Diabetes Mellitus, Type 2REFLECT2DPilotNCT07270016
Pilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes
A study testing Healthmine app in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this study is to pilot test features of a new smartphone app and to gather feedback related to wearing a continuous glucose monitor (CGM) and a Fitbit device, as well as to obtain input on health behavior-focused messages delivered through the app. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia, Physical Inactivity
- What is being tested?
- Healthmine app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to Dec 2026
- 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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 16-24 years, any sex or gender
- Diagnosis of type 2 diabetes in childhood (younger than 18 years of age)
- English-speaking (app in English)
- Possession of personal smartphone that is compatible with FreeStyle Libre app
Who cannot join
- Cognitive impairment or severe psychiatric conditions that could interfere with participation in behavioral intervention for diabetes self-management
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Mary Ellen Vajravelu, MD, MSHP, 412-692-6533, MaryEllen.Vajravelu@pitt.edu
Ana Diaz, RN, 412-692-6862, amd148@pitt.edu
About this study
Official title: Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes: Pilot Study
The goal of this study is to pilot test features of a new smartphone app and to gather feedback related to wearing a continuous glucose monitor (CGM) and a Fitbit device, as well as to obtain input on health behavior-focused messages delivered through the app. The study will enroll English-speaking participants aged 16-24 years who were diagnosed with type 2 diabetes before age 18. Participants will be asked to fill out surveys about diabetes, physical activity, and diet before and after wearing a CGM for 30 days. At the end of wearing the CGM, participants will complete an interview about their experience.
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia, Physical Inactivity, Lifestyle (Sedentary Behavior and Physical Activity), Continuous Glucose Monitoring
- Being tested
- Healthmine app
- Keywords
- adolescent, young adult, type 2 diabetes, CGM
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthmine appOther
Participants will wear study-provided continuous glucose monitoring device and Fitbit physical activity tracker for 30 consecutive days. During the same period, they will use an investigator-developed smartphone app (Healthmine), which is being developed to pair CGM and Fitbit data. Participants will receive up to one message about health behavior change (e.g., physical activity, nutrition) daily and will be able to use Healthmine to log exercise and dietary intake.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm pilot study | Experimental | Participants will engage in pilot-testing a novel smartphone app supporting health behavior change and wear a continuous glucose monitoring device and Fitbit physical activity tracker for 30 days. Questionnaires and interviews will be used to gather participant experiences with the app and device wear. Receives: Other: Healthmine app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Healthmine app
Assessed via the System Usability Scale (SUS), a 10-item questionnaire measuring perceived usability of a system or technology. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total SUS score is calculated by summing the score contributions from each item (for odd-numbered items, subtract 1 from the user response; for even-numbered items, subtract the user response from 5), multiplying the sum by 2.5, resulting in a score ranging from 0 to 100. Higher scores indicate better perceived usability, with scores above 68 considered above average usability.
Measured: 15 days and 30 days after starting study-provided CGM and Healthmine app use
Secondary outcomes (14)
Days with CGM data
The number of days with continuous glucose monitoring data available will be divided by the total number of requested days of wear (30) to obtain percentage of days with data.
Measured: 30-day CGM wear period
Days with Fitbit data
The number of days with Fitbit data available will be divided by the total number of requested days of wear (30) to obtain percentage of days with data.
Measured: 30-day Fitbit wear period
Mean CGM glucose
Mean glucose obtained from study-provided CGM
Measured: 30-day CGM wear period
Step count
Step count data will be obtained via study-provided Fitbit.
Measured: 30-day Fitbit wear period
Diabetes Self-Management
Assessed via the Diabetes Self-Management Questionnaire (DSMQ), a 16-item self-report questionnaire measuring diabetes self-care activities associated with glycemic control. Each item is rated on a 4-point Likert scale (0 = "does not apply to me" to 3 = "applies to me very much"). Items are summed (after reverse-coding negatively worded items) and transformed to a 0-10 scale, where higher scores indicate better self-management.
Measured: Baseline and 30 days (change from baseline to 30 days)
Treatment Self-Regulation
Assessed via the Treatment Self-Regulation Questionnaire (TSRQ), a questionnaire measuring the degree to which a person's motivation for health behaviors is relatively autonomous (self-determined) versus controlled (motivated by external factors). Items are rated on a 7-point Likert scale (1 = "not at all true" to 7 = "very true"). The TSRQ yields subscale scores for autonomous regulation, controlled regulation, and amotivation, with higher scores on each subscale indicating greater levels of that type of motivation.
Measured: Baseline and 30 days (change from baseline to 30 days)
Self-Reported Physical Activity
Assessed via the PACE+ Physical Activity Measure, a brief self-report questionnaire measuring physical activity levels. Participants report the number of days per week they engage in moderate or vigorous physical activity for at least 30 minutes (or 60 minutes for adolescents). The measure yields separate scores for moderate and vigorous activity (each ranging from 0-7 days per week), with higher scores indicating greater physical activity frequency.
Measured: Baseline and 30 days (change from baseline to 30 days)
Diet Quality
Assessed via the Prime Diet Quality Score (PDQS), a food-based dietary assessment tool that evaluates diet quality across 15 food group components. The PDQS includes 10 adequacy components (dark green leafy vegetables, cruciferous vegetables, carrots, other vegetables, citrus fruits, other fruits, fish/seafood, eggs, whole grains, and low-fat dairy) and 5 moderation components (red meat as main dish, processed meat, refined grains and baked goods, sugar-sweetened beverages, and fried foods). Each component is scored based on consumption frequency, with higher scores indicating greater intake of health-promoting foods and lower intake of foods that should be consumed in moderation. The total PDQS ranges from 0-30, with higher scores indicating better overall diet quality.
Measured: Baseline and 30 days (change from baseline to 30 days)
Glucose monitoring satisfaction
Assessed via the Glucose Monitoring Satisfaction Survey (GMSS) for Type 2 Diabetes, a 15-item questionnaire measuring patient satisfaction with their glucose monitoring device. Items are rated on a 5-point Likert scale (1 = "strongly disagree" to 5 = "strongly agree"). The GMSS yields four subscale scores: Openness (items 1, 8, 10, 14), Emotional Burden (items 2, 5, 9, 13), Behavioral Burden (items 3, 6, 11, 15), and Worthwhileness (items 4, 7 [reverse coded], 12). Subscale scores are calculated as the mean of item responses, with higher scores indicating greater openness, greater burden (for burden subscales), and greater worthwhileness, respectively. A total satisfaction score is calculated as the mean of all items after reverse-coding items 2, 3, 5, 6, 7, 9, 11, 13, and 15, with higher total scores indicating greater overall satisfaction with glucose monitoring.
Measured: 30 days (following CGM wear period)
Glucose coefficient of variation
Based on CGM glucoses, coefficient of variation will be calculated by dividing the standard deviation of glucose readings by the mean glucose level, then multiplying by 100 to get a percentage.
Measured: 30-day CGM wear period
Glucose time below range
Percent of time with CGM glucose less than 70 mg/dL
Measured: 30-day CGM wear period
Glucose time in range
Percent of time with CGM glucose 70-180 mg/dL
Measured: 30-day CGM wear period
Glucose time above range
Percent of time with CGM glucose above 180 mg/dL
Measured: 30-day CGM wear period
Mean amplitude of glycemic excursions
A measure of glucose variability calculated from CGM data, calculated by dividing the standard deviation of glucose readings by the mean glucose level, then multiplying by 100 to get a percentage.
Measured: 30-day CGM wear period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start16 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University, Emory University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Dartmouth College
- Responsible party
- Principal investigator, Mary Ellen Vajravelu, MD, University of Pittsburgh
- Investigators
- Mary Ellen Vajravelu, MD, MSHP, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270016
- Sponsor's protocol ID
- STUDY25100193
- Other IDs
- 1R01DK137803-01A1
- Acronym
- REFLECT2DPilot
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 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: Pilot Study
- ClinicalTrials.gov ID
- NCT07270016
- Acronym / sponsor ID
- REFLECT2DPilot / STUDY25100193
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia, Physical Inactivity, Lifestyle (Sedentary Behavior and Physical Activity), Continuous Glucose Monitoring
- Keywords
- adolescent, young adult, type 2 diabetes, CGM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- San Diego State University, Emory University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Dartmouth College
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (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 study is to pilot test features of a new smartphone app and to gather feedback related to wearing a continuous glucose monitor (CGM) and a Fitbit device, as well as to obtain input on health behavior-focused messages delivered through the app. The study will enroll English-speaking participants aged 16-24 years who were diagnosed with type 2 diabetes before age 18. Participants will be asked to fill out surveys about diabetes, physical activity, and diet before and after wearing a CGM for 30 days. At the end of wearing the CGM, participants will complete an interview about their experience.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm pilot study | Experimental | Other: Healthmine appParticipants will engage in pilot-testing a novel smartphone app supporting health behavior change and wear a continuous glucose monitoring device and Fitbit physical activity tracker for 30 days. Questionnaires and interviews will be used to gather participant experiences with the app and device wear. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Ages 16-24 years, any sex or gender
- Diagnosis of type 2 diabetes in childhood (younger than 18 years of age)
- English-speaking (app in English)
- Possession of personal smartphone that is compatible with FreeStyle Libre app
Key exclusion criteria (1 listed)
- Cognitive impairment or severe psychiatric conditions that could interfere with participation in behavioral intervention for diabetes self-management
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 |
|---|---|---|
| Healthmine appParticipants will wear study-provided continuous glucose monitoring device and Fitbit physical activity tracker for 30 consecutive days. During the same period, they will use an investigator-developed smartphone app (Healthmine), which is being developed to pair CGM and Fitbit data. Participants will receive up to one message about health behavior change (e.g., physical activity, nutrition) daily and will be able to use Healthmine to log exercise and dietary intake. | Other | Single-arm pilot study |
Primary outcome
Usability of Healthmine app
Time frame: 15 days and 30 days after starting study-provided CGM and Healthmine app use
Assessed via the System Usability Scale (SUS), a 10-item questionnaire measuring perceived usability of a system or technology. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total SUS score is calculated by summing the score contributions from each item (for odd-numbered items, subtract 1 from the user response; for even-numbered items, subtract the user response from 5), multiplying the sum by 2.5, resulting in a score ranging from 0 to 100. Higher scores indicate better perceived usability, with scores above 68 considered above average usability.
14 secondary outcomes
Days with CGM data
Time frame: 30-day CGM wear period
Days with Fitbit data
Time frame: 30-day Fitbit wear period
Mean CGM glucose
Time frame: 30-day CGM wear period
Step count
Time frame: 30-day Fitbit wear period
Diabetes Self-Management
Time frame: Baseline and 30 days (change from baseline to 30 days)
Treatment Self-Regulation
Time frame: Baseline and 30 days (change from baseline to 30 days)
Self-Reported Physical Activity
Time frame: Baseline and 30 days (change from baseline to 30 days)
Diet Quality
Time frame: Baseline and 30 days (change from baseline to 30 days)
Glucose monitoring satisfaction
Time frame: 30 days (following CGM wear period)
Glucose coefficient of variation
Time frame: 30-day CGM wear period
Glucose time below range
Time frame: 30-day CGM wear period
Glucose time in range
Time frame: 30-day CGM wear period
Glucose time above range
Time frame: 30-day CGM wear period
Mean amplitude of glycemic excursions
Time frame: 30-day CGM wear period
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 20 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Mary Ellen Vajravelu, MD, MSHP 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 Healthmine app in people with Diabetes Mellitus, Type 2 and Hyperglycemia, 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 4 inclusion and 1 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 20 Feb 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, MSHP (4126926533, maryellen.vajravelu@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of Healthmine app (time frame: 15 days and 30 days after starting study-provided CGM and Healthmine app use). 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 20 Feb 2026.