[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536394":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":55,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Carnegie Mellon University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: DVx-T1D™ app",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"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.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Rema Padman, PhD","CONTACT","412-268-2180","rpadman@andrew.cmu.edu",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Neha Sudhir","412-692-5170","sudhirn2@upmc.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"UPMC Children's Hospital of Pittsburgh","RECRUITING","Pittsburgh","Pennsylvania","15224","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-79.99589,40.44062,{"lat":48,"lon":47},[51,52],{"name":32,"role":28,"phone":18,"phoneExt":18,"email":34},{"name":53,"role":54,"phone":18,"phoneExt":18,"email":18},"Ingrid Libman, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Rema Padman","Trustees Professor of Management Science & Healthcare Informatics",[59],{"name":60,"class":6},"University of Pittsburgh","100536394","game-based-pediatric-diabetes-education-100536394",false,"NCT06264258","Game-based Pediatric Diabetes Education","Evaluating Game-based Pediatric Diabetes Education","DVx-T1D","For youth:\n\n* Be between the age of 6 to 12 years.\n* Have been diagnosed with type 1 diabetes for at least 1 year.\n* Be currently taking insulin through multiple daily injections or an insulin pump.\n* Check blood sugar with a meter at least 4 times per day or use a continuous glucose monitor.\n* Be willing to comply with all study visits and procedures.\n\nFor Parent:\n\n* Biological or adopted parent with custody and medical decision making of the patients\n* Living with identified patients\n* Over 18 years old\n* Resident of Allegheny County\n\nExclusion Criteria:\n\n-Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes.",true,"ALL","6 Years","12 Years",{"count":74,"type":75},80,"ESTIMATED","INTERVENTIONAL",[78],"NA","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).\n\nThe 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.",[81,82],"Diabetes Mellitus, Type 1","Behavior, Health",[84,85,86,87],"app","game","children","pediatrics","2025-02-10",{"date":90,"type":91},"2025-02-12","ACTUAL",{"date":93,"type":91},"2024-05-22",{"date":95,"type":75},"2026-06-30",{"name":5,"class":6},1]