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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-06

Study Completion Date

2024-07-11

Brief Summary

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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.

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Detailed Description

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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

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with type 1 Diabetes equipped with control-IQ closed loop system

Insulin closed-loop delivery system

Intervention Type DEVICE

Insulin closed-loop delivery system

Patients with type 1 diabetes equipped with Smart GUARD closed loop system

Insulin closed-loop delivery system

Intervention Type DEVICE

Insulin closed-loop delivery system

Interventions

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Insulin closed-loop delivery system

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No