<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/NCT01720381</url>
  </required_header>
  <id_info>
    <org_study_id>2001078</org_study_id>
    <nct_id>NCT01720381</nct_id>
  </id_info>
  <brief_title>OptiScanner Versus Standard Blood Glucose Monitoring</brief_title>
  <official_title>Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OptiScan Biomedical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OptiScan Biomedical Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels&#xD;
      in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000,&#xD;
      the reference standard for Erasme University Hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose Prediction error</measure>
    <time_frame>1 year</time_frame>
    <description>Percent (%) predicted error is the percent (%) error result of the OptiScanner on central venous blood from the superior cava versus the YSI and the GEM using arterial blood.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clarke Error Grid analysis</measure>
    <time_frame>1 year</time_frame>
    <description>The Clarke Error Grid analysis shows the percentage of paired values falling within each zone between the glucose results of the OptiScanner on central venous versus the YSI and the GEM using arterial blood.</description>
  </secondary_outcome>
  <enrollment type="Actual">98</enrollment>
  <condition>Hyperglycemia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      One additional blood sample (4 ml)will be collected once a day, separated into Draw an&#xD;
      additional ~ 4.0 mL from the subject into a syringe once per every 24 hour period. The study&#xD;
      site will indicate where and at what time the sample was taken. This sample is placed into a&#xD;
      sodium heparin tube, labeled with the subject number and sampling time and centrifuged on a&#xD;
      refrigerated centrifuge. The gained plasma will be frozen at minus 70 degrees Celsius or less&#xD;
      and may be used for potential analysis by the Sponsor, should an analysis of outliers&#xD;
      indicate the potential presence of an interferent.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients admitted to the intensive care unit (ICU) of Erasme University&#xD;
        Hospital in Brussels, Belgium.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed consent.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Admitted to the ICU of Erasme University Hospital.&#xD;
&#xD;
          -  Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by the Principle&#xD;
             Investigator).&#xD;
&#xD;
          -  APACHE II score of ≥ 10, within the first 24 hours of ICU admission.&#xD;
&#xD;
          -  Existing central venous catheter + arterial catheter.&#xD;
&#xD;
          -  No participation in any other investigational interventional study while enrolled in&#xD;
             this study.&#xD;
&#xD;
          -  Hyperglycemia (BG &gt; 150 mg/dl) at the time of admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Charles Preiser, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasme University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasme University Hospital</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>June 23, 2014</last_update_submitted>
  <last_update_submitted_qc>June 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>monitoring</keyword>
  <keyword>blood glucose</keyword>
  <keyword>intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01720381
org study id: 2001078
nct id: NCT01720381
lead sponsor: 
collaborator: 
has dmc: Yes
The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels
      in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000,
      the reference standard for Erasme University Hospital.
observational model: Case-Control
time perspective: Prospective
measure: Glucose Prediction error
time frame: 1 year
description: Percent (%) predicted error is the percent (%) error result of the OptiScanner on central venous blood from the superior cava versus the YSI and the GEM using arterial blood.
measure: Clarke Error Grid analysis
time frame: 1 year
description: The Clarke Error Grid analysis shows the percentage of paired values falling within each zone between the glucose results of the OptiScanner on central venous versus the YSI and the GEM using arterial blood.
One additional blood sample (4 ml)will be collected once a day, separated into Draw an
      additional ~ 4.0 mL from the subject into a syringe once per every 24 hour period. The study
      site will indicate where and at what time the sample was taken. This sample is placed into a
      sodium heparin tube, labeled with the subject number and sampling time and centrifuged on a
      refrigerated centrifuge. The gained plasma will be frozen at minus 70 degrees Celsius or less
      and may be used for potential analysis by the Sponsor, should an analysis of outliers
      indicate the potential presence of an interferent.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Charles Preiser, MD, PhD
role: Principal Investigator
affiliation: Erasme University Hospital
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Hyperglycemia