NCT06264258 Game-based Pediatric Diabetes Education
| NCT ID | NCT06264258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carnegie Mellon University |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-05-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06264258 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06264258 currently recruiting?
Yes, NCT06264258 is actively recruiting participants. Contact the research team at rpadman@andrew.cmu.edu for enrollment information.
Where is the NCT06264258 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06264258 clinical trial?
NCT06264258 is sponsored by Carnegie Mellon University. The trial plans to enroll 80 participants.
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