IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes, Hypoglycemia, High Blood Sugar
Sponsor: Johns Hopkins University

DATE	  
June	  2023	  
	  
	  
Title	  
CGM Use in Poorly Controlled 
Youth With Type 1 Diabetes 
 
	  
NCT	  
NCT04721145	  
	  
	  
 
	  

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
1 
CGM Use in Poorly Controlled Youth With Type 1 Diabetes 
    
NCT04721145 
 
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 ................................................................................................................................ 3	  
C	  
STUDY DESIGN .................................................................................................................................... 3	  
C1	  
OVERVIEW OF STUDY DESIGN ............................................................................................................ 3	  
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 .......................................................................................................................... 4	  
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 .............................................................. 5	  
D	  
STUDY PROCEDURES ........................................................................................................................ 5	  
D1	  
SCREENING FOR ELIGIBILITY .............................................................................................................. 6	  
D2	  
SCHEDULE OF PROCEDURES ............................................................................................................... 6	  
D3	  
POINT OF CARE CGM PLACEMENT AND EDUCATION ......................................................................... 6	  
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 ......................................................................................................................................................... 7	  
4.e	  
Data Collection Procedures for Adverse Events ........................................................................... 7	  
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 ..................................................................................................................................... 8	  
E4.  STATISTICAL METHODS ......................................................................................................................... 9	  
E5. MISSING OUTCOME DATA ...................................................................................................................... 9	  
F. DATA HANDLING AND RECORD KEEPING ................................................................................... 9	  
F1. CONFIDENTIALITY AND SECURITY ......................................................................................................... 9	  

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
2 
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 
 
 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
3 
 
A  Introduction 
A1 Study Abstract and Background 
The American Diabetes Association (ADA) recommends that continuous glucose 
monitoring (CGM) be considered for all children with Type 1 Diabetes (T1D).1 
Continuous glucose monitoring is associated with improved glycemic control; however, 
only 60% of children use CGM. Further, minority and low-income youth are less likely to 
use diabetes technology, including CGM and insulin pumps.2  
 
Barriers to CGM use are well described; however, initiatives to improve CGM uptake in 
underserved and poorly controlled youth with T1D are limited.3-5  
 
In order to increase use of this technology in this high-risk diabetes population, this study 
will provide complementary trial CGM at the point of care in a prospective study to 
determine if providing a short-term trial use of a CGM device increases subsequent 
uptake of personal CGM and improves glycemic control and measures of diabetes-
related distress.  
A2 Primary Hypothesis 
We hypothesize that providing sample complementary CGM at the point of care with 
standardized CGM education will increase uptake of personal CGM use in pediatric 
patients with diabetes.  
 
B Study Objectives 
 
B1 Primary Aim 
To determine if providing a complementary short-term trial use of CGM increases 
subsequent uptake of personal CGM. 
B2 Secondary Aim 
To determine if providing a complementary short-term trial use of CGM improves 
glycemic control and 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 increases 
uptake of personal CGM.  
 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
4 
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.  Use of personal CGM will be recorded at the next follow-up visit (at 3-
6 months), with CGM data recorded (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 1 diabetes for more than 3 months 
• 
Ages 5-21 years 
• 
CGM naive or no CGM use in the 9 months prior to enrollment  
• 
No minimum A1C level required for eligibility.  
 
2.b 
Exclusion Criteria 
• 
CGM use in the 9 months prior to enrollment 
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 
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. 
 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
5 
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.  
 
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  
 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
6 
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 9 months. 
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.  
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 
 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
7 
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. 
• 
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 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
8 
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 
The following a priori sample size calculation is based on improvements in TIR data and 
assumes 80% power and a 2-tailed type 1 error of 0.05.  In order to detect a 10% 
improvement of TIR from the first 5-days compared to the second 5 days of CGM wear, 
assuming a TIR SD of 15%, a 2-sided alpha level of 0.05 and 80% power, 20 
participants are required. To allow for participant attrition, 30 participants are planned for 
recruitment. 
 
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 outcome is the proportion of participants who obtain a personal CGM and 
are using it at follow-up.  
 
Secondary outcome variables. 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
9 
The secondary outcome is change in glycemic control, as measured by the TIR for the 
first 5 days (days 1-5) of CGM wear compared to the 2nd 5 days (days 6-10) of CGM 
wear, and in the long term as measured by A1C between baseline and follow-up. 
 
Change in patient-reported outcomes through surveys assessing quality of life and 
diabetes-distress will be compared between baseline and followup after trial CGM use.  
 
E4.  Statistical Methods  
Statistical analyses will be performed using SAS version 9.4 Copyright © 2020 SAS 
Institute Inc., Cary, NC, USA.  
 
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 differences in normally distributed continuous measures 
between baseline and follow up, while Wilcoxon signed rank tests will be used for non-
normally distributed measures.   
Two sample t tests will be used to assess differences between groups in survey 
responses.  
The values p< 0.05 will be considered statistically significant. 
 
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  
 
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. 
 

IMPACT PROTOCOL - FINAL 
  
June 2023 
 
 
 
______________________________________________________________________________________ 
 
10 
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. 
American Diabetes A. 13. Children and Adolescents: Standards of Medical Care 
in Diabetes-2020. Diabetes Care 2020;43:S163-S82. 
2. 
Foster NC, Beck RW, Miller KM, et al. State of Type 1 Diabetes Management 
and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther 
2019;21:66-72. 
3. 
Prahalad P, Addala A, Scheinker D, Hood KK, Maahs DM. CGM Initiation Soon 
After Type 1 Diabetes Diagnosis Results in Sustained CGM Use and Wear Time. 
Diabetes Care 2020;43:e3-e4. 
4. 
Prahalad P, Ebekozien O, Alonso GT, et al. Multi-Clinic Quality Improvement 
Initiative Increases Continuous Glucose Monitoring Use Among Adolescents and Young 
Adults With Type 1 Diabetes. Clinical diabetes : a publication of the American Diabetes 
Association 2021;39:264-71. 
5. 
Hobbs A, Thus M, Couper J, Tham E, Fairchild J. Does introduction of 
continuous glucose monitoring at diagnosis of type 1 diabetes increase uptake in 
children and adolescents? Pediatr Diabetes 2022;23:98-103.