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NCT05147324

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

Completed NA Results posted Last updated 23 April 2024
What this trial tests

NA trial testing "MyPlan" - Individualized Planned Eating Pattern in Type 1 Diabetes in 52 participants. Completed in 24 April 2023.

Timeline
13 December 2021
Primary endpoint
24 April 2023
24 April 2023

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment52
Start date13 December 2021
Primary completion24 April 2023
Estimated completion24 April 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

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.

GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern40.6± 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.

GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern41.7± 2.4
Adherence to Each Eating Behavior Goal Primary · 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
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern92.5
Goal 2 Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern30.0
Goal 3 Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern87.5
Goal 4 Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern75.0
Goal 5 Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern92.5
Goal 1 Weekend
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern81.6
Goal 2 Weekend
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern36.8
Goal 3 Weekend
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern86.8
Adherence to 0-5 Eating Behavior Goals Primary · 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
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern0.0
Adherent to 1 Goal Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern0.0
Adherent to 2 Goals Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern7.5
Adherent to 3 Goals Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern25.0
Adherent to 4 Goals Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern50.0
Adherent to 5 Goals Weekday
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern17.5
Adherent to 0 Goals Weekend
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern0.0
Adherent to 1 Goal Weekend
GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern0.0
Mean Adherence to Overall Eating Behavior Pattern Primary · 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
GroupValue95% CI
"MyPlan" - Individualized Eating Pattern3.8± 0.83
Number of Goals - Weekend
GroupValue95% CI
"MyPlan" - Individualized Eating Pattern4.0± 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).

GroupValue95% CI
"MyPlan" - Individualized Eating Pattern7.8± 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.

GroupValue95% CI
"MyPlan" - Individualized Planned Eating Pattern86.4
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).

GroupValue95% CI
"MyPlan" - Individualized Eating Pattern7.8± 2.3
Acceptability Percentage (Guardian) Primary · Week 26

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.

GroupValue95% CI
"MyPlan" - Individualized Eating Pattern93.2
Change in Hemoglobin A1c Percentage Secondary · Baseline (Week 0) and Endline (Week 26)

Change in point-of-care hemoglobin A1c (HbA1c) percentage.

GroupValue95% 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):

  1. Applications and prospects of biomaterials in diabetes management.
    Guan W, Zhang L. · · 2025 · PMID 40124248 · DOI 10.3389/fbioe.2025.1547343

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing