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

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Insulin closed-loop delivery system

• Registration Number: NCT05932966
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

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 Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-03
• Study Start: 2023-07-06
• Study First Posted: 2023-07-06
• Primary Completion: 2024-07-11
• Study Completion: 2024-07-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with type 1 Diabetes equipped with control-IQ closed loop system	Insulin closed-loop delivery system	Patients with type 1 Diabetes equipped with control-IQ closed loop system
Patients with type 1 diabetes equipped with Smart GUARD closed loop system	Insulin closed-loop delivery system	Patients with type 1 diabetes equipped with Smart GUARD closed loop system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France