Game-based Pediatric Diabetes Education

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorCarnegie Mellon University

About this trial

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

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • DVx-T1D™ app

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Carnegie Mellon University

Lead sponsor

University of Pittsburgh

Collaborator