xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06014112</url>
    </required_header>
    <id_info>
      <org_study_id>RECHMPL22_0395</org_study_id>
      <nct_id>NCT06014112</nct_id>
    </id_info>
    <brief_title>Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS</brief_title>
    <acronym>FREESCA</acronym>
    <official_title>Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Montpellier</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Montpellier</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Predictive value of parameters of interstitial glucose monitoring during acute coronary&#xD;
        syndrome&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 6, 2023</start_date>
    <completion_date type="Anticipated">April 5, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 5, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiovascular events</measure>
      <time_frame>12 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diabetes</measure>
      <time_frame>12 months</time_frame>
      <description>Incidence of diabetes at 1-2 months in nondiabetic subjects admitted for ACS: fasting venous glucose measurement (≥ 1.26g/L) and HbA1c (≥ 6.5%).&#xD;
  Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">852</enrollment>
    <condition>Acute Coronary Syndrome</condition>
    <condition>Continuous Glucose Measurement</condition>
    <condition>Glycemic Variability</condition>
    <condition>Cardiovascular Event</condition>
    <arm_group>
      <arm_group_label>Freestyle libre pro sensor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>No intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Freestyle libre Pro</intervention_name>
      <description>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.&#xD;
  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 &quot;black box&quot; 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.</description>
      <arm_group_label>Freestyle libre pro sensor</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS&#xD;
               will be made in the presence of chest pain with ST-segment elevation on the ECG for&#xD;
               STEMI or ST-segment change and/or a positive troponin cycle (values in accordance with&#xD;
               the center's protocol) for NSTEMI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects in cardiogenic or septic shock&#xD;
  &#xD;
            -  Subjects with ACS initially managed in a non-investigating center&#xD;
  &#xD;
            -  Failure to obtain free, informed, written consent signed by the participant and&#xD;
               investigator upon admission to the ICU&#xD;
  &#xD;
            -  Person participating in another research study with an ongoing exclusion period&#xD;
  &#xD;
            -  Subjects participating in a study that may have an impact on post ACS prognosis&#xD;
  &#xD;
            -  Person deprived of his or her rights, person under guardianship or curatorship&#xD;
  &#xD;
            -  Person deprived of liberty (by judicial or administrative decision)&#xD;
  &#xD;
            -  Persons whose physical and/or psychological health is severely impaired, which, in the&#xD;
               opinion of the investigator, may affect the participant's compliance to the study&#xD;
  &#xD;
            -  Pregnant or breastfeeding women&#xD;
  &#xD;
            -  Person who is not affiliated to a social security system or who is a beneficiary of&#xD;
               such a system.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ariane SULTAN, Professor</last_name>
      <phone>0467338431</phone>
      <email>a-sultan@chu-montpellier.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Coronary Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06014112
  org study id: RECHMPL22_0395
  nct id: NCT06014112
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Predictive value of parameters of interstitial glucose monitoring during acute coronary
        syndrome
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cardiovascular events
  time frame: 12 months
  description: 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.
  measure: Diabetes
  time frame: 12 months
  description: 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%).
  arm group label: Freestyle libre pro sensor
  arm group type: Experimental
  arm group label: No intervention
  arm group type: No Intervention
  intervention type: Device
  intervention name: Freestyle libre Pro
  description: 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.
  arm group label: Freestyle libre pro sensor
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Ariane SULTAN, Professor
  phone: 0467338431
  email: a-sultan@chu-montpellier.fr
  responsible party type: Sponsor
  mesh term: Acute Coronary Syndrome
  mesh term: Syndrome