Recruiting

CGM & Fitbit

Sponsor:

University of Pittsburgh

Code:

NCT07270016

Conditions

Diabetes Mellitus, Type 2

Hyperglycemia

Physical Inactivity

Lifestyle (Sedentary Behavior and Physical Activity)

Continuous Glucose Monitoring

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Interventions

Healthmine app

Study Details

Brief 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. 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

Study ID

NCT07270016

Start date

Feb 16, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Inclusion criteria:

  • 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

Exclusion Criteria:

• Cognitive impairment or severe psychiatric conditions that could interfere with participation in behavioral intervention for diabetes self-management

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single-arm pilot study

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.

Interventions

Healthmine app

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.

Primary outcome measure

  • Usability of Healthmine app [ Time Frame: 15 days and 30 days after starting study-provided CGM and Healthmine app use ]

Central Contacts and Locations

Central contacts

Mary Ellen Vajravelu, MD, MSHP

4126926533maryellen.vajravelu@pitt.edu

Locations

Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Mary Ellen Vajravelu, MD, MSHP

412-692-6533MaryEllen.Vajravelu@pitt.edu

Ana Diaz, RN

412-692-6862amd148@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • adolescent
  • young adult
  • type 2 diabetes
  • CGM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-20.