Recruiting

Diabetes Education

Sponsor:

Carnegie Mellon University

Code:

NCT06264258

Conditions

Diabetes Mellitus, Type 1

Behavior, Health

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

Interventions

DVx-T1D™ app

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Behavior, Health

Study ID

NCT06264258

Start date

May 22, 2024

Status verified date

Feb, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

DVx-T1D™ app

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.

Primary outcome measure

  • Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention [ Time Frame: Three months ]
  • Change in glucose average and variability [ Time Frame: Three months ]

Central Contacts and Locations

Central contacts

Rema Padman, PhD

412-268-2180rpadman@andrew.cmu.edu

Neha Sudhir

412-692-5170sudhirn2@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Neha Sudhir

sudhirn2@upmc.edu

Principal Investigator:

Ingrid Libman, MD, PhD

More Information

Sponsor

Carnegie Mellon University

Last update posted

Feb 12, 2025

Last verified

Feb, 2024

Keywords

  • app
  • game
  • children
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carnegie Mellon University on 2025-02-12.