NCT06264258

Game-based Pediatric Diabetes Education

Evaluating Game-based Pediatric Diabetes Education

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Carnegie Mellon University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

Youth with T1D who comply with inclusion criteria and provide consent will be randomized to either the treatment arm (will be given a tablet with the game) or the control arm (no tablet will be given, no exposure to the game). Participants in both arms will continue receiving standard of care treatment. Participants will be asked to maintain food and activity logs and answer questionnaires about lifestyle. Participants will be evaluated at baseline and at 3 months with interim contact in between. Devices will be downloaded to collect app usage data (game telemetry). Exposure time will be tracked by the application. Survey to elicit barriers and challenges encountered during the study will also be conducted.

Conditions

• Diabetes Mellitus, Type 1
• Behavior, Health

Interventions

Type	Name	Description
BEHAVIORAL	DVx-T1D™ app	The intervention group will be introduced to the DVx-T1D™ app and the participants will go home with the tablets that has the game installed. Participants will be asked to play the game for 20 mins or more daily. The aim of the app is to impart good behavioral changes in children with T1D in terms of diabetes education, on how to treat a low or a high blood sugar event and make healthy eating choices.

Timeline

• Start date: 2024-05-22
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-02-16
• Last updated: 2025-02-12

Locations

1 site across 1 country: United States