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 (CARB-AI)

June 22, 2026 updated by: Dr. Hussain Al Saffar, Sultan Qaboos University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hussain Alsaffar, FACE, MSc, FRCPCH, CCT, MD
  • Phone Number: +96896399402
  • Email: hussaina@squ.edu.om

Study Contact Backup

Study Locations

  • Oman
      • Muscat, Oman, 123
        • Sultan Qaboos University Hospital
  • United Arab Emirates
      • Dubai, United Arab Emirates
        • Al Jalila Children's Hospital
      • Sharjah city, United Arab Emirates
        • Al Qasimi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-Powered Carbohydrate Counting Educational Platform + Enhanced Usual Care
Participants receive access to an AI-powered carbohydrate counting educational platform in addition to enhanced usual diabetes care. The platform provides interactive educational support, carbohydrate counting practice, personalized feedback, scenario-based learning, and educational guidance under dietitian and diabetes specialist oversight. Participants also receive standard diabetes education materials and routine clinical care for 12 weeks.
Behavioral: 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 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.
No Intervention: Enhanced Usual Care Alone
Participants receive enhanced usual diabetes care consisting of standard diabetes education provided by their clinical care team, printed carbohydrate counting educational materials, portion size reference materials, educational PDF resources, and routine clinical care. Participants do not receive access to the AI-powered carbohydrate counting educational platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: 12 months
Number and proportion of eligible participants recruited into the study across participating sites.
12 months
Retention Rate
Time Frame: 12 weeks
Proportion of enrolled participants who complete the 12-week follow-up assessment.
12 weeks
Intervention Adherence
Time Frame: 12 weeks
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.
12 weeks
Data Completeness
Time Frame: 12 weeks
Proportion of participants with complete primary outcome data collected at baseline and 12-week follow-up assessments.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention Measure
Time Frame: 12 weeks
Participant-rated acceptability of the AI-powered carbohydrate counting educational platform using the validated 4-item Acceptability of Intervention Measure.
12 weeks
System Usability Scale
Time Frame: 12 weeks
Participant-rated usability of the AI-powered carbohydrate counting educational platform using the validated 10-item System Usability Scale.
12 weeks
Net Promoter Score
Time Frame: 12 weeks
Participant likelihood of recommending the AI-powered carbohydrate counting educational platform to other parents of children with type 1 diabetes
12 weeks
Carbohydrate Counting Accuracy
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks
Time in Range (70-180 mg/dL)
Time Frame: Baseline and 12 weeks
Percentage of time glucose values remain within the target range of 70-180 mg/dL based on continuous glucose monitoring or glucose meter data.
Baseline and 12 weeks
Glucose Variability
Time Frame: Baseline and 12 weeks
Change in glucose variability measured by coefficient of variation of glucose values.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Qaboos University

Collaborators

Applied Science Private University
Al Jalila Children's Specialty Hospital

Investigators

  • Study Chair: Moez AlIslam Faris, PhD, Applied Science Private University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SultanQU-PEDU-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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