Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes: A Pilot Clinical Trial
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: University of North Carolina, Chapel Hill

 
1 
 
MyPlan - Planned Eating Feasibility Pilot 
 
 
 
STUDY PROTOCOL 
 
 
Complete Title: 
 
 
 
 
 
Short Title: 
 
 
Sponsor: 
 
 
Protocol Date: 
 
 
 
Individualized Planned Eating 
Patterns to Improve Glycemic 
Control in Adolescents with Type 1 
Diabetes: A Pilot Clinical Trial  
 
 
“MyPlan” – Pilot Planned Eating 
Trial for Adolescents with Type 1 
Diabetes 
 
NIH/NIDDK 
 
 
July 27, 2022 
 
 
 
 
 
 
Study Principal Investigators (Multi-PI): 
 
 
 
 
 
 
 
 
Elizabeth J Mayer-Davis, PhD 
UNC Chapel Hill 
245A Rosenau Hall, CB 7461 
Chapel Hill, NC, 27599 
919-966-1991 
mayerdav@email.unc.edu 
 
Sarah Couch, PhD 
University of Cincinnati, 
Cincinnati, OH 
859-816-3962 
couchsc@ucmail.uc.edu 
 

 
Version 4 - July 27 2022 
 
Contact PI: 
Elizabeth Mayer-Davis, PhD 
University of North Carolina at Chapel Hill 
Protocol Version: 4 
Version Date: July 27, 2022 
 
I confirm that I have read this protocol and understand it. 
Principal Investigator Name: 
_____Sarah Couch_____________________ 
 
Principal Investigator Signature: ______Sarah C. Couch__________________ 
 
Principal Investigator Name: 
_____Beth Mayer-Davis__________________ 
 
Principal Investigator Signature: ___
_______ 
 
 
 

 
Version 4 - July 27 2022 
List of Modifications 
 
12-2021 
 
Terminology change from  “Structured Eating” to “Planned Eating”  
 
3-2022  
 
Definition of “recent HbA1c” clarified to any measurement within 9 months of screening for 
eligibility 
 
Inclusion of non UNC and CCHMC participants (i.e., participants who attend clinics outside UNC 
or CCHMC hospital system if participant agrees for study to be in contact with participant’s usual 
diabetes care provider) 
 
Inclusion of personal continuous glucose monitoring data  
 
4-2022 
 
Adjustment of endline CGM wear-time to occur during active intervention period between 22-24 
weeks instead of 24-26 weeks.  
 
Adjustment of last in-person visit to occur between 24-25 weeks (maximum 26 weeks). 
 
7-2022 
 
Adjustment of HbA1c inclusion criteria to 7.5 – 11.0% from 8.0 – 11.0%  
 
Option of virtual endline or baseline visit  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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CONTENTS 
List of Abbreviations: .................................................................................................................................... 4 
Protocol Synopsis .......................................................................................................................................... 5 
1. 
Executive Summary ............................................................................................................................... 9 
2.  Background and Significance ................................................................................................................. 10 
3.  Study Objectives ..................................................................................................................................... 12 
4.  Site Descriptions ..................................................................................................................................... 13 
5.  Selection & Recruitment of Subjects ..................................................................................................... 14 
6.  Consent, Assent, Withdrawals ............................................................................................................... 16 
8.  Standardized Measurements ................................................................................................................... 1 
8a. Primary Outcomes .............................................................................................................................. 1 
8b. Secondary Outcomes .......................................................................................................................... 2 
8c. Other Measurements: ......................................................................................................................... 2 
9.    Trial Procedures and Components ......................................................................................................... 7 
10. Data management .................................................................................................................................. 9 
11.  Statistical Considerations ....................................................................................................................... 9 
12. Potential Risks, Discomforts, Inconveniences, & Precautions: ............................................................. 12 
13. Risk/Benefit Analysis ............................................................................................................................. 16 
14.  Data Safety & Monitoring: ................................................................................................................... 17 
15.  Privacy & Confidentiality ...................................................................................................................... 20 
16.  Study Timeline ...................................................................................................................................... 22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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List of Abbreviations:  
AE – Adverse Event 
DSMB – Data Safety and Monitoring Board 
MI – Motivational Interviewing 
PSST – Problem Solving Skills Training 
SAE – Serious Adverse Event 
SMBG – Self Monitored Blood Glucose 
T1D – Type 1 Diabetes 
TIR – Time in Range 
 
 

 
Version 4 - July 27 2022 
Protocol Synopsis 
Study Title 
Individualized Planned Eating Patterns to Improve Glycemic Control in 
Adolescents with Type 1 Diabetes: A Pilot Clinical Trial  
Funder 
NIH/NIDDK R21DK125033 – 01A1 
Clinical Phase 
Feasibility Trial 
Study Rationale 
Emphasis of the last two decades on flexible patterns of dietary intake for youth 
with type 1 diabetes (T1D) has clearly not corresponded with adequate 
glycemic control, despite increased use of insulin pumps and continuous 
glucose monitoring (CGM) in that time period. Some major T1D clinical practice 
guidelines explicitly recommend use of planned eating patterns. Additionally, 
consensus in some pediatric diabetes clinics with excellent glycemic control 
suggests that planned eating is a key element in successful diabetes 
management. Remarkably, there are no clinical trial data on the effectiveness 
of this strategy for glycemic control, nor data on the acceptability of and 
adherence to this strategy among youth with T1D. 
Study 
Objectives 
• 
To a) assess acceptability of and adherence to a 6-month individualized 
planned eating strategy (“MyPlan”) among 40-50 youth with T1D and 
sub-optimal glycemic levels b) compare glycemic control at baseline 
and 6-months of the intervention 
o This information is required to inform and develop a fully 
powered trial designed to test the impact of behavioral strategies 
on diabetes outcomes in T1D youth receiving ongoing care in 
clinical settings 
Test Article(s) 
• 
Individualized planned eating plan with the following five behavioral 
targets (“MyPlan goals”): 
o 3-4  meals and  0-2 snacks  consumed;  
o Meals/snacks  consumed  >2 hours  and  <4  hours  apart 
o Carbohydrate (CHO)  distributed across  waking  hours  (meals 
>15% daily CHO, with ~10-15% of daily CHO at snacks and 
~20-30% at meals) 
o No  snack  consumed after  dinner;   
o Snack/meal  consumed  1-2 hours  of  waking. 
• 
If relevant, snacks will be recommended based on the participants’ 
usual food intake, age, sex, activity and growth   
• 
Participant and  family-specific eating schedules and routines will be 
incorporated into each individualized planned eating plan. 
• 
Behavioral counseling strategies will identify barriers to adherence and 
acceptability and address them through targeted education, problem 
solving and goal setting skills training.  
Study Design 
This is a pilot  single  arm  clinical  trial  to assess whether planned eating is an 
acceptable and effective dietary strategy to be included in future fully powered 
trials aimed at optimizing diabetes outcomes in T1D youth.  
This pilot study will be conducted at two clinical sites (University of Cincinnati, 
and University of North Carolina at Chapel Hill), coordinated from the University 
of North Carolina at Chapel Hill.  Approximately 33 teen/guardian dyads will be 
enrolled at University of Cincinnati and 17 at UNC for a total of 50 enrolled 
participant/guardian dyads (with 40 or more expected completers). 

 
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A total study participation time of 6-months allows for evaluation of the 
acceptability of and adherence to the eating strategy and its influence on 
glycemic levels (comparing percent time within the glycemic range 70-180 
mg/dL during 2-week wear time at baseline and 6 months). 
Following the baseline data collection and a 2-week run-in period, all 
participant dyads will be counseled to follow an individualized planned eating 
plan developed based on caloric needs, usual physical activity level, food 
preferences, previous intake and participant/family eating schedules. 
Counseling will take the form of weekly telehealth visits during the first 2 
months followed by bi-weekly telehealth visits during the remaining 4 months. 
The underlying  behavioral  strategy  for  the intervention derives  from  the  
FLEX intervention, the DASH-4-Teens intervention, and Social Cognitive 
Theory  in  that  motivation and self-efficacy enhancement, problem-solving 
skills training (PSST) and goal-setting training, and targeted education  will  be 
integrated with instruction on individualized  eating plans. Barriers  for 
adherence  to  the eating  plan will  be discussed and action  steps  for  
overcoming  barriers  will  be set  using principles  of  motivational interviewing 
(MI), PSST, and  family-based strategies  (FSB). The goal-setting will be 
focused  on  making incremental  progress towards  meeting  the  MyPlan 
eating behavior targets/goals that  pose the greatest  challenges  to  youth 
achievement  of  all five targets/goals that comprise the “MyPlan” way of eating. 
Adjustment to the plan (within general guidelines) at months 3 will incorporate 
both indicators (i.e. weight status, MyFitnessPal logs) as well as acceptability of 
the eating strategy to the participant and caregiver/parent.   
Subject 
Population 
Key Criteria for 
Inclusion and 
Exclusion 
Inclusion Criteria mimic the criteria planned for the future fully powered trial: 
1. Individuals ages 12-17 years old 
2. History of type 1 diabetes of at least one year 
3. A measurement of HbA1C 7.5-11% over the preceding 9 months (Note: 
HbA1c at the time of the baseline visit will not preclude participation) 
4. Guardian willing to also participate 
5. English as preferred language 
 
Exclusion Criteria mimic the criteria planned for the future fully powered trial: 
1. Individuals with other metabolic disorders, unstable thyroid disease, 
diagnosed eating disorder, prohibitively strict dietary restrictions, or 
those with other serious condition that renders participation 
inappropriate. 
2. Females who are pregnant, breast feeding, planning to become 
pregnant during the study period or delivered a baby in the last 12 
months 
3. Unwillingness to follow a personalized eating plan for 6 months or 
complete MyFitnessPal logs at least 3 days/week throughout the study 
Number of 
Subjects 
40-50 subjects (33 enrolled at University of Cincinnati and 17 at University of 
North Carolina at Chapel Hill) 
Study Duration 
Each subject’s participation will last approximately 6 months 
Study data collection is expected to end by October 2021 
Study Phases 
1. Screening and Pre-Intervention Data Collection: Screening for eligibility, 
recruiting and obtaining consent; Collection of basic demographic, health, 
diabetes knowledge, eating and physical activity pattern information via 

 
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questionnaires 
at 
baseline 
visit. 
HbA1c, 
height, 
and 
weight 
measurements at baseline visit.  
2. Run-in (2 weeks): Set-up mobile device and text reminders for mobile 
data collection; Collection of daily logs and two 24-hour recalls to inform 
eating plan designed by RD; 2-week CGM wear. 
3. Intervention (22 weeks): Study intervention  
4. Post-Trial Data Collection: Completion of eating plan acceptability 
Assessment, questionnaires, 2-week CGM wear, HbA1c, height, weight 
measurements. 
Safety 
Evaluations 
Participants will be asked about hypoglycemic events at each study visit and 
support session with the RD (by phone or in-person). Participants will be 
instructed to contact the study endocrinologist and/or RD to report any cases of 
severe hypoglycemia. The RDs will communicate with the study 
endocrinologist to ensure that any needed insulin adjustments are made 
throughout the study period. Participants will be encouraged to monitor their 
weight at home throughout the study period. Weight and height will also be 
collected at baseline, 3 months, and 6 months to monitor any changes and 
ensure healthy maintenance of weight and growth. 
Statistical and 
Analytic Plan 
Adherence outcome:  
• 
Planned eating adherence (primary measures):  Weekday  and 
weekend  adherence  to  five eating behavior targets/goals that define 
the MyPlan strategy  will be calculated continuously and categorically. 
Additional measures will include adherence consistency, defined as the 
extent  to  which  youth  performance  on  the  adherence  metrics  
differs  between  the dietary recall days, as well as proportion of 
completed telehealth visits/phone calls, and diet-self-monitoring days 
(exploratory measures). 
Acceptability outcome:  
• 
Categorical and continuous 5-item measure of acceptability (primary 
measures) 
• 
Additional measures include qualitative information, which will be 
analyzed for themes (exploratory measures). 
Glycemic outcomes:  
• 
Percent time in the glycemic range 70-180mg/dL comparing CGM wear 
time at baseline and 6 months (primary measure) 
• 
HbA1c (secondary measure) 
Data and Safety 
Monitoring Plan 
Data quality and safety monitoring will occur within the research team (data 
quality committee). There will be an internal DSMB committee composed of 
Baiming Zou, PhD (Study Design and Statistical Analysis), Abby Pears, PhD 
(Nutrition) and Ingrid Libman, MD, PhD, MPH (Pediatric Endocrinology), in 
addition to our internal research team members (Elizabeth Mayer-Davis, PhD 
RD; Sarah Couch PhD RD; Amy Shah, MD; and study manager Angelica 
Cristello Sarteau, MSPH).  The committee will monitor participant accrual and 
retention, progress, completeness of standardized measures, and attendance 
at intervention sessions, as well as occurrence of hypoglycemia or other 
adverse events. All aspects of data collection and data storage will be carefully 
monitored to ensure rapid detection of errors, inconsistencies or other 
problems.  Distributions of key variables will be monitored for data quality and 
safety. AE and SAE, as defined by NIH, will be reported to the local site 
investigator and corresponding IRBs. AE/SAEs will be reviewed monthly. 

 
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1. Executive Summary  
 
Average  HbA1c among  youth in  the  US  in 2016 was  8.8%,  considerably  above 
the standard clinical  target  of  <  7.5%,  and had worsened  significantly  since  
2011.  The emphasis of  the  last  two decades  on  flexible  patterns  of  dietary  
intake for  youth  with  T1D  has clearly  not corresponded  with adequate glycemic 
control,  despite  increased use  of  insulin  pumps  and  continuous glucose 
monitoring  (CGM)  in that  time  period.   There  are major  gaps  in knowledge  
about  what interventions  might  achieve  improved glycemic  control,  and what  
approach  to  patterns  of  dietary  intake  might be beneficial.  Some T1D  clinical  
practice  guidelines  explicitly  recommend use  of planned eating patterns. 
Additionally, consensus in some pediatric diabetes clinics with excellent glycemic 
control suggests that planned eating is a key element in successful diabetes 
management. Remarkably, there are no clinical trial data on the effectiveness of this 
strategy for glycemic control, nor data on the acceptability of and adherence to this 
strategy among youth with T1D. Thus,  our  overarching goal  is  to  rigorously  
test  the  effectiveness of  individualized,  planned eating  patterns  to  improve 
glycemic levels so as to  inform T1D  clinical  practice guidelines.  We  have 
completed  several  preliminary  studies  that  support  the likely  acceptability  and 
effectiveness  of  an  individualized structured  eating plan intervention we called  
“MyPlan”,  that  includes collaborative  development  of  the individualized  planned 
eating  plan  to spread intake  of  carbohydrate  and calories  over  the  day.   Here 
we propose  a pilot  single  arm  6-month clinical  trial  to inform  a  future,  
fully  powered pragmatic  trial  that tests the addition of  individualized 
structured  eating plans  to  ongoing  diabetes  care  in  clinical settings.   Our  
Specific  Aims are:   Aim  1.   Assess acceptability  and adherence (primary 
outcomes) to  a 6-month individualized  planned eating  intervention  (“MyPlan”)  
among 40-50  youth  with T1D.  We  will recruit adolescents,  age 12-17  years,  with 
T1D  of  at  least  1-year  duration and  with HbA1c  between 7.5  %  and  11%  (total  
n=50 recruited  to  ensure n=40  active participants  across two  clinical  sites)   to 
participate  in a 6-month MyPlan intervention,  which will  guide participants  in 
setting behavioral  goals  in  relation to  five tenets  that  comprise a structured  
eating  pattern.   Aim  2.  Compare  glycemic  control  among adolescents  with  T1D  
at  baseline  and at  the end  of  the  6-month MyPlan  intervention.  Measures  of  
glycemic  control  will  include %  time  in range (TIR)  based  on  continuous  
glucose monitoring (primary outcome)  and HbA1c (secondary outcome).    
 
 
 
 
 
 
 
 
 

 
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2.  Background and Significance 
 
Intensive glucose control among people with type 1 diabetes (T1D) has been 
demonstrated to confer health benefits over 30 years later.1-3 However, higher mean 
HbA1c in youth with T1D compared to adults (over 9% in 17-year-olds that remains 
elevated above 8% until a mean age of 30 years) indicates that despite significant 
advances in technology and therapeutics, obstacles remain in reducing youth HbA1c to 
the recommended levels that minimize diabetes-related complications.4 Given that 
suboptimal T1D management behaviors and the negative effects of elevated HbA1c in 
youth carry into adulthood, there is a compelling need to develop a program of 
behavioral strategies that optimize management of the risk factors that lead to poor 
health outcomes in this population. 
 
Clinical consensus in some pediatric diabetes clinics with excellent glycemic control 
(HbA1c < 7.5%) suggests that a planned way of eating  -- characterized by daily 
consistency in the timing and distribution of meals, snacks, and carbohydrates —is a 
key element in successful diabetes management. For example, at the John Hunter 
Children’s Hospital pediatric endocrinology clinic in Newcastle Australia where 
counseling on planned eating has been a standard part of diabetes management for 
several years, among their approximately 400 adolescent patients with T1D, recent 
estimate of average HbA1c is 7.1%.  Although there are no clinical trial data on this 
topic, current international consensus guidelines and the research literature suggest the 
potential benefit of this strategy. Current recommendations regarding nutritional 
management in children and adolescents with type 1 diabetes caution that "optimal" 
nutrition therapy varies based on the individual and thus should be developed through 
an interdisciplinary clinical team to account for the individual child's unique growth, 
physical activity habits, cultural, ethnic, family traditions, psychosocial, and behavioral 
needs. Although emphasizing the importance of matching insulin dose to carbohydrate 
intake and providing guidelines for appropriate ranges of daily macronutrient intakes 
(carbohydrates: 50–55% of energy, fat: <35% of energy (saturated fat <10%), and 
protein 15–20%) is cited in the most recent International Society for Pediatric and 
Adolescent Diabetes (ISPAD) consensus guidelines, these guidelines stop short of 
prescribing daily consistency in the timing and distribution of meals, snacks, and 
carbohydrates. However, some suggestive statements of the potential benefit of 
planned eating practices are included: "implementation of an individualized meal plan 
with appropriate insulin adjustments can improve glycemic control" and  "regularity in 
meal times and eating routines are…important for glycemic outcomes"5. 
 
Although no clinical trials to-date have purposefully evaluated whether planned eating 
as a behavioral strategy improves diabetes outcomes in T1D youth, studies have 
illustrated negative associations between irregular dietary intake (e.g., skipping 
meals/eating frequency, day-to-day variability in macronutrient composition of intake) 
and T1D diabetes management and outcomes. An American study of 144 adolescents 
with T1D showed 56% admitted to missing meals and snacks6. Highlighting the 
potentially problematic nature of such habits for diabetes management, the Norwegian 
Childhood Diabetes and Quality Project found that skipping meals was associated with 

 
Version 4 - July 27 2022 
higher odds of sub-optimal HbA1c (>7.5%), LDL cholesterol levels (OR: 4.0, CI: 2.0-8.2; 
p <0.001), and being overweight (OR: 2.8, CI: 1.1-7.2; p = 0.03) among 655 children 
and adolescents with T1D (mean 11.4 yrs, mean duration of diabetes 3.8 years)7. 
Another study from the Norwegian Childhood Diabetes and Quality project, which 
examined 550 adolescents and children 2-19 years of age (mean age 11.3, diabetes 
duration 3.8 years) further demonstrated that even when intensive insulin treatment with 
insulin pumps and multiple injections were used, not skipping meals and having 
breakfast and supper regularly (defined as six times per week) was significantly 
associated with improved HbA1c8. Additional examination by Øverby et al. of the 
associations between high eating frequency and glycemic control found that two 
snacking events a day increased odds of suboptimal HbA1c (OR: 1.8, CI: 1.1–3.1; 
p=0.03)7. This finding was reinforced by a recent analysis of 821 T1D youth in the 
SEARCH for Diabetes in Youth study, where eating frequency (≤3, 4‐5, or 6‐10 
times/day) measured at baseline and follow‐up visits was significantly related to HbA1c 
and serum lipid levels measured repeatedly over 5 years. Increased eating frequency 
was associated with larger increases in HbA1c among youth with T1D. For example, for 
those who ate ≤3 times per day at the outset and ate 6‐10 times per day 5 years later, 
longitudinal models predicted greater absolute increases in HbA1c (2.77%)9. Despite 
the paucity of published studies examining day-to-day variation in the timing or 
composition of dietary intake among the T1D population, Wolever et al. reported day-to-
day variation of carbohydrate (p=0.0097), but not fat or protein, to be positively related 
to HbA1c in T1D youth, which remained significant when adjusted for age, sex, duration 
of diabetes and BMI10. 
 
Insights from pediatric clinics, consensus guidelines, and the literature thus suggest that 
day-to-day irregularity in meal/snack times and distribution of carbohydrates may be a 
target of intervention to improve T1D management and outcomes in youth.  A potentially 
beneficial behavioral strategy insufficiently explored to-date, planned eating in T1D 
youth would benefit from rigorous testing through a fully powered clinical trial.   Our  
overarching  goal  is thus to  establish  the role  of  individualized planned eating  
as  part  of  effective diabetes  self-management  strategies for  youth  with  T1D  
to  improve glycemic  levels. We have already conducted  a  small  feasibility pilot  
across  two  centers  in the  US  that  indicates  interest  and  willingness  of  patients  
and  parents  to  engage in an  individualized  planned  eating behavioral  intervention  
we  call  “MyPlan.”  MyPlan included  the  collaborative  development of  pattern of  
eating occasions  and carbohydrate  distribution  individualized to  youth  and parent  
lifestyle constraints  and  preferences.  MyPlan  demonstrated  initial  adherence  to  
and acceptability  of  this  approach  over a one-month  period.   
 
We propose  a  feasibility  study  of  longer  duration  to  assess  acceptability  and  
adherence, and  to  estimate  impact  on  glycemic  control  of  a  6-month  
individualized  planned eating  behavioral  intervention.  The  present R21 will  enable  
the  design  of  a  rigorous  randomized  clinical  trial to include planned eating  as  part  
of  a comprehensive  approach to  improve outcomes that  will  inform  clinical  practice  
and  medical  nutrition therapy  guidelines. 

 
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3.  Study Objectives 
Our objective is to build on our initial pilot study (UNC-CH IRB 18-2767) with a 6-
month feasibility study of longer duration to assess the adherence to and acceptability 
of the MyPlan eating strategy in youth with type 1 diabetes (T1D), as well as to 
estimate impact on glycemic levels between baseline and 6 months.  This project will 
inform the design of a future pragmatic randomized clinical trial of behavioral 
strategies to improve diabetes self-management in youth with T1D. Our specific aims 
are: 
Aim  1.  Assess  acceptability  and  adherence to  a  6-month  individualized  
planned eating strategy (“MyPlan”) among  40  youth  with  T1D.  We  will recruit  
adolescents,  age  12-17  years,  with T1D  of  at  least  1-year  duration and  with  
HbA1c  7.5  %  and  11%.  Coordinated  at  the University  of  North Carolina  at  
Chapel Hill  (UNC),  we  will recruit  17  participants  at  UNC  and  33  participants  at  
Cincinnati Children’s  Hospital Medical  Center  diabetes  clinic  (total  n=50  recruited 
to  ensure approximately n=40 completers)  to participate in a 26 week  MyPlan 
intervention,  which  will guide  participants  in setting  behavioral  goals  in relation to  
five  behavioral targets  that comprise  a  eating behavior pattern  (“MyPlan”) 
developed based on clinical  expertise and  international consensus guidelines:  1)  3-
4 meals and  1-2  optional  snacks;  2)  spacing  eating occasions  throughout  the  
day;  3)  spacing  carbohydrates  across  the day;  4)  no  post-dinner  snacking;  and  
5)  eating within a short  period of  waking.   
• To assess acceptability we will use a previously developed five-item 
questionnaire for diet acceptability (all participants) as well as a post-study 
qualitative evaluation (sub-sample of participants): 
o Satisfaction, perceived ability to stay on the plan, enjoyment of the plan, 
ease of staying on the plan, how the participant feels on the plan and 
ability to manage blood sugar on the plan.    
o Perceived pros and cons of the plan, and other acceptability related 
themes that emerge from answers to questionnaire free response items 
and qualitative evaluation questions 
• To assess adherence we will use 24-hour dietary recalls and MyFitnessPal logs 
to calculate: 
o Weekday  and weekend  adherence (categorically and continuously 
specified) to  five  behavioral targets  that define the MyPlan pattern will be 
calculated 
o Consistency will be defined as the extent  to  which  youth  performance  
on  the  adherence  metrics  differs  between  the dietary recall/log days. 
 
Aim  2.  Compare  glycemic  control  among adolescents  with  T1D  at  baseline  
and at  the end  of  the  6 month MyPlan intervention.   
• To assess glycemic control we will use  %  time  in range (TIR)  and HbA1c.  
The primary  glycemic control outcome  will be  pre-post  within-person  change in  
%  TIR  measured by  CGM.  With  80%  power,  we  will be able to  detect  an 
approximate  change in TIR  of  6.8%,  equivalent  to a  change in HbA1c  of  about  

 
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0.52%.24  We will collect HbA1c as a secondary outcome measure. We will  conduct  
exploratory  analyses  to  determine if  change in  glycemic  control  differs  
according to  degree  of  adherence to  planned eating and other clinical and 
demographic factors. As part of the planned post-hoc qualitative evaluation of the 
MyPlan project with a sub-sample of participants and their parents, 
we will assess self-reported/subjective effectiveness and more deeply explore 
potential reasons underlying why MyPlan may have improved or failed to improve 
participants’ glycemic management to identify intervention levers for future studies. 
 
4.  Site Descriptions 
The two clinical sites include 1) University of Cincinnati in Ohio) and 2) University of 
North Carolina Medical System. All clinical sites are well-established academic 
medical centers with vast experience in diabetes translational research. UNC-CH will 
oversee coordination of the pilot trial.  The study investigators across UNC-CH and 
University of Cincinnati have over a decade of collaborative experiences in research 
among youth with T1D, and comprise the core team for the future trial for which these 
pilot data are being collected. 
 
 
 

 
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5.  Selection & Recruitment of Subjects 
Exclusion criteria: The following individuals will be excluded from study 
participation. Individuals with other metabolic disorders, unstable thyroid disease, 
diagnosed eating disorder, prohibitive strict dietary restrictions, or those with other 
serious condition that renders participation inappropriate. Females who are currently 
pregnant will be excluded.  
 
Inclusion criteria: Male and female individuals ages 12-17 years old with a 
diagnosis of type 1 diabetes of greater than one year, and a HbA1c measurement 
between 7.5-11% in the preceding 9 months.  A parent (or legal guardian) will also be 
included for each participant. 
 
Recruitment will use a combination of in-person and remote strategies: 
 
Introductory Recruitment Step “Initial Contact”: 
Medical records will be used to identify adolescents who potentially meet the eligibility 
criteria for this study. A mix of active and passive recruitment strategies will be used to 
establish initial contact with potential participants: 
• We will work with NC TraCS to establish recruitment through MyChart. 
• Potential participants identified in Epic will be sent a brief e-mail overviewing the 
study with a link and QR code which will lead to a Qualtrics interest form where 
the parent participant can fill out their contact information in order to be 
contacted by study personnel for further information about the study. 
• Research4Me will connect potential participants to the Qualtrics interest form. 
• Facebook posts in T1D specific groups will identify potential participants. 
• Providers (i.e., endocrinologists, nurses, dieticians) at each site will alert 
patients about the study during routine care visits, asking parents whether they 
would be willing to be contacted by the study coordinator to be presented 
information about the study. Providers will either share the parent’s contact 
information with the study recruitment staff, or share the Qualtrics form QR 
code, which will lead the participant to a short eligibility questionnaire where 
their parent can fill out their contact information in order to be contacted by 
study personnel for further information about the study. 
• Recruitment personnel will scan Epic for upcoming visits and send an Epic 
message to the provider to remind him/her to mention the study to the 
participant during the visit. Providers will either share the parent’s contact 
information with the study recruitment staff, or share the Qualtrics form QR 
code, which will lead the participant to a short eligibility questionnaire where 
their parent can fill out their contact information in order to be contacted by 
study personnel for further information about the study. 
• Recruitment materials will also be prominently displayed in the diabetes clinic 
waiting area and exam rooms at both sites. The materials will have a QR code 
that will lead the participant to a short eligibility questionnaire where the parent 
can fill out their contact information in order to be contacted by study personnel 
for further information about the study.  

 
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• Recruitment personnel may also utilize in-person recruitment of eligible 
participants during usual care visits by screening Epic for upcoming 
appointments and intercepting the participant before or after the care 
appointment. If in-person, the personnel will introduce the study to the parent 
and obtain contact information to discuss the study further at a later date. In 
some cases when the parent and participant have additional time to discuss the 
study, personnel may be able to proceed to covering the content in 
“Recruitment Step 1”.  
 
Recruitment Step 1 “First Meaningful Interaction”: 
Once the parent agrees to be contacted at a later date and shares his/her contact 
information, study personnel will call the parent and adolescent to explain the study in 
detail. Both parent and adolescent must be present for this interaction. After this call, 
study personnel will send the parent and adolescent a study information sheet and the 
schedule of encounters, and set up another call once the parent and adolescent think 
they will have had a chance to review the information.  
 
Recruitment Step 2 “Commitment Interaction”: Both parent and adolescent must 
be present for this interaction. During this second call, study personnel will address 
any questions or concerns that may have arisen while parent and participant reviewed 
the material. If the parent and adolescent agree, the study personnel will then 
schedule up a time and date for in-person consent/assent and the baseline 
measurement visit. The consent/assent forms will be e-mailed to the participant in 
advance of the baseline measurement visit. 
 
Strategies to Optimize Recruitment and Retention: Study staff at Ohio, and 
University of North Carolina at Chapel Hill sites will be responsible for local recruitment 
activities. As described above recruitment will use a combination of passive, active, 
remote and clinic-based strategies.  
 
 The two step-recruitment process is a pre-emptive retention strategy because it 
ensures parents and adolescents have an in-depth understanding of study 
expectations and helps them reflect on barriers to participation before signing on to the 
study. Further, staff will remotely monitor participation (i.e., adherence to MyFitnessPal 
logs) on a weekly basis to actively and pre-emptively troubleshoot engagement issues. 
Additionally, we will incorporate successful retention strategies from previous research 
in this study population (e.g., offering flexible visit options, incentives [up to $200] 
based on questionnaire/measurement completion and intervention participation, 
reminder texts/e-mails, cards and phone calls, easy parking instructions).   Using 
similar strategies in the 18-month FLEX trial, our retention was 93%.91 We expect the 
same success for MyPlan because it has approximately identical inclusion criteria as 
FLEX, is significantly shorter in length, and only requires two in-person measurements 
visits (counseling sessions and questionnaires will be completed online) –all of which 
make the study lower burden and more convenient for participants than the FLEX 
study. We also anticipate that the point-based incentive system that rewards 
participants We will recruit 50 youth-guardian dyads (33 at CCHMC, 17 at UNC).  We 

 
Version 4 - July 27 2022 
conservatively plan for 80% retention, resulting in at least 40 completers (26 at 
CCHMC, 14 at UNC).   
 
 
Participant Recruitment: Ohio: The recruitment goal for Ohio is 33 participant/guardian 
dyads.  Participants will be recruited from the Cincinnati Children’s Hospital and 
Medical Center pediatric endocrinology clinic, located on the campus adjacent to 
University of Cincinnati. Clinics outside of Cincinnati Children’s Hospital and Medical 
Center may also be sources of potential participants, who will either be identified 
through Facebook groups or MyPlan staff networks.     
 
Participant Recruitment: University of North Carolina: The recruitment goal for 
University of North Carolina at Chapel Hill is 17 participant/guardian dyads.  
Participants will be recruited from the University of North Carolina medical system. 
Clinics outside of University of North Carolina medical system may also be sources of 
potential participants, who will either be identified through Facebook groups or MyPlan 
staff networks.     
6.  Consent, Assent, Withdrawals 
Participant guardians and participants will have the opportunity to provide informed 
consent and assent, respectively, following the recruitment processes detailed above. 
For guardians and participants who agree to participate and schedule a baseline visit, 
at the time of the visit, study staff will review the full study consent in detail before 
standardized data collection begins. Guardians and participants will be given as much 
time as needed to review the consent and assent forms and ask any questions prior to 
signing it. They will be informed that participation in the study is voluntary and that they 
are free to withdraw their consent and discontinue participation in this research study 
at any time by contacting the primary investigators or study staff.  
 
Following assent, participants may be involuntarily withdrawn from the study per 
the investigator’s discretion if they develop a serious condition that would render 
participation unwise, including clinical diagnoses of serious physical or psychiatric 
conditions. The study physicians (Shah, Jain) will review this information and make a 
determination about withdrawal from the study. Females who become pregnant will 
also be withdrawn from study participation.  
 
If a participant chooses  to withdraw or is withdrawn from the study, they will be asked 
the reason for withdrawal, which will be recorded in a withdrawal form in REDcap by 
study staff.

 
Version 4 - July 27 2022 
8.  Standardized Measurements 
Measurement 
2-week run-in 
 
Baseline Data 
Collection 
 
Visit 1 
Insert CGM 
Week 3 
 
Baseline Data 
Collection* 
 
First Session 
 
Week 4-10 
 
 
 
 
7 Weekly 
Sessions 
Week 12-22 
 
 
 
 
6 Bi-weekly 
Sessions 
Week 22 
 
 
 
 
 
Insert CGM 
Week 24 
 
 
 
 
Last Session 
take-off CGM 
Week 26 
 
Endline Data 
Collection 
 
Visit 2 
return CGM 
Adherence 
 
 
Mobile Phone MyFitnessPal Logs  
 
X 
 
          X 
X 
X 
X 
X 
 
24-Hour Diet and Physical Activity 
Recalls 
 
X 
 
 
 
X 
 
 
Acceptability 
 
MyPlan Acceptability Assessment 
(Parent, Participant)  
 
 
 
 
 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
X 
MyPlan Adjustment Form 
 
MyPlan post-hoc qualitative evaluation 
 
 
 
 
 
 
X 
Psychosocial and Behavioral 
Factors 
 
 
Baseline Lifestyle Questionnaire 
Diabetes Self-Management Support 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
X 
Food Frequency Questionnaire  
X 
 
 
 
 
 
X 
Diabetes Eating Problem Survey 
X 
 
 
 
 
 
X 
Hypoglycemia Fear Survey 
 
X 
 
 
 
 
 
X 
Knowledge Survey 
X 
 
 
 
 
 
X 
Self-Efficacy Survey* 
 
X* 
 
 
 
 
X 
Motivation* 
 
X* 
 
 
 
 
X 
Problem Solving Skills*  
 
X* 
 
 
 
 
X 
Glycemic Control 
 
Continuous glucose monitoring 
 
X 
 
 
 
 
X 
 
 
X 
HbA1c (Note: value does not have to 
be 7.5-11% at time of baseline visit) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 

 
Version 4 - July 27 2022 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Hypoglycemia Reporting Questionnaire 
 
MyPlan post-hoc qualitative evaluation 
 
 
 
            
 
 
 
 
X 
Anthropometrics 
 
Height 
Weight 
X 
 
 
X1 
 
 
             X 
Demographics and Health History 
 
X 
 
 
 
 
 
X 
Process Measures 
 
SMART Goals set, Goals 
Achieved/Points received, Behavioral 
strategies delivered, Fidelity 
checklist, Behavior Change 
Techniques 
 
X 
 
 
 
 
X 
 
X 
 
X 
 
 
 
 
        X 
 
 
X 
 
 
 
 
 
 
 
 
 
MyPlan post-hoc qualitative 
evaluation 
 
 
 
 
 
 
X 
 
 
        * baseline assessed at Week 4 (1 week after being introduced to eating plan) 
        1. self-report weight at midpoint to ensure no significant loss (Week 14) 

 
Version 4 - July 27 2022 
8a. Primary Outcomes    
 
Time in range 
We will compare participants’ average TIR during the blinded CGM wear time at 
baseline (0-2 week run-in period before the active intervention period) when participants 
will be following their usual diet to their TIR at 22-24 weeks of the active intervention 
period. TIR can capture the impact of short term behavior change and allows for blood 
glucose fluctuations to be compared between days and weeks instead of months.97 
Because 24-hour dietary recalls will be administered during the time the CGM is worn at 
0-2 and 22-24 weeks, in exploratory analyses we can examine the difference in 
participants’ alignment to the prescribed eating behavior pattern at 22-24 vs. 0-2 weeks 
alongside the difference in TIR at 22-24 vs. 0-2 weeks using the matched two days of 
24-hour recall and CGM data pre vs. post intervention. 
 
The 24-hour dietary recalls will be obtained by trained staff certified from the 
NIH/NIDDK-funded UNC Nutrition Obesity Research Center (P30DK056350; MPI 
Mayer-Davis)  using the Nutrient Data System for Research software and the multiple 
pass interviewing method.98,99 It is possible that the eating behavior pattern participants 
follow during the intervention will affect glycemic control differently during the day and 
night. For instance, not eating after dinner (i.e. no bedtime snack) may reduce 
hyperglycemia and improve TIR overnight. As such we will also examine differences in 
pre- and post-intervention TIR by day and night using time cut points established by 
international diabetes research consensus guidelines.100  
 
More detail about the unadjusted and adjusted outcome models that will be analyzed 
can be found in the Statistical Considerations section. 
 
 
Eating behavior pattern adherence 
Alignment of participant behavior to the prescribed eating behavior pattern will be 
objectively assessed via two unannounced 24-hour dietary recalls (1 weekday, 1 
weekend per week) collected during the 0-2 week and 22-24 week CGM wear time of 
the MyPlan study. Adherence metrics (weekday and weekend) will include proportion of 
participants who followed each eating behavior target, proportion of participants who 
met 0-5 eating behavior targets, and average number of targets met 
 
In exploratory analyses, participant logs and 24-hr recalls will also enable identification 
of which snacks/meals are most often missed, which snacks/meals deviate the most 
from time or carbohydrate distribution targets as specified in the planned eating plan, as 
well as which aspects of regular eating pose the biggest challenges to adherence. 
These metrics will help with targeting counseling and focusing goal-setting, as well as 
areas to focus the design of future trials. 
 
Eating behavior pattern acceptability 
Although acceptability of the individualized planned eating plan will be ascertained 
every week after the plan is introduced, acceptability will be reviewed formally at 3 
months, and again at the conclusion of the intervention period. Participants and their 
parent/guardians will fill out an acceptability assessment that we have used in previous 
studies.101 17 We will calculate separate composite acceptability scores (5 highly 
acceptable, 20 highly unacceptable, >10 unacceptable) from ordinal responses to 
statements from an 5-item instrument designed to capture ease of eating pattern 

 
Version 4 - July 27 2022 
adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar 
management. As part of the post-hoc qualitative evaluation of the intervention, we will 
conduct short semi-structured qualitative exit interviews with teenager and parent 
participants and project staff to ascertain barriers and facilitators to following the eating 
strategy, likes and dislikes, recommendations for modifications, likelihood of 
recommending the strategy to others, and the eating behavior target participants found 
most difficult to follow, alongside other feedback related to intervention design, 
materials, and implementation.    
 
8b. Secondary Outcomes    
 
HbA1c 
At baseline and 26 weeks, HbA1c will be measured using point-of-care testing. 
 
Comparing HbA1c collected at the end of the intervention to the value collected at 
baseline provides insight into glycemic effects of the eating behavior pattern that are 
complementary to the insights produced by the blinded CGM: Hba1c collected at 
baseline will generate understanding of ‘usual’ youth glycemic control up to three 
months before starting the intervention; HbA1c collected at 26 weeks will generate 
understanding of glycemic control between the midpoint and end of the intervention, 
thus providing information about glycemic control during up to half of the time that 
participants are following the eating behavior pattern.  
 
The HbA1c values will also be less affected by the potential bias of participants 
engaging in extra conscientious diabetes self-management behaviors during the two 
weeks at baseline and endline when they are wearing the study CGM, which could alter 
behavior even though blinded to participants. Because 2 weeks of CGM wear time can 
be used to estimate HbA1c with high accuracy, in exploratory analyses the CGM and 
HbA1c values can be compared to assess the extent to which the data produced by the 
blinded CGM (and transitively, the diabetes behaviors during this period) are 
representative of the individual’s ‘usual’ behavior.100  
 
8c. Other Measurements: 
 
Potential confounders and effect modifiers 
The DAG below highlights the key variables that we will consider in our exploratory multiple 
linear regression outcome models (Figure 1).  

 
Version 4 - July 27 2022 
 
 
To address the possibility that the observed effect of the eating behavior pattern on TIR 
may be obscured by a differential number of CGM wear hours, we will calculate and 
report this metric in order to describe the extent to which wear time varies across our 
study sample and may bias our assessments of eating behavior pattern effects on 
glycemic control. We acknowledge that unplanned physical activity can alter usual 
eating habits and also affect glycemia in unpredictable ways, which may confound the 
effect of the eating strategy on TIR. On the days during which 24-hour dietary and 
physical activity recalls are conducted, data collectors will additionally probe for any 
unplanned physical activity as defined by consensus guidelines (>20 minutes of activity 
that resulted in sweating or heavy breathing).102 Insulin timing will also be collected as 
part of 24-hour dietary recalls in order to understand the extent to which dosing 
inaccuracy may contribute to the glycemic data collected via blinded CGM at 0-2 weeks 
and 22-24 weeks of the study. At baseline of the trial, a medical chart review will provide 
information on diabetes duration, age, sex, race, ethnicity, height, weight, insurance 
type, diabetes self-care regimen (self-monitoring frequency, insulin dose, insulin 
regimen, usual use of CGM), and highest level of parental education. This data will help 
us understand the generalizability of our results to other populations with T1D and will 
also be incorporated in more fully adjusted exploratory outcome assessment models.  
 
Anthropomorphic measurements 
The planned eating plans are not anticipated to significantly change weight status 
because the timing and distribution of participants’ usual dietary intake throughout the 
Figure 1. MyPlan R21 directed acyclic graph - adherence to individualized a priori developed eating 
behavior pattern and glycemic management 

 
Version 4 - July 27 2022 
day are the target of study, not the magnitude or quality of intake. Nevertheless, to 
monitor healthy weight and growth throughout the study period, weight and height will 
be measured at baseline and at the end of the study utilizing standardized methods 
described in the SEARCH for Diabetes in Youth study protocol (available online, 
www.searchfordiabetes.org). Participants will also be encouraged to self-monitor their 
weight and communicate any changes to the RD.  They will use their home scale to 
self-report weight at baseline, midpoint, and end of the study. 
 
Psychosocial and behavior change measurements 
A conceptual framework 
(Figure 2) underpins the 
design of the structured 
behavior change counseling 
module, which is based on 
the Social Cognitive Theory 
and the Transtheoretical 
Model.92,93 The underlying 
premise is that improving 
knowledge (i.e., targeted 
education), motivation (i.e., 
creating a motivational 
framework for change), and 
skills (i.e., decisional 
balancing, problem solving 
skills) will reduce perceived barriers to adherence,  improve diabetes self-management, 
and subsequently glycemic control.92-94 Our previous testing in the FLEX study of a 
structured counseling module with the same core elements improved scores for 
motivation (p=0.01), problem solving (p=0.02), and diabetes self-management profile 
(p=0.01) among adolescents with T1D over an 18-month period.91 We are thus 
confident that the structured counseling module we plan to use will support youth in our 
study adopt and maintain their adherence to the eating behavior pattern over a 
significantly shorter six month period than the FLEX trial. We will assess problem-
solving skills, self-efficacy, motivation, knowledge, and adherence self-management 
behaviors at the beginning and end of the study, so that we can monitor change in 
these intervention targets throughout the study and conduct exploratory structural 
equation modeling to test the conceptual model underpinning intervention design. We 
will assess problem-solving skills, self-efficacy, and motivation using validated 
instruments that were adapted to ask questions about these constructs as pertains to 
the personalized eating plan because the intervention is designed specifically to target 
motivation, self-efficacy, and problem-solving skills in relation to plan adherence. We 
will use the validated Nutrition Knowledge Questionnaire (NQS) and Diabetes Self-
Management Profile Survey to assess knowledge and overall diabetes self-
management adherence, respectively. 
 
To capture perceptions of food and body weight, as well as disordered eating behavior 
that may pose challenges for planned eating plan adherence, the validated Diabetes 
Eating Problem Survey17 will be administered to participants at baseline and at the end 
of the study. It is also possible that personalized eating plan may positively or negatively 
impact disordered eating behavior. Results from this survey, including change in survey 
scores throughout the study, will facilitate identification of barriers to planned eating 
Figure 2. MyPlan Study Conceptual Framework 

 
Version 4 - July 27 2022 
plans and help inform the counseling strategies and individualized eating plans given to 
participants.  
 
 
Hypoglycemia 
Severe and non-severe hypoglycemia will be defined according to recent consensus 
guidelines (54-70mg/dl; <54 mg/dl; requiring external assistance for recovery)11.  To 
ensure continued safety of participants and the compatibility of the planned eating plan 
with the participant’s lifestyle, the participants will be systematically queried regarding 
occurrence of serious hypoglycemia, at the end of the study, and during each meeting 
and support call with the RD using the hypoglycemia reporting instrument that queries 
instances of hypoglycemia that occurred since the last session. Fear of hypoglycemia 
and behaviors used to manage this fear will also be assessed at baseline and the end 
of the study through a questionnaire in order to ascertain whether this fear is impacted 
at all by the predictability of the planned eating intervention that the participant is being 
asked to follow. In the case of any event of serious hypoglycemia in between structured 
meetings and calls, participants will be instructed to contact their study physician either 
directly, or through the RD, to determine any needed adjustments to the planned eating 
plan or insulin dosing.   
 
Eating and Physical Activity Pattern 
In order to assess participants’ baseline eating and physical activity patterns and inform 
the design of the individualized planned eating plan, a questionnaire will also be 
administered to participants during the pre-trial data collection that queries frequency 
and timing of meals, snacks, insulin administration, and physical activity on week days 
and weekends. The questionnaire will also collect how frequency and timing of 
participants’ weekday or weekend meals, snacks, and physical activity vary from day-to-
day. Participants will be asked whether they take insulin each time they eat a snack or 
meal, and will be asked to report any common variability in this practice. They will also 
be queried about hypoglycemic events. Additionally, participants will be asked about 
carbohydrate counting for insulin dosing and any other dietary intake planning method 
they or their caregivers/parents use, if applicable. The questionnaire will also assess 
participant waking and sleeping times and the extent to which these times vary 
throughout the week.  
 
In addition to providing information about baseline eating pattern, two 24-hour dietary 
recalls will be collected at baseline and at 6 months to assess change in dietary 
behavior and adherence to the planned eating plan. Recalls will be obtained by 
telephone by trained and certified interviewers from the UNC NIH/NIDDK Nutrition 
Obesity Research Center (NORC) staff (P30DK056350; MPI Mayer-Davis) under the 
direction of Dr. Mayer-Davis (Diet Assessment Core Director), using the Nutrient Data 
System for Research (NDSR) software and the multiple pass interviewing method.12,13 
 
The Previous Day Physical Activity Recall (PDPAR) will also be administered to help 
ascertain baseline physical activity pattern and contextualize glycemic levels observed 
in the trial. The validated14,15 Previous Day Physical Activity Recall (PDPAR) will be 

 
Version 4 - July 27 2022 
under the direction of the UNC NORC, to be administered concurrent with the 24-hr 
dietary recalls, as we have done previously.16 The PDPAR divides the day into half-hour 
time blocks and queries the dominant activity and the approximate intensity of that 
activity for that period, categorized as ‘‘light,’’ ‘‘medium,’’ ‘‘hard,’’ or ‘‘very hard.’’  
 
To assist participants and families in planning meals and snacks that align with 
participants’ individualized planned eating plans, participants will be given a subscription 
to MyFitnessPal Premium, which will also conveniently serve as the platform through 
which mobile phone logs are collected.  Any changes to the personalized eating plan 
made throughout the study will be captured in Qualtrics. 
 
Because it is possible that planful eating may also affect types of foods consumed, we 
will also administer a food frequency questionnaire at baseline and end of the study to 
capture dietary quality throughout the study. 
 
MyFitnessPal logs 
Eating pattern and physical activity will be monitored via participant mobile phone logs 
collected through MyFitnessPal.  
 
In addition to the 24-hour dietary recalls, the logs collected during the first two weeks 
will be used to understand participants’ preferred foods and timing of snacks and meals. 
This information will inform the design of the individualized planned eating plan. This 
information will also be used to inform the design of a sample menu of meals and 
snacks that will be introduced to and adjusted with the participant on the first week of 
the active intervention (week 3). Participants will therefore be instructed to follow their 
usual eating and physical activity habits during this run-in week, and RDs will 
emphasize that honesty in logging usual habits will optimize the RD’s ability to design a 
planned eating plan that fits into the participant’s lifestyle and is sustainable. Once the 
planned eating plan has been designed and delivered to the participant in the first week 
of the active intervention (week 3), subsequent logs collected throughout the 
intervention period will facilitate discussions about challenges with adherence, focus 
problem solving and goal setting, and inform needed adjustments to the planned eating 
plan. As discussed in a subsequent section, adherence to logging will be used to 
allocate points/incentive money to participants throughout the study.   
 
 
Other Health Information 
At the Pre-Trial Data Collection Visit, we will conduct a medical chart review to collect 
basic demographics, including birth date, sex, ethnicity, and race. Medical chart review 
will also enable ascertainment of date of diabetes diagnosis, diabetes care (i.e. insulin 
regimen), and other relevant health history. 
 
 
 

 
Version 4 - July 27 2022 
9.    Trial Procedures and Components 
 
The schedule of intervention sessions, measurements, and questionnaires is depicted in Figure 
3 below. 
 
 
 
 
In-person visits 
Participants and their parents/guardians will attend two in-person measurement visits at 
baseline and end (26 weeks) of the intervention. HbA1c, height, and weight will be 
collected at these time points. Although participants will be sent questionnaires 
electronically ahead of the measurement visit, participants will finish any outstanding 
questionnaires in person to ensure data completeness. At the baseline visit, after 
consent/assent is completed, the participants will be given the blinded CGM, and 
explained how to insert it independently. They will insert it at the Baseline session with 
the study dietician. Participants will be provided a pre-paid envelope to send back the 
CGM after 2 weeks of wear time. Participants will receive another CGM in the mail at 22 
weeks, which they will insert independently to avoid the burden of another in-person 
visit. They will receive virtual insertion assistance from the study dietician at the 22 
week session. They will return the CGM at the 26 week in-person visit. Two 24-hour 
dietary and physical activity recalls will be collected during the 2 week CGM wear time 
at both time points. 
 
Counseling and online intervention sessions 
A dietitian will meet with the participant via HIPAA compliant videoconference every 
week for the first 2 months, and bi-weekly for the last 4 months. Sessions will involve a 
structured behavior change counseling module focused on a) anticipating barriers to 
adhering to the eating behavior pattern b) developing and revising SMART goals 
focused on meeting the five targets that comprise the eating behavior pattern, and c) 
adding on new goals or increasing the challenge level of goals week to week. The 
structured behavior change counseling module is designed so that participants will 
incrementally improve behavioral alignment with the eating behavior pattern throughout 
Figure 3. MyPlan Study Schedule of Intervention Sessions, Measurements, Questionnaires 

 
Version 4 - July 27 2022 
the study. The design, underpinned by the previously described conceptual framework,  
also considers that motivation, self-efficacy, knowledge, and baseline eating behavior 
will shape the rate at which participants increase the number of goals they set, how 
advanced the goals are (i.e., meet carbohydrate target at lunch vs. meet carbohydrate 
target at lunch and improve carbohydrate quality), and ultimately, how closely they 
adhere with the eating behavior pattern.  
In addition to the content of the intervention sessions themselves, which will focus goal 
setting on meeting the eating behavior pattern and target psychosocial barriers to 
behavior change, we will use other behavior change strategies to promote adherence. 
Participants will log their food intake and physical activity in MyFitnessPal at least three 
days per week throughout the study. The benefits of self-monitoring for behavior change 
have been widely documented and MyFitnessPal has features (i.e., carbohydrate 
estimation) that facilitate choosing types and amounts of food that align with the eating 
behavior pattern.95,96 Logs collected during the 2 week baseline period will reflect usual 
intake, which together with the 24-hour recalls collected at baseline and a questionnaire 
about usual eating pattern, will help the dietician understand participant preferred foods 
and eating schedule. This information will be incorporated into the eating behavior 
pattern the dietician presents to the participant and parent at the first intervention 
session to enhance acceptability and adherence to the pattern. The logs collected 
throughout the study will also enable the dietician to remotely monitor adherence to the 
eating behavior pattern between sessions, provide personalized feedback, help the 
participant troubleshoot barriers to adherence, and focus goal setting around the eating 
behavior targets the participants find particularly challenging.  
Logs will additionally be used by dieticians to reward participants with points for 
achieving their goals every week. In order to maintain participant engagement with 
logging and meeting weekly goals, participants will earn points that translate into dollars 
based on the number of days they log and the number of goals they achieve throughout 
the course of the intervention –for a total possible incentive amount of 200 USD. 
Incentives are discussed in greater detail in the following section 
Participant incentives 
The point/incentive allocation scheme (Table 2) is designed to incentivize participants to 
complete all questionnaires/measurements, maximize the number of days they log and 
the number of eating behavior targets they try to meet each week, and minimize 
disengagement over the course of the intervention. 
 
To reduce the risk of logging fatigue, participants will be asked to log all their meals, 
snacks, and physical activity on a minimum of three days per week, but will receive 
points for each additional day they log above the minimum. This minimum of three logs 
per week will be required to reward the participant with points for making progress 
towards their goals (i.e., points for meeting the goals focused on the targets that define 
Table 2. MyPlan Study Point/Incentive Allocation Procedure 

 
Version 4 - July 27 2022 
the eating behavior pattern). Participants will receive points for every goal they set as 
long as they meet the goal on at least two of the three required days of logs. The best 
three days of logs will be used to assess goal attainment, so that participants are 
incentivized instead of penalized for logging more than the minimum, since more days 
of logs may reveal more days where the participant struggle to meet their goals. 
Participants will receive text reminders on the three minimum days they are expected to 
log. Study staff will monitor logs throughout the week, and the RD will reach out such to 
troubleshoot logging issues with participants and encourage participants to get back on 
track if they have not completed any logs.  
To promote logging adherence, the dietician will thoroughly instruct the participant and 
parent/guardian how to log in MyFitnessPal, provide additional resources for navigating 
MyFitnessPal, and help troubleshoot barriers to logging at the beginning of the study. 
Dieticians will monitor logging adherence over time, so that in the case that participants 
begin to disengage from logging, additional strategies will be used to keep the 
participant engaged in self-monitoring such as simpler MyFitnessPal logs (i.e., entry of 
grams of carbohydrate at each meal and snack and the corresponding time), paper/pdf 
logs (i.e., entry of number of carbohydrate servings/exchanges per meal and the 
corresponding time), and having parents systematically help with logging. 
To encourage the participant adherence, the RD will review the number of points the 
participant has earned each week as well as the total possible points that can be earned 
the upcoming week. The total amount of incentive earned by the participant will be 
disbursed upon completion of the study. In the case of study withdrawal, participants will 
receive an incentive amount based on the total number of points they earned up until 
study withdrawal.  
 
Parent/guardian involvement in online intervention sessions 
Parent/guardian will be required to attend the first three online counseling sessions in 
order to learn how to log in MyFitnessPal, become familiar with the eating behavior 
pattern, and understand the process of setting and revising SMART goals session-to-
session. This information will enable the parent to support participant adherence to 
logging and meeting goals week-to-week, (i.e., parent/guardian can ensure meal times, 
cooking, and grocery shopping are supportive of participant’s eating behavior pattern). 
The parent/guardian will also attend the midpoint online intervention session when the 
eating behavior pattern will be formally reviewed and revised based on participant and 
parent/guardian acceptability.  
10. Data management  
All  data will  be transmitted  to  UNC,  which serves  as  the Coordinating  Center  as  
was  done for  the  FLEX  trial.  To  ensure impeccable data  quality  and cost  efficiency  
for  this  pilot  work,  we will  build on the secure data  management  system (RedCAP)  
already  in place  at  UNC  for  our  MyPlan  feasibility  work. All questionnaires 
collected at baseline, 3 months, and 6 months of the intervention will be completed by 
participants in RedCAP. The counseling guide that the RD uses to deliver online 
intervention sessions with participants will be created in Qualtrics, which ensures 
standardization of content delivery within and across study participants, while also 
enabling certain process and intermediary outcome data are captured. The eligibility 
questionnaire used as part of recruitment will also be created in Qualtrics. 
11.  Statistical Considerations 
 

 
Version 4 - July 27 2022 
Statistical power 
Power analyses are based on matched-pairs t-tests and a conservative estimate of 40 
participants (alpha level of 0.05). Drawing from our previous study with a similar population to 
estimate the within-subject correlation, we have 80% power to detect an improvement in TIR of 
10%.94 In this previous study, the average TIR was 34.7% (SD=13.6), so this would correspond 
to an increase to an average of 42.5% TIR. The detectable effects are large, which is 
appropriate in this study that aims to assess preliminary effectiveness and acceptability to 
inform the design of a future fully-powered RCT of longer duration. 
 
Outcome evaluation 
Aim  1.  Assess  acceptability  and  adherence to  a  6-month  individualized  
planned eating  intervention  (“MyPlan”) among  40  youth  with  T1D.   
 
 
1) Adherence:  
We will calculate and report continuous and categorical overall adherence 
to the eating behavior pattern and adherence specific to each of the five 
eating behavior targets that make up the pattern (i.e. mean number of 
eating behavior targets met, proportion of participants who met each type 
of target, proportion of individuals who met 0, 1, 2, 3, 4, or 5 targets). 
Further exploratory modeling will be conducted to identify the contributions 
that adherence to each of the five individual behavioral targets make to 
overall adherence scores, as well as the relative magnitude of 
associations between adherence to each of the five individual behavioral 
targets and glycemic measures. 
Acceptability: 
o We will calculate continuous and categorical participant and guardian 
acceptability of the eating behavior pattern. Additional analyses include 
combined composite scores, exploratory modeling of demographic, 
clinical, and psychosocial predictors of acceptability will be conducted to 
inform both recruitment and targeted counseling strategies in future 
trials. We will assess acceptability related themes that emerge from 
answers to questionnaire free response items and questions posed as 
part of the qualitative post-hoc analysis of the intervention. 
  
Aim  2.  Compare  glycemic  control  among adolescents  with  T1D  at  baseline  
and at  the end  of  the  6month MyPlan intervention.   
 
2) Effect on glycemic control: 
We will compare continuous difference in TIR under the eating behavior pattern (22-
24 weeks) vs. usual diet (0-2 weeks). We hypothesize that  a) TIRMyPlan eating behavior 
pattern > TIRusual diet 
 
 
 
a) Matched-pairs t-tests will compare average TIR at 22-24 weeks vs. 0-2 weeks 
(overall and stratified by day/night) 
 

 
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b) Linear regression modeling will examine whether change in overall degree of 
adherence (comparing the two 24-hour recall days at 22-24 weeks and two 24-
hour recall days during 0-2 weeks) is associated with average change in 14 day 
TIR at endline vs. baseline  
 
c) Linear regression modeling will examine whether change in overall degree of 
adherence (comparing the two 24-hour recall days at 22-24 weeks and two 24-
hour recall days at during 0-2 weeks) is associated with change in TIR using the 
two days of CGM data at 22-24 weeks and 0-2 weeks that are matched to the 
two 24-hour recalls collected at those time points.  
 
d) Exploratory linear regression modeling will assess whether the differences in TIR 
observed in models (a) (b) and (c) above persist after adjustment for self-
management technology use (i.e., insulin pump vs. multiple daily injections, 
routine personal CGM use), physical activity, and other key clinical and 
demographic factors (i.e., age, sex, insurance status, parental education or other 
measure of socioeconomic status). Before including any of these factors in the 
model, we will examine their distributions as well as their bivariate associations 
with TIR to assess the magnitude, precision, and functional form of the 
relationship. An a priori ranking of the relative importance of these factors based 
on theory and existing literature will also inform the sequence with which we add 
them to the model. Changes in magnitude and precision of beta coefficients 
when different combinations of the variables are included in the model will also 
be considered in selection of the fully adjusted model. 
 
e) As part of the post-hoc qualitative evaluation of the MyPlan pilot intervention 
(detailed in a subsequent section), we will more deeply explore potential reasons 
underlying why the MyPlan eating behavior strategy may have improved or failed 
to improve participants’ glycemic management to identify intervention levers for 
future studies. We will probe participants and staff about their perceived 
effectiveness of the strategy and reasons for this self-reported effectiveness via 
interviews and focus groups with project staff and a sub-sample of participants. 
 
 
 
 
 
 
Process evaluation 
To identify the “active ingredients” and intermediary outcomes that may explain the observed 
results of the intervention and help inform future efforts to change eating behavior in the study 
population, we will collect a series of additional measures (Table 3) to enable a robust process 
evaluation. 
Table 3. MyPlan Process and Intermediary Outcome Measures 
Fidelity checklist coded with Behavior Change Technique Taxonomy (BCT) 
Number of sessions attended by participants 
Number of sessions attended by parents 
Number of logs completed 
Type of logs completed (i.e. original, simple, paper) 
Number of goals met 
Number of points earned 
Participant perceived challenge level of goals 
RD perceived challenge level of goals set 

 
Version 4 - July 27 2022 
 
Intervention sessions 
will be coded a priori 
with Behavior Change 
Technique Taxonomy 
(BCTs) based on the 
activities, messaging, 
and counseling techniques to be delivered by the dietician, which will produce a checklist for 
each session.103,104 Fidelity will be assessed by audio-recording all intervention sessions and 
coding the sessions for alignment with this checklist. Modeling will also explore the type and 
frequency of BCTs delivered that are associated with the outcomes observed. Number of points 
achieved by participants (i.e., number of logs made, number of goals met), characteristics of 
goals set by participants (i.e., type of goal areas focused on, self-perceived and dietician 
perceived challenge level of the goal), number and type of optional counseling/educational 
materials delivered, level of parental involvement, and adjustments made to the eating behavior 
pattern throughout the course of the study will also be reported and examined in association 
with study outcomes.  
Post-hoc qualitative evaluation of the MyPlan pilot  
A qualitative evaluation of the MyPlan pilot will also be undertaken via focus groups and 
interviews with MyPlan project staff who implemented the intervention, as well as a sub-sample 
of teenage and parent project participants who will be purposively sampled from intervention 
responders and non-responders (responder = participant or parent of participant who 
experienced an improvement in HbA1c or TIR over between baseline and endline, non-
responder = participant or parent of participant who experienced no change or deterioration in 
HbA1c or TIR between baseline and endline). Financial and human resources available nearing 
project completion will guide the number of teenager and parent participants sampled, and 
comprise no fewer than 10% of the teenager and parent participants. The purpose of this 
evaluation is to complement the quantitative process and outcome data collected by the MyPlan 
project and inform refinement of the MyPlan intervention and its implementation to improve 
efficacy and implementation in future studies and real-world clinical settings. As such, 
qualitative questions will be selected according to each of the dimensions of the RE-AIM 
framework. In order to promote obtainment of unbiased perspectives from project staff and 
participants and minimize recall bias, this evaluation will occur within 12 months of project 
completion, and will be conducted by independent researchers who played no role in project 
implementation.  
12. Potential Risks, Discomforts, Inconveniences, & Precautions:   
 
Potential Risks 
Since  the  majority  of the  data  collection  will occur at  the  CCHMC  and  NC  TraCS  
with  medical confidentiality  safeguards  in  place,  the  potential  risks  to  study  
subjects  are  minimal  and  do not  exceed  what  occurs  in  a  routine  visit  to  the  
CCHMC  and  UNC  Pediatric  Endocrinology. Safeguards  will  be  taken  to  code,  
encrypt  and  lock  access  to  study  data,  thus,  the  risk  of disclosure  of  medical  
information  is  low  (see  protection  against  risks  for further  details).  All data 
collection  instruments  are  benign  in  nature  or are  used  in  routine  care  
assessment  at the  CCHMC  and  UNC  Pediatric  Endocrinology  without  any  adverse  
effects  or risks.   No  social or legal  risks  could  be  identified.   The  physical  risks  
from  the  study  do  not  exceed  what occurs  as  a result  of routine  care  at  the  
Optional counseling/educational materials used 
Adjustments made to the eating behavior pattern throughout trial 
Semi-structured interview questions from post-hoc qualitative evaluation 
(focus groups with MyPlan staff, interviews and focus groups with 
responder and non-responder teenagers and parents) 

 
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CCHMC  and  UNC  Pediatric  Endocrinology.  This  could include  slight  pain  
associated  with  the  finger  stick  for  accessing  blood  for point  of care HbA1c  or  
with  sensor insertion  for CGM  and  unanticipated  impact  on  glycemic  control  as  a 
result  of dietary  intervention. (e.g.,  potential  embarrassment  about  answering 
questions  related  to  adherence).  The completion  of diet  recalls  using  MyFitnessPal  
©  app  and  questionnaires  could  be burdensome;  however,  we  will work  with  
adolescents  to  make  data  collection  as  easy  and meaningful as  possible. 
Adequacy of Protection against Risks  
Recruitment and Informed Consent  
Research  staff  at  the  clinical sites  will  obtain  written  informed  consent  from  
parents  and assent  from  youth.  The  study  consent  and  assent  forms  will  explain  
the  purpose  of  the study  and  measures  taken  to  protect confidentiality  (e.g.,  the 
data  will  not be linked  with personal identifying  information).  Patients  and  their 
parents  will be  assured  that participation  is  voluntary  and  that  non-participation  will 
not  result  in  any  consequences  to them.  In  addition,  they  will  be  informed  that  
they  may  withdraw  from  the  study  at  any  time without  consequences.  Finally,  
youth  and  parents  are  informed  that  the  data  are  used exclusively  for  research  
purposes,  that  identifying  data  will not  be  released  by  the investigators  to  their  
families  or to  any  other individual or  organization,  and  that  any identifying  
information  will  be destroyed  at the  end  of  the project.  In  soliciting  the cooperation  
of each  adolescent  in  our study,  we  will stress  the  data  safeguards  that  will be 
taken  to  protect  the confidentiality  of  the survey  and  other  data.  Minimizing  the  
risk  of disclosure  requires  careful  data safeguards.  Most  important  is  the  need  to  
prevent  the association  of an  individual’s  name  with  sensitive  information.  We  will  
keep  participants’ names  separate  from  their  survey  responses  and  other  data  
and  store  the  link  between names  and  study  identification  numbers  in  a  
password-protected  file  that  is  accessible  only to  authorized  staff at  the  respective  
clinical sites.  Consent  and  assent  will be  documented via signature  on  electronic 
copy  consent  and  assent  forms.  Parents  and  participants  will be provided  a  copy  
of  the  consent/assent  documents.  Date of  consent/assent  will  be documented  in  
the  study  data  management  system. 
Protections against Risk  
All  institutions  associated  with  this  study  are  experienced  with  handling sensitive  
and confidential data.  Routine  administrative,  personnel,  physical security,  
information management,  and  computer system  or network  security  practices  are  
always  in  place given  the  policies  and  the requirements  for  safeguards  
consistent  with  the  management of  PHI  at  both  clinical  sites.  All PHI  will be  
used  or  disclosed  in  compliance  with  the  Health Insurance  Portability  and  
Accountability  Act  (HIPAA).  Forms  will  be  kept  in password protected files when  
not  in  use.  Subjects  will  be  assigned  identification  numbers  in  lieu  of  names  on  
data management  and  data analysis  files.  A  master list  of identification  numbers  
and  names will be  kept  separate  from  all data base  files  and  will be  maintained  
in  a password protected  file  that  is  accessible  only  to  authorized  staff at  the  
respective  clinical sites. Upon  completion  of  the  study,  these  files  will  be  

 
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destroyed.  No  individual  PHI  will  be  used in  reports  or  manuscripts.  Data  
entered  and  stored  on  the  microcomputer  will  be  archived daily.  The  data 
collectors  will follow  a  strict  written  protocol  that  describes  study measures  for 
protecting  data privacy.  Patients  and  parents  always  have  the  right  to  refuse to  
participate  or  to  refuse  to  answer any  individual question  they  might  find 
objectionable.   Raw  data  will be  cleaned  and  edited  prior to  data  entry,  and  
again once data are  entered.  Databases  will not  contain  any  identifying  
information.  We  will  develop a master database  of  the  data collection  for all 
participants.   
The  physical  risks  to  adolescents  in  this  study  are  the  same  as  those  that  
would  occur as  a result  of routine  nutrition  care;  however,  any  adverse  changes  
in  glycemic  control  as  a result  of  dietary  intervention  will be  reported  to  CCHMC  
and  UNC  providers  and  medical staff  who  will  evaluate  these  cases  individually.  
Study  personnel  will  be  trained  to  identify the  signs  and  symptoms  of a blood  
glucose  level  that  is  low  or  high.  They  will also  be trained  to  check  the  blood  
glucose  level if necessary,  using  a glucometer.  Any  youth experiencing 
hypo/hyperglycemia  or  an  otherwise  potentially  expected  symptom  related to  
diabetes  will  be encouraged  by  study  personnel  to  consult  their  diabetes  care  
provider or  to  go  to  the  emergency  room  immediately  as  needed.  Local  medical  
policies  and procedures  for  handling  adverse  events  in  clinic  will  be  followed.   If  
participants experience  hypoglycemia  or  hyperglycemia outside  of study  visits,  
they  will  be  advised  to treat  these situations  per  their  usual  diabetes  care  plan.   
Participants  will  receive  the results  for study  HbA1c  and  CGM  measurements 
after the study. Their  providers  will  also  receive  these results.   Participants  and  
their parents  will be  encouraged  to  discuss  their results  with their  providers.    
The interventionists (Registered Dietitians) and study physicians will communicate 
regularly (verbally and in writing per protocol) regarding glucose control so that any 
changes in medical management can be made in a timely fashion, as it is understood 
that with changes in dietary patterns, adjustments in medical management for 
glycemic control may be needed.   
At each study visit and RD check-in call, hypoglycemia events will be reviewed with 
the participant. Participants will be asked to notify the study team within 48 hours of 
any severe hypoglycemic event (seizure, coma, or need for glucagon administration).   
Psychological and  social risks  are  expected  to  be  minimal  as  previously  
discussed.   We  will briefly  query  use  of illegal  behaviors  including  recreational  
drug  and  alcohol use  as  these may impact  on  adherence  and  priorities  for  
problem  solving  as  relates  to  diabetes  self management.  If  participants  reveal  
information  that  indicates  that  he  or  she  is  a risk  to self or  others,  research  staff 
will  follow  local clinic  site  procedures,  including  mandated reporting.  Participants  
will  be  informed,  as  part  of  the  informed  consent  process, regarding  the  
limitations  of  confidentiality. 
Vulnerable  Subjects  

 
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Children  ages  12-17  at enrollment are included  in  this  study  as  we  are  
specifically examining  the impact  of  structured  eating  on  adolescents  with  Type  1  
diabetes. We anticipate  this  research  does  not  involve greater  than  minimal  risk  
given  that  the participant  will  maintain  usual diabetes  care  and  suggested  
changes  made to  the participant’s  eating  pattern  will be  individualized.  Changes  
in  eating  will  be  monitored  by the  study  registered  dietitians,  pediatric  
endocrinologists,  and  investigators.  As  described earlier,  adequate  provisions  will 
be  put  in  place  to  ensure  both  parent  and  child  are allowed  to  provide  consent  
and  assent  respectively. 
 

 
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13. Risk/Benefit Analysis 
 
Potential Benefits of the Proposed Research to Human Subjects and Others  
The proposed research may lead to potential benefits for individuals with diabetes, 
including improved glycemic control, and thus reduced risk of both short- and long-
term complications. The risks to participants are reasonable in relation to the 
anticipated benefits to participants and others because: the risks are judged to be 
minimal and unlikely; safeguards against these risks are in place, and the potential 
benefits are important, both to individuals who participate in the study and to the 
broader population of individuals with T1D. 
Importance of the Knowledge to be Gained  
This  study  should  yield  new  information  contributing to  the  self-management  of  
diabetes  and the  use  of  structured  eating  combined  with  behavioral strategies  to  
manage  glycemic  variation. This  knowledge  may  lead  to  better  care for  
adolescents  with  diabetes.  The development  of  a feasible  and  effective  novel  
intervention  for  adolescents  far  outweighs  potential risk  of  harm. We  anticipate  
the  risk  associated  with  these  dietary  and  behavioral  changes  does  not  involve 
greater  than  the risk associated with routing diabetes care,  while  potential for impact  
on  improved  glycemic  control for youth with  diabetes  has  potential  long-term  
implications  for  current  and  future  health  of youth  with diabetes. 
Single  IRB  Plan  
We plan  to  comply  with  the  sIRB  plan  by  obtaining consent  from  UNC’s 
Institutional  Review  Board. University  of Cincinnati  and  Cincinnati Children’s  
Hospital and  Medical Center  will rely  on  UNC’s approval  with  sites  signing  an  
authorization/reliance  agreement  that  will  clarify  the  role  and responsibilities  of  
the  sIRB  and  the  relying sites.  Communication  between  the  OH site  and  the  
UNC  IRB will be  facilitated  by  the  UNC  study  project  manager,  Joan  Thomas.  
UNC  Department  of  Nutrition  and the  UNC  IRB  will  maintain  the  records  for the  
authorization/reliance  agreements  along  with documentation  of  the  associated  
communication  plan.    
 

 
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14.  Data Safety & Monitoring:   
 
Data Safety and Monitoring Plan 
To ensure timely completion of the study, MPIs Mayer-Davis and Couch, study  
endocrinologists  (Shah  and  Jain) and program manager (Angelica Cristello Sarteau), 
will constitute the study Executive Committee that will meet weekly during the first six 
months and bi-weekly thereafter to oversee progress, participant well-being, data quality 
and completion, and problem-solve as needed. A 3-member DSMB will be convened to 
meet three times over the course of the study via video conference call.  These meetings 
will be held prior to the start of the study, mid-way through the study, and at the end of 
the study. DSMB members represent expertise in endocrinology, nutrition, and study 
design and statistical analysis. Prior to the start of the study, the DSMB will review and 
approve the final study protocol and any significant changes to the protocol over the 
course of the study especially as related to participant burden or safety. Midway through 
the study, the DSMB will meet to monitor and advise on study participant accrual and 
retention, progress and completeness for all standardized measurement visits and 
attendance at intervention sessions.  Data quality will be reviewed and staff training and 
certification will be monitored. Adverse events will be monitored. A summary of the DSMB 
report will be sent to both the local site IRBs and NIDDK as part of the annual progress 
reports.  
Members of the DSMB have been identified by area of scientific expertise (all with 
relevant expertise applied to T1D), are non-conflicted, and have agreed to serve:    
• 
Pediatric Endocrinology:   Ingrid Libman, MD, PhD, MPH Associate Professor of 
Pediatrics and Epidemiology, Director, Diabetes Program, UPMC Children's 
Hospital of Pittsburgh 
• 
Nutrition: Abigail Peairs, PhD, Associate Professor,  Department of 
Rehabilitation, Exercise and Nutrition Sciences, University of Cincinnati 
• 
Study Design and Statistical Analysis: Baiming Zou, PhD, Gillings School of 
Global Public Health, University of North Carolina, Chapel Hill  
 
 
Data Monitoring  
Questionnaires  will  be  administered  to  participants.  Data will  also  be  obtained  
via CGM,  HbA1c  point  of care  measurement,  and  dietary  recalls.    All  aspects  of  
data collection  and  data  storage  will  be  carefully monitored  to  ensure rapid  
detection  of  errors,  inconsistencies  or  other  problems.  The data  collectors will  
follow  a  strict  written  protocol  that  describes  study  measures  for protecting  data 
privacy.  They  will explain  to  each  participant  that  s/he  has  the  right  to  refuse  to  
participate  or  to  refuse  to  answer  any individual  question  that  s/he  finds  
objectionable,  and  emphasize  the  importance  of  telling the  truth.  All institutions  
associated  with  this  application  are  experienced  in training  data  collection  
fieldwork personnel how  to  handle,  store,  and  process  sensitive  and  confidential 
data.  Certain  routine administrative,  personnel,  physical  security,  information  
management,  and  computer system  or network security  practices  are  always  in  

 
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place.  These  practices  include  building  and  audio-tape  vault  security, non-
disclosure  pledges,  and  account/keyword  security  on  computer  networks.  In  
addition,  we take multiple  project-specific  steps  to  protect  subjects  from  the  risk  
of  a breach  in  confidentiality.  All data will be  collected  using study  identification  
numbers.  Thus,  no  questionnaire  will  contain  identifying information,  and  the  list  
that  links  identification  numbers  to  names  will be  kept  in  a password-protected 
file  that  is  accessible  only  to  authorized  staff  at  the  respective  clinical  sites.  
Only  aggregate  data  that cannot  be  used  to  identify  individuals  will  be  included  
in  any  reports  released  to  other agencies  or for publication.    
 
Adverse Events  
 
The intervention will involve individuals with T1D who are 12-17 years of age. It is 
unlikely that participation in our studies will cause youth to experience an “adverse 
event.” However, trained staff will be conducting the intervention sessions to address 
any potential issues. Any youth experiencing hypo/hyperglycemia or an otherwise 
potentially expected symptom related to diabetes will be encouraged to consult their 
diabetes care provider or to go to the emergency room immediately as needed. 
For purposes of monitoring and reporting adverse events, the following NIH definitions 
will be used:  
Adverse Event (AE): any unanticipated, untoward medical occurrence that may 
present itself during treatment or administration of an intervention, and which may or 
may not have a causal relationship with the treatment. Adverse events could arise 
from the study (e.g., breach of confidentiality) or could arise due to the population 
under study.  
Serious Adverse Event (SAE): Any medical occurrence that results in death; is life-
threatening; requires inpatient hospitalization or prolongation of existing 
hospitalizations; creates persistent or significant disability/incapacity, or a congenital 
anomaly/birth defect.  
 
It  is  highly  unlikely  that  participation  in  the  dietary  intervention  will cause  an  AE  
or SAE.  Should  an  AE occur,  however,  the  research  dietitian  and  study  
coordinator will  immediately  report  any  AE’s connected  to  the implementation  of  
the intervention  to  the study  investigators,  who  will  keep  a  log  of AE’s  and  
SAE’s.  The  log  will  also  be  used  to  provide  information  about  AE’s  in  annual 
progress  reports  to participating  IRBs  and  NIDDK. 
 
Our  team  will  file  a  written  report  to  the  site  IRBs  in  accordance  with  local  
IRB  requirements,  and  to NIDDK.  Outcomes  for  AE’s  will  be  monitored  by  the  
DSMB  and  outcome  information  will  be  entered into  a  log  for  inclusion  in  
reports  to  participating  IRBs  and  NIDDK  as  required. Anticipated  events  relative  
to  the  population  under  study  or  relative  to  the  study  (e.g.,  low  or  high blood  
glucose)  will be  noted  as  potential  risks  on  the  informed  consent  form.  The  
DSMB will  also monitor  the  occurrence of  these events.   Should  any  other 
problems  or concerns  arise  with  the  data collection  or  intervention  program,  the  
PI or local clinical  PI  will  be  available  to  address  these.  In  addition,  resource  

 
Version 4 - July 27 2022 
and  referral  listings  for community  services  will  also  be  provided  on  a routine  
basis  as needed.  Drs.  Mayer-Davis,  Couch,  Jain and  Shah  will  also  work  
extensively  with  the  staff  at  each  of  the  clinics  to  ensure  that  if adolescents 
need  to  be  referred  that these situations  are  managed  in  a  manner  consistent  
with  clinic  preferences/ policies. 
 
 
The following grading scale will be used to adjudicate AE/SAEs.  
 
 
All AEs will be reviewed by the study Data and Safety Monitoring Board to determine if 
an AE is related to the research project. Our team will file a written report to the site 
IRBs in accordance with local IRB requirements. Outcomes for AE’s will be monitored 
by the DSMB and outcome information will be entered into a log for inclusion in reports 
to participating IRBs and NIDDK as required.  
 
Anticipated events relevant to the population under study (e.g., low or high blood 
glucose) will be noted as potential risks on the informed consent form. The DSMB will 
also monitor the occurrence of these events.  The study PIs will also work with the 
staff at each of the clinics to ensure that if participants need to be referred, these 
situations are managed in a manner consistent with clinic preferences/policies.  
 
Should any other problems or concerns arise with the data collection or intervention 
program, the PI or local clinical PI will be available to address these. 
 
 

 
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15.  Privacy & Confidentiality   
In-person recruitment will occur in the diabetes clinics by study personnel. Study visits 
will occur in private settings or on secure videoconference platforms. Unencrypted 
messaging will only occur between study personnel and parents reminding them of 
study sessions, encouraging them to complete questionnaires or other study activities, 
and only if they consent. Encrypted e-mails and text messages will be sent to minors 
to encourage and remind them. 
 
To minimize the risk of loss of confidentiality, all information related to study subjects 
will be confidential and kept in a locked cabinet or in password-protected computer 
files, in compliance with NIH and HIPAA requirements as detailed in NIH Notice OD-
020 issued December 30, 2004.   
 
Each participant will be assigned a unique study identification (ID) number. 
Participants will be identified on all study-related documents only by their study ID 
numbers. The roster containing the unique identifying number and direct participant 
identifiers will be kept in a local password-protected database on a secure network 
drive at the clinical sites. 
 
Almost all data will be entered in REDcap or Qualtrics. Only in rare cases will hard 
copy data collection forms be used, and this data will be entered like the data collected   
electronically within 1 week of collection and the hard copy will be subsequently 
destroyed. Data will be entered onto a secure Web-based data management system. 
Only the study coordinator and relevant research study staff will have access to this 
study database. Secure access will be assured by use of individual login codes and 
password protection. Entered data will be stored securely and accessed in accordance 
with current HIPAA standards, the HCFA’s Internet Security Policy, and other state 
and local requirements.  
 
All data interactions for the study by all users including participants, RDs, clinical staff, 
research staff, and investigators, are web-based communications between the given 
user’s web browser and the web server running the study website and/or data 
management software. All of these web-based communications are configured to use 
the standard HTTPS protocol with 128-bit encryption. This includes online forms 
submitted by participants as they are transferred to the servers at UNC.  
 
For the purposes of tracking recruitment, scheduling, and reminders, basic participant 
information, including first and last name, Study ID, and dates and other pertinent 
information regarding scheduled appointments (reminder calls, etc.) will be kept in a 
password-protected Microsoft Access database stored securely at each clinical site. 
 
As is the case with all behavior intervention utilizing current technology, particularly 
mobile phones, we will explain to participants that transmission of such information is 
not secure.   
 

 
Version 4 - July 27 2022 
All aspects of data collection and data storage will be carefully monitored to ensure 
rapid detection of errors, inconsistencies or other problems. The data collectors will 
follow a strict written protocol that describes study measures for protecting data 
privacy, explain to each participant that s/he has the right to refuse to participate or to 
refuse to answer any individual question that s/he finds objectionable, and emphasize 
the importance of telling the truth. All institutions associated with this study are 
experienced in training data collection fieldwork personnel how to handle, store, and 
process sensitive and confidential data. Certain routine administrative, personnel, 
physical security, information management, and computer system or network security 
practices are always in place. These practices include non-disclosure pledges, and 
account/keyword security on computer networks.   
 
In addition, we take multiple project-specific steps to protect subjects from the risk of a 
breach in confidentiality. All data will be collected using study ID numbers. Thus, no 
questionnaire will contain identifying information, and the roster containing the unique 
identifying number and direct participant identifiers will be kept in a local password-
protected database on a secure network drive at the clinical sites. Finally, only 
aggregate data that cannot be used to identify individuals will be included in any 
reports released to other agencies or for publication. 
 
 
 
 
 

 
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16.  Study Timeline   
 
The study is planned to complete in May 2023.  The timeline is as follows [see detailed table in spreadsheet]: 
 
IRB approval:  March 2021 
Staff training:   April/May 2021 
Participant recruitment:  October 2021 
Intervention:  December 2021 – May 2023 
Analysis, Abstract and Publication preparation:  January – December 2024

 
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Bibliography 
f 
1. 
Effect of intensive diabetes treatment on the development and progression of long-term 
complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and 
Complications Trial. Diabetes Control and Complications Trial Research Group. JPediatr 1994; 125(2): 
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