An observational study in Diabetes Mellitus, Type 1, sponsored by Centre Hospitalier Sud Francilien. Completed at 1 site in France. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Centre Hospitalier Sud Francilien · Observational
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
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 317 is above the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Centre Hospitalier Sud Francilien is the lead sponsor of 57 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.
Exclusion Criteria:
Patients with type 1 Diabetes equipped with control-IQ closed loop system
Device: Insulin closed-loop delivery system
Patients with type 1 diabetes equipped with Smart GUARD closed loop system
Device: Insulin closed-loop delivery system
Insulin closed-loop delivery system
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).
Time frame: at 12 months
Time below target (< 70 mg/dL)
Compare glycemic control
Time frame: at 12 months
Glycemic coefficient of variation (CV)
Compare glycemic control
Time frame: at 12 months
glucose management indicator
Compare glycemic control
Time frame: at 12 months
HBA1c
Compare glycemic control
Time frame: at 12 months
weight daily insulin dose
Compare glycemic control
Time frame: at 12 months
daily insulin dose
Compare glycemic control
Time frame: at 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Sud Francilien