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

Diabetes Mellitus, Type 1 Clinical Trial

— COMPARE-CLIDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932966
• Other study ID #: 2023/0024
• Status: Recruiting
• Start date: July 6, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: Coralie AMADOU, PHD
• Phone: 01 61 69 33 87
• Email: coralie.amadou[@]chsf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 386
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 16 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Insulin closed-loop delivery system
Insulin closed-loop delivery system

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at 12 months
Secondary	Time below target (< 70 mg/dL)	Compare glycemic control	at 12 months
Secondary	Glycemic coefficient of variation (CV)	Compare glycemic control	at 12 months
Secondary	glucose management indicator	Compare glycemic control	at 12 months
Secondary	HBA1c	Compare glycemic control	at 12 months
Secondary	weight daily insulin dose	Compare glycemic control	at 12 months
Secondary	daily insulin dose	Compare glycemic control	at 12 months