NCT06375460 · University of Pittsburgh
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
(REFLECT2D)
What this study is about
The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time.
View original scientific description
The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time.
Interventions
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).
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.
Primary outcome measures
Glucose time above 180mg/dL
Time frame: daily during micro randomized trial, 90 days
measured using continuous glucose monitor
Mean daily glucose
Time frame: daily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
Maximum daily glucose
Time frame: daily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
Minimum daily glucose
Time frame: daily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
Glucose coefficient of variability
Time frame: daily during micro randomized trial, 90 days
measured using continuous glucose monitor
Mean amplitude of glycemic excursions
Time frame: daily during micro randomized trial, 90 days
measured using continuous glucose monitor
Hemoglobin A1c
Time frame: through study completion, 6 months average
lab-based measure to assess longer-term glycemic control, collected at study visit
Fasting glucose
Time frame: through study completion, 6 months average
lab-based measure to assess glycemic control, collected at study visit
Objective physical activity (step count)
Time frame: daily during micro randomized trial, 90 days;
step count measured using the Fitbit physical activity tracker
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
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
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
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
Healthmine app use
Time frame: during microrandomized trial, observational period
Percent of days with app use, per study period will be determined.
Continuous glucose monitor use use
Time frame: during microrandomized trial, observational period
Defined as percent of days with CGM data available, per study period.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
- 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
Where
- Pittsburgh, Pennsylvania
Collaborators
Dartmouth College, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, San Diego State University, Emory University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations