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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Insulin closed-loop delivery system

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 Type: Observational
• Enrollment (Estimated): 386

Contacts and Locations

• Study Contact: Name: Caroline TOURTE; Phone Number: 0161693150; Email: caroline.tourte@chsf.fr
• Study Contact Backup: Name: Coralie AMADOU, PHD; Phone Number: 01 61 69 33 87; Email: coralie.amadou@chsf.fr

Study Locations

• France
  • Corbeil-essonnes Cedex, France, 91106
    • Recruiting
    • Centre Hospitalier Sud Francilien
    • Contact: Coralie AMADOU; Phone Number: 0161693387; Email: coralie.amadou@chsf.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with type 1 Diabetes equipped with control-IQ closed loop system	Device: Insulin closed-loop delivery system; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time below target (< 70 mg/dL)	Compare glycemic control	at 12 months
Glycemic coefficient of variation (CV)	Compare glycemic control	at 12 months
glucose management indicator	Compare glycemic control	at 12 months
HBA1c	Compare glycemic control	at 12 months
weight daily insulin dose	Compare glycemic control	at 12 months
daily insulin dose	Compare glycemic control	at 12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Coralie AMADOU, PHD, Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: continuous glucose monitoring; diabetes type 1; closed loop insulin delivery system; sensor-augmented pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2023/0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No