Actively Recruiting
Game-based Pediatric Diabetes Education
Led by Carnegie Mellon University · Updated on 2025-02-12
80
Participants Needed
1
Research Sites
109 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
The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D). The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.
CONDITIONS
Official 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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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
CONTACT
N
Neha Sudhir
CONTACT
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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