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

July 28, 2025 updated by: University Hospital, Montpellier

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

Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33604
      • Béziers, France, 34500
        • Recruiting
        • Hospital of Béziers
        • Contact:
          • Frédéric GEORGER, MD
          • Phone Number: 33 0467357134
        • Contact:
          • Jean-Michel ANDRIEU, MD
          • Phone Number: 33 0467357636
        • Principal Investigator:
          • Frédéric GEORGER
      • Montpellier, France, 34295
        • Recruiting
        • University Hospital of Montpellier
        • Principal Investigator:
          • Ariane SULTAN
        • Contact:
        • Contact:
        • Sub-Investigator:
          • François ROUBILLE
      • Nîmes, France, 30029
        • Recruiting
        • University Hospital of Nîmes
        • Principal Investigator:
          • Benoît LATTUCA
        • Contact:
          • Benoît LATTUCA, Pr
          • Phone Number: 33 0466683116
        • Contact:
          • Véronique TAILLARD, Dr
          • Phone Number: 33 0466683321
      • Paris, France, 75010
        • Recruiting
        • AP-HP Lariboisière Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick HENRI
      • Paris, France, 75015
        • Recruiting
        • APHP - Hôpital Européen Georges Pompidou
        • Contact:
        • Principal Investigator:
          • PUYMIRAT Etienne, MD
      • Pau, France, 64046
        • Recruiting
        • Hospital of Pau
        • Principal Investigator:
          • Nicolas DELARCHE
        • Contact:
          • Christel VOINOT, MD
          • Phone Number: 33 0559727301
        • Contact:
          • Pierre POUSTIS, MD
          • Phone Number: 33 0559924878
      • Toulouse, France, 31059
        • Recruiting
        • University Hospital of Toulouse
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meyer Elbaz
      • Vannes, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Freestyle Libre PRO iQ sensor
Eligible patients
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes
Time Frame: 12 months
Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%).
12 months
Diabetes
Time Frame: 2 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%).
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

May 6, 2028

Study Completion (Estimated)

May 6, 2028

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0395

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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