[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr. Juwayria Omar\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":4},"100659075","diabuddy-ai-enabled-digital-self-management-for-youth-with-type-1-diabetes-100659075",false,"NCT07861373","DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes","Effect of an AI-Empowered Digital Self-Management Intervention on Glycemic Control and Caregiver Burden in Children and Adolescents With Type 1 Diabetes Mellitus: A Multicenter Randomized Controlled Trial in Pakistan","DiaBuddy","Inclusion Criteria:\n\n1. Children and adolescents aged 6-17 years at the time of enrollment.\n2. Confirmed diagnosis of Type 1 diabetes mellitus for at least 6 months.\n3. Resident of Pakistan.\n4. Parent or primary caregiver actively involved in the participant's diabetes care and willing to participate in the study.\n5. Access to a compatible smartphone or digital device capable of running the DiaBuddy application.\n6. Parent or legally authorized representative willing to provide informed consent.\n7. Child\u002Fadolescent willing to provide age-appropriate assent, where applicable.\n8. Participant and caregiver willing and able to comply with study procedures and follow-up assessments.\n\nExclusion Criteria:\n\n1. Cognitive, developmental, or other impairment that substantially limits the participant's ability to understand or use the intervention or complete study assessments.\n2. Severe or unstable medical illness that, in the judgment of the study investigator, would substantially interfere with study participation or follow-up.\n3. End-stage renal disease.\n4. Proliferative diabetic retinopathy.\n5. Recurrent severe diabetic ketoacidosis requiring intensive care that would substantially interfere with study participation or follow-up.\n6. Any other medical, psychosocial, or logistical condition that, in the judgment of the investigator, would make participation inappropriate or prevent completion of the study procedures.","ALL","6 Years","17 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether DiaBuddy, a digital self-management app, can help children and adolescents with Type 1 diabetes better manage their condition and reduce the burden experienced by their caregivers. The study will include children and adolescents aged 6 to 17 years with Type 1 diabetes who live in Pakistan.\n\nThe main questions it aims to answer are:\n\n* Does using DiaBuddy along with usual diabetes care improve diabetes self-management and adherence?\n* Does using DiaBuddy along with usual diabetes care reduce caregiver burden?\n* Does using DiaBuddy affect blood sugar control, diabetes-related distress, and other diabetes-related health outcomes?\n* Is DiaBuddy acceptable and useful for children, adolescents, and their caregivers?\n\nResearchers will compare participants who use DiaBuddy along with their usual diabetes care with participants who receive usual diabetes care alone.\n\nParticipants will:\n\n* Use DiaBuddy to record and review information related to their diabetes, including blood glucose and self-management activities.\n* Receive diabetes education, reminders, and self-management support through the app.\n* Complete questionnaires about diabetes self-management, diabetes-related experiences, and caregiver burden.\n* Have blood sugar control assessed through laboratory-verified HbA1c measurements.\n* Attend scheduled follow-up assessments at approximately 3 and 6 months.\n* Report relevant diabetes-related health events, such as hypoglycemia, diabetic ketoacidosis, emergency visits, and hospitalization.",[28,29,30],"Type 1 Diabetes Mellitus","Diabetes Self-Management Education","Caregiver Burden",[32,33,34,15,35,36,37,38,39,40,41,42,43,44],"Pediatric Diabetes","Digital health","Mobile health","Diabetes self-management education","Digital diabetes intervention","Glycemic control","HbA1c","Caregiver burden","Artificial intelligence","AI-assisted self-management","Pakistan","Type 1 diabetes","Patient education","NOT_YET_RECRUITING","2026-10-03",{"date":48,"type":49},"2026-10-06","ACTUAL",{"date":51,"type":22},"2026-10-02",{"date":53,"type":22},"2027-09-02",{"name":55,"class":56},"Dr. Juwayria Omar","OTHER",""]