An interventional study of Focused App Prompt and No App Prompt in Diabetes Mellitus, Type 2, Lifestyle and Hyperglycemia, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 14 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
Among 23 studies in Diabetes Mellitus, Type 2 by University of Pittsburgh — 3 open to participants now, 7 under way, none of them phase 3. Diabetes Mellitus, Type 2 · University of Pittsburgh.
Among the 23 studies in Diabetes Mellitus, Type 2 by University of Pittsburgh, this one is the 8th largest by planned enrollment of the 20 interventional ones, is one of 3 that started in 2026, is one of 18 with no phase, and was the 20th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →3 of the 23 studies in Diabetes Mellitus, Type 2 by University of Pittsburgh are open now, in 1 country. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 14 Years to 26 Years · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2026.
Median enrollment 60 across the 20 interventional studies, 58 across the 3 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
3 of the studies in Diabetes Mellitus, Type 2 by University of Pittsburgh that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07270016University of PittsburghPilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes | 2026-12 |
| NCT06740435University of PittsburghEnhancing Telemedicine for T2D | 2027-01-30 |
| NCT05227105University of PittsburghPA Moves Trial - Patient Participants | 2027-08 |
Among the 23 studies in Diabetes Mellitus, Type 2 by University of Pittsburgh, from their registry updates:
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. The main questions it aims to answer are:
Participants will:
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 an initial educational session and run-in period, 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. 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
No app prompt will be sent to the participant
Behavioral: No 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).
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.
Glucose time above 180mg/dL
measured using continuous glucose monitor
Time frame: daily during micro randomized trial, 90 days
Mean daily glucose
measured using continuous glucose monitor; mg/dL
Time frame: daily during micro randomized trial, 90 days
Maximum daily glucose
measured using continuous glucose monitor; mg/dL
Time frame: daily during micro randomized trial, 90 days
Minimum daily glucose
measured using continuous glucose monitor; mg/dL
Time frame: daily during micro randomized trial, 90 days
Glucose coefficient of variability
measured using continuous glucose monitor
Time frame: daily during micro randomized trial, 90 days
Mean amplitude of glycemic excursions
measured using continuous glucose monitor
Time frame: daily during micro randomized trial, 90 days
Hemoglobin A1c
lab-based measure to assess longer-term glycemic control, collected at study visit
Time frame: through study completion, 6 months average
Fasting glucose
lab-based measure to assess glycemic control, collected at study visit
Time frame: through study completion, 6 months average
Objective physical activity (step count)
step count measured using the Fitbit physical activity tracker
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, 6 months average
Healthmine app use
Percent of days with app use, per study period will be determined.
Time frame: during microrandomized trial, observational period
Continuous glucose monitor use use
Defined as percent of days with CGM data available, per study period.
Time frame: 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.
Time frame: through study completion, 6 months average
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m\^2
Time frame: 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.
Time frame: through study completion; 6 months average
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 3 months and ending 5 years following article publication
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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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