Real-time app and wearable sensors to help young people control type 2 diabetes
Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes: Pilot Study
This project will try a smartphone app together with a continuous glucose monitor and a Fitbit for English-speaking 16–24-year-olds diagnosed with type 2 diabetes before age 18 to learn which messages and features help with activity and glucose monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 24 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07270016 on ClinicalTrials.gov |
What this trial studies
This pilot enrolls English-speaking participants aged 16–24 who were diagnosed with type 2 diabetes before age 18 and who own a smartphone compatible with the FreeStyle Libre app. Participants will use a Healthmine smartphone app, wear a continuous glucose monitor (CGM) and a Fitbit for 30 days, and receive health behavior-focused messages through the app. Surveys about diabetes, physical activity, and diet will be completed before and after the 30-day wear period, and a qualitative interview will be conducted at the end to gather feedback on the devices and app features. The goal is to refine app features and message content based on real-world use and participant input.
Who should consider this trial
Good fit: Ideal candidates are English-speaking 16–24-year-olds diagnosed with type 2 diabetes before age 18 who own a smartphone compatible with the FreeStyle Libre app and do not have cognitive or severe psychiatric conditions that would interfere with participation.
Not a fit: People who are outside the age range, non-English speakers, lack a compatible smartphone, have significant cognitive or psychiatric impairments, or are unwilling to wear a CGM or Fitbit are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could improve engagement with self-monitoring and tailor messages that support better activity habits and glucose awareness in young people with early-onset type 2 diabetes.
How similar studies have performed: Mobile health and CGM interventions have shown promise in adults and some adolescents for improving monitoring and engagement, but combining real-time app messaging with CGM and Fitbit specifically for childhood-onset type 2 diabetes is relatively novel and remains lightly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Mary Ellen Vajravelu, MD, MSHP — University of Pittsburgh
- Study coordinator: Mary Ellen Vajravelu, MD, MSHP
- Email: maryellen.vajravelu@pitt.edu
- Phone: 4126926533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.