CompletedNot Applicable

"MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes

United States52 participantsStarted 2021-12-13

Plain-language summary

The purpose of this study is to test the acceptability and effectiveness of an individualized eating strategy as part of diabetes self-management to improve glycemic levels among youth with type 1 diabetes (T1D) and suboptimal glycemic management. Investigators will assess participant acceptability of and adherence to a 6-month individualized eating strategy ("MyPlan") characterized by approximate day-to-day consistency in the frequency and timing of meals and snacks and distribution of carbohydrate throughout the day. Within-individual change in glycemic levels between baseline and 6-months of the study will also be compared. The goal of the study is to inform the design of a future randomized clinical trial to test the addition of the MyPlan eating strategy to ongoing diabetes clinical care among youth with T1D.

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Youth 12-17 years old * History of T1D of at least one year * HbA1c 7.5-11% * Guardian willing to also participate * English as preferred language Exclusion Criteria: * Youth with other metabolic disorders, unstable thyroid disease, diagnosed eating disorders, prohibitively strict dietary restrictions, or those with other serious condition that renders participation inappropriate. * Females who are pregnant, breast feeding, planning to become pregnant during the study period or delivered a baby in the last 12 months. * Unwillingness to follow a personalized eating plan for 6 months or complete MyFitnessPal logs at least 3 days/week throughout the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Time in Range (Baseline)

Timeframe: Baseline (Week 0-2)

Percent Time in Range (Week 22-24)

Timeframe: Week 22-24

Adherence to Each Eating Behavior Goal

Timeframe: Between Week 22 and Week 24

Adherence to 0-5 Eating Behavior Goals

Timeframe: Between Week 22 and Week 24

Mean Adherence to Overall Eating Behavior Pattern

Timeframe: Between Week 22 and Week 24

Mean Acceptability Score (Youth)

Timeframe: Week 26

Acceptability Percentage (Youth)

Timeframe: Week 26

Mean Acceptability Score (Guardian)

Trial details

NCT IDNCT05147324

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-24

Results submitted2024-02-23

View on ClinicalTrials.gov More Type 1 Diabetes trials

Plain-language summary

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent Time in Range (Baseline)

Timeframe: Baseline (Week 0-2)

Percent Time in Range (Week 22-24)

Timeframe: Week 22-24

Adherence to Each Eating Behavior Goal

Timeframe: Between Week 22 and Week 24

Adherence to 0-5 Eating Behavior Goals

Timeframe: Between Week 22 and Week 24

Mean Adherence to Overall Eating Behavior Pattern

Timeframe: Between Week 22 and Week 24

Mean Acceptability Score (Youth)

Timeframe: Week 26

Acceptability Percentage (Youth)

Timeframe: Week 26

Mean Acceptability Score (Guardian)