Adults 12 to 17, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Time in Range (Baseline)Primary· Baseline (Week 0-2)
Percentage of time spent in the glycemic range of 70-180 mg/dL between Baseline week 0-2 week of blinded continuous glucose monitor (CGM) wear time.
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
40.6
± 3.1
Percent Time in Range (Week 22-24)Primary· Week 22-24
Percentage of time spent in the glycemic range of 70-180 mg/dL during Week 22-24 of blinded continuous glucose monitor (CGM) wear time.
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
41.7
± 2.4
Adherence to Each Eating Behavior GoalPrimary· Between Week 22 and Week 24
Percentage of participants who adhered to each eating behavior goal assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22-24:
Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks \>2 hours and \<4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (\>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking;
Goal 1 Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
92.5
Goal 2 Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
30.0
Goal 3 Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
87.5
Goal 4 Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
75.0
Goal 5 Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
92.5
Goal 1 Weekend
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
81.6
Goal 2 Weekend
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
36.8
Goal 3 Weekend
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
86.8
Adherence to 0-5 Eating Behavior GoalsPrimary· Between Week 22 and Week 24
Percentage of participants who adhered to 0-5 eating behavior goals assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24.
Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks \>2 hours and \<4 hours apart Goal 3. Carbohydrate gram target ranges at meals (\>15% daily carbohydrate) and snacks Goal 4. No snacking after dinner Goal 5. Meal/snack consumed ≤2 hours of waking
Adherent to 0 Goals Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
0.0
Adherent to 1 Goal Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
0.0
Adherent to 2 Goals Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
7.5
Adherent to 3 Goals Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
25.0
Adherent to 4 Goals Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
50.0
Adherent to 5 Goals Weekday
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
17.5
Adherent to 0 Goals Weekend
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
0.0
Adherent to 1 Goal Weekend
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
0.0
Mean Adherence to Overall Eating Behavior PatternPrimary· Between Week 22 and Week 24
Mean number of eating behavior goals (range: 0-5) adhered to by participants as assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24:
Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks \>2 hours and \<4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (\>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking;
Number of Goals - Weekday
Group
Value
95% CI
"MyPlan" - Individualized Eating Pattern
3.8
± 0.83
Number of Goals - Weekend
Group
Value
95% CI
"MyPlan" - Individualized Eating Pattern
4.0
± 0.80
Mean Acceptability Score (Youth)Primary· Week 26
Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable).
Group
Value
95% CI
"MyPlan" - Individualized Eating Pattern
7.8
± 2.4
Acceptability Percentage (Youth)Primary· Week 26
Percentage of youth with a mean acceptability score (range: 5-20) \<=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score \>10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth.
Group
Value
95% CI
"MyPlan" - Individualized Planned Eating Pattern
86.4
Mean Acceptability Score (Guardian)Primary· Week 26
Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable).
Percentage of guardians with a mean acceptability score (range: 5-20) \<=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score \>10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian.
Group
Value
95% CI
"MyPlan" - Individualized Eating Pattern
93.2
Change in Hemoglobin A1c PercentageSecondary· Baseline (Week 0) and Endline (Week 26)
Change in point-of-care hemoglobin A1c (HbA1c) percentage.
Group
Value
95% CI
"MyPlan" - Individualized Eating Pattern
-0.32
± 0.89
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Other University of North Carolina, Chapel Hill trials
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 23 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05147324.