<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/NCT01669616</url>
  </required_header>
  <id_info>
    <org_study_id>VL-2723</org_study_id>
    <nct_id>NCT01669616</nct_id>
  </id_info>
  <brief_title>Point of Service Diabetes Screening Evaluation</brief_title>
  <acronym>POSSE</acronym>
  <official_title>Point of Service Diabetes Screening Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VeraLight, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VeraLight, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the trial is to collect SCOUT DS, random capillary glucose and&#xD;
      Hemoglobin A1c measurements from subject 18 years of age or older.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to compare the accuracy of SCOUT versus random capillary&#xD;
      glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined&#xD;
      dysglycemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia.</measure>
    <time_frame>one week</time_frame>
  </primary_outcome>
  <enrollment type="Actual">667</enrollment>
  <condition>Diabetes Mellitus, Non-Insulin Dependent</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Attendees of Blue Cross Blue Shield Wellness Event&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known to be pregnant (self-reported)&#xD;
&#xD;
          -  Receiving dialysis or known renal compromise&#xD;
&#xD;
          -  Known to have photosensitivity&#xD;
&#xD;
          -  Taking medications that fluoresce&#xD;
&#xD;
          -  Have scars, any tattoos, rashes or other disruption/discoloration on the left volar&#xD;
             forearm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Barrack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Blue Cross Blue Shield of Louisiana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Blue Cross Blue Shield of Louisiana</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>July 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>January 13, 2013</last_update_submitted>
  <last_update_submitted_qc>January 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Adults 18 years and older</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01669616
org study id: VL-2723
nct id: NCT01669616
lead sponsor: 
has dmc: No
The primary objective of the trial is to collect SCOUT DS, random capillary glucose and
      Hemoglobin A1c measurements from subject 18 years of age or older.
The objectives of this study are to compare the accuracy of SCOUT versus random capillary
      glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined
      dysglycemia.
observational model: Cohort
time perspective: Cross-Sectional
measure: To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia.
time frame: one week
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Barrack, MD
role: Principal Investigator
affiliation: Blue Cross Blue Shield of Louisiana
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2