Game-based Pediatric Diabetes Education
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:
🦠 Diabetes Mellitus, Type 1
🦠 Behavior, Health
🗓️ Study Start (Actual)
22 May 2024
🗓️ Primary Completion (Estimated)
31 December 2024
✅ Study Completion (Estimated)
30 June 2025
👥 Enrollment (Estimated)
80
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Pittsburgh, Pennsylvania, United States
Description
- 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.
Ages Eligible for Study:
6 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
12 February 2024
- First Submitted that Met QC Criteria
12 February 2024
- First Posted
16 February 2024
Study Record Updates
- Last Update Submitted that Met QC Criteria
3 June 2024
- Last Update Posted
4 June 2024
- Last Verified
February 2024