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

Summary

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.

Conditions

• Diabetes Mellitus, Type 2
• Lifestyle
• Hyperglycemia
• Physical Inactivity

Interventions

BEHAVIORAL

Focused App Prompt

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).

BEHAVIORAL

No App Prompt

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.

BEHAVIORAL

Outreach for Missing Data

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.

Sponsors & Collaborators

• Dartmouth College

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Michigan

  collaborator OTHER

• San Diego State University

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Mary Ellen Vajravelu, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2029-07-31

Completion

2029-08-31

Countries

• United States

Study Locations