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

Eligibility Criteria

Sex
ALL
Age
14 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Focused App Prompt — BEHAVIORAL
    Prompts 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 — BEHAVIORAL
    No 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 Prompt
    The 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 Prompt
    The 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 Prompt
    No 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

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Mary Ellen Vajravelu, MD, MSHP
412-692-6533
Nyesha Rainey, BS
412-692-8418

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