Clinical trial NCT06264258: Game-based Pediatric Diabetes Education
Official title: Evaluating Game-based Pediatric Diabetes Education
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Behavior, Health
Keywords: app
game
children
pediatrics
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2024-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 participants (40 in each arm) of 6-12 years old youth with type 1 diabetes (T1D).The investigators will quantify the impact of the mobile game app vs. standard care on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters), physical activity levels and food choices of children (measured using food logs and surveys).

The study will also assess changes in children's knowledge about the measured outcomes and investigate the feasibility and acceptability of game adoption and the barriers and challenges faced by patients, families and clinicians.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention
timeFrame: Three months
measure: Change in glucose average and variability
timeFrame: Three months
Secondary outcomes:
measure: Changes in the quality of food consumption
timeFrame: Three months
measure: Change in game play patterns over time
timeFrame: Three months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
References: