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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-24
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

Qualifiers

type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes

HbA1c ≥7.0%, stable medication use

HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use

English-speaking (app in English)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Focused App Prompt
  • No App Prompt
  • Outreach for Missing Data

Treatment groups

100 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Pittsburgh

Lead sponsor

Dartmouth College

Collaborator

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

Collaborator

University of Michigan

Collaborator

San Diego State University

Collaborator

Emory University

Collaborator