Acute Coronary SyndromeFREESCANCT06014112
Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS
A study testing Freestyle Libre Pro iQ in people with Acute Coronary Syndrome and Continuous Glucose Measurement, run by University Hospital, Montpellier at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, Continuous Glucose Measurement, Glycemic Variability
- What is being tested?
- Freestyle Libre Pro iQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 9 sitesFrance
- Study dates
- 6 Nov 2023to 6 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Hospital of Béziers
Béziers, 34500
Frédéric GEORGER, MD, 0467357134 ext. 33
Jean-Michel ANDRIEU, MD, 0467357636 ext. 33
- Recruiting
University Hospital of Bordeaux
Bordeaux, 33604
Edouard GERBAUD, MD, 0557656446 ext. 33, edouard.gerbaud@chu-bordeaux.fr
CATARGI Bogdan Nicolescu, MD, bogdan.catargi@chu-bordeaux.fr
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
François ROUBILLE, PU-PH, 0467335953 ext. 33, f-roubille@chu-montpellier.fr
Ariane SULTAN, PU-PH, 0467338402 ext. 33, a-sultan@chu-montpellier.fr
- Recruiting
University Hospital of Nîmes
Nîmes, 30029
Benoît LATTUCA, Pr, 0466683116 ext. 33
Véronique TAILLARD, Dr, 0466683321 ext. 33
- Recruiting
AP-HP Lariboisière Hospital
Paris, 75010
Patrick HENRI, Pr, 0149959017 ext. 33, patrick.henry@aphp.fr
Jean François GAUTHIER, Pr, 0149959020, jean-francois.gauthier@aphp.fr
- Recruiting
APHP - Hôpital Européen Georges Pompidou
Paris, 75015
PUYMIRAT Etienne, MD, 0156092851 ext. 33, etienne.puymirat@aphp.fr
PUYMIRAT Etienne, MD
- Recruiting
Hospital of Pau
Pau, 64046
Pierre POUSTIS, MD, 0559924878 ext. 33
Christel VOINOT, MD, 0559727301 ext. 33
- Recruiting
University Hospital of Toulouse
Toulouse, 31059
Meyer ELBAZ, Pr, 0561323649 ext. 33, elbaz.m@chu-toulouse.fr
Pierre GOURDY, Pr, 0561323740 ext. 33, pierre.gourdy@inserm.fr
- Recruiting
Vannes Bretagne Atlantique Hospital
Vannes
HUET Fabien, MD, 0297416727 ext. 33, fabien.huet@ch-bretagne-atlantique.fr
ARNAULT Gwénaëlle, MD, gwenaelle.arnault@ch-bretagne-atlantique.fr
About this study
Official title: 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.
Read more
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
- Being tested
- Freestyle Libre Pro iQ
- Keywords
- acute coronary syndrome, continuous glucose measurement, glycemic variability, cardiovascular event
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle Libre Pro iQDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Freestyle Libre PRO iQ sensor | Experimental | Eligible patients Receives: Device: Freestyle Libre Pro iQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Diabetes
Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%).
Measured: 12 months
Diabetes
Incidence of diabetes at 1-2 months in nondiabetic subjects admitted for ACS: fasting venous glucose measurement (≥ 1.26g/L) and HbA1c (≥ 6.5%).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start6 Nov 2023
- Primary completion6 May 2028 (estimated)
- Study completion6 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014112
- Sponsor's protocol ID
- RECHMPL22_0395
- Other IDs
- 2022-A02826-37
- Acronym
- FREESCA
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tournayre S, Gerbaud E, Poustis P, Catargi B, Voinot C, Elbaz M, Gourdy P, Lattuca B, Taillard V, Henry P, Gauthier JF, Georger F, Andrieu JM, Puymirat E, Huet F, Arnault G, Nagot N, Roubille F, Sultan A. Rational and design of the FREESCA study: A multicenter prospective study assessing the prognostic value of continuous glucose monitoring during hospitalization for acute coronary syndrome. Am Heart J Plus. 2026 Oct 19;72:100950. doi: 10.1016/j.ahjo.2026.100950. eCollection 2026 Dec.
PubMed 42985666
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06014112
- Acronym / sponsor ID
- FREESCA / RECHMPL22_0395
- Conditions
- Acute Coronary Syndrome, Continuous Glucose Measurement, Glycemic Variability, Cardiovascular Event
- Keywords
- acute coronary syndrome, continuous glucose measurement, glycemic variability, cardiovascular event
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 6 May 2028 (estimated)
- Study completion
- 6 May 2028 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freestyle Libre PRO iQ sensor | Experimental | Device: Freestyle Libre Pro iQEligible patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freestyle Libre Pro iQFreestyle 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. | Device | Freestyle Libre PRO iQ sensor |
Primary outcome
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.
2 secondary outcomes
Diabetes
Time frame: 12 months
Diabetes
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 42985666Tournayre S, Gerbaud E, Poustis P, Catargi B, Voinot C, Elbaz M, Gourdy P, Lattuca B, Taillard V, Henry P, Gauthier JF, Georger F, Andrieu JM, Puymirat E, Huet F, Arnault G, Nagot N, Roubille F, Sultan A. Rational and design of the FREESCA study: A multicenter prospective study assessing the prognostic value of continuous glucose monitoring during hospitalization for acute coronary syndrome. Am Heart J Plus. 2026 Oct 19;72:100950. doi: 10.1016/j.ahjo.2026.100950. eCollection 2026 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freestyle Libre Pro iQ in people with Acute Coronary Syndrome and Continuous Glucose Measurement, run by University Hospital, Montpellier at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariane SULTAN, Professor (0467338431, a-sultan@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06014112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.