Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| group 1 with Control IQ system Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6 |
Device: Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6
type of hybrid close loop insulin delivery system
Other Names:
|
| Group 2 with SmartGuard system MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4 |
Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
type of hybrid close loop insulin delivery system
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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])
- 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])
- 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
Other Outcome Measures
- safety outcomes [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.
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lucie Radovnická | Usti Nad Labem | Czechia | 401 13 |
Sponsors and Collaborators
- Masaryk Hospital Usti nad Labem
Investigators
- Study Chair: Jiri Lastuvka, Masaryk hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Masaryk Hospital