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NCT06014112Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
850 (estimated)
First submitted
22 Aug 2023
Start date
Nov 2023
Primary completion date
May 2028
Lead sponsor
University Hospital, Montpellier
NCT number
NCT06014112

What you commit to

  • Study type: Interventional
  • Planned participants: 850
  • From Nov 2023 to the primary completion date, May 2028
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU

Other

  • Subjects in cardiogenic or septic shock
  • Subjects with ACS initially managed in a non-investigating center
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital of Béziers
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BéziersFranceRecruiting
University Hospital of Bordeaux
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BordeauxFranceRecruiting
University Hospital of Montpellier
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MontpellierFranceRecruiting
University Hospital of Nimes
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NîmesFranceRecruiting
APHP Hôpital Européen Georges Pompidou
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ParisFranceRecruiting
AP-HP Lariboisière Hospital
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ParisFranceRecruiting
Hospital of Pau
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PauFranceRecruiting
University Hospital of Toulouse
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ToulouseFranceRecruiting
Vannes Bretagne Atlantique Hospital
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VannesFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.