Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes

Официальное название

Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes: A Multicentre Randomized Controlled Trial

Обзор

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.

Подробное описание

This multicentre randomized controlled feasibility trial will evaluate an AI-powered educational platform designed to support carbohydrate counting education for parents of children with type 1 diabetes (T1D). Accurate carbohydrate counting is an essential component of T1D management because insulin dosing is closely linked to carbohydrate intake. However, many parents experience challenges in estimating carbohydrate content accurately, which may affect glycemic control.

The intervention uses conversational artificial intelligence to provide personalized educational support, interactive learning opportunities, and practical guidance related to carbohydrate counting. The platform is intended as an educational tool and does not provide medical advice or insulin dosing recommendations. Educational content and safety oversight are provided by pediatric endocrinologists, diabetes educators, and registered dietitians.

The primary objective of this feasibility study is to evaluate recruitment, retention, participant engagement, intervention adherence, and data collection procedures to determine whether a future definitive efficacy trial is warranted. Secondary objectives include assessment of participant acceptability and usability, as well as exploration of preliminary effects on carbohydrate counting accuracy, parental diabetes management self-efficacy, and glycemic outcomes.

Participants will be recruited from our pediatric diabetes centers, and randomized to receive either access to the AI-powered educational platform in addition to enhanced usual care or enhanced usual care alone. Study findings will inform the development of larger trials evaluating the role of conversational artificial intelligence in diabetes education and chronic disease self-management.

Вмешательства

• Поведенческое AI-Powered Carbohydrate Counting Educational Platform
  Participants 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 pe

Первичные конечные точки

• Recruitment Rate [Срок оценки: 12 months]
• Retention Rate [Срок оценки: 12 weeks]
• Intervention Adherence [Срок оценки: 12 weeks]
• Data Completeness [Срок оценки: 12 weeks]

Вторичные конечные точки (6)

• Acceptability of Intervention Measure [Срок оценки: 12 weeks]
• System Usability Scale [Срок оценки: 12 weeks]
• Net Promoter Score [Срок оценки: 12 weeks]
• Carbohydrate Counting Accuracy [Срок оценки: Baseline and 12 weeks]
• Time in Range (70-180 mg/dL) [Срок оценки: Baseline and 12 weeks]
• Glucose Variability [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

ОАЭ · 2 центра

• Al Jalila Children's Hospital — Dubai
• Al Qasimi Hospital — Sharjah city

Oman · 1 центр

• Sultan Qaboos University Hospital — Muscat

Идентификаторы

NCT: NCT07671053 · SultanQU-PEDU-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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