Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT06375460
- Status
- Not Yet Recruiting
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Conditions
- Diabetes Mellitus, Type 2
- Hyperglycemia
- Lifestyle
- Physical Inactivity
Eligibility Criteria
- Sex
- ALL
- Age
- 14 Years - 26 Years
- Healthy Volunteers
- Not accepted
Interventions
- Focused App Prompt — BEHAVIORALPrompts are designed to develop knowledge and self-efficacy in diabetes-related health behaviors (capability). The paired glycemic and behavior data will provide the opportunity to reflect and to plan diet or exercise for the following day (self-reflective motivation).
- No App Prompt — BEHAVIORALNo app prompts are designed to assess whether health behaviors are affected without being prompted to reflect and change those behaviors related to glycemic control.
Study Details
The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time. The main questions it aims to answer are: * Does using the app help with short-term glycemic control? * Does using the app help with longer-term glycemic control? * Does using the app help increase physical activity? Participants will: * Wear a continuous glucose monitoring device for 6 months * Wear a physical activity tracker for 6 months * Use the study smartphone app for 6 months * Complete 3 in-person study visits with fasting blood draws * Report dietary intake intermittently throughout the study
Key Dates
- First listed
- Apr 19, 2024
- Start date
- Sep 30, 2026
- Status verified
- Sep 2026
- Primary completion
- Jul 31, 2029
- Completion
- Aug 31, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Physical Activity Focused App PromptThe app prompts will ask participants what went well, or did not go well with their physical activity in the previous 24 hours in relation to their blood glucose numbers.
- Experimental: Diet Focused App PromptThe app prompts will ask participants what went well, or did not go well with their diet in the previous 24 hours in relation to their blood glucose numbers.
- Experimental: No App PromptNo app prompt will be sent to the participant
Primary Outcome Measure
Glucose time above 180mg/dL [ Time Frame: daily during micro randomized trial, 90 days ]
Central Contacts
- Mary Ellen Vajravelu, MD412-692-6533
- Margaret Zupa, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 |
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