Type 1 Diabetes MellitusCARB-AINCT07671053
Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes
A study testing AI-Powered Carbohydrate Counting Educational Platform in people with Type 1 Diabetes Mellitus, run by Sultan Qaboos University at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- AI-Powered Carbohydrate Counting Educational Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United Arab Emirates2 sites
Al Jalila Children's Hospital
Dubai
Al Qasimi Hospital
Sharjah city
About this study
Official title: 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
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:
Read more
- 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- AI-Powered Carbohydrate Counting Educational Platform
- Keywords
- Type 1 Diabetes, Carbohydrate Counting, Artificial Intelligence, AI-Powered Education, Digital Health
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Powered Carbohydrate Counting Educational PlatformBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-Powered Carbohydrate Counting Educational Platform + Enhanced Usual Care | Experimental | 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. Receives: Behavioral: AI-Powered Carbohydrate Counting Educational Platform |
| Enhanced Usual Care Alone | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number and proportion of eligible participants recruited into the study across participating sites.
Measured: 12 months
Retention Rate
Proportion of enrolled participants who complete the 12-week follow-up assessment.
Measured: 12 weeks
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.
Measured: 12 weeks
Data Completeness
Proportion of participants with complete primary outcome data collected at baseline and 12-week follow-up assessments.
Measured: 12 weeks
Secondary outcomes (6)
Acceptability of Intervention Measure
Participant-rated acceptability of the AI-powered carbohydrate counting educational platform using the validated 4-item Acceptability of Intervention Measure.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline and 12 weeks
Time in Range (70-180 mg/dL)
Percentage of time glucose values remain within the target range of 70-180 mg/dL based on continuous glucose monitoring or glucose meter data.
Measured: Baseline and 12 weeks
Glucose Variability
Change in glucose variability measured by coefficient of variation of glucose values.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either an AI-powered carbohydrate counting educational platform plus enhanced usual care or enhanced usual care alone. The two groups will be followed in parallel for 12 weeks to evaluate feasibility, acceptability, usability, and preliminary effectiveness outcomes
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Science Private University, Al Jalila Children's Specialty Hospital
- Responsible party
- Principal investigator, Dr. Hussain Al Saffar, Sultan Qaboos University
- Investigators
- Moez AlIslam Faris, PhD, Study chair, Applied Science Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671053
- Sponsor's protocol ID
- SultanQU-PEDU-002
- Acronym
- CARB-AI
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07671053
- Acronym / sponsor ID
- CARB-AI / SultanQU-PEDU-002
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes, Carbohydrate Counting, Artificial Intelligence, AI-Powered Education, Digital Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Collaborators
- Applied Science Private University, Al Jalila Children's Specialty Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either an AI-powered carbohydrate counting educational platform plus enhanced usual care or enhanced usual care alone. The two groups will be followed in parallel for 12 weeks to evaluate feasibility, acceptability, usability, and preliminary effectiveness outcomes
| Arm | Type | Receives |
|---|---|---|
| AI-Powered Carbohydrate Counting Educational Platform + Enhanced Usual Care | Experimental | Behavioral: AI-Powered Carbohydrate Counting Educational PlatformParticipants 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. |
| Enhanced Usual Care Alone | No intervention | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Powered Carbohydrate Counting Educational PlatformParticipants 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. | Behavioural | AI-Powered Carbohydrate Counting Educational Platform + Enhanced Usual Care |
Primary outcome
Recruitment Rate
Time frame: 12 months
Number and proportion of eligible participants recruited into the study across participating sites.
Retention Rate
Time frame: 12 weeks
Proportion of enrolled participants who complete the 12-week follow-up assessment.
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.
Data Completeness
Time frame: 12 weeks
Proportion of participants with complete primary outcome data collected at baseline and 12-week follow-up assessments.
6 secondary outcomes
Acceptability of Intervention Measure
Time frame: 12 weeks
System Usability Scale
Time frame: 12 weeks
Net Promoter Score
Time frame: 12 weeks
Carbohydrate Counting Accuracy
Time frame: Baseline and 12 weeks
Time in Range (70-180 mg/dL)
Time frame: Baseline and 12 weeks
Glucose Variability
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moez AlIslam Faris, PhD study chair
Applied Science Private University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Powered Carbohydrate Counting Educational Platform in people with Type 1 Diabetes Mellitus, run by Sultan Qaboos University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Arab Emirates, Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zainab Al-Abadla, BSN, MSc, BC-ADM (00971554001640, Zainab.alabadla@dubaihealth.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.