Pilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes (REFLECT2DPilot)

University of Pittsburgh

Status: Not yet enrolling

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

Treatments: Other: Healthmine app

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07270016

STUDY25100193

1R01DK137803-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single-arm pilot study

Experimental group

Description:

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.

Treatment:

Other: Healthmine app