Game-based Pediatric Diabetes Education (DVx-T1D)

Carnegie Mellon University

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1; Behavior, Health

Treatments: Behavioral: DVx-T1D™ app

Study type: Interventional

Funder types: Other

Identifiers

NCT06264258

STUDY2023_00000285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

DVx-T1D+Standard Care

Experimental group

Description:

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.

Treatment:

Behavioral: DVx-T1D™ app

Standard Care

No Intervention group

Description:

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.