<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/NCT02211300</url>
  </required_header>
  <id_info>
    <org_study_id>2002055</org_study_id>
    <nct_id>NCT02211300</nct_id>
  </id_info>
  <brief_title>MANAGE Automated Glucose Monitoring</brief_title>
  <acronym>MANAGE IDE</acronym>
  <official_title>MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OptiScan Biomedical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OptiScan Biomedical Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to demonstrate that the OptiScanner® is safe and can provide&#xD;
      accurate blood glucose levels in critically ill subjects.&#xD;
&#xD;
      Accuracy Hypothesis:&#xD;
&#xD;
      The assessment of blood glucose level that results from the OptiScanner is comparable to the&#xD;
      YSI 2300 STAT Plus™ Glucose and Lactate Analyzer (&quot;YSI Analyzer&quot;; YSI Life Sciences, Yellow&#xD;
      Springs, OH).&#xD;
&#xD;
      Safety Hypothesis:&#xD;
&#xD;
      The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated&#xD;
      automated blood glucose levels for critically ill subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Accuracy Endpoint</measure>
    <time_frame>Accurancy up to 72 hours of monitoring per subject</time_frame>
    <description>The mean absolute relative difference (MARD) in glucose level between the OptiScanner and the YSI Analyzer (average of 2 measures). To demonstrate accuracy the MARD must be less than or equal to 10%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Accuracy Endpoint</measure>
    <time_frame>Accuracy up to 72 hours of subject monitoring</time_frame>
    <description>The &quot;population CV&quot; will be computed as the standard deviation of the difference between the glucose level reported by the OptiScanner and the glucose level reported by the YSI Analyzer divided by the mean of the YSI Analyzer values. Repeated measures analyses will be used to account for possible correlation of measurements within patients. The population CV therefore gives an estimate of the extent of the effect of outliers on the accuracy estimation. If the &quot;population CV&quot; is less than 13%, the outcome of the secondary accuracy analysis will be considered a success.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Adverse events</measure>
    <time_frame>up to 72 hours of subject monitoring</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>ICU/CCU Patients Requiring Blood Glucose Monitoring</condition>
  <arm_group>
    <arm_group_label>Optiscanner values vs YSI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Matched samples up to 12 times per 24 hour period</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The OptiScanner</intervention_name>
    <description>treatment of blood glucose per standard of care</description>
    <arm_group_label>Optiscanner values vs YSI</arm_group_label>
    <other_name>OptiScanner</other_name>
    <other_name>Yellow Springs Instrument</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>YSI 2300 STAT Plus™</intervention_name>
    <arm_group_label>Optiscanner values vs YSI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent by participant or his/her legally authorized representative&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Admitted to the ICU or CCU&#xD;
&#xD;
          -  Expected ICU or CCU stay of at least 18 hours at the time of enrollment (as judged by&#xD;
             Investigator)&#xD;
&#xD;
          -  Requires blood glucose monitoring; and&#xD;
&#xD;
          -  A vascular access device that can be dedicated for connection to the OptiScanner is&#xD;
             either already in-place, is planned to be placed for another purpose or can, in the&#xD;
             opinion of the Investigator be safely placed exclusively for use in this study, and&#xD;
             another access device is in place or can be placed for manually drawing samples to be&#xD;
             evaluated using the YSI Analyzer. Note that CVCs should not be placed solely for the&#xD;
             purposes of conducting this study. Refer to section 1.2.7 for details regarding&#xD;
             vascular access devices and guidelines for selection and placement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  In the Investigator's opinion the subject cannot safely tolerate the amount of saline&#xD;
             required to be given to the subject (up to 360 mL per day)&#xD;
&#xD;
          -  Hematocrit less than 15% or greater than 60%&#xD;
&#xD;
          -  Subjects that require placement of an additional vascular access line will be excluded&#xD;
             if they do not have a suitable access site free from any of the following conditions:&#xD;
&#xD;
               -  Peripheral vascular disease&#xD;
&#xD;
               -  History of placement site neuropathy or chronic pain&#xD;
&#xD;
               -  History of placement extremity coagulopathy or clot formation&#xD;
&#xD;
               -  History of vascular surgery on the same extremity as catheter placement&#xD;
&#xD;
          -  Any medical condition that, in the Investigator's opinion, would warrant exclusion&#xD;
             from the study or prevent the subject from completing the study, including but not&#xD;
             limited to a high risk of complications associated with vascular access; or&#xD;
&#xD;
          -  Participation in any other investigational drug or device study in the last 30 days&#xD;
             and/or while enrolled in this 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>
  <overall_official>
    <last_name>Grant V Bochicchio, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stanley A Nasraway, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anthony Furnary, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Providence St. Vincents Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda Moore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hermann Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dana Deyette, RN</last_name>
    <phone>510-342-5836</phone>
    <email>ddeyette@optiscancorp.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Carpenter</last_name>
      <phone>210-632-8883</phone>
      <email>rcarpenter1@tuftsmedicalcenter.org</email>
    </contact>
    <investigator>
      <last_name>Stanley Nasraway, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacey Reese, MS, RN</last_name>
      <email>reeses@wudosis.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Grant Bochicchio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Heart and Vascular Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Aiona, CCRC</last_name>
      <phone>503-216-8770</phone>
      <email>Heather.M.Aiona@providence.org</email>
    </contact>
    <investigator>
      <last_name>Anthony Furnary, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hermann Memorial Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carrie Howard, CCRC</last_name>
      <phone>713-500-5461</phone>
      <email>Carrie.L.Howard@uth.tmc.edu</email>
    </contact>
    <investigator>
      <last_name>Laura Moore, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>June 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>June 25, 2015</last_update_submitted>
  <last_update_submitted_qc>June 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glucose monitoring</keyword>
  <keyword>OptiScanner</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/NCT02211300
org study id: 2002055
nct id: NCT02211300
lead sponsor: 
has dmc: Yes
The objective of this study is to demonstrate that the OptiScanner® is safe and can provide
      accurate blood glucose levels in critically ill subjects.

      Accuracy Hypothesis:

      The assessment of blood glucose level that results from the OptiScanner is comparable to the
      YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI Analyzer"; YSI Life Sciences, Yellow
      Springs, OH).

      Safety Hypothesis:

      The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated
      automated blood glucose levels for critically ill subjects.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Primary Accuracy Endpoint
time frame: Accurancy up to 72 hours of monitoring per subject
description: The mean absolute relative difference (MARD) in glucose level between the OptiScanner and the YSI Analyzer (average of 2 measures). To demonstrate accuracy the MARD must be less than or equal to 10%.
measure: Secondary Accuracy Endpoint
time frame: Accuracy up to 72 hours of subject monitoring
description: The "population CV" will be computed as the standard deviation of the difference between the glucose level reported by the OptiScanner and the glucose level reported by the YSI Analyzer divided by the mean of the YSI Analyzer values. Repeated measures analyses will be used to account for possible correlation of measurements within patients. The population CV therefore gives an estimate of the extent of the effect of outliers on the accuracy estimation. If the "population CV" is less than 13%, the outcome of the secondary accuracy analysis will be considered a success.
measure: Number of Adverse events
time frame: up to 72 hours of subject monitoring
arm group label: Optiscanner values vs YSI
arm group type: Experimental
description: Matched samples up to 12 times per 24 hour period
intervention type: Device
intervention name: The OptiScanner
description: treatment of blood glucose per standard of care
arm group label: Optiscanner values vs YSI
other name: OptiScanner
other name: Yellow Springs Instrument
intervention type: Device
intervention name: YSI 2300 STAT Plus™
arm group label: Optiscanner values vs YSI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Grant V Bochicchio, MD, MPH
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Stanley A Nasraway, MD
role: Principal Investigator
affiliation: Tufts Medical Center
last name: Anthony Furnary, MD
role: Principal Investigator
affiliation: Providence St. Vincents Medical Center
last name: Linda Moore, MD
role: Principal Investigator
affiliation: Hermann Memorial Hospital
last name: Dana Deyette, RN
phone: 510-342-5836
email: ddeyette@optiscancorp.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor