Skip to main content
OpenTrials
Completed

NCT Number: NCT05932966

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin closed-loop delivery system

Device

Insulin closed-loop delivery system

Primary outcomes

  1. 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).

Secondary outcomes

  1. Time below target (< 70 mg/dL)

    Time frame: at 12 months

    Compare glycemic control

  2. Glycemic coefficient of variation (CV)

    Time frame: at 12 months

    Compare glycemic control

  3. glucose management indicator

    Time frame: at 12 months

    Compare glycemic control

  4. HBA1c

    Time frame: at 12 months

    Compare glycemic control

  5. weight daily insulin dose

    Time frame: at 12 months

    Compare glycemic control

  6. daily insulin dose

    Time frame: at 12 months

    Compare glycemic control

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: COMPARE-CLIDS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2023
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.