Clinical Research Directory
Browse clinical research sites, groups, and studies.
DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes
Sponsor: Dr. Juwayria Omar
Summary
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. The main questions it aims to answer are: * Does using DiaBuddy along with usual diabetes care improve diabetes self-management and adherence? * Does using DiaBuddy along with usual diabetes care reduce caregiver burden? * Does using DiaBuddy affect blood sugar control, diabetes-related distress, and other diabetes-related health outcomes? * Is DiaBuddy acceptable and useful for children, adolescents, and their caregivers? Researchers will compare participants who use DiaBuddy along with their usual diabetes care with participants who receive usual diabetes care alone. Participants will: * Use DiaBuddy to record and review information related to their diabetes, including blood glucose and self-management activities. * Receive diabetes education, reminders, and self-management support through the app. * Complete questionnaires about diabetes self-management, diabetes-related experiences, and caregiver burden. * Have blood sugar control assessed through laboratory-verified HbA1c measurements. * Attend scheduled follow-up assessments at approximately 3 and 6 months. * Report relevant diabetes-related health events, such as hypoglycemia, diabetic ketoacidosis, emergency visits, and hospitalization.
Official title: 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
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-10-02
Completion Date
2027-09-02
Last Updated
2026-10-06
Healthy Volunteers
No
Interventions
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.
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.