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

NCT06014112 | Recruiting

• 1 other identifier: RECHMPL22_0395
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Continuous Glucose Measurement; Glycemic Variability; Cardiovascular Event

Keywords

acute coronary syndrome; continuous glucose measurement; glycemic variability; cardiovascular event

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  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 Outcomes (2)

• Diabetes

  12 months

• Diabetes

  2 months

Study Arms (1)

Freestyle Libre PRO iQ sensor

EXPERIMENTAL

Eligible patients

Device: Freestyle Libre Pro iQ

Interventions

Freestyle Libre Pro iQ DEVICE

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.

Freestyle Libre PRO iQ sensor

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (9)

Hospital of Béziers

Béziers, 34500, France

RECRUITING

University Hospital of Bordeaux

Bordeaux, 33604, France

RECRUITING

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

University Hospital of Nîmes

Nîmes, 30029, France

RECRUITING

AP-HP Lariboisière Hospital

Paris, 75010, France

RECRUITING

APHP - Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Hospital of Pau

Pau, 64046, France

RECRUITING

University Hospital of Toulouse

Toulouse, 31059, France

RECRUITING

Vannes Bretagne Atlantique Hospital

Vannes, France

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Ariane SULTAN, Professor

CONTACT

0467338431; a-sultan@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): May 6, 2028
• Study Completion (Estimated): May 6, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

FR (9)