Game-based Pediatric Diabetes Education

NCT06264258 — Not applicable, Unknown, 80 participants, Carnegie Mellon University

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Evaluating Game-based Pediatric Diabetes Education

Registry	NCT06264258, acronym DVx-T1D
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	80 (Estimated)
Sponsor	Carnegie Mellon University (Other); collaborators: University of Pittsburgh
Conditions	Diabetes Mellitus, Type 1, Behavior, Health
Interventions	DVx-T1D™ app (Behavioral)
Dates	start 2024-05-22, primary completion 2025-12-31 (estimated), completion 2026-06-30 (estimated), first posted 2024-02-16, last updated 2025-02-12
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
DVx-T1D+Standard Care	Experimental	Behavioral: DVx-T1D™ app	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.
Standard Care	No intervention		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.

DVx-T1D™ app (Behavioral): 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.

+Outcome measures

Primary outcomes

Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention [Three months]: Change in HbA1C level and insulin dose adjusted HbA1c from baseline to 3 months.
Change in glucose average and variability [Three months]: Change in glucose average and variability as assessed by mean glucose and standard deviation (SD) as well as other continuous glucose monitor (CGM) parameters for those using this device.

Secondary outcomes

Changes in the quality of food consumption [Three months]: Changes in the quality of food consumption by comparing patients' food logs before and after the intervention, reported food choices and physical activity levels in the logs and surveys, and T1D specific diet and physical activity knowledge (for both participants and their parents).
Change in game play patterns over time [Three months]: Game play patterns learned from telemetry data over the 3 months of the experiment will be tracked and used to relate to the outcomes.

+Eligibility

Sex: All, ages: 6 Years to 12 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
UPMC Children's Hospital of Pittsburgh	Pittsburgh, Pennsylvania	United States	Recruiting