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NCT Number: NCT06375460

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Lifestyle Metabolic Diseases Nutritional and Metabolic Diseases Physical Inactivity Sedentary Behavior

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focused App Prompt

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

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

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.

Primary outcomes

  1. Glucose time above 180mg/dL

    Time frame: daily during micro randomized trial, 90 days

    measured using continuous glucose monitor

  2. Mean daily glucose

    Time frame: daily during micro randomized trial, 90 days

    measured using continuous glucose monitor; mg/dL

  3. Maximum daily glucose

    Time frame: daily during micro randomized trial, 90 days

    measured using continuous glucose monitor; mg/dL

  4. Minimum daily glucose

    Time frame: daily during micro randomized trial, 90 days

    measured using continuous glucose monitor; mg/dL

  5. Glucose coefficient of variability

    Time frame: daily during micro randomized trial, 90 days

    measured using continuous glucose monitor

  6. Mean amplitude of glycemic excursions

    Time frame: daily during micro randomized trial, 90 days

    measured using continuous glucose monitor

  7. Hemoglobin A1c

    Time frame: through study completion, 6 months average

    lab-based measure to assess longer-term glycemic control, collected at study visit

  8. Fasting glucose

    Time frame: through study completion, 6 months average

    lab-based measure to assess glycemic control, collected at study visit

  9. Objective physical activity (step count)

    Time frame: daily during micro randomized trial, 90 days;

    step count measured using the Fitbit physical activity tracker

  10. Objective physical activity (moderate-vigorous physical activity)

    Time frame: daily during micro randomized trial, 90 days;

    moderate-vigorous physical activity (>100 steps per minute) will be measured using Fitbit activity tracker

  11. Self-reported physical activity

    Time frame: through study completion, 6 months average

    assessed using PACE+ Adolescent Physical Activity Measure (PACE+) questionnaire to determine days with at least 60 minutes of moderate-vigorous physical activity per week. score ranges from 0-14; lower scores indicate less achievement of physical activity guidelines

  12. Diet quality

    Time frame: through study completion, 6 months average

    24-hour dietary recall will be collected by study staff, who will use the Automated Self Administered 24 Hour Dietary Recall Assessment Tool (ASA24) to record data for diet quality assessment

  13. Capability

    Time frame: through study completion, 6 months average

    Assessed via the Diabetes Empowerment Scale (DES), a measure of self-efficacy. Average score ranges from 28-140; higher scores indicate greater diabetes empowerment

  14. Healthmine app use

    Time frame: during microrandomized trial, observational period

    Percent of days with app use, per study period will be determined.

  15. Continuous glucose monitor use use

    Time frame: during microrandomized trial, observational period

    Defined as percent of days with CGM data available, per study period.

  16. Motivation to engage in diabetes self-management

    Time frame: through study completion, 6 months average

    Measured via Treatment Self-Regulation Questionnaire (TSRQ). score ranges from 15-105; scoring is based on and average between subscales of intrinsic vs. extrinsic motivation.

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: through study completion, 6 months average

    weight and height will be combined to report BMI in kg/m^2

  2. Diabetes distress

    Time frame: through study completion; 6 months average

    Measured via Problem Areas in Diabetes Scale (PAID-5). Score ranges from 0-20; a total score of 8 or more indicates possible diabetes related emotional distress.

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret Zupa, MD

CONTACT

[email protected]

Mary Ellen Vajravelu, MD

CONTACT

[email protected]

412-692-6533

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Dartmouth College
  • Emory University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • San Diego State University
  • University of Michigan

Registry information

Acronym: REFLECT2D

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 19, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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