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

NCT ID: NCT06375460

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2029-09-30

Brief 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.

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 a session with a Registered Dietitian and Diabetes Educator who will support participants in forming diet and activity goals, 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. Prompts will include reviews of glycemic trends in the past 24 hours (e.g., periods of hyperglycemia, max glucose) and will ask participants to use visual summaries of activity or diet and glucose to reflect on and revise their behavioral management goals as needed. 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. In addition to daily micro-randomization, participants will be randomized 1:1 at study start to proactive outreach from the study team in the case of 3 or more days of missing data, versus no outreach for missing data.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Focused App Prompt

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

Focused App Prompt

Intervention Type: 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

No app prompt will be sent to the participant

Group Type: EXPERIMENTAL

No App Prompt

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Outreach for Missing Data

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth College

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Mary Ellen Vajravelu, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Ellen Vajravelu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Mary Ellen Vajravelu, MD

Role: CONTACT

vajravelume@upmc.edu

412-692-6533

Margaret Zupa, MD

Role: CONTACT

zupamf@upmc.edu

Other Identifiers

1R01DK137803-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY24020141

Identifier Type: -

Identifier Source: org_study_id