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This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1.
Since 2021, several closed-loop insulin delivery systems have been reimbursed in France for patients living with type 1 diabetes. The "real-life" efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials.
To date, there are no clinical trial comparing closed-loop systems. There are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology.
Given the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the Centre Hospitalier Sud-Francilien since 2021 (> 400), we propose a single-center analysis to compare real-life performance of Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with type 1 Diabetes equipped with control-IQ closed loop system | Patients with type 1 Diabetes equipped with control-IQ closed loop system |
| |
| Patients with type 1 diabetes equipped with Smart GUARD closed loop system | Patients with type 1 diabetes equipped with Smart GUARD closed loop system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin closed-loop delivery system | Device | Insulin closed-loop delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ | Time spent in target range (between 70 and 180 mg/dL) after 12 months following initiation of the closed-loop system, as measured by continuous glucose monitoring (CGM).system, as measured by continuous glucose monitoring (CGM). | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time below target (< 70 mg/dL) | Compare glycemic control | at 12 months |
| Glycemic coefficient of variation (CV) | Compare glycemic control |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Coralie AMADOU, PHD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91106 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| at 12 months |
| glucose management indicator | Compare glycemic control | at 12 months |
| HBA1c | Compare glycemic control | at 12 months |
| weight daily insulin dose | Compare glycemic control | at 12 months |
| daily insulin dose | Compare glycemic control | at 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |