Game-based Pediatric Diabetes Education

NCT06264258 | Recruiting

• 1 other identifier: STUDY2023_00000285
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

app; game; children; pediatrics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Changes in the quality of food consumption

  Three months

• Change in game play patterns over time

  Three months

Study Arms (2)

DVx-T1D+Standard Care

EXPERIMENTAL

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.

Behavioral: DVx-T1D™ app

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.

Interventions

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.

DVx-T1D+Standard Care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes.

Sponsors & Collaborators

• Carnegie Mellon University: lead
• University of Pittsburgh: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Health Behavior; Alzheimer Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Rema Padman, PhD

CONTACT

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

Neha Sudhir

CONTACT

412-692-5170; sudhirn2@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trustees Professor of Management Science & Healthcare Informatics

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 16, 2024
• Study Start: May 22, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2025

Record last verified: 2024-02

Locations

US (1)