Actively Recruiting
Evaluating Game-based Pediatric Diabetes Education Using the DVx-T1D™ App for Children with Type 1 Diabetes
Led by Carnegie Mellon University · Updated on 2025-02-12
80
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
C
Carnegie Mellon University
Lead Sponsor
U
University of Pittsburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D™) on children aged 6 to 12 years with Type 1 Diabetes (T1D). The study explores whether playing this AI-based, cartoon-style game can encourage healthier eating and physical activity habits, potentially improving diabetes control. The trial is designed as a randomized controlled study lasting three months with 80 participants divided into two groups. One group will receive the DVx-T1D™ app on a tablet and be asked to play it for at least 20 minutes daily, alongside their usual care. The other group will continue with standard care without the app. Both groups will keep food, glucose, and activity logs. Data such as clinical measurements and app usage will be collected at baseline, six weeks, and three months to evaluate changes over time. Participants will attend clinic visits for assessments of blood sugar control and insulin use, including HbA1c testing and continuous glucose monitoring. Surveys and logs will track dietary habits, physical activity, and challenges faced during the study. Researchers will analyze changes in glucose levels, food quality, and game playing behavior to understand the app's effects on diabetes management and lifestyle habits over the study period.
CONDITIONS
Brief Title
Game-based Pediatric Diabetes Education
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between the age of 6 to 12 years.
- Have been diagnosed with type 1 diabetes for at least 1 year.
- Be currently taking insulin through multiple daily injections or an insulin pump.
- Check blood sugar with a meter at least 4 times per day or use a continuous glucose monitor.
- Be willing to comply with all study visits and procedures.
- Biological or adopted parent with custody and medical decision making of the patients.
- Living with identified patients.
- Over 18 years old.
- Resident of Allegheny County.
You will not qualify if you...
- Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants are randomized to either receive the DVx-T1D™ app on a tablet or continue standard care without the app. Those in the app group will be asked to play the game for 20 minutes or more daily to support diabetes education. Participants in both groups will maintain food, glucose, and activity logs and continue their usual care.
3 visits (baseline, 6 weeks, and 3 months) with interim contact between visits
Trial Site Locations
Total: 1 location
1
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
R
Rema Padman, PhD
N
Neha Sudhir
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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