COMPARE-CLIDS: Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with type 1 Diabetes equipped with control-IQ closed loop system Patients with type 1 Diabetes equipped with control-IQ closed loop system |
Device: Insulin closed-loop delivery system
Insulin closed-loop delivery 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 |
Device: Insulin closed-loop delivery system
Insulin closed-loop delivery system
|
Outcome Measures
Primary Outcome Measures
- Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ [at 12 months]
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).
Secondary Outcome Measures
- Time below target (< 70 mg/dL) [at 12 months]
Compare glycemic control
- Glycemic coefficient of variation (CV) [at 12 months]
Compare glycemic control
- glucose management indicator [at 12 months]
Compare glycemic control
- HBA1c [at 12 months]
Compare glycemic control
- weight daily insulin dose [at 12 months]
Compare glycemic control
- daily insulin dose [at 12 months]
Compare glycemic control
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient > 16 years
-
Patient with diabetes type 1.
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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:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Sud Francilien | Corbeil-essonnes Cedex | France | 91106 |
Sponsors and Collaborators
- Centre Hospitalier Sud Francilien
Investigators
- Principal Investigator: Coralie AMADOU, PHD, Centre Hospitalier Sud Francilien
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023/0024