Game-based Pediatric Diabetes Education

Diabetes Mellitus, Type 1 Clinical Trial

— DVx-T1D  

Official title:

Evaluating Game-based Pediatric Diabetes Education

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264258
• Other study ID #: STUDY2023_00000285
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Carnegie Mellon University
• Contact: Rema Padman, PhD
• Phone: 412-268-2180
• Email: rpadman[@]andrew.cmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Health
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Carnegie Mellon University	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention	Change in HbA1C level and insulin dose adjusted HbA1c from baseline to 3 months.	Three months
Primary	Change in glucose average and variability	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.	Three months
Secondary	Changes in the quality of food consumption	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).	Three months
Secondary	Change in game play patterns over time	Game play patterns learned from telemetry data over the 3 months of the experiment will be tracked and used to relate to the outcomes.	Three months