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

August 14, 2024 updated by: Centre Hospitalier Sud Francilien
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

Completed

Conditions

Intervention / Treatment

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 (Actual)

317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil-essonnes Cedex, France, 91106
        • Centre Hospitalier Sud Francilien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 Frame: 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).
at 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Actual)

July 11, 2024

Study Completion (Actual)

July 11, 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 (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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