Group Visits to Improve Technology Use, Glycemic Control, and Quality of Life in High Risk Children With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Children's National Research Institute

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 1 of 36 
 
 
Group Visits to Improve Technology Use, 
Glycemic Control, and Quality of Life in High 
Risk Children with Type 1 Diabetes 
 
 
 
 
 
 
 
 
 
 
 
NCT ID: NCT05431686 
CN IRB Protocol Number: Pro00016268 
Principal Investigator: Shideh Majidi, MD 
Co-Investigators: Jody Grundman, MD, MPH; Brynn-Marks, MD, MSHPEd, 
Maureen Monaghan, PhD, CDE; Randi Streisand, PhD, CDE  
Funding Sponsor (if applicable): American Diabetes Association 
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 2 of 36 
 
 
 
 
Protocol Version Number: v.1.8 
 06/27/2022 
 
 
Table of Contents 
List of Abbreviations ......................................................................................................... 5 
Protocol Summary ............................................................................................................ 7 
Section 2: Introduction, Background Information and Scientific Rationale ..................... 10 
2.1 
Background Information and Relevant Literature ............................................ 10 
2.2 
Scientific Rationale .......................................................................................... 11 
2.3 
Potential Risks ................................................................................................. 12 
2.4 
Potential Benefits ............................................................................................. 13 
Section 3: Objectives and Endpoints ............................................................................. 14 
3.1 
Primary Objective(s) ........................................................................................ 14 
3.2 
Secondary Objective(s) ................................................................................... 14 
3.3 
Primary Outcome Measure(s) .......................................................................... 14 
3.4 
Secondary Outcome Measure(s) ..................................................................... 15 
Section 4: Study Design ................................................................................................. 15 
Section 5: Study Enrollment and Withdrawal ................................................................. 17 
5.1 
Study Population, Recruitment and Retention ................................................. 17 
5.2 
Inclusion Criteria .............................................................................................. 18 
5.3 
Exclusion Criteria ............................................................................................. 18 
5.4  
Vulnerable Subjects ......................................................................................... 19 
5.5 
Recruitment ...................................................................................................... 19 
5.6  
Retention ......................................................................................................... 19 
5.7 
End of Participation Criteria and Procedures ................................................... 20 
6.1 
Informed Consent/Assent and HIPAA Authorization ....................................... 20 
6.2 
Screening Process ........................................................................................... 21 
6.3 
Study Interventions and Follow-Up .................................................................. 21 
6.4 
Description of Study Procedures/Evaluations .................................................. 23 
6.5 
Study Team Training and Intervention Reliability ............................................ 25 
6.6  
Concomitant Interventions and Procedures ..................................................... 25 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 3 of 36 
Section 7: Safety Assessments and Reporting .............................................................. 26 
7.1  
Adverse Events (AEs) ...................................................................................... 26 
7.2  
Study Halting Rules ......................................................................................... 26 
Section 8:  Statistical Considerations and Analysis ....................................................... 26 
8.1 
Statistical and Analytical Plans (SAP) ............................................................. 26 
8.2 
Statistical Hypotheses ..................................................................................... 26 
8.3 
Analysis Datasets ............................................................................................ 27 
8.4 
Description of Statistical Methods .................................................................... 27 
8.5 
Sample Size ..................................................................................................... 29 
8.6 
Measures to Minimize Bias .............................................................................. 29 
9.1 
Study Team Quality Assurance and Quality Control ....................................... 29 
9.2 
Data Safety and Monitoring Plan ..................................................................... 30 
Section 10: Ethical Considerations ................................................................................ 30 
10.1  Ethical Standard .............................................................................................. 30 
10.2 Institutional Review Board (IRB) ...................................................................... 30 
10.3 Maintaining Subject Privacy ............................................................................. 31 
10.4 Maintaining Study Data Confidentiality ............................................................ 31 
10.5 Study Support and Conflicts of Interest ........................................................... 32 
Section 11: Data Handling and Record Keeping ............................................................ 32 
11.1 Data Management Responsibilities ................................................................. 32 
11.2 Data Capture Methods ..................................................................................... 32 
11.3 Study Record Retention Policy ........................................................................ 33 
Section 12: Publication Policy ........................................................................................ 33 
Section 13: References .................................................................................................. 33 
 
 
 
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 4 of 36 
Protocol Revision History 
Protocol Version with Summary of Changes  
 
 
    Version Date 
v. 1.0   
06/01/2021 
v. 1.1 
07/01/2021 
V 1.2 
7/16/2021 
V 1.3 
8/31/2021 
V 1.4 
9/23/2021 
V 1.5 
3/17/2022 
V 1.6 
4/23/2022 
V 1.7 
5/12/2022 
V 1.8 
6/27/2022 
 
 
  
       
. 
 
 
 
 
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 5 of 36 
List of Abbreviations 
 
ADA 
American Diabetes Association 
AE 
Adverse Event 
CDCES 
Certified Diabetes Care and Education Specialist 
CGM 
Continuous Glucose Monitor 
CITI 
Collaborative Institutional Training Initiative 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CV 
Coefficient of Variation 
DCC 
Data Coordinating Center 
DCCT 
Diabetes Control and Complications Trial 
DKA 
Diabetic Ketoacidosis 
DSMB 
Data and Safety Monitoring Board 
DSMP 
Diabetes Self-Management Profile 
ED 
Emergency Department 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMI 
Glucose Management Indicator 
GMP 
Good Manufacturing Practices 
HIPAA 
Health Insurance Portability and Accountability Act 
HRQoL 
Health Related Quality of Life 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 6 of 36 
LAR 
Legally Authorized Representative  
PAID 
Problem Areas In Diabetes 
PHI 
Protected Health Information 
PI 
Principal Investigator 
QC 
Quality Control 
REDCap 
Research Electronic Data Capture 
SAE 
Serious and Reportable Adverse Events 
SEDS 
Self-Efficacy for Diabetes 
SES 
Socioeconomic Status 
SMA 
Shared Medical Appointment 
SOC 
System Organ Class 
SOP 
Standard Operating Procedures 
T1D 
Type 1 Diabetes 
T1DAL 
Type 1 Diabetes and Life 
TAR 
Time Above Range 
TBR 
Time Below Range 
TIR 
Time In Range 
 
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 7 of 36 
Protocol Summary 
Title:  
 
Brief Summary: 
 
Group Visits to Improve Technology Use, Glycemic Control, 
and Quality of Life in High Risk Children with Type 1 
Diabetes 
We propose to conduct a prospective cohort pilot study to 
assess the impact of SMA visits in underserved youth with 
poorly controlled T1D. The trial will employ an enrollment 
visit, SMA visits every 3 months over a 12 month study 
period, followed by a 6-month observational period to 
assess feasibility and acceptability of SMA and the impact 
on glycemic control, self-management skills, and health 
related quality of life.  
Study Population:  
Inclusion criteria are: ages 8-12, T1D duration of at least 1 
year, at least one A1C value > 8% in the past year, Black 
race and/or Latinx ethnicity, public health insurance, and 
English fluency in the youth and parent.  
Study Site(s):  
 
 
Number of 
Participants: 
This study will be conducted entirely at Children’s National 
Hospital and Specialty Care Locations 
 
20 parent-child dyads (40 participants) 
 
 
Accrual Ceiling: 
 
Study Duration: 
20 parent-child dyads (40 participants) 
 
18-24 months 
Subject Duration:  
18 months 
Objective(s):  
 
 
 
 
Methodology: 
Primary Objective: To evaluate the feasibility and 
acceptability of SMA among underserved youth with T1D 
as measured by recruitment, CGM initiation, retention, 
satisfaction surveys, and semi-structured interviews. 
 
Secondary Objectives: To evaluate the preliminary impact 
of SMA on glycemic control, self-management skills, self-
efficacy, diabetes related quality of life, and treatment 
satisfaction among underserved T1D youth 
 
Prospective cohort pilot study 
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 8 of 36 
Outcome Measures: 
 
 
 
 
 
 
 
 
 
 
 
 
Study Intervention/ 
Procedures: 
 
 
 
 
 
 
 
 
 
 
 
Statistical Analysis: 
 
Primary Outcome: Feasibility as assessed by recruitment, 
(>60% of reached/ eligible participants), CGM initiation 
(>80%), SMA sessions attended (>80%), and study 
retention (>80%). Acceptability as assessed by user 
satisfaction surveys (>80%), perceived utility of the 
intervention content, and perceived benefits from 
participation (>80% reporting satisfaction and perceived 
utility).  
 
Secondary Outcomes: Differences in the following within 
subject measures across the SMA intervention and during 
the follow-up period: 1) CGM time in range from 70-180 
mg/dL (TIR), 2) time below range (< 70 mg/dL) (TBR), 3) 
time above range (> 180 mg/dL) (TAR), 4) mean sensor 
glucose, 5) coefficient of variation (CV) of glucose, 6) CGM 
wear time, 7) episodes of DKA, 8) episodes of severe 
hypoglycemia, 9) ED visits, hospital admissions, 10) A1c, 
11) qualitative measures exploring self-management, 
satisfaction, health related quality of life [Type 1 Diabetes 
and Life (T1DAL), Diabetes Self-Management Profile 
(DSMP), Self-Efficacy for Diabetes (SEDS), Problem Areas 
in Diabetes (C-PAID), CGM Benefits and Burdens]. 
 
Secure REDCap surveys will be completed either ahead of 
or at each visit by patients and caretakers. During 
intervention SMA visits, the facilitator role will be shared by 
a pediatric endocrinologist, certified diabetes care and 
education specialist (CDCES), nutritionist, and 
psychologist. SMA sessions will consist of facilitator led-
discussions, and youth and caregivers will individually meet 
with the endocrinologist at different time points during the 
session. Patient CGM data will be analyzed 2 weeks ahead 
of visits, and we will summarize self-management skills, 
health-related quality of life measures, and treatment 
satisfaction at each intervention visit.  
 
CGM data will be analyzed using library GLU in R.73 using 
mixed effect models. The independent variables will be 
baseline time in range, child age, and a random subject 
effect to account for correlation of measurements on the 
same subject. Interaction terms of age and baseline time in 
range with the intervention will explore possible effect 
modification (p<0.10) of these characteristics. Differences 
in participant self-management skills and patient 
satisfaction will be reported as mean Likert scale score and 
standard deviation. Similar analysis using linear longitudinal 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 9 of 36 
regression analysis will be conducted. Results will be 
reported as least-squares means (LSMEANS) with 
standard errors. Casewise deletion will be used to handle 
missing data.  
 
 
Study Design Schematic 
Table 1. Schedule of study procedures. 
 
Construct 
Measure 
Initial 
SMA 
3mo 
SMA 
6mo 
SMA 
9mo 
SMA 
12mo 
SMA 
15mo 
18mo 
14-Day CGM 
Markers of 
Glycemic 
Control 
Mean CGM Glucose 
X 
X 
X 
X 
X 
X 
X 
Coefficient of Variation 
X 
X 
X 
X 
X 
X 
X 
Glycemic Mgmt Indicator 
(GMI) 
X 
X 
X 
X 
X 
X 
X 
CGM Wear Time 
X 
X 
X 
X 
X 
X 
X 
CGM TIR 
X 
X 
X 
X 
X 
X 
X 
CGM TBR 
X 
X 
X 
X 
X 
X 
X 
CGM TAR 
X 
X 
X 
X 
X 
X 
X 
A1c 
X 
X 
X 
X 
X 
X 
X 
Youth 
Surveys 
T1DAL 
X 
X 
X 
X 
X 
X 
X 
DSMP 
X 
X 
X 
X 
X 
X 
X 
SEDS 
X 
X 
X 
X 
X 
X 
X 
PAID 
X 
X 
X 
X 
X 
X 
X 
CGM Ben & Bur 
X 
X 
X 
X 
X 
X 
X 
SMA Evaluation 
X 
X 
X 
X 
X 
X 
X 
Parent 
Surveys 
P-T1DAL 
X 
X 
X 
X 
X 
X 
X 
P-DSMP 
X 
X 
X 
X 
X 
X 
X 
P-SEDS 
X 
X 
X 
X 
X 
X 
X 
P-PAID 
X 
X 
X 
X 
X 
X 
X 
CGM Ben & Bur 
X 
X 
X 
X 
X 
X 
X 
SMA Evaluation 
X 
X 
X 
X 
X 
X 
X 
Semi-Structured Dyad Interview 
 
 
 
 
X 
 
 
 
Section 1: Key Roles 
Principal Investigator 
Oversight Monitor 
Shideh Majidi, MD 
n/a 
Children’s National Hospital 
 
111 Michigan Ave, NW 
Washington, DC 20010 
 
202-476-2020 
 
smajidi4@childrensnational.org  
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 10 of 36 
Section 2: Introduction, Background Information and Scientific 
Rationale 
2.1 
Background Information and Relevant Literature 
There are significant disparities in type 1 diabetes (T1D) care and outcomes. 
Hemoglobin A1c (A1c) levels and rates of acute and chronic T1D complications are 
highest among publicly insured youth and those from racial-ethnic minority groups and 
low socioeconomic status (SES).1-3 CGM use has been associated with improved 
glycemic control and health related quality of life in youth with T1D4, however rates of 
uptake and sustained use are lowest among racial and ethnic minority youth and those 
from lower income households.1,5,6 SMA have shown great promise for improving 
glycemic control, self-management skills, and self-efficacy in adolescents with T1D7, but 
have not been specifically developed to meet the needs of underserved youth. We aim 
to develop SMA specifically designed to meet the needs of racial, ethnic, and 
socioeconomically underserved youth in order to address disparities in T1D care and 
outcomes. 
 
We are including relevant preliminary data that supports the individual components 
proposed in the current intervention, including the need to include diverse populations in 
CGM research, key intervention components of promoting positive quality of life factors 
around diabetes management, and the positive impact that SMA can have on 
underserved diabetes patients and their caretakers. 
 
Health disparities among type 1 diabetic patients: Health disparities exist among 
individuals with T1D of different races and ethnicities, with minorities having worse long-
term outcomes compared to non-Hispanic whites in the U.S.3 Minority youth with 
diabetes are significantly more likely to have higher A1C levels, elevated cardiovascular 
risk factors, early signs of kidney disease, retinopathy, and neuropathy as compared to 
non-Hispanic white youth.3 Black/African American and Hispanic youth remain woefully 
underrepresented in diabetes technology trials. Unfortunately, this mirrors the reality of 
real-world clinical care: non-Hispanic Black and Hispanic youth are much less likely to 
use CGMs as part of T1D management, and worse, those who are not using these 
technologies report that they have not been offered the option to use these treatment 
modalities.8  Using data from the T1D Exchange, Agarwal and colleagues reported that 
72% of non-Hispanic White young adults (ages 18-25) used CGM as compared to 18% 
of non-Hispanic Black youth and 40% of Hispanic Youth.9 The source of health 
disparities in T1D technology access and use are complex and multifaceted. Targeted, 
evidence-based support for technology use and psychosocial functioning must address 
multiple systems and be responsive to the needs of diverse youth with T1D. However, 
diabetes distress and lower rates of diabetes technology use are modifiable barriers that 
are critical to address according to the tenets of social cognitive theory, which 
recognizes that knowledge, self-efficacy, and psychosocial factors all impact health 
behaviors and outcomes. Interventions rooted in this theory hold the potential to 
address barriers in attaining health equity among youth with T1D.10 
 
Health related quality of life in people living with T1D : Health related quality of life 
(HRQoL) has become a fundamental focus of comprehensive healthcare.11 Impaired 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 11 of 36 
HRQoL has been found in children and adolescents with several chronic 
conditions, including diabetes.11 Chronic disease during childhood can result in more 
frequent depressive moods and other negative emotions, lower life satisfaction, poorer 
school performance, and negative self-esteem and self-concept.12-14  Having diabetes 
requires many behavior changes, which can lead to stress in both the patients and their 
families,15 and studies have shown that adolescents with diabetes have a lower life 
satisfaction and health perception than healthy adolescents.16,17 Diabetes-specific 
emotional distress and quality of life are psychosocial variables that are strongly 
associated with key diabetes outcomes, such as adherence and metabolic control.18,19 
Social support from classmates and caretakers,20,21 as well as adaptation and coping 
skills are key to improving medical outcomes.22 
 
Benefits of CGM therapy: CGMs are minimally invasive devices that use a 
subcutaneous sensor to report and record changes in interstitial glucose values every 5 
minutes to 15 minutes.23 This technology can alert patients to hypoglycemia and 
hyperglycemia and also allows them to make diabetes treatment decisions without the 
need for a confirmatory fingerstick blood glucose level. Improvements in the accuracy 
and usability of CGM, better insurance coverage, and greater acceptance by both 
clinicians and patients have led to dramatic increases in the use of this technology over 
the past decade. 1,24-32 In 2011, just 6% of all patients in the United States Type 1 
Diabetes Exchange (T1DX) registry were using CGM as compared to 27% in the period 
from 2016-2018.1 Continuous glucose monitor (CGM) use among youth with T1D is 
recommended whenever possible,33 and has been associated with decreased 
hypoglycemia and severe hypoglycemia,34,35 improvement in A1c, and improved quality 
of life and treatment satisfaction.1  
 
Positive effects of SMA in diabetes: The American Diabetes Association (ADA) 
recommends that education and social support is continually offered to youth and their 
caregivers at routine clinic visits,33 however this is challenging within the constraints of 
the current clinical care model. Shared medical appointments (SMA), wherein small 
groups of patients participate in group education sessions in place of traditional clinic 
visits, have been successfully employed in pediatric chronic disease management, and 
are well suited for diabetes care.7,36-39 SMA visits allow additional time for 
interprofessional self-management education, skill building, self-efficacy, and peer 
support.40  Specifically in pediatric T1D, SMA has been shown to allow for discussion of 
a greater breadth of topics while also placing greater focus on behavioral and 
psychosocial needs.41,42 Adolescents participating in SMA exhibit improved glycemic 
control and reduced diabetes distress through the development of a supportive 
community.7 Increased satisfaction with follow up care can also translate into improved 
attendance and engagement in regularly scheduled clinical care. However, to date, the 
use of SMA has not been well-studied in underserved youth and has not been used 
specifically to promote uptake and sustained use of diabetes technologies.   
 
2.2 
Scientific Rationale 
The primary aim of this pilot study is to assess the impact of a 12-month SMA model 
employing interprofessional facilitator-mediated discussion to promote the uptake and 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 12 of 36 
sustained use of CGM, while also providing peer support, and fostering 
community in order to improve glycemic control and promote health equity among youth 
with T1D. Although SMAs have been used in T1D, few have been designed specifically 
to improve health equity by addressing the needs of diverse youth and their families. 
This proposed intervention will be developed to meet the needs of non-Hispanic Black 
and Latinx youth with public insurance. Furthermore, this SMA will be the first 
specifically developed to support uptake and sustained use of diabetes technology 
among youth who have been historically least likely to access these technologies.1,5,6  
 
We expect that the SMA model will lead to high rates of SMA retention and satisfaction, 
greater CGM wear time and sustained use, improved glycemic control, and improved 
diabetes specific quality of life, self-management behaviors, and self-efficacy scores 
compared to patients in the traditional individual appointment model. The 
interprofessional model incorporating CDCES, psychology, and nutrition will allow for 
youth and caregivers to interact with the entire diabetes care team and will also allow for 
sufficient time to focus on both education and strategies to cope with the psychosocial 
burdens and challenges needed to optimize adherence and outcomes. Lessons learned 
from this comprehensive interprofessional SMA will also provide insights that will allow 
for development of additional strategies needed to promote equal opportunity for all 
youth to achieve health and quality of life targets without being hindered by race, 
ethnicity, or socioeconomic status.  
 
We propose to recruit up to 20 underserved children with poorly controlled T1D and 
their primary diabetes caregiver. Inclusion criteria are: ages 8-12, T1D duration of at 
least 1 year, at least one A1c value > 9% in the past year, Black race and/or Latinx 
ethnicity, public health insurance, and English fluency in the youth and parent. For the 
purposes of this study, because non-Hispanic black and Latinx youth with public 
healthcare insurance are the least likely to have access to CGM technology, we will use 
the term underserved to specifically refer to this population.1  
 
Primary and secondary outcomes will be evaluated at baseline, 4 follow-up points 
during the SMA intervention, and 3 and 6 months after the final group visit. A 3-month 
interval for SMA and assessment was chosen to correspond to standard clinical follow 
up visit schedule. Participant data will be matched by age, race, insurance status, 
duration of diabetes, in the routine follow up model, in order to evaluate the impact of 
SMA on the outcomes of interest.  
 
2.3 
Potential Risks 
Questionnaires and SMA Visit  
As part of the study, participants will participate in SMA and complete validated 
questionnaires which include questions about their private attitudes, feelings and 
behavior regarding the management of diabetes. It is possible that some people may 
find these discussions and/ or questionnaires to be mildly upsetting, however these 
questionnaires have been used in previous research and these types of reactions have 
been uncommon.  Participants who are upset or worried after completing questionnaires 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 13 of 36 
or participating in the study will be referred to our diabetes psychology team for 
additional support. 
 
Privacy Concerns 
Data downloaded from the CGM 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, however this too is 
part of routine diabetes care. The group setting of the SMA removes much of the 
privacy that is provided to patients and their families during a routine individual visit. 
Some families might feel uncomfortable talking about personal experiences or attitudes 
related to their own diabetes care in front of other people. Description of the SMA will be 
clear during the consent process so that only families who are comfortable sharing in a 
group setting will choose to participate in the study. Participants and their caretakers will 
also have the option to withdraw from the intervention at any time if they become 
uncomfortable with the lack of privacy in the SMA. 
 
Other Risks 
Some participants may develop skin irritation or allergic reactions to the adhesives used 
to secure the CGM. If these reactions occur, different adhesives or under dressings will 
be tried (such as with IV 3000, Tegaderm, etc.), sites will be rotated more frequently, 
and a mild topical steroid cream may be required. 
 
Many of the risks associated with participation in this study are the same risks facing all 
patients receiving routine clinical care for T1D. Patient’s diabetes data is routinely 
downloaded as a part of clinical care and is done in compliance with Health Insurance 
Portability and Accountability Act (HIPAA) regulations. While there is concern that the 
questionnaires may be upsetting to some participants, these types of reactions are rare 
and there are psychology staff available in our clinic should these types of reactions 
occur. The potential benefits for improvements in glycemic control and health-related 
quality of life far outweigh the minimal risks.   
 
2.4 
Potential Benefits 
The purpose of this study is to reduce healthcare disparities, promote technology 
uptake, and improve the glycemic control in underserved youth with T1D. Improvements 
in glycemic control may reduce both short-term risks of T1D, including hypoglycemia, 
hyperglycemia, and DKA, and the long-term risks of T1D, including nephropathy, 
neuropathy, retinopathy, cardiovascular disease, and neurocognitive dysfunction. The 
SMA visit structure may also have benefits on health related quality of life for youth and 
their caregivers. It is expected that the results of this study will inform the design of 
future randomized controlled studies that have the potential to alter future provider 
practices and reduce healthcare disparities.     
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 14 of 36 
Section 3: Objectives and Endpoints 
3.1 
Primary Objective(s) 
To evaluate the feasibility and acceptability of SMA among underserved youth with T1D 
as measured by recruitment, CGM initiation, retention, satisfaction surveys, and semi-
structured interviews. 
 
3.2 
Secondary Objective(s) 
To evaluate the preliminary impact of SMA on glycemic control, self-management skills, 
self-efficacy, diabetes related quality of life, and treatment satisfaction among 
underserved T1D youth, as measured by CGM data, and a battery of validated survey 
measures completed by the youth and their caretaker. 
 
3.3 
Primary Outcome Measure(s)  
Given the novelty of the SMA approach for underserved youth and promotion of CGM 
technology uptake and sustained use, feasibility and acceptability of the intervention will 
serve as the primary outcome measure. We will track recruitment, enrollment, 
participation, and retention through a CONSORT table (Table 2) for the intervention 
group. Feasibility benchmarks include: recruitment (>60% of reached/eligible  
participants), CGM initiation, (>80%), SMA 
sessions attended (>80%), and retention 
(>80%). In addition, feasibility encompasses 
demographic characteristics of the enrolled 
sample, with enrollment and overall 
increased uptake of CGM among youth from 
historically underrepresented racial and 
ethnic backgrounds (Black race and/or Latinx 
ethnicity) and income levels. Attrition data 
and team feedback will help determine how 
recruitment rates may be improved. 
Acceptability will be assessed using 
satisfaction surveys and determined by a 
high level of satisfaction with participation, 
perceived utility of the intervention content, 
and perceived benefit from participation 
(>80% reporting that they were satisfied and 
perceived utility and benefit). We will report 
summary statistics on each feasibility and 
acceptability item in the questionnaires (mean and standard deviation as well as percent 
answering a specific Likert level). Acceptability also will be examined by key 
demographic characteristics, including participant age and race/ethnicity. 
Parent-child dyads will participate in semi-structured interviews to assess satisfaction 
with the SMA. Thematic analysis of qualitative data will be conducted by two team 
members who will independently review interview transcripts to generate initial codes. 
Initial codes will be discussed by the group to generate a list of second-cycle codes and 
each team member will then apply the coding framework to all transcripts before 
Table 2. Analytical plan for Aim 1, feasibility and 
acceptability.   
Construct 
Measure 
Interval 
Recruitment  
Feasibility/ 
Acceptability 
#  referred 
# screened 
#  enrolled 
% eligible who enroll 
Study 
initiation 
through 
completion of 
recruitment  
Intervention 
Feasibility 
#/% sessions attended  
 
SMA visits 
every 3mo 
Intervention 
Acceptability 
Child/parent satisfaction ratings 
Child/parent qualitative interview 
After 
completion of 
intervention 
Retention 
Feasibility/ 
Acceptability 
% who initiate CGM 
% who continue on CGM  
% completing follow-up 
assessments 
All 
assessment 
time points 
Assessment 
Feasibility  
 
% participants with missing A1c 
data 
% participants with missing CGM 
data 
% participants with missing 
survey data 
All 
assessment 
time points 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 15 of 36 
identifying dominant themes. ATLAS.ti software will be used to organize and 
analyze the qualitative data.   
 
3.4 
Secondary Outcome Measure(s) 
Secondary outcomes will include CGM metrics and chart review that can be used to 
assess effects on glycemic control, and survey measures designed to explore potential 
psychosocial benefits, including changes in self-management skills, self-efficacy, 
treatment satisfaction, and diabetes related quality of life. We will look at differences in 
the following measures from baseline to completion of the SMA intervention, as well as 
3 and 6-months after completion of the SMA intervention: 1) CGM time in range from 
70-180 mg/dL (TIR), 2) time below range (< 70 mg/dL) (TBR), 3) time above range (> 
180 mg/dL) (TAR), 4) mean sensor glucose, 5) coefficient of variation (CV) of glucose, 
6) CGM wear time, 7) episodes of DKA, 8) episodes of severe hypoglycemia, 9) ED 
visits, hospital admissions, 10) A1c, 11) qualitative measures exploring self-
management, satisfaction, health related quality of life as measured with the following 
validated questionnaires (T1DAL, DSMP, SEDS, C-PAID, CGM Benefits and Burdens 
scale). 
 
CGM time in range from 70-180 mg/dL (TIR) has been correlated with A1c values, 
which have classically been used as primary outcomes in T1D studies because of their 
association with microvascular complications.43 This connection to long-term 
complications also makes TIR a better primary outcome measure than survey measures 
because this data has greater potential to alter real-world prescribing practices than 
patient perceptions captured by questionnaire. We have chosen to focus on TIR rather 
than A1c because of the propensity for A1c variation in Non-Hispanic Black youth who 
also have a higher propensity for hemoglobin variants.44  
 
Additional CGM derived measures of glycemic control are commonly used outcomes in 
studies of T1D technology.45 A1c has been included because it has classically been 
considered the gold standard. The acute complications of T1D being examined are also 
frequently used in T1D studies. The survey measures exploring quality of life are among 
the most widely accepted outcome measures in their specific topic areas.11,46-49  
 
Section 4: Study Design 
Dyads of youth with T1D aged 8-12 years and their primary diabetes caretakers 
identifying as non-Hispanic Black or Latinx will be recruited to participate in a 
prospective cohort pilot study exploring feasibility and acceptability of SMA and the 
impact on glycemic control, self-management skills, and health related quality of life. 
This trial will employ an enrollment visit, SMA visits every 3 months over a 12-month 
study period, and a follow-up 6-month observational period to continue to evaluate 
outcomes once patients return to routine individual follow up care. The study will include 
a single intervention group participating in the SMA visits (n=20). 
 
All staff participating in the SMA visit will receive comprehensive training on how to 
facilitate the SMA discussion sessions effectively. All topics that will be covered at each 
SMA visit will be reviewed by the study staff ahead of the visit. Potential participants will 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 16 of 36 
be screened for participation using our electronic medical records system and will 
be approached during routine clinical visits. After explaining all study procedures, 
informed consent using an IRB-approved consent form will be obtained for all 
participants. After obtaining consent, a blinded Dexcom G6 CGM will be placed on the 
participant. Participants will be instructed to wear the blinded CGM for 10 days in order 
to obtain baseline glycemic control data prior to starting the SMA visit intervention. At 
the completion of the 10 day wear period, participants will mail back the blinded CGM in 
a pre-addressed envelope so that the data can be assessed within 30 days of the wear 
time. Because SMA visits will be used in place of routine clinic visits and because 
participants will not require any additional in person study visits, we anticipate significant 
interest in participation with minimal barriers. Secure REDCap surveys will be sent to 
participants via email 1 week before each follow-up visit. If the surveys have not been 
completed at the time of the visit the participant will be asked to complete the measures 
using an iPad or paper in clinic at the time of their visit. Youth who elected not to use a 
CGM for routine clinical care, will be asked to wear a blinded professional CGM for 10 
days prior to each visit whenever possible.  
 
SMA Structure: SMAs will consist of 4-6 underserved youth with T1D and their primary 
diabetes caregiver. All youth and caretakers will complete standard check-in procedures 
with the clinic medical staff, including routine clinical intake questionnaires, vital sign 
assessments and point-of-care fingerstick A1c measurements. Before each session, 
dyads will be invited to submit questions to the research team that will then be 
anonymously reviewed and discussed among the group during the SMA. In the event 
that no questions are submitted by families, the facilitator will begin the discussion with 
stories and questions related to technology use and potential barriers in order to focus 
the discussion on the aspect of diabetes management being highlighted in that specific 
SMA. After discussing the questions, the facilitator will lead a group discussion focusing 
on the topic of the day. During each visit, the facilitator role will be shared by a pediatric 
endocrinologist, CDCES, nutritionist, and psychologist. Youth and caregivers will 
individually meet with the endocrinologist at different time points during the session to 
update personal management plans and goals of care. The group visit will conclude 
with a review of the core concepts discussed. Youth will be encouraged to set and 
share individual goals to be addressed before the next SMA.  
 
Enrollment visit: This visit will occur at a routine clinic visit once a patient expresses 
interest in participating in the study. Alternatively, patients expressing interest in 
enrolling who are unable to do so at a routine clinic visit will have the option to come 
back for enrollment at a different time.  A study team member will meet with the patient 
and family to review the study details and obtain consent. Randomization will be 
completed after consent has been obtained.  A blinded Dexcom G6 pro CGM will be 
placed on the patient and be worn for 10 days in order to collect baseline data prior to 
starting the intervention. Phone applications that will allow for sharing of CGM data 
between patients and the diabetes clinical care team will be downloaded and 
established before the end of the visit. 
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 17 of 36 
Initial SMA: The structure of the group visits will be reviewed with patients and 
families, and all members of the diabetes team will introduce themselves and explain 
their role in diabetes care. As some patients will be CGM naïve before this visit, 
education will focus on insertion and removal of the CGM along with appropriate use of 
the CGM receiver, alerts and alarms, data sharing, and troubleshooting common CGM 
problems. Established sharing of CGM data between patients and the diabetes clinical 
care team will be confirmed before the end of the visit. The group visit will conclude with 
a review of the core concepts discussed, and patients will set goals for the next SMA.  
 
Follow Up SMA: Follow up SMA will be scheduled 3, 6, 9, and 12 months from the initial 
group visit. CGM data from 14 days prior to each SMA will be reviewed by the 
endocrinologist ahead of the group visit. Discussions and education guided by the 
facilitators will focus on issues that have been described in the literature as potential 
barriers to CGM use and adherence. Recurrent alerts and alarms can result in alarm 
fatigue,50 and falsely low glucose readings and sensor or transmitter failures have been 
cited as reasons for discontinuing CGM use.51 The continuous nature of CGM data has 
been shown to place significant demands on patients and their families,50 and to create 
stress related to the constant need for diabetes-related attention.52  Follow up visits will 
focus on optimized use of CGM alarms  and prevention of alarm fatigue. Psychologists 
and CDCES will discuss strategies to cope with the on-body presence and potential 
embarrassment resulting from CGM wear and to optimize parent-child communication 
surrounding CGM. Nutritionists will highlight the impact of different foods on glycemic 
trends and discuss strategies to optimize control. SMA will also allow ample opportunity 
to jointly review de-identified CGM reports and how to effectively interpret data and 
make management changes in response to CGM data, empowering patients and 
families to improve self-management and reduce stress related to CGM use. Active 
participation in discussions and group exercises will continue to strengthen the 
community feeling and social support network within the SMA group. Any participant 
that chooses to discontinue CGM during the 12 month study period will wear a blinded 
CGM 10 days prior to the follow up visits to allow for complete data collection. Upon 
completion of the final SMA visit at month 12, dyads will be contacted to schedule a 
semi-structured interview and will then return to standard clinical care.   
 
3-Month and 6-Month Post-Intervention Follow-Ups: Survey measures and 
assessments of glycemic control will be repeated after 3 months and 6 months of 
routine clinical care to assess for long-lasting effects of the intervention. 
 
Section 5: Study Enrollment and Withdrawal 
5.1 
Study Population, Recruitment and Retention 
We propose to recruit up to 20 dyads of underserved children with poorly controlled T1D 
and their primary diabetes caregiver who express an interest in starting CGM therapy. 
We aim to recruit children with T1D ages 8-12 with T1D duration for at least 1 year, at 
least one A1c value > 8% in the past year, Black race and/or Latinx ethnicity, public 
health insurance, and English fluency in the youth and parent. The lower limit of the age 
inclusion criteria was selected so that patients will be able to fully participate in the SMA 
visits. The inclusion criteria were selected in order to demonstrate the effects that that 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 18 of 36 
CGM technology can have in patients who are the least likely to have access to 
diabetes technologies.   
 
Potential participants will be screened for participation using our electronic medical 
records system of the diabetes outpatient clinic, in accordance with the HIPAA rules. 
This study will include the vulnerable study population of children aged 8-12 years old, 
however no special considerations will need to be taken given that there is no greater 
than minimal risk with study participation. Parents/guardians will have access to the 
results of the children’s participation once the study has been completed, as to not bias 
results while the intervention is still ongoing.  
 
Eligible participants will be approached to participate during routine clinic visits after 
discussion with their primary endocrine clinician. For patients who cannot be 
approached in person at the time of the visit, we will attempt to contact individuals by 
email or phone. The email will include an option to opt-out of further contact. If a 
cellphone number is listed, the study team will also send a text (using a study 
designated number) after attempting to call. If an email address is not on file, a letter will 
be sent via mail. The text will not contain PHI and provides general information about 
the project and encourages those interested to respond and talk via phone. Patients 
and families who are still considering whether to enroll after the clinic appointment will 
be contacted by phone or text message after the visit. Participants will be offered 
parking or transportation reimbursement for each of the group clinic visits, and $20 at 
each of the visits as well as at the 3-month and 6-month post intervention visit for 
completion of survey measures, regardless of if a patient withdraws early. Non-English 
speaking individuals will be excluded as the Dexcom CGM technology is currently 
available only in English.  
 
5.2 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
1. Patients clinically diagnosed with T1D managed with insulin injections for at least 
1 year  
2. Non-Hispanic Black or Latinx ethnicity 
3. Public healthcare insurance  
4. Male or female ages ≥ 8 and < 12 years  
5. No prior use of CGM within 60 days of enrolment 
6. Poorly controlled T1D: one A1c value > 8% in the preceding year 
7. Fluent in English as the Dexcom technology is currently available only in English 
8.  Participation of the primary diabetes caregiver 
 
5.3 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation 
in this study: 
1. Use of insulin pump therapy for diabetes management at time of enrolment 
2. Major illnesses other than T1D 
3. Significant cognitive limitations and major psychiatric disorders in the child or 
parent 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 19 of 36 
4. Concurrent use of any non-insulin diabetes medication to control blood 
glucose levels. 
5. Concurrent participation in any other clinical studies during study period   
 
5.4  
Vulnerable Subjects  
This research will involve the federally recognized vulnerable subject population of 
children. As this research will not involve greater than minimal risk, no special 
considerations will need to be taken. Adequate provisions will be made for soliciting the 
assent of the children and the permission of their parents or guardians.  
 
5.5 
Recruitment 
All patients scheduled for routine clinical diabetes appointments at Children’s National 
Specialty Care Locations will be screened through chart review by study team members 
to assess for eligibility after a HIPAA authorization waiver for recruitment is granted. We 
anticipate enrolling 5-7 patients per month over 3-4 months to meet our target 
enrollment of up to 20 participants. Patients will be approached to participate during 
routine clinical visits. For patients who cannot be approached in person at the time of 
the visit, we will attempt to contact individuals by email or phone. The introductory email 
will be co-signed by the PI and Dr. Grundman, CNH Child and Adolescent Diabetes 
Program. The email will include an option to opt-out of further contact. If a cellphone 
number is listed, the study team will also send a text (using a study designated 
number) after attempting to call. If an email address is not on file, a letter will be sent via 
mail. The text will not contain PHI and provides general information about the project 
and encourages those interested to respond and talk via phone. Patients and families 
who are still considering whether to enroll after the clinic appointment will be contacted 
by phone or text message after the visit. Once a potential participant has been 
identified, a study team member will give an IRB approved study information letter to the 
participant’s legally authorized representative (LAR). If the LAR expresses interest in 
the study, a copy of the IRB approved consent will be provided to the LAR. The 
informed consent will be signed by the LAR and assent will be obtained from the patient 
at an in-person visit before any research interventions are done. For patients who 
cannot be approached in person at the time of the visit, we will attempt to contact 
individuals by phone and obtain e-consent and/or e-assent with REDCap. The REDCap 
link of the IRB approved consent will be provided to the LAR via text or email. The 
informed consent will be electronically signed by the LAR and assent will be obtained 
electronically from the patient. All study team pre-screening materials that contain 
patient information will be maintained on password protected computers. Only 
authorized team members will have access to the pre-screening materials, Any pre-
screening PHI that was collected will be destroyed once study enrollment has been 
completed.   
 
5.6  
Retention 
To enhance participant retention, we will obtain multiple methods for contact for 
participants and their parents. Patients and parents will receive reminders- via email, 
text, and/ or phone call as per participants’ preference to alert them to upcoming SMA 
visits. Participants will also receive reimbursement for transportation or parking. 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 20 of 36 
Participants who complete the survey measures will be compensated with $20 at 
the baseline and for each follow-up visit. If a participant unexpectedly misses an in-
person SMA visit, the participant’s legally authorized representative will be contacted by 
a member of the study team to check on the participant’s welfare and to see if there are 
any barriers to the participant attending future group sessions. Efforts will be made to 
have participants join an alternative session to make up for any missed scheduled SMA 
sessions.  
 
5.7 
End of Participation Criteria and Procedures 
Participants are free to withdraw from participation in the study at any time upon 
request. The reason for participant discontinuation or withdrawal from the study will be 
recorded on the Premature Termination Case Report Form (CRF). Subjects who sign 
the informed consent but do not receive the study intervention may be replaced.  
Subjects who sign the informed consent form, begin the study intervention, and 
subsequently withdraw, or are withdrawn or discontinued from the study, will try and be 
replaced.   
 
Participants who experience significant psychological distress as a result of the 
intervention or whose presence at SMA visits will be terminated from study participation.  
Anyone experiencing psychological distress will be referred to the diabetes psychology 
team for support (Drs. Monaghan and Streisand, Co-I’s).   
 
Section 6: Study Procedures 
6.1 
Informed Consent/Assent and HIPAA Authorization  
Informed consent is a process that is initiated prior to the individual’s agreeing to 
participate in the study.  It continues throughout the individual’s study participation. 
Consent forms describing in detail the study intervention, study procedures, and risks 
will be given to the participant. Written documentation of informed consent will be 
required prior to starting intervention/administering study intervention. Child assent form 
and informed consent form will be submitted with this protocol. Consent forms will be 
Institutional Review Board (IRB)-approved and the participant/legally authorized 
representative (LAR) will be asked to read and review the document. The principal 
investigator and co-investigator will explain the research study to the participant and 
answer any questions that may arise. This conversation will take place in a private 
room. Assent will be conducted for patients 12 years of age. A verbal explanation will be 
provided in terms suited to the participant’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants. 
Participants/families/LAR will have the opportunity to carefully review the written 
consent form and ask questions prior to signing. The participants/family/LAR should 
have the opportunity to discuss the study with their family or surrogates, or think about it 
prior to agreeing to participate. The participant’s caregiver or LAR will sign the informed 
consent document and the participant will sign the Assent form prior to any procedures 
being done specifically for the study. Assent for subjects aged 8-12 years old will be 
obtained and documented on the parental/LAR consent form.  
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 21 of 36 
Participants/families/LAR must be informed that participation is voluntary and that 
they may withdraw from the study at any time, without prejudice. A copy of the informed 
consent and assent documents will be given to the participants/families/LAR for their 
records. The rights and welfare of the participants will be protected by emphasizing that 
the quality of their medical care will not be adversely affected if they decline to 
participate in this study. 
 
6.2 
Screening Process 
Patients scheduled for routine clinical diabetes appointments will all be screened for 
participation up to 90 days prior to the scheduled visit using chart review. This will be 
conducted in accordance with the HIPAA rules. Those meeting inclusion criteria based 
on chart review will be discussed with their provider to assess confidence that the 
potential participant can successfully operate the CGM and is capable of adhering to the 
protocol. Suitable participants identified through screening will be approached in person 
to participate at the time of a clinic appointment. Patients and families who are still 
considering whether to enroll after the clinic appointment will be contacted by phone 
after the visit.   
 
Before completing any procedures or collecting any data that are not part of usual care, 
written informed consent will be obtained. Informed consent will be obtained in a 
manner that will minimize undue influence or coercion and will allow participants 
sufficient time to review the document and answer questions before signing. Ideally all 
discussion of the study will be conducted in person, however in the event that this is not 
possible the research team will contact participants via phone within 28 days of initially 
discussing the study.   
 
A caregiver/legal guardian (referred to subsequently as “caregiver”) will be provided with 
the Informed Consent Form to read and will be given the opportunity to ask questions. 
Potential participants will be given a Child Assent Form to read and discuss with his/her 
caregiver and study personnel. If the parent and child agree to participate, the Informed 
Consent Form and Child Assent Form will be signed, either in person or electronically 
via REDCap. A copy of the consent form will be provided to the participant and his/her 
parent and another copy will be added to the participant’s study record. 
 
As part of the informed consent process, each participant will be asked to sign an 
authorization for release of personal information. The investigator, or his or her 
designee, will review the study-specific information that will be collected and to whom 
that information will be disclosed. After speaking with the participant, questions will be 
answered about the details regarding authorization. A participant is considered enrolled 
when the informed consent form has been signed. 
 
6.3 
Study Interventions and Follow-Up 
Enrollment visit 
Those who have met eligibility criteria and express interest in study participation will 
meet with study staff to review the study specifics in more detail and obtain consent. 
Randomization will occur after consent has been obtained.  A blinded Dexcom G6 pro 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 22 of 36 
CGM will be placed on the patient and be worn for 10 days in order to collect 
baseline data prior to starting the SMA intervention. Phone applications that will allow 
for sharing of CGM data between patients and the diabetes clinical care team will be 
downloaded and established before the end of the visit. 
 
Initial SMA visit 
After enrollment is complete, data will be collected from routine clinical care, including 
height, weight, BMI, and a point of care fingerstick A1c.  A battery of validated survey 
measures exploring diabetes-specific quality of life will be completed by the parent and 
youth, including: T1DAL, DSMP, SEDS, PAID, CGM benefits and burdens, and an SMA 
evaluation. The caregiver will be asked to complete parental versions of the P-T1DAL, 
P-DSMP, P-PAID, P-SEDS, CGM benefits and burdens, and SMA evaluation. Surveys 
will be completed by caregiver, preferably the one most involved in medical care, but 
not both. If the caregiver elects not to complete these measures the patient is still 
eligible to participate in the study. Participants will have the option to complete these 
measures online or in clinic. Secure REDCap surveys will be sent to participants via 
email 1 week before their visit. If the survey has not been completed at the time of the 
visit, the participant will be given the option to complete the measures using an iPad or 
paper in clinic at the time of their visit.   
 
The structure of the group visits will be reviewed with patients and families, and all 
members of the diabetes team will introduce themselves and explain their role in 
diabetes care. As some patients will be CGM naïve at this visit, education will focus on 
insertion and removal of the CGM along with appropriate use of the CGM receiver, 
alerts and alarms, data sharing, and troubleshooting common CGM problems. 
Established sharing of CGM data between patients and the diabetes clinical care team 
will be confirmed before the end of the visit. The group visit will conclude with a review 
of the core concepts discussed, and patients will set goals for the next SMA. After 
completing the visit, patients will continue using the CGM for diabetes management.  
Follow up SMA at 3, 6, 9, and 12-months 
Follow up SMA will be scheduled 3, 6, 9 and, 12 months from the initial group visit. Data 
will be collected from routine clinical care, including height, weight, BMI, and a point of 
care fingerstick A1c.  Survey measures will be completed again as described 
previously. CGM data will be analyzed for the 14 days preceding each visit. Chart 
review from the time of the initial baseline visit will be conducted to assess the incidence 
of DKA, severe hypoglycemia, ED visits, and hospital admissions. Details obtained from 
the chart review will be confirmed with participants. Data from the CGM will be obtained 
through online software used to securely query these devices for routine clinical care 
(Dexcom Clarity).   
 
Discussions and education guided by the facilitators will focus on issues that have been 
described in the literature as potential barriers to CGM use and adherence. Recurrent 
alerts and alarms can result in alarm fatigue,50 and falsely low glucose readings and 
sensor or transmitter failures have been cited as reasons for discontinuing CGM use.51 
The continuous nature of CGM data has been shown to place significant demands on 
patients and their families50, and to create stress related to the constant need for 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 23 of 36 
diabetes-related attention.52 Follow up visits will focus on optimized use of CGM 
alarms and prevention of alarm fatigue. Psychologists and CDCES will discuss 
strategies to cope with the on-body presence and potential embarrassment resulting 
from CGM wear and to optimize parent-child communication surrounding CGM. 
Nutritionists will highlight the impact of different foods on glycemic trends and discuss 
strategies to optimize control. SMA will also allow ample opportunity to jointly review 
deidentified CGM reports and how to effectively interpret data and make management 
changes in response to CGM data, empowering patients and families to improve self-
management and reduce stress related to CGM use. Active participation in discussions 
and group exercises will continue to strengthen the community feeling and social 
support network within the SMA group. Any participant that chooses to discontinue 
CGM during the 12 month study period will wear a blinded CGM 10 days prior to the 
follow up visits to allow for complete data collection.  
If a visit is missed by the participant, he/she will have the option to attend a different 
group’s SMA that corresponds to the same timing as the SMA that was missed. In the 
event of withdrawal or early termination, participants will be asked to come for an end of 
study visit. If any participant chooses to discontinue CGM use, they will be asked to 
wear a blinded CGM for each of the 10 day periods ahead of their planned clinic visits. 
 
Upon completion of the final SMA visit at month 12, dyads will be contacted to schedule 
a semi-structured interview and will then return to standard clinical care. A structured 
focus group guide consisting of broad, open-ended questions to elicit details from 
patients and parents will be provided to facilitators. These sessions will last 45 minutes 
(± 15 minutes).  The sessions will be recorded on two separate devices and 
subsequently transcribed to allow for data analysis. 
 
3-Month and 6-Month Post-Intervention Follow-Up 
Survey measures and assessments of glycemic control will be repeated 3 months and 6 
months after the final SMA.  
 
6.4 
Description of Study Procedures/Evaluations 
Study Visits  
All SMA appointments will be scheduled at the time that consent is obtained. Biometric 
data (height, weight, BMI, A1c) will be obtained as part of routine care. Data from 14 
days prior to the visit for the CGM will be obtained through online software used to 
securely query these devices for routine clinical care (Dexcom Clarity).  Secure 
REDCap surveys will be sent to participants via email 1 week before their visit (including 
the T1DAL, DSMP, SEDS, PAID, CGM Benefits and Burdens, and an SMA evaluation 
for patients; and for parents: P-T1DAL, P-DSMP, P-SEDS, and P-PAID, CGM Benefits 
and Burdens, and SMA evaluation). If the surveys have not been completed at the time 
of the visit participants will be given the option to complete the measures using an iPad 
or paper surveys in clinic at the time of their visit. 
   
Prior to the study visit, chart review will be conducted to assess the interval incidence of 
DKA, severe hypoglycemia, ED visits, and hospital admissions. This will be conducted 
in accordance with the HIPAA rules. Information obtained through chart review will be 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 24 of 36 
corroborated with patients during study visits to ensure accuracy.  Biometric data, 
CGM data obtained from Clarity, and A1c values will be provided to participants as part 
of routine clinical care. The results from the battery of questionnaires will not be 
provided to patients.   
 
Primary Outcome  
Given the novelty of the SMA approach for underserved youth and promotion of CGM 
technology uptake and sustained use, feasibility and acceptability of the intervention will 
serve as the primary outcome measure. We will track recruitment, enrollment, 
participation, and retention through a CONSORT table (Table 2) for the intervention 
group. Feasibility benchmarks include: recruitment (>60% of reached/eligible 
participants), CGM initiation, (>80%), SMA sessions attended (>80%), and retention 
(>80%). In addition, feasibility encompasses demographic characteristics of the enrolled 
sample, with enrollment and overall increased uptake of CGM among youth from 
historically underrepresented racial and ethnic backgrounds (Black race and/or Latinx 
ethnicity) and income levels. Attrition data and team feedback will help determine how 
recruitment rates may be improved. Acceptability will be assessed using satisfaction 
surveys and determined by a high level of satisfaction with participation, perceived utility 
of the intervention content, and perceived benefit from participation (>80% reporting that 
they were satisfied and perceived utility and benefit as indicated by a Likert scale score 
of 4 or 5). We will report summary statistics on each feasibility and acceptability item in 
the questionnaires (mean and standard deviation well as percent answering a specific 
Likert level). Acceptability also will be examined by key demographic characteristics, 
including participant age and race/ethnicity.  
 
Parent-child dyads will participate in semi-structured interviews to assess satisfaction 
with the SMA. Thematic analysis of qualitative data will be conducted by two team 
members who will independently review interview transcripts to generate initial codes. 
Initial codes will be discussed by the group to generate a list of second-cycle codes and 
each team member will then apply the coding framework to all transcripts before 
identifying dominant themes. ATLAS.ti software will be used to organize and analyze 
the qualitative data. 
 
Secondary Outcomes 
Secondary outcomes will include CGM metrics that can be used to assess effects on 
glycemic control and survey measures designed to explore potential psychosocial 
benefits, including changes in self-management skills, self-efficacy, treatment 
satisfaction, and diabetes related quality of life. CGM time in range from 70-180 mg/dL 
(TIR) has been correlated with A1c values, which have classically been used as primary 
outcomes in T1D studies because of their association with microvascular 
complications.43 We have chosen to focus on use TIR rather than A1c because of the 
propensity for A1c variation in Non-Hispanic Black youth who also have a higher 
propensity for hemoglobin variants.44 CGM data will be obtained at each follow up visit 
through online software used to securely query the device for routine clinical care. 
Glycemic variability indicators will be obtained from CGM downloads for the 14 days 
prior to a follow-up data collection time point. As guided by published standardized 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 25 of 36 
CGM metrics,53 data will be transformed to identify number of measurements and 
percent TIR, time below range (<70 mg/dL) (TBR), and time above range (≥180 mg/dL) 
(TAR), mean sensor glucose, and coefficient of variation (CV) of glucose values during 
each 14-day period. We also will track the percent CGM wear time.  
 
CGM data will be analyzed using library GLU in R.73 using mixed effect models. These 
models will quantify the impact of our intervention on glucose control over time. The 
independent variables will be baseline time in range, child age, and a random subject 
effect to account for correlation of measurements on the same subject. Interaction terms 
of age and baseline time in range with the intervention will explore possible effect 
modification (p<0.10) of these characteristics. We will also explore differences between 
intervention time points and average outcome by parent education level and income. 
 
A battery of validated survey measures exploring diabetes-specific self-management 
skills and quality of life will be completed by the child and caretaker, including: Type 1 
Diabetes and Life (T1DAL), Diabetes Self-Management Profile (DSMP), Self-Efficacy 
for Diabetes (SEDS), and Problem Areas in Diabetes (C-PAID). Perceived benefits and 
barriers to CGM use will be assessed using the CGM Benefits and Burdens scale. 
Surveys will be completed by a single, consistent parent/caregiver throughout the study, 
preferably the one most involved in medical care.  
 
We will summarize self-management skills and treatment satisfaction from baseline to 
completion of the SMA visits, as well as 3-months and 6-months after completion of the 
SMA intervention. Differences in participant self-management skills and patient 
satisfaction will be reported as mean Likert scale score and standard deviation. Similar 
analysis using linear longitudinal regression analysis will be conducted. Results will be 
reported as least-squares means (LSMEANS) with standard errors. Casewise deletion 
will be used to handle missing data. 
 
6.5 
Study Team Training and Intervention Reliability 
All personnel involved in the conduct of this study have completed Human Subjects 
Protection and ICH GCP training. Study team members will be trained in how to 
properly score the various questionnaire results, so that scoring practices are objective 
and standardized. Data collection is the responsibility of the clinical trial staff at the site 
under the supervision of the site investigator. The investigator is responsible for 
ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
Separate semi-structured qualitative interviews will be conducted with patients and 
parents upon completion of the study to gain insight into satisfaction with the SMA visits. 
The sessions will be recorded on two separate devices and subsequently transcribed to 
allow for data analysis. 
 
6.6  
Concomitant Interventions and Procedures 
Not applicable 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 26 of 36 
 
Section 7: Safety Assessments and Reporting 
7.1  
Adverse Events (AEs) 
Risk to participants is minimal. While it is unlikely that participants will experience any 
risk, there may be minimal distress associated with completing questionnaires that ask 
about diabetes management, mood, or diabetes technology burden. Participants may 
also feel some distress related to discussing diabetes management, mood, or 
technology burden in the group SMA setting. Another potential source of risk in this 
study is the risk of gathering sensitive social, behavioral, and medical 
information. Data collection via the internet will be conducted through secure 
applications (REDCap) and no more than minimal risk.  
 
7.2  
Study Halting Rules 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to study 
participants, investigator, funding agency, the sponsor and regulatory authorities. If the 
study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Institutional Review Board (IRB), and sponsor 
and will provide the reason(s) for the termination or suspension. Study participants will 
be contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited 
to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Demonstration of efficacy that would warrant stopping    
• Insufficient compliance to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 
• Determination that the primary endpoint has been met 
• Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality 
are addressed, and satisfy the sponsor, IRB and/or Food and Drug Administration 
(FDA). 
 
Section 8:  Statistical Considerations and Analysis  
8.1 
Statistical and Analytical Plans (SAP) 
There will not be a formal SAP 
 
8.2 
Statistical Hypotheses 
Primary Outcome: feasibility and acceptability of SMA among underserved youth with 
T1D.  
Hypothesis 1a. Rates of SMA retention (>80%) at 12-months and satisfaction with visits 
(>80%) will be high.  
Null Hypothesis 1a: n/a 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 27 of 36 
Hypothesis 1b: Thematic analysis of semi-structured interviews will identify high 
satisfaction with SMA.  
Null Hypothesis 1b: n/a  
 
Secondary Outcome: preliminary impact of SMA on glycemic control, self-management 
skills, self-efficacy, diabetes related quality of life, and treatment satisfaction among 
underserved children with T1D and their caregivers 
Hypothesis 2a. CGM percentage wear time and sustained use, as defined by use within 
the 2 weeks prior to the visit, will be greater upon completion of the SMA 
intervention at 12 months compared to baseline 
Null Hypothesis 2a: CGM percentage wear time and sustained use, as defined by use 
within the 2 weeks prior to the visit, will not be significantly different upon 
completion of the SMA intervention at 12 months 
 
Hypothesis 2b. CGM time in range (70-180 mg/dL) will be greater and the glucose 
management indicator (GMI) lower for youth upon completion of the SMA 
intervention group at 12 months compared to baseline.  
Null Hypothesis 2b: CGM time in range (70-180 mg/dL) will not be significantly different 
upon completion of the SMA intervention at 12 months 
 
Hypothesis 2c. Diabetes-specific quality of life, self-management behaviors, and self-
efficacy scores will be greater upon completion of the SMA intervention at 12 
months compared to baseline.  
Null Hypothesis 2c:  Diabetes-specific quality of life, self-management behaviors, and 
self-efficacy scores will not be significantly different upon completion of the SMA 
intervention at 12 month 
 
8.3 
Analysis Datasets 
Data analysis will be conducted according to a per-protocol analysis as we will be 
unable to obtain appropriate data from those who withdraw from the study. Participants 
with incomplete data will be included in analyses when possible.   
 
8.4 
Description of Statistical Methods 
General Approach 
Descriptive measures will be used to summarize participant demographic information.   
P-values and confidence intervals will be two-tailed. Covariates will be pre-specified. 
Tests to assess normality will be performed and data transformation or non-parametric 
analyses will be used when necessary.  
 
Analysis of the Primary Efficacy Endpoint(s) 
We will track recruitment, enrollment, participation, and retention through a CONSORT 
table (Table 2) for the intervention group. Feasibility benchmarks include: recruitment 
(>60% of reached/eligible participants), CGM initiation, (>80%), SMA sessions attended 
(>80%), and retention (>80%). In addition, feasibility encompasses demographic 
characteristics of the enrolled sample, with enrollment and overall increased uptake of 
CGM among youth from historically underrepresented racial and ethnic backgrounds 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 28 of 36 
(Black race and/or Latinx ethnicity) and income levels. Attrition data and team 
feedback will help determine how recruitment rates may be improved. Acceptability will 
be assessed using satisfaction surveys and determined by a high level of satisfaction 
with participation, perceived utility of the intervention content, and perceived benefit 
from participation (>80% reporting that they were satisfied and perceived utility and 
benefit). We will report summary statistics on each feasibility and acceptability item in 
the questionnaires (mean and standard deviation well as percent answering a specific 
Likert level). Acceptability also will be examined by key demographic characteristics, 
including participant age and race/ethnicity.  
Parent-child dyads will participate in semi-structured interviews to assess satisfaction 
with the SMA. Thematic analysis of qualitative data will be conducted by two team 
members who will independently review interview transcripts to generate initial codes. 
Initial codes will be discussed by the group to generate a list of second-cycle codes and 
each team member will then apply the coding framework to all transcripts before 
identifying dominant themes. ATLAS.ti software will be used to organize and analyze 
the qualitative data.  
Analysis of the Secondary Efficacy Endpoint(s) 
Glycemic variability indicators will be obtained from CGM downloads for the 14 days 
prior to a follow-up data collection time point. As guided by published standardized 
CGM metrics,53 data will be transformed to identify number of measurements and 
percent TIR, time below range (<70 mg/dL) (TBR), and time above range (≥180 mg/dL) 
(TAR), mean sensor glucose, and coefficient of variation (CV) of glucose values during 
each 14-day period. We also will track the percent CGM wear time.  
 
CGM data will be analyzed using library GLU in R. using mixed effect models. These 
models will quantify the impact of our intervention on glucose control over time. The 
independent variables will be baseline time in range, child age, and a random subject 
effect to account for correlation of measurements on the same subject. Interaction terms 
of age and baseline time in range with the intervention will explore possible effect 
modification (p<0.10) of these characteristics. We will also explore differences between 
time points and average outcome by parent education level and income. Results will be 
reported as least-squares means (LSMEANS) with standard errors. Casewise deletion 
will be used to handle missing data.  
 
A battery of validated survey measures exploring diabetes-specific self-management 
skills and quality of life will be completed by the child and caretaker, including: Type 1 
Diabetes and Life (T1DAL), Diabetes Self- Management Profile (DSMP), Self-Efficacy 
for Diabetes (SEDS), and Problem Areas in Diabetes (C-PAID). Perceived benefits and 
barriers to CGM use will be assessed using the CGM Benefits and Burdens scale. 
Surveys will be completed by a single, consistent parent/caregiver throughout the study, 
preferably the one most involved in medical care. We will summarize self-management 
skills and treatment satisfaction by different time points. Differences in participant self-
management skills and patient satisfaction will be reported as mean Likert scale score 
and standard deviation. Similar analysis using linear longitudinal regression analysis will 
be conducted. Results will be reported as least-squares means (LSMEANS) with 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 29 of 36 
standard errors. Casewise deletion will be used to handle missing data.  
The incidence of DKA and DKA event rate per 100 person-years, incidence of severe 
hypoglycemia and severe hypoglycemia event rate per 100 person-years, incidence of 
ED visits and ED visit event rate per 100 person-years, incidence of hospital admissions 
and hospital admission event rate per 100 person-years, will also be compared using 
linear longitudinal regression analysis. Results will be reported as least-squares means 
(LSMEANS) with standard errors. Casewise deletion will be used to handle missing 
data.   
 
Baseline Descriptive Statistics 
Age, gender, race, duration of diabetes, height, weight, BMI, and A1c  
 
Sub-Group Analyses 
The primary and secondary endpoints will be analyzed without regard to age and sex 
given the narrow inclusion criteria for age and the lack of evidence to suggest sex-
based differences in glycemic control among youth with T1D. Race/ ethnicity will not be 
factored in as the study will not have a large enough sample size and sufficient power to 
stratify findings based on race/ethnicity. 
 
Tabulation of Individual participant Data 
Individual participant data will be listed by measure and time point.   
 
Exploratory Analyses 
Thematic analysis of qualitative data from interview transcripts will be performed by two 
research team members. Initial codes will be developed independently by these team 
members who will then generate a second-cycle list of codes. All team members will 
then apply the revised coding framework to the transcription. The team will meet to 
reach consensus on the final codes and identify dominant themes.   
 
8.5 
Sample Size 
As this is a pilot study, we plan to enroll up to 20 parent-child dyads. We anticipate low 
dropout rates, but do plan to enroll new subjects to keep the total number of subjects at 
up to 20 in case of attrition. If there is a sufficient number of new subjects enrolled to 
replace those that drop out, a new SMA group will be created so that newly enrolled 
subjects will be able to start the intervention from the baseline visit.  
 
8.6 
Measures to Minimize Bias 
Not applicable 
 
Section 9: Data Quality and Oversight 
9.1 
Study Team Quality Assurance and Quality Control 
Study staff will perform internal quality management of study conduct, data and 
biological specimen collection, documentation and completion. An individualized quality 
management plan will be developed to describe the study’s quality management.  
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 30 of 36 
Quality control (QC) procedures will be implemented beginning with the data 
entry system and data QC checks that will be run on the database will be generated. 
Any missing data or data anomalies will be communicated to the site(s) for 
clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the study staff will verify that 
the clinical trial is conducted and data are generated and biological specimens are 
collected, documented (recorded), and reported in compliance with the protocol, 
International Conference on Harmonization Good Clinical Practice (ICH GCP), and 
applicable regulatory requirements (e.g., Good Laboratory Practices (GLP), Good 
Manufacturing Practices (GMP)).  
 
The investigational site will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor, 
and inspection by local and regulatory authorities. 
 
9.2 
Data Safety and Monitoring Plan 
Safety oversight will be under the direction of the PI without a Data Safety Monitoring 
Board.   
 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial 
participants are protected, that the reported trial data are accurate, complete, and 
verifiable, and that the conduct of the trial is in compliance with the currently approved 
protocol/amendment(s), with International Conference on Harmonization Good Clinical 
Practice (ICH GCP), and with applicable regulatory requirement(s).  
 
• The PI will direct the conduct of site monitoring on-site prior to the start of the 
study and will direct review 100% of the data.  
• Independent audits will not be conducted. 
 
Section 10: Ethical Considerations 
10.1  Ethical Standard 
The study team will ensure that this study is conducted in full conformity with the 
Regulations for the Protection of Human Subjects of Research codified in 45 Part 46 of 
the Code of Federal Regulations, Children’s National Policies and Procedures and 
Good Clinical Practices.    
 
10.2 Institutional Review Board (IRB) 
The protocol, informed consent form(s) and all participant materials will be submitted to 
the Children’s National IRB for review and approval. Approval of both the protocol and 
the consent form will be obtained before any participant is consented. Any change to 
the protocol, consent, and participant information sheets or letters will require IRB 
approval before implementation and use. The IRB will determine whether previously 
consented participants need to be re-consented and whether consent of more than one 
parent is required for minors.   
 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 31 of 36 
The IRB will be notified of study team updates via an amendment. DSMB Reports 
will be submitted at the time of the continuing review or with another applicable IRB 
transaction. Other study events (e.g., protocol deviations, data monitoring reports) will 
be submitted per the Children’s National IRB Reportable Events Module. 
 
10.3 Maintaining Subject Privacy 
To protect privacy, identification numbers will be used to identify all study information, 
and only authorized study personnel will have access to study records, with the 
permission of the PI. When participants fill out questionnaires, their responses will be 
paired with this unique number instead of their names. Each participant's identifying 
data will be separated from the study data and all clinically- relevant and study data will 
be stored in a password-protected database, on a password-protected computer, or in a 
locked filing cabinet in a locked office. Information about subjects will not be accessible 
to any non-authorized study personnel without the written consent of the subject. SMA 
sessions will occur as a group with other participants and caregivers, but each youth 
and their caregiver will meet with the pediatric endocrinologist individually and have the 
opportunity to discuss sensitive information in private.  
 
10.4 Maintaining Study Data Confidentiality 
Participant confidentiality and privacy is strictly held in trust by the participating 
investigators, their staff, and the sponsor(s) and their interventions. This confidentiality 
is extended to cover clinical information relating to participants. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. All research 
activities will be conducted in as private a setting as possible. 
 
Dr. Majidi assures that informed consent is obtained prior to performing any research 
procedures, that all subjects meet eligibility criteria, and that the study is conducted 
according to the IRB-approved research plan. Study data are accessible at all times for 
the PI to review. The PI review(s) study conduct on a weekly basis. The PI review(s) 
AEs individually in real-time and in aggregate on a twice weekly basis. The PI review(s) 
serious and reportable adverse events (SAEs) in real-time. The PI ensures all protocol 
deviations, AEs, and SAEs are reported to the IRB according to the applicable 
regulatory requirements. 
 
The sponsor representatives and regulatory authorities (e.g., IRB, OHRP) may inspect 
all documents and records required to be maintained by the investigator. The clinical 
study site will permit access to such records. 
 
The study participant’s contact information and data will be securely stored at Children’s 
National Hospital for internal use during the study. At the end of the study, all records 
will continue to be kept in a secure location for as long a period as dictated by the 
reviewing IRB, Institutional policies, or FDA requirements. The research data will not 
include the participant’s contact or identifying information. Rather, individual participants 
and their research data will be identified by a unique study identification number. The 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 32 of 36 
study data entry and study management systems used by research staff will be 
secured and password protected. At the end of the study, all study databases will be 
archived at Children’s National. 
 
10.5 Study Support and Conflicts of Interest 
Salary support for this study is provided by the American Diabetes Association.  
REDCap® support is provided by The Clinical and Translational Science Institute (CTSI) 
at Children’s National. All key study personnel will follow the Human Research 
Protections Program Investigator, Study Staff, and Family Member Conflicts of Interest 
(COI) Policy. The independence of this study from any actual or perceived influence, such 
as by the pharmaceutical industry, is critical. Therefore, any actual conflict of interest of 
persons who have a role in the design, conduct, analysis, publication, or any aspect of 
this trial will be disclosed and managed. Furthermore, persons who have a perceived 
conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the design and conduct of this trial.  The study 
leadership will follow established policies and procedures for all study group members to 
disclose all conflicts of interest and will establish a mechanism for the management of all 
reported dualities of interest. 
 
Section 11: Data Handling and Record Keeping 
11.1 Data Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the 
supervision of the site investigator. The investigator is responsible for ensuring the 
accuracy, completeness, legibility, and timeliness of the data reported. All source 
documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document 
worksheets for recording data for each participant enrolled in the study.  Data recorded 
in the electronic case report form (eCRF) derived from source documents should be 
consistent with the data recorded on the source documents.  
 
Clinical data (including adverse events (AEs), concomitant medications, and expected 
adverse reactions data) and clinical laboratory data will be entered into REDCap. The 
data system includes password protection and internal quality checks, such as 
automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate. Clinical data will be entered directly from the source documents 
 
11.2 Data Capture Methods 
The PI is responsible for ensuring the accuracy, completely, legibility, timeliness, and 
completeness of the data reported. Source data includes all information and original 
records of clinical findings, observations, or other activity necessary for the 
reconstruction and evaluation of the trial. Examples of original source documentation 
include electronic medical records, laboratory reports, participant questionnaires, and 
online software. Source data will be recorded for each participant enrolled in the study 
into final data capture. Data reported from source documents will be consistent with the 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 33 of 36 
source documents. Research data will be entered into a password protected, 
secure, HIPAA compliant, spreadsheet with a built-in audit trail. IRB approved research 
team members who have current HIPAA and CITI GCP and human subjects protection 
training will be authorized to extract data from source documents and enter it into the 
data spreadsheet. Data should be entered directly from the source documents into the 
spreadsheet within 14 days of collection.  
 
11.3 Study Record Retention Policy 
Clinical trial documents will be retained for a minimum of 3 years after the termination of 
the study.   
 
Section 12: Publication Policy 
This study will be conducted in accordance with the following publication and data 
sharing policies and regulations: 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination 
of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results 
Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, 
and results information from this trial will be submitted to ClinicalTrials.gov. In addition, 
every attempt will be made to publish results in peer-reviewed journals. Data from this 
study may be requested from other researchers for 3 years after the completion of the 
primary endpoint by contacting the PI.  
 
Section 13: References 
1. 
Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from 
the T1D Exchange in 2016–2018. Diabetes technology & therapeutics. 2019;21(2):66-72. 
2. 
Agarwal S, Kanapka LG, Raymond JK, et al. Racial-ethnic inequity in young adults With type 1 
diabetes. Journal of Clinical Endocrinology and Metabolism. 2020;105(8):e2960-e2969. 
3. 
Hamman RF, Bell RA, Dabelea D, et al. The SEARCH for Diabetes in Youth study: rationale, 
findings, and future directions. Diabetes care. 2014;37(12):3336-3344. 
4. 
Chase HP, Beck RW, Xing D, et al. Continuous glucose monitoring in youth with type 1 diabetes: 
12-month follow-up of the Juvenile Diabetes Research Foundation continuous glucose 
monitoring randomized trial. Diabetes technology & therapeutics. 2010;12(7):507-515. 
5. 
Lai CW, Lipman TH, Willi SM, Hawkes CP. Racial and Ethnic Disparities in Rates of Continuous 
Glucose Monitor Initiation and Continued Use in Children With Type 1 Diabetes. Diabetes Care. 
2020(December 2018):dc201663-dc201663. 
6. 
Addala A, Auzanneau M, Miller K, et al. A decade ofdisparities in diabetes technology use and 
HbA 1c in pediatric type 1 diabetes: A transatlantic comparison. Diabetes Care. 2020:dc200257-
dc200257. 
7. 
Kichler JC, Kaugars AS, Marik P, Nabors L, Alemzadeh R. Effectiveness of groups for adolescents 
with type 1 diabetes mellitus and their parents. Families, Systems, & Health. 2013;31(3):280. 
8. 
Willi SM, Miller KM, DiMeglio LA, et al. Racial-ethnic disparities in management and outcomes 
among children with type 1 diabetes. Pediatrics. 2015;135(3):424-434. 
9. 
Agarwal S, Schechter C, Gonzalez J, Long JA. Racial–Ethnic Disparities in Diabetes Technology 
Use Among Young Adults with Type 1 Diabetes. Diabetes technology & therapeutics. 2020. 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 34 of 36 
10. 
Hood KK, Rohan JM, Peterson CM, Drotar D. Interventions with adherence-promoting 
components in pediatric type 1 diabetes: Meta-analysis of their impact on glycemic control. 
Diabetes Care. 2010;33(7):1658-1664. 
11. 
Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and 
adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 
disease categories/severities utilizing the PedsQL™ 4.0 Generic Core Scales. Health and quality 
of life outcomes. 2007;5(1):1-15. 
12. 
Gledhill J, Rangel L, Garralda E. Surviving chronic physical illness: psychosocial outcome in adult 
life. Archives of disease in childhood. 2000;83(2):104-110. 
13. 
LeBovidge JS, Lavigne JV, Donenberg GR, Miller ML. Psychological adjustment of children and 
adolescents with chronic arthritis: a meta-analytic review. Journal of pediatric psychology. 
2003;28(1):29-39. 
14. 
Boman KK, Viksten J, Kogner P, Samuelsson U. Serious illness in childhood: the different threats 
of cancer and diabetes from a parent perspective. The Journal of pediatrics. 2004;145(3):373-
379. 
15. 
Santiprabhob J, Likitmaskul S, Kiattisakthavee P, et al. Glycemic control and the psychosocial 
benefits gained by patients with type 1 diabetes mellitus attending the diabetes camp. Patient 
education and counseling. 2008;73(1):60-66. 
16. 
Faulkner MS. Quality of life for adolescents with type 1 diabetes: parental and youth 
perspectives. Pediatric nursing. 2003;29(5):362. 
17. 
Graue M, Wentzel-Larsen T, Hanestad B, Båtsvik B, Søvik O. Measuring self-reported, health-
related, quality of life in adolescents with type 1 diabetes using both generic and disease-
specific instruments. Acta Paediatrica. 2003;92(10):1190-1196. 
18. 
Weissberg-Benchell J, Antisdel-Lomaglio J. Diabetes-specific emotional distress among 
adolescents: feasibility, reliability, and validity of the problem areas in diabetes-teen version. 
Pediatric diabetes. 2011;12(4pt1):341-344. 
19. 
Weissberg-Benchell J, Nansel T, Holmbeck G, et al. Generic and diabetes-specific parent–child 
behaviors and quality of life among youth with type 1 diabetes. Journal of pediatric psychology. 
2009;34(9):977-988. 
20. 
von Weiss RT, Rapoff MA, Varni JW, et al. Daily hassles and social support as predictors of 
adjustment in children with pediatric rheumatic disease. Journal of pediatric psychology. 
2002;27(2):155-165. 
21. 
Wallander JL, Varni JW. Social support and adjustment in chronically ill and handicapped 
children. American journal of community psychology. 1989;17(2):185-201. 
22. 
Pihoker C, Forsander G, Fantahun B, et al. The delivery of ambulatory diabetes care to children 
and adolescents with diabetes. Pediatric diabetes. 2014;15(S20):86-101. 
23. 
Chen C, Zhao X-L, Li Z-H, Zhu Z-G, Qian S-H, Flewitt AJ. Current and emerging technology for 
continuous glucose monitoring. Sensors. 2017;17(1):182. 
24. 
Wong JC, Foster NC, Maahs DM, et al. Real-time continuous glucose monitoring among 
participants in the T1D Exchange clinic registry. Diabetes Care. 2014;37(10):2702-2709. 
25. 
Shalitin S, Peter Chase H. Diabetes technology and treatments in the paediatric age group. 
International Journal of Clinical Practice. 2011;65:76-82. 
26. 
Shulman R, Stukel TA, Miller FA, Newman A, Daneman D, Guttmann A. Insulin pump use and 
discontinuation in children and teens: a population-based cohort study in Ontario, Canada. 
Pediatric diabetes. 2017;18(1):33-44. 
27. 
Sherr JL, Hermann JM, Campbell F, et al. Use of insulin pump therapy in children and 
adolescents with type 1 diabetes and its impact on metabolic control: comparison of results 
from three large, transatlantic paediatric registries. Diabetologia. 2016;59(1):87-91. 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 35 of 36 
28. 
Hanberger L, Samuelsson U, Holl RW, Fröhlich-Reiterer E, Åkesson K, Hofer S. Type 1 
diabetes during adolescence: International comparison between Germany, Austria, and Sweden. 
Pediatric diabetes. 2018;19(3):506-511. 
29. 
Danne T, Nimri R, Battelino T, et al. Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri 
O, Kovatchev B, Kowalski a, Laffel L, Maahs D, Murphy HR, Nørgaard K, parkin CG, Renard E, 
Saboo B, Scharf M, Tamborlane Wv, Weinzimer Sa, Phillip M. international consensus on use of 
continuous glucose monitoring. Diabetes Care. 2017;40(12):1631. 
30. 
Charleer S, Mathieu C, Nobels F, et al. Effect of Continuous Glucose Monitoring on Glycemic. 
2018. 
31. 
Tauschmann M, Hovorka R. Technology in the management of type 1 diabetes mellitus—current 
status and future prospects. Nature Reviews Endocrinology. 2018;14(8):464-475. 
32. 
Beck RW, Bergenstal RM, Laffel LM, Pickup JC. Advances in technology for management of type 
1 diabetes. The Lancet. 2019;394(10205):1265-1273. 
33. 
American Diabetes A. 13. Children and Adolescents: Standards of Medical Care in Diabetes—
2021. Diabetes Care. 2021;44(Suppl 1):S180-S199. 
34. 
Beck RW, Group JDRFCGMS. Effectiveness of Continuous Glucose Monitoring in a Clinical Care 
Environment: Evidence from the JDRF-CGM Trial. Diabetes Care. 2009. 
35. 
Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time 
continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis 
of randomised controlled trials using individual patient data. Bmj. 2011;343. 
36. 
Mejino A, Noordman J, van Dulmen S. Shared medical appointments for children and 
adolescents with type 1 diabetes: perspectives and experiences of patients, parents, and health 
care providers. Adolescent health, medicine and therapeutics. 2012;3:75. 
37. 
Sanchez I. Implementation of a diabetes self-management education program in primary care 
for adults using shared medical appointments. The Diabetes Educator. 2011;37(3):381-391. 
38. 
Heyworth L, Rozenblum R, Burgess JF, et al. Influence of shared medical appointments on 
patient satisfaction: a retrospective 3-year study. The Annals of Family Medicine. 
2014;12(4):324-330. 
39. 
Grey M, Boland EA, Davidson M, Yu C, Tamborlane WV. Coping skills training for youths with 
diabetes on intensive therapy. Applied Nursing Research. 1999;12(1):3-12. 
40. 
Majidi S, Reid MW, Fogel J, et al. Psychosocial Outcomes in Young Adolescents with Type 1 
Diabetes Participating in Shared Medical Appointments. Pediatr Diabetes. 2021. 
41. 
Noffsinger EB. Running Group Visits in Your Practice. New York, NY: Springer, 2009b.[Google 
Scholar]. 
42. 
Wagner EH, Grothaus LC, Sandhu N, et al. Chronic care clinics for diabetes in primary care: a 
system-wide randomized trial. Diabetes care. 2001;24(4):695-700. 
43. 
Group DCaCTR. The effect of intensive treatment of diabetes on the development and 
progression of long-term complications in insulin-dependent diabetes mellitus. New England 
journal of medicine. 1993;329(14):977-986. 
44. 
Little RR, Roberts WL. A review of variant hemoglobins interfering with hemoglobin A1c 
measurement. Journal of diabetes science and technology. 2009;3(3):446-451. 
45. 
Kovatchev BP, Raghinaru D, Lum JW, et al. Six-month randomized, multicenter trial of closed-
loop control in type 1 diabetes. 2019. 
46. 
Shapiro JB, Vesco AT, Weil LE, Evans MA, Hood KK, Weissberg-Benchell J. Psychometric 
properties of the Problem Areas in Diabetes: Teen and Parent of Teen versions. Journal of 
pediatric psychology. 2018;43(5):561-571. 

Version # 1.8 
 
06/27/2022 
CNMC Behavioral Procedural Template_v2_3/13/18 
 
 
 
Page 36 of 36 
47. 
Weissberg-Benchell J, Shapiro J, Hood K, et al. Assessing patient-reported outcomes for 
automated insulin delivery systems: the psychometric properties of the INSPIRE measures. 
Diabetic Medicine. 2019;36(5):644-652. 
48. 
Mehta S, Nansel T, Volkening L, Butler D, Haynie D, Laffel L. Validation of a contemporary 
adherence measure for children with Type 1 diabetes: the Diabetes Management 
Questionnaire. Diabetic Medicine. 2015;32(9):1232-1238. 
49. 
Tanenbaum ML, Adams RN, Hanes SJ, et al. Optimal use of diabetes devices: clinician 
perspectives on barriers and adherence to device use. Journal of diabetes science and 
technology. 2017;11(3):484-492. 
50. 
Giani E, Snelgrove R, Volkening LK, Laffel LM. Continuous glucose monitoring (CGM) adherence 
in youth with type 1 diabetes: associations with biomedical and psychosocial variables. Journal 
of diabetes science and technology. 2017;11(3):476-483. 
51. 
Jeon J, Leimbigler PJ, Baruah G, Li MH, Fossat Y, Whitehead AJ. Predicting glycaemia in type 1 
diabetes patients: experiments in feature engineering and data imputation. Journal of 
Healthcare Informatics Research. 2020;4(1):71-90. 
52. 
Hilliard ME, Levy W, Anderson BJ, et al. Benefits and barriers of continuous glucose monitoring 
in young children with type 1 diabetes. Diabetes technology & therapeutics. 2019;21(9):493-498. 
53. 
Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring 
data interpretation: recommendations from the international consensus on time in range. 
Diabetes care. 2019;42(8):1593-1603.