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.
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
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
Parallel
AI-Powered Carbohydrate Counting Educational Platform
BehavioralParticipants will receive access to an AI-powered carbohydrate counting educational platform designed for parents of children with type 1 diabetes. The platform provides interactive carbohydrate counting education, personalized educational guidance, carbohydrate estimation practice, natural-language question answering, and scenario-based learning. Participants will use the platform for 12 weeks in addition to enhanced usual diabetes care. All educational content is developed and supervised by pediatric endocrinologists, certified diabetes educators, and registered dietitians. The platform functions as an educational support tool only and does not provide medical advice or insulin dosing recommendations.
Recruitment Rate
Number and proportion of eligible participants recruited into the study across participating sites.
Retention Rate
Proportion of enrolled participants who complete the 12-week follow-up assessment.
Intervention Adherence
Proportion of participants in the intervention group who engage with the AI-powered carbohydrate counting educational platform for at least 10 sessions during the study period.
Data Completeness
Proportion of participants with complete primary outcome data collected at baseline and 12-week follow-up assessments.
Acceptability of Intervention Measure
Participant-rated acceptability of the AI-powered carbohydrate counting educational platform using the validated 4-item Acceptability of Intervention Measure.
System Usability Scale
Participant-rated usability of the AI-powered carbohydrate counting educational platform measured using the System Usability Scale (SUS), a validated 10-item questionnaire. The SUS total score ranges from 0 to 100, with higher scores indicating better perceived usability.
Net Promoter Score
Participant likelihood of recommending the AI-powered carbohydrate counting educational platform to other parents of children with type 1 diabetes, measured using the Net Promoter Score (NPS). Participants rate their likelihood of recommending the platform on a scale from 0 (Not at all likely) to 100 (Extremely likely). Higher scores indicate a greater likelihood of recommending the intervention.
Carbohydrate Counting Accuracy
Change in carbohydrate counting accuracy assessed using a standardized carbohydrate counting assessment. Accuracy will be defined as the percentage of estimates within 20% of dietitian-calculated carbohydrate values.
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Sultan Qaboos University
Lead sponsor
Applied Science Private University
Collaborator
Al Jalila Children's Specialty Hospital
Collaborator
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