Clinical trial NCT05932966: Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
Official title: Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes type 1
closed loop insulin delivery system
continuous glucose monitoring
sensor-augmented pump
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 317
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ
timeFrame: at 12 months
Secondary outcomes:
measure: Time below target (< 70 mg/dL)
timeFrame: at 12 months
measure: Glycemic coefficient of variation (CV)
timeFrame: at 12 months
measure: glucose management indicator
timeFrame: at 12 months
measure: HBA1c
timeFrame: at 12 months
measure: weight daily insulin dose
timeFrame: at 12 months
measure: daily insulin dose
timeFrame: at 12 months
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Coralie AMADOU, PHD
role: PRINCIPAL_INVESTIGATOR
References: