Game-based education for children with Type 1 Diabetes
Evaluating Game-based Pediatric Diabetes Education
This study is testing a fun mobile game for kids with Type 1 Diabetes to see if it helps them make healthier choices and manage their diabetes better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Carnegie Mellon University Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06264258 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™ in promoting healthy behaviors among children aged 6 to 12 with Type 1 Diabetes. Participants will be randomly assigned to either receive the app along with standard care or standard care alone over a 3-month period. The study aims to measure changes in dietary and physical activity behaviors, as well as improvements in diabetes control, through app usage data and lifestyle questionnaires. The trial will involve 80 participants and will track their progress through regular evaluations.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 12 years diagnosed with Type 1 Diabetes for at least one year who are currently managing their condition with insulin.
Not a fit: Patients with Type 2 Diabetes or other forms of diabetes, such as cystic fibrosis-related diabetes, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance diabetes management and improve health outcomes for children with Type 1 Diabetes.
How similar studies have performed: Other studies have shown promise in using digital therapeutics for behavior change in chronic conditions, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
For youth: * 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. For Parent: * 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 Exclusion Criteria: -Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Rema Padman, PhD
- Email: rpadman@andrew.cmu.edu
- Phone: 412-268-2180
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.