Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS
NCT ID: NCT06014112
Last Updated: 2025-07-31
Study Results
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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RECRUITING
NA
850 participants
INTERVENTIONAL
2023-11-06
2028-05-06
Brief Summary
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Hyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes.
Metabolically, several situations can be distinguished:
* Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c \< 6.5%).
* Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement).
To our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM.
Published studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements.
The freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.
Our hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Freestyle Libre PRO iQ sensor
Eligible patients
Freestyle Libre Pro iQ
Freestyle Libre Pro iQ is a professional sensor, marketed by the Abbott laboratory, for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.
The study will be offered to any subject with an ACS. The installation of the Freestyle Libre Pro iQ sensor will be performed upon admission to intensive care Cardiology and left in place for the duration of hospitalization. In case of the Freestyle Libre Pro iQ sensor defective or removed before discharge from hospital, and if the patient tolerates it, a new the Freestyle Libre Pro iQ sensor will be placed. If the duration of hospitalization exceeds 14 days, a 2nd sensor will be placed.
Interventions
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Freestyle Libre Pro iQ
Freestyle Libre Pro iQ is a professional sensor, marketed by the Abbott laboratory, for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.
The study will be offered to any subject with an ACS. The installation of the Freestyle Libre Pro iQ sensor will be performed upon admission to intensive care Cardiology and left in place for the duration of hospitalization. In case of the Freestyle Libre Pro iQ sensor defective or removed before discharge from hospital, and if the patient tolerates it, a new the Freestyle Libre Pro iQ sensor will be placed. If the duration of hospitalization exceeds 14 days, a 2nd sensor will be placed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects with ACS initially managed in a non-investigating center
* Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU
* Person participating in another research study with an ongoing exclusion period
* Subjects participating in a study that may have an impact on post ACS prognosis
* Person deprived of his or her rights, person under guardianship or curatorship
* Person deprived of liberty (by judicial or administrative decision)
* Persons whose physical and/or psychological health is severely impaired, which, in the opinion of the investigator, may affect the participant's compliance to the study
* Pregnant or breastfeeding women
* Person who is not affiliated to a social security system or who is a beneficiary of such a system.
18 Years
85 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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Hospital of Béziers
Béziers, , France
University Hospital of Bordeaux
Bordeaux, , France
University Hospital of Montpellier
Montpellier, , France
University Hospital of Nîmes
Nîmes, , France
AP-HP Lariboisière Hospital
Paris, , France
APHP - Hôpital Européen Georges Pompidou
Paris, , France
Hospital of Pau
Pau, , France
University Hospital of Toulouse
Toulouse, , France
Vannes Bretagne Atlantique Hospital
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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Frédéric GEORGER, MD
Role: primary
Jean-Michel ANDRIEU, MD
Role: backup
Benoît LATTUCA, Pr
Role: primary
Véronique TAILLARD, Dr
Role: backup
Pierre POUSTIS, MD
Role: primary
Christel VOINOT, MD
Role: backup
Other Identifiers
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RECHMPL22_0395
Identifier Type: -
Identifier Source: org_study_id
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