FREESCA: Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06014112

Collaborator

(none)

852

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Predictive value of parameters of interstitial glucose monitoring during acute coronary syndrome

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Continuous Glucose Measurement Glycemic Variability Cardiovascular Event	Device: Freestyle libre Pro	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

852 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome

Anticipated Study Start Date :

Oct 6, 2023

Anticipated Primary Completion Date :

Apr 5, 2026

Anticipated Study Completion Date :

Apr 5, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Freestyle libre pro sensor	Device: Freestyle libre Pro Freestyle Libre Pro, is marketed by the Abbott laboratory and has a CE mark for measuring glucose levels in interstitial fluid in people with diabetes. The FSL Pro provides continuous interstitial glucose measurement using a subcutaneous sensor that produces an electrical current that varies in intensity according to the interstitial glucose level. It allows continuous measurement, without access to real-time information, with retrospective reading of the data by a health professional. The professional LSP is based on a "black box" system that accumulates the data measured by the sensor for several days. This data is then restored by downloading the system, a posteriori, thanks to a software dedicated to health professionals.
No Intervention: No intervention

Arm

Intervention/Treatment

Experimental: Freestyle libre pro sensor

Device: Freestyle libre Pro

Freestyle Libre Pro, is marketed by the Abbott laboratory and has a CE mark for measuring glucose levels in interstitial fluid in people with diabetes. The FSL Pro provides continuous interstitial glucose measurement using a subcutaneous sensor that produces an electrical current that varies in intensity according to the interstitial glucose level. It allows continuous measurement, without access to real-time information, with retrospective reading of the data by a health professional. The professional LSP is based on a "black box" system that accumulates the data measured by the sensor for several days. This data is then restored by downloading the system, a posteriori, thanks to a software dedicated to health professionals.

No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

Cardiovascular events [12 months]
Occurrence within 12 months of hospital discharge of a composite end point including cardiovascular clinical events: recurrent MI, cardiovascular death, stroke, rhythm disturbance, and/or heart failure requiring hospitalization.

Secondary Outcome Measures

Diabetes [12 months]
Incidence of diabetes at 1-2 months in nondiabetic subjects admitted for ACS: fasting venous glucose measurement (≥ 1.26g/L) and HbA1c (≥ 6.5%). Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS will be made in the presence of chest pain with ST-segment elevation on the ECG for STEMI or ST-segment change and/or a positive troponin cycle (values in accordance with the center's protocol) for NSTEMI.

Exclusion Criteria:

Subjects in cardiogenic or septic shock
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT06014112

Other Study ID Numbers:

RECHMPL22_0395

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Study Results

No Results Posted as of Aug 28, 2023