protocolSection identificationModule nctId: NCT06264258, orgStudyIdInfo id: STUDY2023_00000285, briefTitle: Game-based Pediatric Diabetes Education, acronym: DVx-T1D, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Carnegie Mellon University, class: OTHER, collaborators name: University of Pittsburgh, descriptionModule briefSummary: 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., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Behavior, Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: DVx-T1D™ app, outcomesModule primaryOutcomes measure: Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention, primaryOutcomes measure: Change in glucose average and variability, secondaryOutcomes measure: Changes in the quality of food consumption, secondaryOutcomes measure: Change in game play patterns over time, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: UPMC Children's Hospital of Pittsburgh, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, contacts name: Neha Sudhir, role: CONTACT, email: sudhirn2@upmc.edu, contacts name: Ingrid Libman, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False