<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/NCT01699763</url>
  </required_header>
  <id_info>
    <org_study_id>CTD-2012-007-01</org_study_id>
    <nct_id>NCT01699763</nct_id>
  </id_info>
  <brief_title>Evaluation of Blood Glucose Monitoring Systems</brief_title>
  <official_title>Evaluation of Blood Glucose Meter Systems - Contour® NEXT LINK Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascensia Diabetes Care</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascensia Diabetes Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring&#xD;
      System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other&#xD;
      companies. All meter BG results were compared with plasma results obtained with a reference&#xD;
      laboratory glucose method (YSI Glucose Analyzer).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring&#xD;
      System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other&#xD;
      companies. All meter BG results were compared with plasma results obtained with a reference&#xD;
      laboratory glucose method (YSI Glucose Analyzer). Performance of the three systems was&#xD;
      evaluated across the glucose range of the BGMSs using capillary blood. All testing and&#xD;
      lancing was performed by study staff and some samples were tested from subject fingertips.&#xD;
      Additionally, some blood samples were glycolyzed to lower the glucose concentration levels&#xD;
      and glucose solution was added to other samples to raise glucose concentration levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range</measure>
    <time_frame>8 hours</time_frame>
    <description>Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (&lt;=80 mg/dL)</measure>
    <time_frame>8 hours</time_frame>
    <description>Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (&gt;180 mg/dL)</measure>
    <time_frame>8 hours</time_frame>
    <description>Using samples with YSI plasma Blood Glucose (BG) &gt;180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Subjects with and without Diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All testing and lancing were performed by the study staff; Subjects with and without Diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contour® NEXT LINK BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Contour® NEXT LINK BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Subjects with and without Diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OneTouch® UltraLink® BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® UltraLink® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Subjects with and without Diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nova Max Link® BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Nova Max Link® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Subjects with and without Diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, 18 years of age or older&#xD;
&#xD;
          -  Willing to complete all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood Borne infections like hepatitis or HIV or infections such as tuberculosis&#xD;
&#xD;
          -  Hemophilia or any other bleeding disorder&#xD;
&#xD;
          -  Pregnancy&#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>David Simmons, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ascensia Diabetes Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bayer HealthCare LLC, Diabetes Care</name>
      <address>
        <city>Mishawaka</city>
        <state>Indiana</state>
        <zip>46544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>September 20, 2013</results_first_submitted>
  <results_first_submitted_qc>September 20, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 28, 2013</results_first_posted>
  <last_update_submitted>January 29, 2016</last_update_submitted>
  <last_update_submitted_qc>January 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Subjects With and Without Diabetes</title>
          <description>All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Subjects With and Without Diabetes</title>
          <description>All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="112"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" lower_limit="19" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range</title>
        <description>Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
        <time_frame>8 hours</time_frame>
        <population>Same number 333 (336-3) BG results possible for each BGMS. Staff collected 3 capillary samples from each subject - total 336 samples. Three samples from one subject were not analyzed. Subject hematocrit (58.5) was above the study evaluable limit of 55.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects With and Without Diabetes</title>
            <description>All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.</description>
          </group>
        </group_list>
        <measure>
          <title>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range</title>
          <description>Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
          <population>Same number 333 (336-3) BG results possible for each BGMS. Staff collected 3 capillary samples from each subject - total 336 samples. Three samples from one subject were not analyzed. Subject hematocrit (58.5) was above the study evaluable limit of 55.</population>
          <units>Percent Difference</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>BG test results</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="333"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Contour® NEXT LINK BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OneTouch® UltraLink® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nova Max Link® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (&lt;=80 mg/dL)</title>
        <description>Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
        <time_frame>8 hours</time_frame>
        <population>Same number (107) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 107 samples were less than or equal to 80 mg/dL.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects With and Without Diabetes</title>
            <description>All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.</description>
          </group>
        </group_list>
        <measure>
          <title>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (&lt;=80 mg/dL)</title>
          <description>Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
          <population>Same number (107) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 107 samples were less than or equal to 80 mg/dL.</population>
          <units>Percent Difference</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>BG test results</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Contour® NEXT LINK BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OneTouch® UltraLink® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.92" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nova Max Link® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.81" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (&gt;180 mg/dL)</title>
        <description>Using samples with YSI plasma Blood Glucose (BG) &gt;180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
        <time_frame>8 hours</time_frame>
        <population>Same number (106) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 106 samples were greater than 180 mg/dL.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects With and Without Diabetes</title>
            <description>All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.</description>
          </group>
        </group_list>
        <measure>
          <title>MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (&gt;180 mg/dL)</title>
          <description>Using samples with YSI plasma Blood Glucose (BG) &gt;180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.</description>
          <population>Same number (106) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 106 samples were greater than 180 mg/dL.</population>
          <units>Percent Difference</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>BG test results</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Contour® NEXT LINK BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.66" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OneTouch® UltraLink® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.76" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nova Max Link® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Subjects With and Without Diabetes</title>
          <description>All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>hypoglycemia</sub_title>
                <description>Adverse event was mild, anticipated, non-device related.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Carmine Greene</name_or_title>
      <organization>Ascensia Diabetes Care</organization>
      <phone>574-257-3040</phone>
      <email>carmine.greene@ascensia.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01699763
org study id: CTD-2012-007-01
nct id: NCT01699763
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring
      System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other
      companies. All meter BG results were compared with plasma results obtained with a reference
      laboratory glucose method (YSI Glucose Analyzer).
The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring
      System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other
      companies. All meter BG results were compared with plasma results obtained with a reference
      laboratory glucose method (YSI Glucose Analyzer). Performance of the three systems was
      evaluated across the glucose range of the BGMSs using capillary blood. All testing and
      lancing was performed by study staff and some samples were tested from subject fingertips.
      Additionally, some blood samples were glycolyzed to lower the glucose concentration levels
      and glucose solution was added to other samples to raise glucose concentration levels.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
time frame: 8 hours
description: Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)
time frame: 8 hours
description: Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
time frame: 8 hours
description: Using samples with YSI plasma Blood Glucose (BG) >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.
arm group label: Subjects with and without Diabetes
arm group type: Experimental
description: All testing and lancing were performed by the study staff; Subjects with and without Diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
intervention type: Device
intervention name: Contour® NEXT LINK BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Contour® NEXT LINK BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Subjects with and without Diabetes
intervention type: Device
intervention name: OneTouch® UltraLink® BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® UltraLink® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Subjects with and without Diabetes
intervention type: Device
intervention name: Nova Max Link® BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Nova Max Link® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Subjects with and without Diabetes
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Simmons, MD
role: Principal Investigator
affiliation: Ascensia Diabetes Care
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 