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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 with Control IQ system | Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6 |
| |
| Group 2 with SmartGuard system | MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6 | Device | type of hybrid close loop insulin delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| glycated hemoglobin | The difference and changes in glycated hemoglobin (HbA1c, % DCCT [mmol/mol]) between baseline and at 12 months after using HCL. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| tim spent in TIR | changes in percentage of time in range (%TIR, 70-180 mg/dL [3.9-10.0 mmol/L]) | 12 month |
| time spent in hypoglycemia | percentage of time spent in hypoglycemia (%TBR, <70 mg/dL [<3.9 mmol/L] and <54 mg/dL [<3.0 mmol/L]) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | the incidence of severe hypoglycemia (requiring third-party assistance to treat), ketoacidosis requiring hospitalization, skin reaction, infection, or hematoma at the site of insertion of the sensor. | 12 month |
Inclusion Criteria:
Exclusion Criteria:
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adult patients with Type 1 diabetes
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucie Radovnická | Contact | +420777624793 | radovnickal@gmail.com | |
| Jiri Lastuvka | Contact | 1420477114202 | jiri.lastuvka@kzcr.eu |
| Name | Affiliation | Role |
|---|---|---|
| Jiri Lastuvka | Masaryk hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucie Radovnická | Recruiting | Ústí nad Labem | 401 13 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33269551 | Result | 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. | |
| 33453783 | Result | 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. |
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blood samples for measurement of glycated hemoglobin
|
| MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4 | Device | type of hybrid close loop insulin delivery system |
|
|
| 12 month |
| time spent in hyperglycemia | percentage of time spent in hyperglycemia (%TAR, >180 mg/dL [>10.0 mmol/L] and >250 mg/dL [>13.9 mmol/L]) | 12 month |
| glycemic variability | glycemic variability expressed as the percentage coefficient of variation (%CV) and standard deviation (SD) | 12 m,onth |
| mean sensor glucose value | mean sensor glucose value | 12 month |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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