NCT05932966

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 317 (actual)
• Sponsor: Centre Hospitalier Sud Francilien · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

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.

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

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Insulin closed-loop delivery system	Insulin closed-loop delivery system

Timeline

• Start date: 2023-07-06
• Primary completion: 2024-07-11
• Completion: 2024-07-11
• First posted: 2023-07-06
• Last updated: 2024-08-15

Locations

1 site across 1 country: France