Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6
* Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1 with Control IQ system<br>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<br>* type of hybrid close loop insulin delivery system<br>* Other names: Control IQ;|
| Group 2 with SmartGuard system<br>MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4 | Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4<br>* type of hybrid close loop insulin delivery system<br>* Other names: SmartGuard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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]) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes mellitus, hybrid closed loop system for automatic insulin dosing, glycated hemoglobin