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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1
Hospital Pablo Tobón Uribe
Medellín, Antioquia, Colombia