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

NCT05932966 | Completed

• 1 other identifier: 2023/0024
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes type 1; closed loop insulin delivery system; continuous glucose monitoring; sensor-augmented pump

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time below target (< 70 mg/dL)

  at 12 months

• Glycemic coefficient of variation (CV)

  at 12 months

• glucose management indicator

  at 12 months

• HBA1c

  at 12 months

• weight daily insulin dose

  at 12 months

Study Arms (2)

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

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

Device: Insulin closed-loop delivery system

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

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

Device: Insulin closed-loop delivery system

Interventions

Insulin closed-loop delivery system DEVICE

Insulin closed-loop delivery system

Patients with type 1 Diabetes equipped with control-IQ closed loop system; Patients with type 1 diabetes equipped with Smart GUARD closed loop system

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Coralie AMADOU, PHD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 6, 2023
• Study Start: July 6, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)