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NCT07861373
DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes
Conditions: Type 1 Diabetes Mellitus, Diabetes Self-Management Education, Caregiver Burden
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
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.
Eligibility Criteria
Inclusion Criteria:
1. Children and adolescents aged 6-17 years at the time of enrollment.
2. Confirmed diagnosis of Type 1 diabetes mellitus for at least 6 months.
3. Resident of Pakistan.
4. Parent or primary caregiver actively involved in the participant's diabetes care and willing to participate in the study.
5. Access to a compatible smartphone or digital device capable of running the DiaBuddy application.
6. Parent or legally authorized representative willing to provide informed consent.
7. Child/adolescent willing to provide age-appropriate assent, where applicable.
8. Participant and caregiver willing and able to comply with study procedures and follow-up assessments.
Exclusion Criteria:
1. Cognitive, developmental, or other impairment that substantially limits the participant's ability to understand or use the intervention or complete study assessments.
2. Severe or unstable medical illness that, in the judgment of the study investigator, would substantially interfere with study participation or follow-up.
3. End-stage renal disease.
4. Proliferative diabetic retinopathy.
5. Recurrent severe diabetic ketoacidosis requiring intensive care that would substantially interfere with study participation or follow-up.
6. 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.
Source: ClinicalTrials.gov (NCT07861373). StuddyBuddy aggregates publicly available trial information.