Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Insulin closed-loop delivery system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient > 16 years Patient with diabetes type 1. Patient treated with a CONTROL-IQ or SMARTGUARD closed-loop insulin delivery system between 01/2021 and 05/2022. Follow-up patient in Centre Hospitalier Sud Francilien Exclusion Criteria: Women who had pregnancy within 12 months of system initiation. Patient who have been treated with both systems within 12 months. Patient or parental authority objecting the use of data

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 1 Diabetes equipped with control-IQ closed loop system<br>Patients with type 1 Diabetes equipped with control-IQ closed loop system | Device: Insulin closed-loop delivery system<br>* Insulin closed-loop delivery system<br>|
| Patients with type 1 diabetes equipped with Smart GUARD closed loop system<br>Patients with type 1 diabetes equipped with Smart GUARD closed loop system | Device: Insulin closed-loop delivery system<br>* Insulin closed-loop delivery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time below target (< 70 mg/dL) | Compare glycemic control | at 12 months | 
| Glycemic coefficient of variation (CV) | Compare glycemic control | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes type 1, closed loop insulin delivery system, continuous glucose monitoring, sensor-augmented pump