[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659075":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":39,"studyPopulation":33,"armGroups":40,"interventions":53,"overallOfficials":33,"centralContacts":33,"locations":33,"responsibleParty":63,"collaborators":67,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":108,"whyStopped":33,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":33},{"fullName":5,"class":6},"Air University, Islamabad","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Child Diabetes Self-Management\u002FAdherence Score","Change in child diabetes self-management\u002Fadherence score assessed using the modified Self-Care Inventory-Revised (SCI-R). Higher scores indicate better self-management\u002Fadherence.","Baseline and 6 months after randomization",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Change in Child Diabetes-Related Distress Score","Change in diabetes-related distress assessed using the study's specified child distress measure\u002Femoji-based assessment. Lower scores indicate lower diabetes-related distress.",{"measure":18,"description":19,"timeFrame":12},"Change in Glycated Hemoglobin (HbA1c) Level","Change in glycated hemoglobin (HbA1c), measured as a clinical indicator of glycemic control.",{"measure":21,"description":22,"timeFrame":12},"Change in Diabetes-Related Caregiving Time","Change in caregiver-reported time spent on diabetes-related caregiving activities, reported in hours per day. Lower values indicate reduced caregiving time.",[24],{"measure":25,"description":26,"timeFrame":27},"Number of Participants With Diabetes-Related Adverse Events","Occurrence of hypoglycemia, severe hypoglycemia, diabetic ketoacidosis (DKA), emergency department visits, and diabetes-related hospitalizations will be recorded and compared between study arms.","Throughout the 6-month intervention period",{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":33,"timePerspective":33,"maskingInfo":34},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either DiaBuddy plus usual diabetes care or usual diabetes care alone. Participants will remain in their assigned group throughout the 6-month study period and will undergo assessments at baseline, approximately 3 months, and approximately 6 months. The study will compare changes in diabetes self-management\u002Fadherence, caregiver burden, and other prespecified clinical, behavioral, and safety outcomes between the two groups.","SUPPORTIVE_CARE",null,{"masking":35,"maskingDescription":36,"whoMasked":37},"SINGLE","Participants, caregivers, intervention staff, and treating clinicians will not be blinded to group assignment because of the nature of the digital intervention. Outcome assessors will be blinded to treatment assignment where feasible. Allocation labels will also be masked to the statistician\u002Fdata analyst where feasible until the primary analysis is finalized.",[38],"OUTCOMES_ASSESSOR","Type 1 diabetes mellitus (T1DM) requires continuous daily management, including glucose monitoring, insulin administration, dietary decisions, physical activity, recognition of abnormal glucose levels, and management of diabetes-related risks. For children and adolescents, this management is shared between the child and caregiver, and responsibility gradually shifts toward the child with increasing age and independence. This can create challenges related to adherence, diabetes-related distress, and caregiver burden.\n\nDiaBuddy is an artificial intelligence (AI)-empowered digital self-management intervention developed to support children and adolescents with T1DM and their caregivers. The intervention is intended to complement, rather than replace, routine diabetes care. It provides digital tools for recording and reviewing diabetes-management information, educational content, reminders, motivational features, and caregiver support.\n\nThe application includes functions such as glucose logging and trend visualization, insulin and meal\u002Fsnack reminders, physical activity reminders, hypoglycemia alerts, diabetes safety and diabetic ketoacidosis (DKA) education, educational videos, interactive quizzes, Urdu and English content, points, badges and rewards, caregiver dashboards, child-caregiver account linking, weekly summaries, synchronization, offline functionality where supported, and technical support.\n\nDiaBuddy will also incorporate AI-supported analysis of available longitudinal diabetes-management information, such as glucose readings, insulin information, dietary information, physical activity information, and previous glucose patterns. The AI may provide individualized information concerning glucose trends, dietary considerations, physical activity, anticipated glucose patterns, diabetes-management reminders, and when medical review may be appropriate.\n\nThe AI component is designed as a decision-support and self-management tool. It will not independently change or administer insulin doses. Any insulin-related suggestion will remain subject to the participant's or caregiver's existing clinical management plan and treating clinician oversight. DiaBuddy will not replace treating physicians, routine diabetes care, emergency medical services, or clinical decision-making.\n\nThe definitive trial follows a preliminary DiaBuddy pilot. The pilot provided information about feasibility, usability, technical issues, questionnaire administration, recruitment, follow-up, and preliminary changes in self-management, caregiver burden, diabetes-related distress, and reported caregiving time. Because the pilot did not include a control group and was short in duration, it cannot determine whether observed changes were specifically attributable to DiaBuddy. The randomized controlled trial is therefore designed to provide a controlled comparison of DiaBuddy added to usual diabetes care versus usual diabetes care alone.\n\nParticipants will be followed for six months, with assessments planned at baseline, approximately three months, and approximately six months. Clinical and participant-reported information will be collected throughout follow-up. Laboratory-verified glycated hemoglobin (HbA1c) will be used to assess glycemic control. The study will also monitor relevant diabetes-related events and healthcare utilization, including hypoglycemia, severe hypoglycemia, DKA, emergency department visits, and diabetes-related hospitalization.\n\nSafety monitoring will include potentially harmful AI outputs and technical failures that could affect participant safety in addition to clinical safety events. Participants will be informed that DiaBuddy is not an emergency service and that clinical emergencies should be managed through their treating healthcare team or appropriate emergency services.\n\nBefore the trial begins, the randomized controlled trial (RCT) version of the application will be documented, including the permitted and prohibited AI outputs, insulin-related safeguards, human oversight procedures, software and AI version control, handling of erroneous or incomplete information, and procedures for reporting potentially serious AI-related incidents. Changes to the software or AI system during the trial will be documented.\n\nThe trial is intended to determine whether adding DiaBuddy to usual diabetes care provides meaningful improvements in diabetes self-management and caregiver outcomes while also evaluating clinical outcomes, safety, usability, and engagement. The longer-term objective is to develop a safe and evidence-based digital self-management platform that may subsequently be evaluated for implementation within routine diabetes care in Pakistan.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"DiaBuddy + Usual Diabetes Care","EXPERIMENTAL","Participants assigned to this arm will receive access to DiaBuddy in addition to their usual diabetes care for 6 months. DiaBuddy is an AI-empowered digital self-management and decision-support intervention that provides tools for glucose logging and trend visualization, insulin, meal\u002Fsnack, and physical activity reminders, hypoglycemia alerts, diabetes safety and DKA education, educational videos and quizzes, Urdu and English content, motivational features, caregiver support, and weekly summaries. The AI component may provide individualized self-management information and recommendations based on available diabetes-management information. DiaBuddy will not independently change or administer insulin doses and will not replace routine clinical care or emergency medical services.",[46],"Behavioral: DiaBuddy: AI-Enabled Digital Self-Management Intervention",{"label":48,"type":49,"description":50,"interventionNames":51},"Usual Care","ACTIVE_COMPARATOR","Participants in this arm will receive usual standard diabetes care as provided by their treating healthcare team. They will not receive access to the DiaBuddy digital intervention during the study period. Usual care may include routine clinical follow-up, insulin therapy, blood glucose monitoring, dietary and physical-activity guidance, diabetes education, and other standard services according to the participant's treating team.",[52],"Other: Usual Diabetes Care",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":33},"BEHAVIORAL","DiaBuddy: AI-Enabled Digital Self-Management Intervention","DiaBuddy is an AI-enabled digital self-management intervention designed to support children aged 6-17 years with T1DM and their caregivers. The intervention provides tools for glucose logging and trend visualization, insulin and medication reminders, snack and exercise reminders, hypoglycemia and DKA educational alerts, diabetes education through videos, quizzes, cartoons and animations, and English and Urdu language options. It also includes points, badges and rewards to encourage engagement, caregiver-child linking, and a caregiver dashboard with weekly summaries. AI-supported features may assist with interpretation of glucose trends and provide general self-management recommendations; however, the system does not autonomously modify insulin doses, and insulin-related decisions remain under clinical supervision. Participants will use DiaBuddy alongside their usual diabetes care during the intervention period.",[42],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":33},"Usual Diabetes Care","Participants assigned to the usual care arm will continue to receive standard diabetes care according to the routine practices of their treating healthcare team. Usual care may include routine clinical follow-up, insulin therapy, blood glucose monitoring, dietary and physical-activity counseling, diabetes education, and management of acute and chronic diabetes-related concerns as clinically indicated. Participants in this arm will not receive access to the DiaBuddy digital self-management intervention during the study period.",[48],{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Dr. Juwayria Omar","Assistant Professor",[68,69],{"name":5,"class":6},{"name":70,"class":71},"Pakistan Institute of Medical Sciences","OTHER_GOV","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":84,"type":85},140,"ESTIMATED","INTERVENTIONAL",[88],"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.",[91,92,93],"Type 1 Diabetes Mellitus","Diabetes Self-Management Education","Caregiver Burden",[95,96,97,78,98,99,100,101,102,103,104,105,106,107],"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":111,"type":112},"2026-10-06","ACTUAL",{"date":114,"type":85},"2026-10-02",{"date":116,"type":85},"2027-09-02",{"name":65,"class":6}]