Real-time Engagement for Learning to Effectively Control Type 2 Diabetes (REFLECT2D)

University of Pittsburgh

Status: Begins enrollment in 1 month

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

Treatments: Behavioral: No App Prompt; Behavioral: Outreach for Missing Data; Behavioral: Focused App Prompt

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06375460

STUDY24020141

1R01DK137803-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Physical Activity Focused App Prompt

Experimental group

Description:

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.

Treatment:

Behavioral: Focused App Prompt

Diet Focused App Prompt

Experimental group

Description:

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.

Treatment:

Behavioral: Focused App Prompt

No App Prompt

Experimental group

Description:

No app prompt will be sent to the participant

Treatment:

Behavioral: No App Prompt

Outreach for Missing Data

Experimental group

Description:

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

Treatment:

Behavioral: Outreach for Missing Data