"MyPlan" - Individualized Eating Pattern for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 1 Diabetes"MyPlan" - Individualized Eating Pattern - Behavioral
Eligibility
12 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing an individualized eating strategy to improve glycemic management in youth with type 1 diabetes. Participants will be assessed for acceptability and adherence to the plan, and changes in glycemic levels will be compared to baseline. The goal is to inform the design of a future randomized clinical trial.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Week 26

Week 26
Change in hemoglobin A1c percentage
Change in percent time in range
Week 26
Guardian composite acceptability score
Mean adherence to each of the personalized eating behavior goals
Mean adherence to personalized eating behavior pattern
Mean number of personalized eating behavior goals adhered to by participants
Percentage of time participant adhered to each personalized eating behavior goal
Youth composite acceptability score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

"MyPlan" - Individualized Structured Eating Plan
1 of 2
"MyPlan" - Individualized Eating Pattern
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: "MyPlan" - Individualized Eating Pattern · No Placebo Group · N/A

"MyPlan" - Individualized Structured Eating Plan
Behavioral
Experimental Group · 1 Intervention: "MyPlan" - Individualized Structured Eating Plan · Intervention Types: Behavioral
"MyPlan" - Individualized Eating Pattern
Behavioral
Experimental Group · 1 Intervention: "MyPlan" - Individualized Eating Pattern · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 26

Who is running the clinical trial?

University of CincinnatiOTHER
389 Previous Clinical Trials
635,689 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,371 Previous Clinical Trials
3,930,634 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,149 Previous Clinical Trials
4,074,759 Total Patients Enrolled
Elizabeth J Mayer-Davis, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Sarah Couch, PhDPrincipal InvestigatorUniversity of Cincinnati

Eligibility Criteria

Age 12 - 17 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of type 1 diabetes for at least one year.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of North Carolina at Chapel Hill100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References