Evaluating Game-based Pediatric Diabetes Education

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Pennsylvania
UPMC Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Rema Padman, PhD
rpadman@andrew.cmu.edu
412-268-2180
Backup
Neha Sudhir
sudhirn2@upmc.edu
412-692-5170
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 80
Treatments
Experimental: DVx-T1D+Standard Care
Participants will continue receiving the clinic's standard of care. Anthropometrics, clinical and laboratory data will be collected at three time points, baseline, 6 weeks and 3 months. Participants will be asked to maintain food, glucose, and activity logs. In addition, participants in this arm will be provided a tablet that has the gaming applications already loaded and receive training on the application. Exposure time will be tracked by the application.
No_intervention: Standard Care
Participants will receive the clinic's standard of care. Anthropometrics, clinical and laboratory data will be collected at three time points, baseline, 6 weeks and 3 months. Participants will be asked to maintain food, glucose, and activity logs.
Related Therapeutic Areas
Sponsors
Leads: Carnegie Mellon University
Collaborators: University of Pittsburgh

This content was sourced from clinicaltrials.gov