N/A
Completed N=52
"MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes
Source: ClinicalTrials.gov NCT05147324 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Percent Time in Range (Baseline) — 40.6 percentage of CGM wear time — p=0.70
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Time in Range (Baseline) |
40.6 | 0.70 |
| PRIMARY Percent Time in Range (Week 22-24) |
41.7 | 0.70 |
| PRIMARY Adherence to Each Eating Behavior Goal |
92.5; 30.0; 87.5; 75.0; 92.5; 81.6 | — |
| PRIMARY Adherence to 0-5 Eating Behavior Goals |
0.0; 0.0; 7.5; 25.0; 50.0; 17.5 | — |
| PRIMARY Mean Adherence to Overall Eating Behavior Pattern |
3.8; 4.0 | — |
| PRIMARY Mean Acceptability Score (Youth) |
7.8 | — |
| PRIMARY Acceptability Percentage (Youth) |
86.4 | — |
| PRIMARY Mean Acceptability Score (Guardian) |
7.8 | — |
| PRIMARY Acceptability Percentage (Guardian) |
93.2 | — |
| SECONDARY Change in Hemoglobin A1c Percentage |
-0.32 | 0.03 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05147324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.