Clinical trial NCT05924932: Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D
Official title: Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 diabetes mellitus
hybrid closed loop system for automatic insulin dosing
glycated hemoglobin
Lead sponsor: Masaryk Hospital Usti nad Labem
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with Type 1 diabetes

Brief summary: 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.

Detailed 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 criteria: 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).

Primary outcomes:
measure: glycated hemoglobin
timeFrame: 12 month
Secondary outcomes:
measure: tim spent in TIR
timeFrame: 12 month
measure: time spent in hypoglycemia
timeFrame: 12 month
measure: time spent in hyperglycemia
timeFrame: 12 month
measure: glycemic variability
timeFrame: 12 m,onth
measure: mean sensor glucose value
timeFrame: 12 month
Other outcomes:
measure: Safety and Tolerability
timeFrame: 12 month
Locations:
city: Usti Nad Labem
country: Czechia
facility: Lucie Radovnická
Study officials:
affiliation: Masaryk hospital
name: Jiri Lastuvka
role: STUDY_CHAIR
References:
citation: Leelarathna L, Choudhary P, Wilmot EG, Lumb A, Street T, Kar P, Ng SM. Hybrid closed-loop therapy: Where are we in 2021? Diabetes Obes Metab. 2021 Mar;23(3):655-660. doi: 10.1111/dom.14273. Epub 2020 Dec 20.
citation: Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.