Real-time Engagement for Learning to Effectively Control Type 2 Diabetes (REFLECT2D)
This study, called REFLECT2D, is looking at how a smartphone app can help young people (ages 16-24) with type 2 diabetes manage their blood sugar better. The app uses information from a continuous glucose monitor (CGM), which tracks blood sugar, and a Fitbit, which tracks activity. Participants will use the app to see their blood sugar trends and activity, and get prompts to help them make choices about their diet and exercise. Researchers want to see if these app prompts (called "Focused App Prompt") lead to better blood sugar control compared to not getting prompts ("No App Prompt"). The study will measure success by looking at how much time blood sugar is above 180mg/dL, and daily average and maximum blood sugar levels over 90 days. The study status is currently unclear.
- Study design
- This is an interventional study with a planned enrollment of 100 participants. It includes a 90-day micro-randomized trial where participants will be randomly assigned daily to receive different types of app prompts or no prompts.
- What's involved
- You would use a continuous glucose monitor (CGM), a Fitbit activity tracker, and a research app (Healthmine) for a 90-day micro-randomized trial period, followed by a 90-day observational period. There will also be a session with a Registered Dietitian and Diabetes Educator.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be observed for 90 days after the micro-randomized trial period for ongoing use of the Healthmine app and engagement with CGM.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mary Ellen Vajravelu, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Glucose time above 180mg/dLdaily during micro randomized trial, 90 days
measured using continuous glucose monitor
- Mean daily glucosedaily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
- Maximum daily glucosedaily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
- Minimum daily glucosedaily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
- Glucose coefficient of variabilitydaily during micro randomized trial, 90 days
measured using continuous glucose monitor
- Mean amplitude of glycemic excursionsdaily during micro randomized trial, 90 days
measured using continuous glucose monitor
- Hemoglobin A1cthrough study completion, 6 months average
lab-based measure to assess longer-term glycemic control, collected at study visit
- Fasting glucosethrough study completion, 6 months average
lab-based measure to assess glycemic control, collected at study visit
- Objective physical activity (step count)daily during micro randomized trial, 90 days;
step count measured using the Fitbit physical activity tracker
- Objective physical activity (moderate-vigorous physical activity)daily during micro randomized trial, 90 days;
moderate-vigorous physical activity (\>100 steps per minute) will be measured using Fitbit activity tracker
- Self-reported physical activitythrough 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
- Diet qualitythrough 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
- Capabilitythrough 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
- Healthmine app useduring microrandomized trial, observational period
Percent of days with app use, per study period will be determined.
- Continuous glucose monitor use useduring microrandomized trial, observational period
Defined as percent of days with CGM data available, per study period.
- Motivation to engage in diabetes self-managementthrough 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.