DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorDr. Juwayria Omar
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Proliferative diabetic retinopathy.
Trial design
Design model
Parallel
Treatments tested in this trial
DiaBuddy: AI-Enabled Digital Self-Management Intervention
BehavioralDiaBuddy 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
Other interventionParticipants 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: DiaBuddy + Usual Diabetes CareExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Child Diabetes Self-Management/Adherence Score
Change in child diabetes self-management/adherence score assessed using the modified Self-Care Inventory-Revised (SCI-R). Higher scores indicate better self-management/adherence.
Time frame
Baseline and 6 months after randomizationSecondary outcomes
1
Change in Child Diabetes-Related Distress Score
Change in diabetes-related distress assessed using the study's specified child distress measure/emoji-based assessment. Lower scores indicate lower diabetes-related distress.
Time frame
Baseline and 6 months after randomization2
Change in Glycated Hemoglobin (HbA1c) Level
Change in glycated hemoglobin (HbA1c), measured as a clinical indicator of glycemic control.
Time frame
Baseline and 6 months after randomization3
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.
Time frame
Baseline and 6 months after randomizationOther outcomes
1
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.
Time frame
Throughout the 6-month intervention periodLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Juwayria Omar
Lead sponsor
Air University, Islamabad
Sponsor institution
Air University, Islamabad
Collaborator
Pakistan Institute of Medical Sciences
Collaborator
Source ClinicalTrials.gov
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