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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperglycemia; Diabetes Mellitus, Type 2; Lifestyle; Physical Inactivity
• Intervention / Treatment: Behavioral: Focused App Prompt; Behavioral: No App Prompt; Behavioral: Outreach for Missing Data

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Ellen Vajravelu, MD; Phone Number: 412-692-6533; Email: vajravelume@upmc.edu
• Study Contact Backup: Name: Margaret Zupa, MD; Email: zupamf@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).
Experimental: 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.	Behavioral: 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).
Experimental: No App Prompt; No app prompt will be sent to the participant	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.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose time above 180mg/dL	measured using continuous glucose monitor	daily during micro randomized trial, 90 days
Mean daily glucose	measured using continuous glucose monitor; mg/dL	daily during micro randomized trial, 90 days
Maximum daily glucose	measured using continuous glucose monitor; mg/dL	daily during micro randomized trial, 90 days
Minimum daily glucose	measured using continuous glucose monitor; mg/dL	daily during micro randomized trial, 90 days
Glucose coefficient of variability	measured using continuous glucose monitor	daily during micro randomized trial, 90 days
Mean amplitude of glycemic excursions	measured using continuous glucose monitor	daily during micro randomized trial, 90 days
Hemoglobin A1c	lab-based measure to assess longer-term glycemic control, collected at study visit	through study completion, 6 months average
Fasting glucose	lab-based measure to assess glycemic control, collected at study visit	through study completion, 6 months average
Objective physical activity (step count)	step count measured using the Fitbit physical activity tracker	daily during micro randomized trial, 90 days;
Objective physical activity (moderate-vigorous physical activity)	moderate-vigorous physical activity (>100 steps per minute) will be measured using Fitbit activity tracker	daily during micro randomized trial, 90 days;
Self-reported physical activity	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	through study completion, 6 months average
Diet quality	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	through study completion, 6 months average
Capability	Assessed via the Diabetes Empowerment Scale (DES), a measure of self-efficacy. Average score ranges from 28-140; higher scores indicate greater diabetes empowerment	through study completion, 6 months average
Healthmine app use	Percent of days with app use, per study period will be determined.	during microrandomized trial, observational period
Continuous glucose monitor use use	Defined as percent of days with CGM data available, per study period.	during microrandomized trial, observational period
Motivation to engage in diabetes self-management	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.	through study completion, 6 months average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2	through study completion, 6 months average
Diabetes distress	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.	through study completion; 6 months average

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); San Diego State University; University of Michigan; Emory University; Dartmouth College
• Investigators: Principal Investigator: Mary Ellen Vajravelu, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hyperglycemia; Sedentary Behavior
• Other Study ID Numbers: STUDY24020141; 1R01DK137803-01A1 (U.S. NIH Grant/Contract: NIDDK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: proposals should be directed to vajravelume@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No