<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/NCT01714232</url>
  </required_header>
  <id_info>
    <org_study_id>CTD-2012-008-01</org_study_id>
    <nct_id>NCT01714232</nct_id>
  </id_info>
  <brief_title>Evaluation of Blood Glucose Meter Systems</brief_title>
  <official_title>Evaluation of Blood Glucose Meter Systems - Contour® PLUS 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 four additional Blood Glucose Monitoring Systems (BGMS) from other&#xD;
      manufacturers. All meter BG results were compared with plasma results obtained with a&#xD;
      reference 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 four additional Blood Glucose Monitoring Systems (BGMS) from other&#xD;
      manufacturers. All meter BG results were compared with plasma results obtained with a&#xD;
      reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems&#xD;
      were evaluated across the glucose range of the BGMSs using capillary blood. All testing and&#xD;
      lancing were 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">November 2012</completion_date>
  <primary_completion_date type="Actual">November 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 (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences 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 Blood Glucose (BG) &lt;=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences 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 Blood Glucose &gt;180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Study Staff Test BGMSs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contour® PLUS BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Study Staff Test BGMSs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OneTouch® SelectSimple™ BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Study Staff Test BGMSs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accu-Chek® Performa BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Study Staff Test BGMSs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accu-Chek® Active BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Study Staff Test BGMSs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Freestyle Freedom® BGMS</intervention_name>
    <description>Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).</description>
    <arm_group_label>Study Staff Test BGMSs</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 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>November 8, 2013</results_first_submitted>
  <results_first_submitted_qc>November 8, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 27, 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>Study Staff Test BGMSs</title>
          <description>All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® 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="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
              </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>Study Staff Test BGMSs</title>
          <description>All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="106"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="18" upper_limit="84"/>
                  </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="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </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="106"/>
                  </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 (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.</description>
        <time_frame>8 hours</time_frame>
        <population>314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Staff Test BGMSs</title>
            <description>All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® 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 (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.</description>
          <population>314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed.</population>
          <units>Percent Difference</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Contour® PLUS BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accu-Chek® Performa BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accu-Chek® Active BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OneTouch® SelectSimple™ BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Freestyle Freedom® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="0.31"/>
                  </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 Blood Glucose (BG) &lt;=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.</description>
        <time_frame>8 hours</time_frame>
        <population>Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Staff Test BGMSs</title>
            <description>All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® 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 Blood Glucose (BG) &lt;=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.</description>
          <population>Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 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="105"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>BG Test Results</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Contour® PLUS BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accu-Chek® Performa BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accu-Chek® Active BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OneTouch® SelectSimple™ BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Freestyle Freedom® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.7" spread="0.60"/>
                  </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 Blood Glucose &gt;180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.</description>
        <time_frame>8 hours</time_frame>
        <population>Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Staff Test BGMSs</title>
            <description>All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® 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 Blood Glucose &gt;180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.</description>
          <population>Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 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="105"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>BG Test Results</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Contour® PLUS BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accu-Chek® Performa BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accu-Chek® Active BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OneTouch® SelectSimple™ BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Freestyle Freedom® BGMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Study Staff Test BGMSs</title>
          <description>All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® 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="106"/>
              </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="3" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <description>Adverse events were mild, anticipated, non-device related</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="106"/>
              </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>Jane Wallace</name_or_title>
      <organization>Ascensia Diabetes Care</organization>
      <phone>574-257-3063</phone>
      <email>jane.wallace@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/NCT01714232
org study id: CTD-2012-008-01
nct id: NCT01714232
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring
      System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other
      manufacturers. 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 four additional Blood Glucose Monitoring Systems (BGMS) from other
      manufacturers. All meter BG results were compared with plasma results obtained with a
      reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems
      were evaluated across the glucose range of the BGMSs using capillary blood. All testing and
      lancing were 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 (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences 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 Blood Glucose (BG) <=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences 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 Blood Glucose >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.
arm group label: Study Staff Test BGMSs
arm group type: Experimental
description: All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
intervention type: Device
intervention name: Contour® PLUS BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Study Staff Test BGMSs
intervention type: Device
intervention name: OneTouch® SelectSimple™ BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Study Staff Test BGMSs
intervention type: Device
intervention name: Accu-Chek® Performa BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Study Staff Test BGMSs
intervention type: Device
intervention name: Accu-Chek® Active BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Study Staff Test BGMSs
intervention type: Device
intervention name: Freestyle Freedom® BGMS
description: Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
arm group label: Study Staff Test BGMSs
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: 