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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Mary Ellen Vajravelu, MD, MSHP contact

4126926533

maryellen.vajravelu@pitt.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT07270016
Study groupRoleWhat they receive
Single-arm pilot studyExperimentalParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. Mean CGM glucose

    Mean glucose obtained from study-provided CGM

    Measured: 30-day CGM wear period

  4. Step count

    Step count data will be obtained via study-provided Fitbit.

    Measured: 30-day Fitbit wear period

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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

  11. Glucose time below range

    Percent of time with CGM glucose less than 70 mg/dL

    Measured: 30-day CGM wear period

  12. Glucose time in range

    Percent of time with CGM glucose 70-180 mg/dL

    Measured: 30-day CGM wear period

  13. Glucose time above range

    Percent of time with CGM glucose above 180 mg/dL

    Measured: 30-day CGM wear period

  14. 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.

  1. First posted8 Dec 2025
  2. Study start16 Feb 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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

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.

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