Game-based Pediatric Diabetes Education
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorCarnegie Mellon University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
DVx-T1D™ app
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: DVx-T1D+Standard CareExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Three months2
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.
Time frame
Three monthsSecondary outcomes
1
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).
Time frame
Three months2
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.
Time frame
Three monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Carnegie Mellon University
Lead sponsor
University of Pittsburgh
Collaborator
Source ClinicalTrials.gov