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
16 Years - 24 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.
  • Outreach for Missing Data — BEHAVIORAL
    For participants randomized to proactive outreach, after 3 or more days of missing CGM data, the study team will reach out to participants by phone and/or text message to troubleshoot and support participants in re-connecting with CGM and apps. For participants randomized to not receive proactive outreach, participants will be instructed to reach out to the study team at their discretion when help is needed related to CGM or app connection.

Study Details

This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 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
  • Experimental: Outreach for Missing Data
    Participants will be randomized to receive proactive outreach by the study team in the case of 3 or more days of missing CGM data, versus no proactive outreach

Primary Outcome Measure

Glucose time above 180mg/dL [ Time Frame: daily during micro randomized trial, 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PittsburghPittsburghPennsylvania15224-

Find similar trials in Pittsburgh, PA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital of Pittsburgh· Pittsburgh, PA

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