Diabetes Mellitus, Type 2REFLECT2DNCT06375460
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
A study testing Focused App Prompt and No App Prompt in people with Diabetes Mellitus, Type 2 and Lifestyle, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 26 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Lifestyle, Hyperglycemia
- What is being tested?
- Focused App Prompt and No App Prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
- English-speaking (app in English)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Margaret Zupa, MD contact
United States1 site, 1 recruiting
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Mary Ellen Vajravelu, MD, MSHP, 412-692-6533, vajravelume@upmc.edu
Nyesha Rainey, BS, 412-692-8418, raineyns@upmc.edu
About this study
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:
- Does using the app help with short-term glycemic control?
- Does using the app help with longer-term glycemic control?
- Does using the app help increase physical activity?
Read more
Participants will:
- Wear a continuous glucose monitoring device for 6 months
- Wear a physical activity tracker for 6 months
- Use the study smartphone app for 6 months
- Complete 3 in-person study visits with fasting blood draws
- Report dietary intake intermittently throughout the study
Read the 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 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.
- Being tested
- Focused App Prompt, No App Prompt
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused App PromptBehavioural
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 PromptBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Focused App Prompt | Experimental | 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. Receives: Behavioral: Focused App Prompt |
| Diet Focused App Prompt | Experimental | 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. Receives: Behavioral: Focused App Prompt |
| No App Prompt | Experimental | No app prompt will be sent to the participant Receives: Behavioral: No App Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose time above 180mg/dL
measured using continuous glucose monitor
Measured: daily during micro randomized trial, 90 days
Mean daily glucose
measured using continuous glucose monitor; mg/dL
Measured: daily during micro randomized trial, 90 days
Maximum daily glucose
measured using continuous glucose monitor; mg/dL
Measured: daily during micro randomized trial, 90 days
Minimum daily glucose
measured using continuous glucose monitor; mg/dL
Measured: daily during micro randomized trial, 90 days
Glucose coefficient of variability
measured using continuous glucose monitor
Measured: daily during micro randomized trial, 90 days
Mean amplitude of glycemic excursions
measured using continuous glucose monitor
Measured: daily during micro randomized trial, 90 days
Hemoglobin A1c
lab-based measure to assess longer-term glycemic control, collected at study visit
Measured: through study completion, 6 months average
Fasting glucose
lab-based measure to assess glycemic control, collected at study visit
Measured: through study completion, 6 months average
Objective physical activity (step count)
step count measured using the Fitbit physical activity tracker
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, 6 months average
Healthmine app use
Percent of days with app use, per study period will be determined.
Measured: during microrandomized trial, observational period
Continuous glucose monitor use use
Defined as percent of days with CGM data available, per study period.
Measured: 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.
Measured: through study completion, 6 months average
Secondary outcomes (2)
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m^2
Measured: 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.
Measured: through study completion; 6 months average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start20 Sep 2026
- Primary completionJul 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, San Diego State University, Emory University
- Responsible party
- Principal investigator, Mary Ellen Vajravelu, MD, University of Pittsburgh
- Investigators
- Mary Ellen Vajravelu, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375460
- Sponsor's protocol ID
- STUDY24020141
- Other IDs
- 1R01DK137803-01A1
- Acronym
- REFLECT2D
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06375460
- Acronym / sponsor ID
- REFLECT2D / STUDY24020141
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Dartmouth College, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, San Diego State University, Emory University
- Study start
- 20 Sep 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does using the app help with short-term glycemic control?
- Does using the app help with longer-term glycemic control?
- Does using the app help increase physical activity?
Participants will:
- Wear a continuous glucose monitoring device for 6 months
- Wear a physical activity tracker for 6 months
- Use the study smartphone app for 6 months
- Complete 3 in-person study visits with fasting blood draws
- Report dietary intake intermittently throughout the study
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Focused App Prompt | Experimental | Behavioral: Focused App PromptThe 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. |
| Diet Focused App Prompt | Experimental | Behavioral: Focused App PromptThe 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. |
| No App Prompt | Experimental | Behavioral: No App PromptNo app prompt will be sent to the participant |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
- English-speaking (app in English)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused App PromptPrompts 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). | Behavioural | Diet Focused App Prompt, Physical Activity Focused App Prompt |
| No App PromptNo app prompts are designed to assess whether health behaviors are affected without being prompted to reflect and change those behaviors related to glycemic control. | Behavioural | No App Prompt |
Primary outcome
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.
2 secondary outcomes
Body Mass Index (BMI)
Time frame: through study completion, 6 months average
Diabetes distress
Time frame: through study completion; 6 months average
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret Zupa, MD contact
Mary Ellen Vajravelu, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused App Prompt and No App Prompt in people with Diabetes Mellitus, Type 2 and Lifestyle, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Ellen Vajravelu, MD (412-692-6533, vajravelume@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose time above 180mg/dL (time frame: daily during micro randomized trial, 90 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.