Pilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes

NCT07270016 | Recruiting

• 2 other identifiers: STUDY251001931R01DK137803-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Hyperglycemia; Physical Inactivity; Diabetes Mellitus, Type 2; Lifestyle (Sedentary Behavior and Physical Activity); Continuous Glucose Monitoring

Keywords

adolescent; young adult; type 2 diabetes; CGM

Outcome Measures

Primary Outcomes (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.

  15 days and 30 days after starting study-provided CGM and Healthmine app use

Secondary Outcomes (14)

• Days with CGM data

  30-day CGM wear period

• Days with Fitbit data

  30-day Fitbit wear period

• Mean CGM glucose

  30-day CGM wear period

• Step count

  30-day Fitbit wear period

• Diabetes Self-Management

  Baseline and 30 days (change from baseline to 30 days)

Study Arms (1)

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.

Other: Healthmine app

Interventions

Healthmine app OTHER

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.

Single-arm pilot study

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Michigan: collaborator
• Dartmouth College: collaborator
• University of Pittsburgh: lead
• San Diego State University: collaborator
• Emory University: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Mary Ellen Vajravelu, MD, MSHP

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Ellen Vajravelu, MD, MSHP

CONTACT

4126926533; maryellen.vajravelu@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)