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Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D

Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this study is compare the effect of hybrid closed loop system (HCL) for automatic insulin dosing treatment on the glycemic control of type 1 diabetes (T1D) in patient with different initial glycated hemoglobin.

Description

Rationale for the Study:

According to our hypothesis, even T1D patients with an initially optimal glucose level should benefit from this treatment method in the form of a reduction in glycemic variability.

There are very few clinical studies from real practice in a larger group of patients.

Eligibility

Inclusion Criteria:

  • patients with T1D
  • Type 1 diabetes for > 1 years
  • ≥ 18 years old
  • CSII (without HCL) or MDI

Exclusion Criteria:

  • Severe noncompliance
  • Known severe diabetic retinopathy and/or macular edema,
  • Lactation, pregnancy, or intending to become pregnant during the study;
  • A condition likely to require MRI. Use of acetaminophen-containing medication;
  • Unwillingness to use the study device for >70% of time.
  • Conditions that affect red blood cell turnover (hemolytic and other anemias, glucose-6-phosphate dehydrogenase deficiency, recent blood transfusion, use of drugs that stimulate erythropoesis, end-stage kidney disease).

Study details
    Diabetes Mellitus
    Type 1

NCT05924932

Masaryk Hospital Usti nad Labem

28 January 2024

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