NCT07861373Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Dr. Juwayria Omar
- Diseases
- Type 1 diabetes
- NCT number
- NCT07861373
What you commit to
- Study type: Interventional
- Planned participants: 140
- From Oct 2026 to the primary completion date, Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive, developmental, or other impairment that substantially limits the participant's ability to understand or use the intervention or complete study assessments.
- Severe or unstable medical illness that, in the judgment of the study investigator, would substantially interfere with study participation or follow-up.
- End-stage renal disease.
- 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.
Other
- Proliferative diabetic retinopathy.
- Recurrent severe diabetic ketoacidosis requiring intensive care that would substantially interfere with study participation or follow-up.
Who the study is looking for
- Children and adolescents aged 6-17 years at the time of enrollment.
- Confirmed diagnosis of Type 1 diabetes mellitus for at least 6 months.
- Resident of Pakistan.
- Parent or primary caregiver actively involved in the participant's diabetes care and willing to participate in the study.
- Access to a compatible smartphone or digital device capable of running the DiaBuddy application.
- Parent or legally authorized representative willing to provide informed consent.
- Child/adolescent willing to provide age-appropriate assent, where applicable.
- Participant and caregiver willing and able to comply with study procedures and follow-up assessments.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.