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

University Hospital, Montpellier (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Freestyle libre Pro

Study Design

Study Type:
Anticipated Enrollment :
852 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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


Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
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


No locations specified.

Sponsors and Collaborators

  • University Hospital, Montpellier


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
University Hospital, Montpellier Identifier:
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:

Study Results

No Results Posted as of Aug 28, 2023