Diabetes Mellitus, Type 1
Conditions
Keywords
Type 1 diabetes mellitus, hybrid closed loop system for automatic insulin dosing, glycated hemoglobin
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.
Interventions
DEVICETandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6
type of hybrid close loop insulin delivery system
DEVICEMiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
type of hybrid close loop insulin delivery system
Sponsors
Masaryk Hospital Usti nad Labem
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycated hemoglobin | 12 month | The difference and changes in glycated hemoglobin (HbA1c, % DCCT \[mmol/mol\]) between baseline and at 12 months after using HCL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tim spent in TIR | 12 month | changes in percentage of time in range (%TIR, 70-180 mg/dL \[3.9-10.0 mmol/L\]) |
| time spent in hypoglycemia | 12 month | percentage of time spent in hypoglycemia (%TBR, \<70 mg/dL \[\<3.9 mmol/L\] and \<54 mg/dL \[\<3.0 mmol/L\]) |
| glycemic variability | 12 m,onth | glycemic variability expressed as the percentage coefficient of variation (%CV) and standard deviation (SD) |
| mean sensor glucose value | 12 month | mean sensor glucose value |
| time spent in hyperglycemia | 12 month | percentage of time spent in hyperglycemia (%TAR, \>180 mg/dL \[\>10.0 mmol/L\] and \>250 mg/dL \[\>13.9 mmol/L\]) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 12 month | 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. |
Countries
Czechia
Contacts
Primary ContactLucie Radovnická
Backup ContactJiri Lastuvka
Outcome results
None listed