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

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

Recruiting
14-26 years
All
Phase N/A

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Overview

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

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

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

Study details
    Diabetes Mellitus
    Type 2
    Lifestyle
    Hyperglycemia
    Physical Inactivity

NCT06375460

University of Pittsburgh

21 October 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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