Status:

COMPLETED

Carbohydrate Count Aided by a Simulation in People With Type 1 Diabetes Mellitus. A Protocol for a Clinical Trial

Lead Sponsor:

Hospital Pablo Tobón Uribe

Collaborating Sponsors:

Universidad de Antioquia

Conditions:

Diabetes Mellitus, Type 1

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

Insulin remains the only approved treatment for type 1 diabetes mellitus patients and is used by many with type 2 diabetes. Carbohydrate counting is the most recommended way to prescribe prandial insu...

Detailed Description

Study setting Patients with T1DM trained in carbohydrate counting whose follow-up is considered feasible will be recruited from university hospitals and clinics dedicated to treating people with DM in...

Eligibility Criteria

Inclusion

  • Age: Adults 18 years old or older.
  • T1DM with at least one year since diagnosis.
  • Treatment with a multiple daily injection scheme or insulin pump.
  • Trained in advance CHOC.
  • Have an HbA1c above 7.5% and below 10% in the three months before the randomization.
  • Be able to use a Smartphone app for carbohydrate counting.

Exclusion

  • A confirmation or possible diabetic gastroparesia.
  • With a chronic renal disease and an estimated filtration rate of 65 ml/min/1.73m2 or less using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.
  • Patients been treated with any other form of medication different from insulin for DM.
  • Pregnant women.

Key Trial Info

Start Date :

May 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2023

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT05181917

Start Date

May 1 2023

End Date

November 30 2023

Last Update

June 6 2024

Active Locations (1)

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Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia