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NCT06375460NARecruiting

Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

University of Pittsburgh

Start Date

9/20/2026

Completion Date

8/1/2029

Summary

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

Detailed Description

The objective of REFLECT2D (Real-time Engagement For Learning to Effectively Control Type 2 Diabetes) is to evaluate whether pairing real-time glycemic and health behavior data leads to improved glycemic control among adolescents and young adults with type 2 diabetes. Participants will use a mobile app that integrates continuous glucose monitor data, Fitbit activity tracker data, and diet logging, with the aim of increasing capability to interpret glycemic data (including impacts of physical activity and dietary intake), providing opportunity to plan and implement behavior change, and increasing motivation to engage in health behaviors. After an initial educational session and run-in period, a 90-day micro-randomized trial (MRT) period will involve once daily randomization of each participant to: 1) physical-activity focused prompt, 2) dietary intake-focused prompt, or 3) no prompt. After the MRT, a 90-day observation period without prompts but with ongoing availability of continuous glucose monitor data, Fitbit, and Healthmine app will examine persistence of glycemic and behavior changes.

Eligibility Criteria

Age Range: 14 years to 26 years

Inclusion Criteria: * type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes * English-speaking (app in English) Exclusion Criteria: * Current pregnancy * Hydroxyurea use (CGM sensor inaccuracies) * Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management * Current or previously diagnosed eating disorder

Interventions

BEHAVIORAL

Focused App Prompt

BEHAVIORAL

No App Prompt

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Conditions

Diabetes Mellitus, Type 2LifestyleHyperglycemiaPhysical Inactivity

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States