Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D
NCT ID: NCT05924932
Last Updated: 2023-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2022-12-01
2024-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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group 1 with Control IQ system
Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6
Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6
type of hybrid close loop insulin delivery system
Group 2 with SmartGuard system
MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
type of hybrid close loop insulin delivery system
Interventions
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Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6
type of hybrid close loop insulin delivery system
MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
type of hybrid close loop insulin delivery system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes for \> 1 years
* ≥ 18 years old
* CSII (without HCL) or MDI
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Masaryk Hospital Usti nad Labem
OTHER
Responsible Party
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Lucie Radovnická
MD
Principal Investigators
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Jiri Lastuvka
Role: STUDY_CHAIR
Masaryk hospital
Locations
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Lucie Radovnická
Ústí nad Labem, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Masaryk Hospital
Identifier Type: -
Identifier Source: org_study_id
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