Status:

RECRUITING

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

Lead Sponsor:

University of Sao Paulo

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

6+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07150052

Start Date

May 1 2025

End Date

December 1 2026

Last Update

September 2 2025

Active Locations (1)

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1

University of Sao Paulo

São Paulo, São Paulo, Brazil, 04026-001