<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/NCT02238041</url>
  </required_header>
  <id_info>
    <org_study_id>2014-02</org_study_id>
    <nct_id>NCT02238041</nct_id>
  </id_info>
  <brief_title>GlucoClear ICU Study</brief_title>
  <official_title>An ICU Study of Safety and Accuracy Using the GlucoClear CGM System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear&#xD;
      CGM System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: Non-randomized, non-treatment, prospective, open label Study.&#xD;
&#xD;
      The GlucoClear System will not display real-time glucose values, glucose trend graphs, or&#xD;
      glucose alarms to either the Study subjects or the Study site clinical personnel. There will&#xD;
      be no treatment of any subject based on the output of the System.&#xD;
&#xD;
      After providing written informed consent, subjects meeting inclusion/exclusion criteria will&#xD;
      be monitored by the System for a maximum of 72 hours.&#xD;
&#xD;
      Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose&#xD;
      measurements on blood glucose analyzers over the 72 hour period.&#xD;
&#xD;
      After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14&#xD;
      days later, and any subsequent adverse events will be documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Discontinued program&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>15/20% Accuracy</measure>
    <time_frame>During 72 hours of anticipated Sensor dwell time.</time_frame>
    <description>15/20% Accuracy: The proportion of GlucoClear glucose measurements within ± 15 mg/dL of Comparator values &lt; 75 mg/dL and within ± 20% of Comparator values ≥ 75 mg/dL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>12/15% Trend Accuracy</measure>
    <time_frame>During 72 hours of anticipated Sensor dwell time.</time_frame>
    <description>12/15% Trend Accuracy: The proportion of GlucoClear glu-cose measurements within ± 12 mg/dL of the interpolated value between two sequential Com-parator values if that interpolat-ed comparator value is &lt; 80 mg/dL and within ± 15% of in-terpolated Comparator values ≥ 80 mg/dL).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Intensive Care Unit Blood Glucose Monitoring</condition>
  <arm_group>
    <arm_group_label>GlucoClear System</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GlucoClear System</intervention_name>
    <arm_group_label>GlucoClear System</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with an anticipated surgical lCU or surgical lCU plus intermediate care unit&#xD;
        stay of at least 24 hours.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours&#xD;
             Signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Transplant patient End stage medical conditions or diseases Restricted venous access&#xD;
        History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy&#xD;
        test In another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 29, 2015</last_update_submitted>
  <last_update_submitted_qc>September 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glucose monitoring</keyword>
  <keyword>Intensive care unit</keyword>
  <!-- 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/NCT02238041
org study id: 2014-02
nct id: NCT02238041
lead sponsor: 
has dmc: No
The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear
      CGM System.
Design: Non-randomized, non-treatment, prospective, open label Study.

      The GlucoClear System will not display real-time glucose values, glucose trend graphs, or
      glucose alarms to either the Study subjects or the Study site clinical personnel. There will
      be no treatment of any subject based on the output of the System.

      After providing written informed consent, subjects meeting inclusion/exclusion criteria will
      be monitored by the System for a maximum of 72 hours.

      Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose
      measurements on blood glucose analyzers over the 72 hour period.

      After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14
      days later, and any subsequent adverse events will be documented.
time perspective: Prospective
measure: 15/20% Accuracy
time frame: During 72 hours of anticipated Sensor dwell time.
description: 15/20% Accuracy: The proportion of GlucoClear glucose measurements within ± 15 mg/dL of Comparator values < 75 mg/dL and within ± 20% of Comparator values ≥ 75 mg/dL)
measure: 12/15% Trend Accuracy
time frame: During 72 hours of anticipated Sensor dwell time.
description: 12/15% Trend Accuracy: The proportion of GlucoClear glu-cose measurements within ± 12 mg/dL of the interpolated value between two sequential Com-parator values if that interpolat-ed comparator value is < 80 mg/dL and within ± 15% of in-terpolated Comparator values ≥ 80 mg/dL).
arm group label: GlucoClear System
intervention type: Device
intervention name: GlucoClear System
arm group label: GlucoClear System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor