Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
COMPARE-CLIDS
1 other identifier
observational
317
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedStudy Start
First participant enrolled
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2024
CompletedAugust 15, 2024
August 1, 2024
1 year
June 21, 2023
August 14, 2024
Conditions
Keywords
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
- +1 more secondary outcomes
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
Patients with type 1 diabetes equipped with Smart GUARD closed loop system
Patients with type 1 diabetes equipped with Smart GUARD closed loop system
Interventions
Insulin closed-loop delivery system
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Coralie AMADOU, PHD
Centre Hospitalier Sud Francilien
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