IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus
Sponsor: Johns Hopkins University

DATE	  
July	  12,	  2023	  
	  
	  
Title	  
CGM Use in Children With 
Type 2 Diabetes 
 
	  
NCT	  
NCT04721158	  
	  
	  
 
	  

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1 
 CGM Use in Children With Type 2 Diabetes 
    
NCT04721158 
 
FINAL PROTOCOL - TABLE OF CONTENTS 
A	  
INTRODUCTION .................................................................................................................................. 3	  
A1	  
STUDY ABSTRACT AND BACKGROUND ............................................................................................... 3	  
A2	  
PRIMARY HYPOTHESIS ........................................................................................................................ 3	  
B	  
STUDY OBJECTIVES .......................................................................................................................... 3	  
B1	  
PRIMARY AIM ..................................................................................................................................... 3	  
B2	  
SECONDARY AIM ................................................................................................................................ 4	  
C	  
STUDY DESIGN .................................................................................................................................... 4	  
C1	  
OVERVIEW OF STUDY DESIGN ............................................................................................................ 4	  
C2	  
SUBJECT SELECTION AND WITHDRAWAL ............................................................................................ 4	  
2.a	  
Inclusion Criteria .......................................................................................................................... 4	  
2.b	  
Exclusion Criteria ......................................................................................................................... 4	  
2.c	  
Subject Recruitment Plans and Consent Process .......................................................................... 4	  
2.d	  
Randomization Method and Blinding ............................................................................................ 4	  
2.e	  
Risks and Benefits .......................................................................................................................... 5	  
2.f	  
Early Withdrawal of Subjects ......................................................................................................... 5	  
2.g	  
When and How to Withdraw Subjects ........................................................................................... 5	  
2.h	  
Data Collection and Follow-up for Withdrawn Subjects .............................................................. 6	  
D	  
STUDY PROCEDURES ........................................................................................................................ 6	  
D1	  
SCREENING FOR ELIGIBILITY .............................................................................................................. 6	  
D2	  
SCHEDULE OF PROCEDURES ............................................................................................................... 6	  
D3	  
POINT OF CARE CGM PLACEMENT AND EDUCATION ......................................................................... 7	  
D4	  
SAFETY AND ADVERSE EVENTS .......................................................................................................... 7	  
4.a	  
Safety and Compliance Monitoring ............................................................................................... 7	  
4.b	  
Medical Monitoring for adverse events ......................................................................................... 7	  
Participants will be monitored for adverse events during the study visit, during their CGM wear, and 
during the follow-up period of up to 6 months. ....................................................................................... 7	  
4.c	  
Definitions of Adverse Events ........................................................................................................ 7	  
4.d	  
Classification of Events ................................................................................................................. 7	  
•	  
Relationship ................................................................................................................................................. 7	  
•	  
Severity ......................................................................................................................................................... 8	  
4.e	  
Data Collection Procedures for Adverse Events ........................................................................... 8	  
4.f	  
Reporting Procedures ..................................................................................................................... 8	  
4.g	  
Adverse Event Reporting Period ................................................................................................... 8	  
4.h	  
Post-study Adverse Event .............................................................................................................. 8	  
E. STATISTICAL PLAN .............................................................................................................................. 8	  
E1. SAMPLE SIZE DETERMINATION AND POWER .......................................................................................... 8	  
E2. INTERIM MONITORING AND EARLY STOPPING ....................................................................................... 8	  
E3. ANALYSIS PLAN ..................................................................................................................................... 9	  
E4.  STATISTICAL METHODS ......................................................................................................................... 9	  
E5. MISSING OUTCOME DATA ...................................................................................................................... 9	  
F. DATA HANDLING AND RECORD KEEPING ................................................................................... 9	  

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F1. CONFIDENTIALITY AND SECURITY ....................................................................................................... 10	  
F2. RECORDS RETENTION ........................................................................................................................... 10	  
G.	  
STUDY ADMINISTRATION ............................................................................................................ 10	  
G1. ORGANIZATION AND PARTICIPATING CENTERS ................................................................................... 10	  
G2. FUNDING SOURCE ................................................................................................................................ 10	  
G3. SUBJECT STIPENDS OR PAYMENTS ....................................................................................................... 10	  
E	  
REFERENCES ..................................................................................................................................... 10 
 
 

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A  Introduction 
A1 Study Abstract and Background 
The prevalence of youth-onset type 2 diabetes (T2D) is on the rise, especially in minority 
and disadvantaged populations.1 During the COVID-19 pandemic there was a further 
increase in youth-onset T2D, likely due to more sedentary behaviors.2 Family history of 
diabetes, quality of and access to health care, differences by race/ethnicity in insulin 
sensitivity, diet quality, and minimal physical activity are some of the risk factors for 
T2D.3 Furthermore, T2D in youth has been found to be more aggressive in nature with 
rapid deterioration in 𝛽-cell functioning and high rates of diabetes complications, 
compared to T2D in adults.4,5 Given the clinical course of youth-onset T2D and limited 
treatment options (metformin, insulin or subcutaneous GLP-1 agonist), there is an 
increasing need for interventions that not only improve glycemic control and reduce 
insulin resistance, but also promote behavioral modifications such as exercise and 
healthy eating. 
 
In youth with type 1 diabetes (T1D), the use of continuous glucose monitoring (CGM) 
has been associated with decreased hemoglobin A1c (HbA1c) levels and increased time 
in range (TIR), while also improving quality of life6,7. Similar trends have been noted in 
adults with T2D, in which investigators concluded that the real-time glycemic feedback 
provided by CGM gave way to lifestyle modifications, including more physical activity, 
that led to improvements in glycemic control.8,9 The SEARCH study found that most 
youth with T2D test their glucose levels fewer than 3 times per day8 and 27% of youth 
with T2D had poor glycemic control (HbA1c > 9.5%)10-12. 
 
Given the improvements observed when implementing CGM in youth with T1D and 
adults with T2D, there is reason to believe that CGM could play a pivotal role in helping 
youth with T2D check their blood sugars more frequently, while also promoting 
behavioral modifications that improve glycemic control. There is limited information on 
the use of CGM in youth with T2D.  
 
We conducted a pilot clinical trial to determine if a complementary 10-day trial of CGM 
use in youth with T2D impacts glycemic control and behavior. 
A2 Primary Hypothesis 
We hypothesize that providing sample complementary CGM at the point of care with 
standardized CGM education will improve glycemic control in pediatric patients with type 
2 diabetes.  
 
B Study Objectives 
 
B1 Primary Aim 
To determine if 10-day trial CGM use in youth with T2D improves glycemic control  
(changes in time in range and Hemoglobin A1c). 

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B2 Secondary Aim 
To determine if 10-day trial CGM use in youth with T2D improves measures of diabetes 
distress and diabetes related quality of life. 
 
C Study Design  
C1 Overview of Study Design 
This is a hypothesis-driven, pre-registered, prospective cohort study to determine if point 
of care placement of complementary CGM with standardized CGM education improves 
glycemic control.  
 
The study will consist of a baseline visit (coincident with routine clinical care) where a 
complementary trial CGM is placed at the point of care with standardized CGM 
education.  CGM-related apps will be downloaded on the participant’s smartphone. 
Follow-up phone calls will be conducted by the study team at 5-days and 10-days after 
CGM placement.  CGM data will be recorded at the next follow-up visit (if available) and 
hemoglobin A1c level (performed as part of routine clinical care) recorded.   
Surveys will be completed at baseline, 10-days (via email), and at follow-up (3-6months) 
 
C2 Subject Selection and Withdrawal  
2.a 
Inclusion Criteria  
 
• 
Patients with type 2 diabetes for more than 3 months 
• 
Ages 8-21 years 
• 
CGM naive or no CGM use in the 12 months prior to enrollment  
• 
No minimum A1C level required for eligibility.  
2.b 
Exclusion Criteria 
• 
CGM use in the 12 months prior to enrollment 
• 
Participants with T2D not on insulin 
2.c 
Subject Recruitment Plans and Consent Process  
Individual(s) responsible for approaching participant(s): Research coordinators 
 
Where and when recruitment will take place: 
Participants will be recruited, screened for eligibility, and consented in a private 
clinic/room to ensure privacy.   
 
Consent process: 
Participants will read through the consent form with the research coordinator, have time 
to review it and ask questions about the study and study procedures.  
2.d 
Randomization Method and Blinding 
Not applicable 

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2.e 
Risks and Benefits 
This study involves no more than minimal medical risk to the participants as use of CGM 
is considered standard of care per the American Diabetes Association guidelines.   
 
Risks associated with use of CGM may include hypoglycemia (low blood sugar) or 
hyperglycemia (high blood sugar) in cases where information provided by the CGM 
device is inaccurate and used to make treatment decisions or where hardware or set-up 
issues disable alarms and alerts. Patients will be advised to confirm with a fingerstick 
blood sugar if symptoms do not match CGM readings. 
 
Patients may also experience skin irritation or redness around the CGM device’s 
adhesive patch.  The CGM may inadvertently fall off, and if that occurs, the patient will 
resume checking fingerstick blood sugars as they were previously. 
 
To minimize risk, when the diabetes nurse/CDCES places the CGM, the nurse will 
perform routine standardized education including setting up alerts.  The CGM devices 
provide blood sugars every 5 minutes (that creates a continuous reading) versus the 
typical 4-5 fingerstick blood sugars usually checked per day.  Therefore, the CGM 
actually minimizes risk of hypoglycemia by alerting users to impending hypoglycemia 
which may not have been previously detected.   Participants will have been taught 
signs/symptoms of hypoglycemia per routine new-onset diabetes education.  They will 
be educated to check blood sugar via fingerstick if they have any sign/symptoms of 
hypoglycemia and treat accordingly.  If they do not understand how to use the device, 
they have access to Pediatric Endocrinology on-call provider and Dexcom customer 
service for assistance, and device may be removed early. The risk of device malfunction 
is extremely low.  
 
The CGM will be applied in clinic by diabetes nursing staff.  If patient reports any 
irritation or signs of infection at the site, the CGM will be removed early.  If the CGM is 
removed early either accidentally or intentionally, participants will be offered a 
replacement CGM.  They will have to resume previous blood sugar monitoring with 
glucometer and fingersticks, as the patient was using prior to placement of CGM. 
 
Confidentiality: There is the risk that psychological, emotional, financial, social, and legal 
risks might result if confidentiality cannot be maintained in this study.  All study team 
members are HIPPA trained and will take every step to respect participants’ privacy and 
protect their confidentiality throughout the study.  We share the information gathered in 
the study only with the people who need to know this information.  All information 
gathered during this study will be kept in a secure HIPAA compliant database, REDCap.   
 
Benefit: Use of CGM may increase blood sugar monitoring, reduce hypoglycemia, and 
improve glycemic control. 
 
2.f 
Early Withdrawal of Subjects  
Participants may withdraw from the study at any time by notifying the study team.  
2.g 
When and How to Withdraw Subjects  
The participant may choose to withdraw from the study. It will also not impact the course 
of the participant’s clinical care.  

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2.h 
Data Collection and Follow-up for Withdrawn Subjects  
Data collected from subjects will remain in the dataset, but no follow-up will be 
conducted on withdrawn subjects.  
 
D Study Procedures  
 
D1 Screening for Eligibility 
 
Patients being seen in the diabetes center will be pre-screened for eligibility by the 
research team based on the inclusion criteria.  Eligibility will be confirmed with the 
patient’s diabetes provider at the time of the clinic visit, and with the potential participant 
based on the inclusion criteria.  The study coordinator will confirm that the participant 
that they have never used a CGM, or have not used CGM in the prior 12 months and are 
currently on insulin therapy. 
D2 Schedule of Procedures 
 
Eligibility and Consent: If the patient is eligible and interested in the study, the research 
coordinator will meet with the patient and caregiver in an exam room for privacy and 
confidentiality.  The research coordinator will explain the study and study procedures, 
read the informed consent form with the participant and caregiver, and allow time for 
questions on the study and consent form.  
If the participant is less than 18 years of age, the parent will sign the consent form and 
the participant will sign the assent. If the participant is 18 years of age or over, the 
participant will sign the consent.  
 
At the time of consent, 3 phone numbers are collected from the participant for future 
follow-up.  
At the baseline visit, barriers to prior CGM use or sustained use will be recorded.   
The certified diabetes educator (CDCES) will place the CGM and provide standardized 
education, including education on use of the Dexcom apps, including Dexcom G6 
Dexcom Clarity, and Dexcom Follow (optional) for caregivers. The participant’s Dexcom 
Clarity account will be connected to the clinic portal for remote viewing of data.  
The nurse/CDCES will follow up with the patient by phone in 5 days (4-6 days if day 5 
falls over a weekend) and again at 10 (9-11) days at the end of the CGM session. 
Assessment and education during these follow-up phone calls will include report of 
behavior changes related to blood glucose monitoring and insulin administration, and 
nurse/CDCES recommended dose adjustments based on observed patterns, as well as 
education on obtaining personal CGM.  CGM data (when available) will be recorded.  

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At the participant’s next follow-up visit at 3 months (or up until 6 months if a visit is 
cancelled), use of personal CGM will be recorded, in addition to Hemoglobin A1c 
measured at that visit, questions about behavioral changes, and CGM data, if available.  
 
Questionnaires will be administered before and after initiation of the CGM and at their 
routine diabetes clinic visit 3-months later to assess changes in psychosocial outcomes 
of diabetes distress and hypoglycemia worry.  Surveys will be administered via REDcap 
survey.    
 
 
D3 Point of Care CGM Placement and education 
 
Participants will be provided with a Dexcom G6 CGM, which will be placed during the 
clinic visit by diabetes staff, and CGM education will be provided at the point of care by 
the nurse/Certified Diabetes Care and Education Specialist (CDCES). Additionally, 
participants will download apps on their smartphones including Dexcom G6 and Dexcom 
Clarity. Caregivers and family members will download Dexcom Follow (optional).  
Education will be provided on using all the apps. Participants’ Dexcom Clarity app will be 
connected to the clinic’s Clarity account for remote viewing of data.  
Participants without a compatible smartphone will be provided a loaner smartphone for 
the duration of the 10-day CGM use.  
D4 Safety and Adverse Events  
 
4.a 
Safety and Compliance Monitoring 
Site investigators will monitor compliance with the protocol and good clinical practice 
(GCP) guidelines.  
4.b 
Medical Monitoring for adverse events    
Participants will be monitored for adverse events during the study visit, during their CGM 
wear, and during the follow-up period of up to 6 months.   
4.c 
Definitions of Adverse Events 
An adverse event (AE) is defined as any untoward medical occurrence in a patient or 
clinical investigation subject. 
4.d 
Classification of Events 
• 
 Relationship 
Medical judgement should be used to determine the relationship, considering all relevant 
factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, 
confounding factors such as concomitant medication, concomitant diseases and relevant 
history. 

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• 
Severity 
The severity of the AE should be judged based on the following: 
Mild:   
Awareness of sign(s) or symptom(s) that is/are easily tolerated 
Moderate:  
Sufficient discomfort to cause interference with usual activity 
Severe:  
Incapacitating or causing inability to work or to perform usual activities 
 
4.e 
Data Collection Procedures for Adverse Events 
All enrolled participants will be monitored for untoward incidents (e.g., “Adverse Events”) 
occurring during the study. The Principal Investigator (and other designated individuals, 
if necessary) will conduct regular monitoring for safety concerns and provide general 
oversight for human subject safety requirements during the study visit and followup 
period. All adverse events that are anticipated or described in the informed consent form 
will be logged appropriately and reported to the IRB on at least an annual basis (e.g., at 
continuing review).   
 
4.f 
Reporting Procedures 
Any Unanticipated Problems or unexpected “Serious Adverse Events” related to the 
study intervention or in the follow-up period, will be reported to the IRB 
promptly.  Unplanned and non-emergent deviations from the IRB approved protocol will 
be logged and reported to the IRB annually at continuing review; all planned deviations 
will be submitted as a Change in Research to the IRB for approval and prior to 
implementation. All other event reporting requirements will be followed and all necessary 
parties will be notified of events/problems encountered in the study and/or changes in 
research, in accordance with all applicable regulations and guidelines.  
 
4.g 
Adverse Event Reporting Period 
Any Unanticipated Problems or unexpected “Serious Adverse Events” related to the 
study intervention and/or test article and affecting the risk/benefit profile of the study, will 
be reported to the IRB promptly, and, in all cases, within 10 business days of discovery.  
4.h 
Post-study Adverse Event 
Not applicable 
 
 
E. Statistical Plan  
E1. Sample Size Determination and Power 
We calculated the sample size to detect a 10% difference in TIR from the first 5-days 
compared to the second 5 days of CGM wear. Assuming a TIR SD of 18% (20), a 2-
sided alpha level of 0.05 and 80% power, a sample size of 28 participants was required. 
Allowing for 30% attrition, we planned to recruit 40 participants. 

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E2. Interim Monitoring and Early Stopping 
Interim monitoring will be performed by the study team.  No early stopping rules planned 
for this study.  
 
E3. Analysis Plan 
 
Primary outcome variable. 
The primary outcomes of the study were change in TIR from the first 5 days compared to 
the second 5 days of CGM wear, and change in HbA1c level from baseline to follow up 
at 3-6 months, both assessed with paired t-tests. 
 
Secondary outcome variables. 
Secondary endpoints included behavioral modification assessed via questions during 5-
day and 10-day follow up call. Change in patient-reported outcomes through surveys 
assessing quality of life and diabetes-distress compared between baseline and follow-up 
after trial CGM use.  
 
E4.  Statistical Methods  
Categorical variables will be described using frequencies and percentages. The Shapiro-
Wilks test will be used to assess the normality distribution of continuous variables. 
Normally distributed variables will be described by mean and standard deviation. Non-
normally distributed variables will be described by median and interquartile range. Paired 
t-tests will be used to assess most differences between baseline and follow up. Wilcoxon 
signed rank tests will be used for the Diabetes Distress Scale scores and sub-scores. 
Time in range data from the first 5 ( ± 1) days of CGM wear will be compared to the 
second 5 ( ± 1) days for any patients with at least 8+ days of CGM wear. Additional 
comparisons will be made with the follow-up CGM data recorded at the 3 or 6-month 
follow-up. Three month follow up data will be used when available. If the 3-month visit is  
missing, but there is a later 6-month follow-up, the 6-month visit data will be used. Two 
sample t-tests, and Wilcoxon rank sum tests (for the Diabetes Distress Scale), will be 
used to assess differences between groups in survey responses. The values p< 0.05 are 
considered statistically significant. Statistical analysis generated using SAS version 9.4 
Copyright © 2020 SAS Institute Inc., Cary, NC. 
 
E5. Missing Outcome Data  
Dataset will be assessed for missing-ness and noted in results. Statistical tests will be 
performed to compare groups with and without missing data, to assess for data missing 
at random. 
 
F. Data Handling and Record Keeping  
 

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F1. Confidentiality and Security 
 
All data for this study will be recorded, stored and analyzed in a password-protected file 
on a HIPAA-compliant and secure drive through Johns Hopkins Medicine, called the 
SAFE (Secure Analytic Framework Environment) Desktop.  This secure environment is 
provided by JHM and includes productivity software and statistical software. Storing the 
Data on the SAFE Desktop complies with federal and institutional requirements to 
protect patient data. Using SAFE reduces the risk of copying data to an unencrypted 
desktop or device because the SAFE provides the tools to securely analyze and share 
PHI/PII all within the SAFE environment. Only authorized persons will have access to 
SAFE Desktop, login and passwords will not be shared and databases will not be left 
unattended to further minimize risk of loss of confidentiality. 
 
F2. Records Retention 
Informed consent documents will be securely stored in a locked file cabinet within a 
locked office.  Informed consents will also be scanned into the participant’s electronic 
medical record.  Data will be stored for up to 7 years.    
 
 
G. Study Administration 
 
G1. Organization and Participating Centers 
Johns Hopkins Pediatric Diabetes Center 
Mount Washington Pediatric Hospital Diabetes Center 
G2. Funding Source 
Funding for this study is provided by the Johns Hopkins Children’s Center Innovation 
Award (PI: Wolf) and an investigator initiated research grant from Dexcom, Inc (PI: Wolf) 
G3. Subject Stipends or Payments  
Participants will receive a $10.00 gift card, and a parking pass at the baseline study visit 
and a $10.00 gift card at the completed follow-up visit.  
 
E References 
 
 
1. 
Dabelea D, Mayer-Davis EJ, Saydah S, et al. Prevalence of type 1 and type 2 
diabetes among children and adolescents from 2001 to 2009. Jama 
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2. 
Magge SN, Wolf RM, Pyle L, et al. The coronavirus disease 2019 pandemic is 
associated with a substantial rise in frequency and severity of presentation of 

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youth-onset type 2 diabetes. J Pediatr 2022 (In eng). DOI: 
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Arslanian S, Bacha F, Grey M, Marcus MD, White NH, Zeitler P. Evaluation and 
Management of Youth-Onset Type 2 Diabetes: A Position Statement by the 
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Nelson RG, Hanson RL, Knowler WC. Long-Term Complications in Youth-Onset 
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vs Insulin Injection Therapy With Severe Hypoglycemia, Ketoacidosis, and 
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9. 
Allen NA, Fain JA, Braun B, Chipkin SR. Continuous glucose monitoring 
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Petitti DB, Klingensmith GJ, Bell RA, et al. Glycemic control in youth with 
diabetes: the SEARCH for diabetes in Youth Study. J Pediatr 2009;155(5):668-
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Malik FS, Sauder KA, Isom S, et al. Trends in Glycemic Control Among Youth 
and Young Adults With Diabetes: The SEARCH for Diabetes in Youth Study. 
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Bharill S, Lin T, Arking A, et al. Worsening glycemic control in youth with type 2 
diabetes during COVID-19. Frontiers in Clinical Diabetes and Healthcare 2022;3. 
DOI: 10.3389/fcdhc.2022.968113. 
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Thabit H, Prabhu JN, Mubita W, et al. Use of Factory-Calibrated Real-time 
Continuous Glucose Monitoring Improves Time in Target and HbA(1c) in a 
Multiethnic Cohort of Adolescents and Young Adults With Type 1 Diabetes: The 
MILLENNIALS Study. Diabetes Care 2020;43(10):2537-2543. (In eng). DOI: 
10.2337/dc20-0736.