NCT07150052 Efficacy and Safety of an Artificial Intelligence Tool for Carbohydrate Counting (Tiabete) in Children and Adults With Type 1 Diabetes Mellitus
| NCT ID | NCT07150052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-05-01 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
IntroductionType 1 Diabetes Mellitus (T1DM) requires lifelong exogenous insulin therapy, along with self-management strategies, such as carbohydrate counting, to appropriately adjust insulin doses in response to meals. However, many patients face challenges in adhering consistently to carbohydrate counting, compromising glycemic control and increasing the risk of diabetes-related complications. Emerging technologies, such as artificial intelligence (AI), hold significant potential for optimizing disease management by enhancing the accuracy and efficiency of self-care practices. ObjectiveThe primary aim of this study is to evaluate the efficacy and safety of the AI-based tool Tia Bete, designed to assist patients with T1DM in carbohydrate counting and insulin dose adjustment. The tool provides real-time recommendations based on personalized insulin-to-carbohydrate ratios, insulin sensitivity factors, and individualized glycemic goals. MethodsThis is a prospective, longitudinal study involving 40 patients with T1DM, stratified into two cohorts: 20 children and adolescents (6-18 years) and 20 adults (\>18 years), recruited at the Hospital das Clínicas, University of São Paulo (HCFMUSP). Participants will be assessed before and after six months of using the Tia Bete tool. Glycemic control will be evaluated using parameters such as glycated hemoglobin (HbA1c), time in range, and the incidence of hypoglycemia and hyperglycemia. Quality of life and satisfaction with the tool will also be assessed. Overview of the AI Tool Launched in June 2024, Tia Bete is an AI-based digital solution designed to facilitate glycemic control and improve quality of life for patients with T1DM. By offering real-time assistance with carbohydrate counting and insulin dose recommendations, the tool aims to enhance patient autonomy while enabling flexible treatment adherence in collaboration with their multidisciplinary healthcare team. Results and ConclusionsPreliminary data indicate high engagement, with over 35,000 active users interacting with the platform at least four times per week. Initial findings suggest significant improvements in glycemic control, as well as increased confidence in carbohydrate counting and insulin dose adjustments. The dissemination of this project is crucial for advancing T1DM care, offering a scalable, accessible, and effective technological solution. Final results are expected by October 2025.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus * children between 6 and 18 years old and their caregivers; and adults \> 18 years old. Glycated Hb between 7.2-10.5% in the last 6 months. Being on a basal-bolus regimen Participating in and understanding the guidelines on how to use the program to be tested in this study Agreeing to the free and informed consent form. Performing periodic monitoring at the DM outpatient clinic at HC-FMUSP Exclusion Criteria: * Not understanding the instructions. * Being illiterate * Not attending the visits proposed by the study * Not using the tool via WhatsApp. * Not accepting consent. * Interacting with the tool less than 3 days a week during the study period.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07150052 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07150052 currently recruiting?
Yes, NCT07150052 is actively recruiting participants. Contact the research team at carol.passone@gmail.com for enrollment information.
Where is the NCT07150052 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07150052 clinical trial?
NCT07150052 is sponsored by University of Sao Paulo. The trial plans to enroll 50 participants.
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