<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/NCT02236364</url>
  </required_header>
  <id_info>
    <org_study_id>Irisense</org_study_id>
    <nct_id>NCT02236364</nct_id>
  </id_info>
  <brief_title>Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye</brief_title>
  <official_title>Blood Glucose Monitoring Based on Imaging of the Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toledo Health Science Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toledo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toledo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown&#xD;
      that glucose present in the fluid in the front of the eye, called the aqueous humor,&#xD;
      correlates well with blood glucose. As blood glucose changes, the optical properties of the&#xD;
      aqueous humor change, causing a change in the appearance of the iris of the eye.. The data&#xD;
      collected in this study will be shared with IRISense to assist in validating the algorithm&#xD;
      being used to develop the database needed. The data collected so far is in a narrow band of&#xD;
      the normal glycemic range (healthy volunteers). We will collect standard digital photographic&#xD;
      images of the eyes of subjects with diabetes along with corresponding blood glucose&#xD;
      concentrations using the finger stick glucose monitoring method. In order to do this we will&#xD;
      use standard digital photography techniques that is embedded in our benchtop prototype device&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No positive results were detected&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Photographic Images of the eye</measure>
    <time_frame>60 day period</time_frame>
    <description>The subject will be scheduled for 3 visits. Scheduling for testing will be performed by the principal investigator. Each subject will be required to take part in three individual or group testing sessions of 45-90 minutes over a 60 day period.&#xD;
Eight digital photographic image of the subject's iris will be obtained at various times during each visit under standard illumination using the developed instrumentation. A point-of-care fingerstick blood glucose reading will be taken with an FDA approved blood glucose measurement device (i.e., Contour, Bayer Healthcare, LLC) as close to simultaneously as possible with the photograph.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>New device for OPTICAL determination of blood glucose level</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contour, Bayer Healthcare, LLC</intervention_name>
    <description>Blood glucose measurement</description>
    <arm_group_label>New device for OPTICAL determination of blood glucose level</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Diabetes Type 1 and 2 and can be verified by the principal investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any disease or abnormality of the eye&#xD;
&#xD;
          -  Patients who are mentally incapacitated, cognitively impaired or with severe&#xD;
             psychological disorders and cannot sign consent on their own&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Toledo, Health Science Campus</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <pending_results>
    <submitted>November 3, 2020</submitted>
    <returned>November 25, 2020</returned>
  </pending_results>
  <!-- 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/NCT02236364
org study id: Irisense
nct id: NCT02236364
lead sponsor: 
collaborator: 
has dmc: No
Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown
      that glucose present in the fluid in the front of the eye, called the aqueous humor,
      correlates well with blood glucose. As blood glucose changes, the optical properties of the
      aqueous humor change, causing a change in the appearance of the iris of the eye.. The data
      collected in this study will be shared with IRISense to assist in validating the algorithm
      being used to develop the database needed. The data collected so far is in a narrow band of
      the normal glycemic range (healthy volunteers). We will collect standard digital photographic
      images of the eyes of subjects with diabetes along with corresponding blood glucose
      concentrations using the finger stick glucose monitoring method. In order to do this we will
      use standard digital photography techniques that is embedded in our benchtop prototype device
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Photographic Images of the eye
time frame: 60 day period
description: The subject will be scheduled for 3 visits. Scheduling for testing will be performed by the principal investigator. Each subject will be required to take part in three individual or group testing sessions of 45-90 minutes over a 60 day period.
Eight digital photographic image of the subject's iris will be obtained at various times during each visit under standard illumination using the developed instrumentation. A point-of-care fingerstick blood glucose reading will be taken with an FDA approved blood glucose measurement device (i.e., Contour, Bayer Healthcare, LLC) as close to simultaneously as possible with the photograph.
arm group label: New device for OPTICAL determination of blood glucose level
arm group type: Experimental
intervention type: Device
intervention name: Contour, Bayer Healthcare, LLC
description: Blood glucose measurement
arm group label: New device for OPTICAL determination of blood glucose level
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
submitted: November 3, 2020
returned: November 25, 2020