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

Centre Hospitalier Sud Francilien

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: Insulin closed-loop delivery system

Study type

Observational

Funder types

Other

Identifiers

NCT05932966

2023/0024

Details and patient eligibility

About

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.

Full 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

Enrollment

317 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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