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

Masaryk Hospital Usti nad Labem

Status

Enrolling

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4

Device: Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6

Study type

Observational

Funder types

Other

Identifiers

NCT05924932

Masaryk Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).