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

Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes

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.

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.

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).