<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/NCT02246582</url>
  </required_header>
  <id_info>
    <org_study_id>CEP292</org_study_id>
    <nct_id>NCT02246582</nct_id>
  </id_info>
  <brief_title>Adult Accuracy Study of the Enlite 3 Glucose Sensor</brief_title>
  <acronym>E3</acronym>
  <official_title>A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Diabetes</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Diabetes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168&#xD;
      hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G&#xD;
      Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the&#xD;
      performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and&#xD;
      used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or&#xD;
      type 2 diabetes for at least one year.&#xD;
&#xD;
      Subjects are randomized into either Group A or Group B. The groups assigned will determine&#xD;
      when the subject will be participating in the in-clinic YSI frequent sample testing (FST).&#xD;
      For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B&#xD;
      begins FST 14 hours after Enlite 3 Sensor Insertion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)</measure>
    <time_frame>7 Days</time_frame>
    <description>Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retrospective Re-Analysis (MARD With 1 Additional Calibration)</measure>
    <time_frame>7 Days</time_frame>
    <description>Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)</measure>
    <time_frame>7 Days</time_frame>
    <description>Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Enlite 3</intervention_name>
    <description>Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Guardian Mobile App</intervention_name>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>640G Insulin Pump</intervention_name>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is 14-75 years of age at time of screening&#xD;
&#xD;
          2. A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 months duration&#xD;
             as determined via medical record or source documentation by an individual qualified to&#xD;
             make a medical diagnosis&#xD;
&#xD;
          3. Adequate venous access as assessed by investigator or appropriate staff&#xD;
&#xD;
          4. Subjects participating in the high and low glucose challenges must have an established&#xD;
             insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term &quot;established&quot;&#xD;
             refers to a ratio that has been previously defined and tested prior to screening&#xD;
             visit). Subjects without established ratios may participate under observation only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as&#xD;
             assessed by qualified individual&#xD;
&#xD;
          2. Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor&#xD;
             or device placement (e.g. psoriasis, rash, Staphylococcus infection)&#xD;
&#xD;
          3. Subject is actively participating in an investigational study (drug or device) in the&#xD;
             last 2 weeks&#xD;
&#xD;
          4. Subject is female and has a positive pregnancy screening test&#xD;
&#xD;
          5. Females of child bearing age and who are sexually active should be excluded if they&#xD;
             are not using a form of contraception deemed reliable by the investigator&#xD;
&#xD;
          6. Subject is female and plans to become pregnant during the course of the study&#xD;
&#xD;
          7. Subject has had a hypoglycemic seizure within the past 6 months&#xD;
&#xD;
          8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6&#xD;
             months prior to screening visit&#xD;
&#xD;
          9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months&#xD;
             prior to screening visit&#xD;
&#xD;
         10. Subject has a history of a seizure disorder&#xD;
&#xD;
         11. Subject has central nervous system or cardiac disorder resulting in syncope&#xD;
&#xD;
         12. Subject has a history of myocardial infarction, unstable angina, coronary artery&#xD;
             bypass surgery, coronary artery stenting, transient ischemic attack (TIA),&#xD;
             cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm&#xD;
             disturbances or thromboembolic disease&#xD;
&#xD;
         13. Subject has a hematocrit (Hct) lower than the normal reference range&#xD;
&#xD;
         14. Subject has a history of adrenal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald Brazg, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rainier Clinical Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Christiansen, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diablo Clinical Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Timothy Bailey, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>AMCR Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Satish Garg, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barbara Davis Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Slover, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barbara Davis Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruce Bode, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Atlanta Diabetes Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AMCR Institute</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Davis Center for Childhood Diabetes</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Davis Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes Associates</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <results_first_submitted>August 24, 2016</results_first_submitted>
  <results_first_submitted_qc>October 31, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 2, 2016</results_first_posted>
  <last_update_submitted>October 31, 2016</last_update_submitted>
  <last_update_submitted_qc>October 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Enlite 3</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>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>118 subjects consented and enrolled in the overall study. Of the 118, 89 subjects utilized the latest sensor version.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A (FST 30 Mins After Sensor Insertion)</title>
          <description>Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.&#xD;
Guardian Mobile App&#xD;
640G Insulin Pump</description>
        </group>
        <group group_id="P2">
          <title>Group B (FST 14 Hrs After Sensor Insertion)</title>
          <description>Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.&#xD;
Guardian Mobile App&#xD;
640G Insulin Pump</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</population>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>Subjects will be randomly assigned to 2 groups (Group A &amp; Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.&#xD;
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.&#xD;
Guardian Mobile App&#xD;
640G Insulin Pump</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="89"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.7" spread="19.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="43"/>
                  </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="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)</title>
        <description>Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
        <time_frame>7 Days</time_frame>
        <population>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</population>
        <group_list>
          <group group_id="O1">
            <title>Group</title>
            <description>Subjects will be randomly assigned to 2 groups (Group A &amp; Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.&#xD;
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.&#xD;
Guardian Mobile App&#xD;
640G Insulin Pump</description>
          </group>
        </group_list>
        <measure>
          <title>Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)</title>
          <description>Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
          <population>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>640G Pump</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.55" spread="9.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Guardian Mobile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.35" spread="10.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retrospective Re-Analysis (MARD With 1 Additional Calibration)</title>
        <description>Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
        <time_frame>7 Days</time_frame>
        <population>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</population>
        <group_list>
          <group group_id="O1">
            <title>Group</title>
            <description>Subjects will be randomly assigned to 2 groups (Group A &amp; Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.&#xD;
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.&#xD;
Guardian Mobile App&#xD;
640G Insulin Pump</description>
          </group>
        </group_list>
        <measure>
          <title>Retrospective Re-Analysis (MARD With 1 Additional Calibration)</title>
          <description>Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
          <population>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>640G Pump</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.64" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Guardian Mobile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.43" spread="9.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)</title>
        <description>Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
        <time_frame>7 Days</time_frame>
        <population>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</population>
        <group_list>
          <group group_id="O1">
            <title>Group</title>
            <description>Subjects will be randomly assigned to 2 groups (Group A &amp; Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.&#xD;
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.&#xD;
Guardian Mobile App&#xD;
640G Insulin Pump</description>
          </group>
        </group_list>
        <measure>
          <title>Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)</title>
          <description>Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.</description>
          <population>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>minimum calibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.09" spread="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-4 calibrations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.68" spread="7.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group</title>
          <description>Subjects will be randomly assigned to 2 groups (Group A &amp; Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.&#xD;
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen &amp; arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.&#xD;
Guardian Mobile App&#xD;
640G Insulin Pump</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="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>worsening of BPH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Smita Barua, Clinical Trial Manager</name_or_title>
      <organization>Medtronic Diabtes</organization>
      <phone>818.576.5534</phone>
      <email>smita.barua@medtronic.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/NCT02246582
org study id: CEP292
nct id: NCT02246582
lead sponsor: 
has dmc: Yes
The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168
      hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G
      Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.
This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the
      performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and
      used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or
      type 2 diabetes for at least one year.

      Subjects are randomized into either Group A or Group B. The groups assigned will determine
      when the subject will be participating in the in-clinic YSI frequent sample testing (FST).
      For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B
      begins FST 14 hours after Enlite 3 Sensor Insertion.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
time frame: 7 Days
description: Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
measure: Retrospective Re-Analysis (MARD With 1 Additional Calibration)
time frame: 7 Days
description: Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
measure: Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
time frame: 7 Days
description: Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
arm group label: Group A
arm group type: Other
description: Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
arm group label: Group B
arm group type: Other
description: Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
intervention type: Device
intervention name: Enlite 3
description: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
arm group label: Group A
arm group label: Group B
intervention type: Device
intervention name: Guardian Mobile App
arm group label: Group A
arm group label: Group B
intervention type: Device
intervention name: 640G Insulin Pump
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 14 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ronald Brazg, M.D
role: Principal Investigator
affiliation: Rainier Clinical Research Center
last name: Mark Christiansen, M.D
role: Principal Investigator
affiliation: Diablo Clinical Research
last name: Timothy Bailey, M.D
role: Principal Investigator
affiliation: AMCR Institute
last name: Satish Garg, M.D
role: Principal Investigator
affiliation: Barbara Davis Center
last name: Robert Slover, M.D
role: Principal Investigator
affiliation: Barbara Davis Center
last name: Bruce Bode, M.D
role: Principal Investigator
affiliation: Atlanta Diabetes Associates
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 