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NCT07671053
Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes
Conditions: Type 1 Diabetes Mellitus
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Sultan Qaboos University
Location: Sultan Qaboos University Hospital Muscat
Summary
The goal of this clinical trial is to learn whether an AI-powered carbohydrate counting educational platform can help parents of children with type 1 diabetes improve their carbohydrate counting skills and diabetes management. The study will include parents or primary caregivers of children aged 2-12 years with type 1 diabetes.
The main questions it aims to answer are:
* Is the AI-powered educational platform feasible, acceptable, and easy for parents to use?
* Can the platform improve carbohydrate counting accuracy, parental confidence in diabetes management, and diabetes outcomes compared with usual education alone?
Researchers will compare parents who receive access to the AI-powered carbohydrate counting educational platform plus usual diabetes education with parents who receive usual diabetes education alone to see whether the AI-supported approach provides additional benefits.
Participants will:
* Complete baseline assessments, including questionnaires and a carbohydrate counting test.
* Be randomly assigned to either the AI-supported education group or the usual education group.
* Use the assigned educational resources for 12 weeks.
* Complete a follow-up assessment at 6 weeks and a final assessment at 12 weeks.
* Provide information about their child's diabetes management, including HbA1c and glucose monitoring data.
* Complete questionnaires about confidence, usability, and satisfaction with the educational support they receive.
The AI platform is designed to provide educational support only and does not replace medical advice, insulin dosing decisions, or routine diabetes care provided by healthcare professionals.
Eligibility Criteria
Inclusion Criteria:
* Primary responsibility for carbohydrate counting and insulin dosing decisions for the child
* English-speaking
* Access to a smartphone (iOS or Android) with internet connectivity
* Willing and able to provide informed consent and complete study procedures
* Diagnosis of type 1 diabetes for at least 1 month
* Receiving intensive insulin therapy (multiple daily injections or insulin pump)
* Using carbohydrate counting for insulin dosing
Exclusion Criteria:
* Child has significant developmental delay or a medical condition that substantially alters nutritional requirements or carbohydrate metabolism (e.g., celiac disease, cystic fibrosis)
* Parent or caregiver has significant cognitive impairment that would preclude participation
* Family plans to relocate from the study area during the study period
* Participation in another diabetes intervention study
Source: ClinicalTrials.gov (NCT07671053). StuddyBuddy aggregates publicly available trial information.