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

NCT ID: NCT07270016

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Healthmine app

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Dartmouth College

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Mary Ellen Vajravelu, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Ellen Vajravelu, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Mary Ellen Vajravelu, MD, MSHP

Role: CONTACT

4126926533

Facility Contacts

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Mary Ellen Vajravelu, MD, MSHP

Role: primary

412-692-6533

Ana Diaz, RN

Role: backup

412-692-6862

Other Identifiers

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1R01DK137803-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY25100193

Identifier Type: -

Identifier Source: org_study_id

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