<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/NCT01726114</url>
  </required_header>
  <id_info>
    <org_study_id>C8CSP_19042012</org_study_id>
    <nct_id>NCT01726114</nct_id>
  </id_info>
  <brief_title>A Clinical Study of the C8 MediSensors Optical Glucose Monitor™</brief_title>
  <acronym>Spectrum</acronym>
  <official_title>A Clinical Study to Evaluate the Performance of the C8 MediSensors Optical Glucose Monitor™ During On-Site Testing and Real Time Use Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>C8 MediSensors, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>C8 MediSensors, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare glucose measurements from the C8 MediSensors&#xD;
      non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow&#xD;
      Springs Instrument(YSI) blood glucose analyzer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, open label study to evaluate the performance of the C8&#xD;
      MediSensors non-invasive Optical Glucose Monitor™ on individuals with diabetes mellitus.&#xD;
      Capillary blood samples will be obtained throughout a daily study session; the study session&#xD;
      may last for up to 12 hours. Blood glucose will be measured on a YSI blood glucose analyzer.&#xD;
      Subjects may adjust food intake and insulin administration so device performance is evaluated&#xD;
      across a broad range of glucose concentrations. Glucose measurements will be time matched and&#xD;
      paired for comparison. Skin effects and adverse events will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of the test device in comparison to the reference device</measure>
    <time_frame>6 months</time_frame>
    <description>The primary objective is to characterize the accuracy of the non-invasive glucose measurements from the Optical Glucose Monitor™ to blood glucose measurements on a sample size of approximately 30 subjects with 1000 time matched, paired data points.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Non-invasive Optical Glucose Monitor™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-invasive Optical Glucose Monitor™</intervention_name>
    <description>Test device</description>
    <arm_group_label>Non-invasive Optical Glucose Monitor™</arm_group_label>
    <other_name>Continuous glucose monitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>YSI blood glucose analyzer</intervention_name>
    <description>Reference device</description>
    <arm_group_label>Non-invasive Optical Glucose Monitor™</arm_group_label>
    <other_name>Yellow Springs Instruments (YSI) blod glucose analyzer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older.&#xD;
&#xD;
          2. Understands and agrees to comply with study instructions.&#xD;
&#xD;
          3. Read, understood, signed and dated the Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Extensive skin changes or diseases that preclude wearing the test device at the&#xD;
             proposed wear site(s) (e.g., extensive psoriasis, recent burns or severe sunburn,&#xD;
             extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).&#xD;
&#xD;
          3. Employed by a company within the diabetes field other than the study sponsor.&#xD;
&#xD;
          4. Medical history or any condition that may, in the opinion of the investigator,&#xD;
             compromise the subject's ability to participate.&#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>Vice President, Clincal, Regulatory, Quality</last_name>
    <role>Principal Investigator</role>
    <affiliation>C8 MediSensors, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>C8 MediSensors, Inc.</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>March 23, 2013</last_update_submitted>
  <last_update_submitted_qc>March 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>continuous Glucose Monitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT01726114
org study id: C8CSP_19042012
nct id: NCT01726114
lead sponsor: 
has dmc: No
The purpose of this study is to compare glucose measurements from the C8 MediSensors
      non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow
      Springs Instrument(YSI) blood glucose analyzer.
This is a prospective, non-randomized, open label study to evaluate the performance of the C8
      MediSensors non-invasive Optical Glucose Monitor™ on individuals with diabetes mellitus.
      Capillary blood samples will be obtained throughout a daily study session; the study session
      may last for up to 12 hours. Blood glucose will be measured on a YSI blood glucose analyzer.
      Subjects may adjust food intake and insulin administration so device performance is evaluated
      across a broad range of glucose concentrations. Glucose measurements will be time matched and
      paired for comparison. Skin effects and adverse events will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Performance of the test device in comparison to the reference device
time frame: 6 months
description: The primary objective is to characterize the accuracy of the non-invasive glucose measurements from the Optical Glucose Monitor™ to blood glucose measurements on a sample size of approximately 30 subjects with 1000 time matched, paired data points.
arm group label: Non-invasive Optical Glucose Monitor™
arm group type: Experimental
description: Test device
intervention type: Device
intervention name: Non-invasive Optical Glucose Monitor™
description: Test device
arm group label: Non-invasive Optical Glucose Monitor™
other name: Continuous glucose monitor
intervention type: Device
intervention name: YSI blood glucose analyzer
description: Reference device
arm group label: Non-invasive Optical Glucose Monitor™
other name: Yellow Springs Instruments (YSI) blod glucose analyzer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vice President, Clincal, Regulatory, Quality
role: Principal Investigator
affiliation: C8 MediSensors, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus