each clinical site.   
All of the participating clinical centers have an endocrinologist on call 24/7 for any severe events that should 
occur.  Likewise, a licensed clinical psychologist is available for any concerns on the psychological side. Severe 
events are not anticipated but will be monitored. Study personnel are always available for questions.  

 
22 
 
Hyperglycemia and ketone formation are always a risk in subjects with type 1 diabetes and subjects will be closely 
monitored for this.  Subjects will have blood ketone meters provided through routine clinical care. Insulin can be 
given as a subcutaneous injection to treat hyperglycemia. Participants will have access to phone numbers for the 
study physician and endocrinologist on call.  
Participants in the intervention group will receive standardized education about CGM and its use after 
randomization. Participants in the control group who wish to start CGM at six months will receive standardized 
education about CGM and its use. Both groups will be instructed on inserting and calibrating the sensor. 
Participants are free to check blood glucose via fingerstick at any time and encouraged to do so if/when the child 
or parent notices a potential discrepancy between CGM and fingerstick values. A person trained in delivering 
education about CGM will deliver the education about CGM use and will assist with inserting the first sensor. This 
individual will be available to assist with questions from participating families. In addition, Dexcom 
representatives are available to the family for technical questions or issues with the system, just like the access any 
Dexcom user has.   
 
3.11.  Study stopping criteria 
 
Individual subjects will be removed from the study for the following reasons:  pregnancy, study-related adverse 
events (i.e. severe hypoglycemia, loss of consciousness, hypoglycemia related seizure, DKA related to non-
adjunctive CGM use or study-related event requiring hospitalization), severe skin infection requiring systemic 
antibiotics, severe reaction to sensor tape, or other reasons that develop during the study that in the judgment of 
the investigator make it unadvisable for the subject to continue with the study.

 
23 
 
CHAPTER 4: MISCELLANEOUS CONSIDERATIONS 
 
4.1.  Benefits 
 
It is expected that this protocol will yield knowledge about the impact of continuous glucose monitoring on 
families with newly diagnosed children with type 1 diabetes. The introduction of CGM in youth with T1D at 
diagnosis might allay parents’ fears, ease their sense of diabetes-related distress and foreboding, and impact 
glycemic variables measured during the first year of T1D, however there is no guarantee of any benefit from 
participating in this research study. 
 
4.2.  Subject compensation 
 
There will be no cost to the subjects to participate in this research study. Parents will receive $40 for the 
completion of each of three assessments. Youth 11-17 years of age will receive $25 for the completion of each of 
three assessments. In total, a family can receive $195 for completion of the study and keep the CGM system. All 
CGM sensors and required equipment for the protocol will be provided for study participants free of charge.   
 
4.3.  Subject withdrawal 
 
Participation in the study is voluntary, and a subject may withdraw at any time.  The investigator may withdraw a 
subject who is not complying with the protocol. For subjects who withdraw, their data will be used up until the 
time of withdrawal. 
 
4.4.  Confidentiality 
 
For security and confidentiality purposes, subjects will be assigned an identifier that will be used instead of their 
name. De-identified subject information may also be provided to research sites involved in the study. 
 
4.5.  Level of risk 
 
This research proposal in children is consistent with 21 CFR 50.53 - Clinical investigations involving greater than 
minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge 
about the subjects' disorder or condition.  
 
 

 
24 
 
 
 
 
 
 
 
 

 
25