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Efficacy and Safety of an Artificial Intelligence Tool for Carbohydrate Counting (Tiabete) in Children and Adults With Type 1 Diabetes Mellitus

RecruitingNAAges 6 Years - anyAllUniversity of Sao Paulo
NCT07150052 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sensitiv

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📋 Eligibility rules (as published)
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.
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What it tests

  • Artifical intelligence in whatsapp
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Where

1 site
University of Sao Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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