<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/NCT04436822</url>
  </required_header>
  <id_info>
    <org_study_id>CIP330</org_study_id>
    <nct_id>NCT04436822</nct_id>
  </id_info>
  <brief_title>Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics</brief_title>
  <official_title>Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Diabetes</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Diabetes</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in&#xD;
      subjects age 2 - 80 years, for the span of 170 hours (7 days).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in&#xD;
      subjects age 2 - 80 years, for the span of 170 hours (7 days).&#xD;
&#xD;
      This is a multi-center study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">April 12, 2022</completion_date>
  <primary_completion_date type="Actual">April 12, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Readings Within 20% Agreement</measure>
    <time_frame>7 days (170 hours)</time_frame>
    <description>Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL [1.1 mmol/L] when sensor values &lt; 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">317</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Subjects with diabetes wearing DS5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects wearing DS5 over 7 days and participating in FSTs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitoring</intervention_name>
    <description>CGM and frequent sample testing</description>
    <arm_group_label>Subjects with diabetes wearing DS5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individual is 2 - 80 years of age at time of enrollment.&#xD;
&#xD;
          2. Subject has a clinical diagnosis of type 1 or type 2 diabetes:&#xD;
&#xD;
               1. If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or&#xD;
                  type 2 diabetes for a minimum of 6 months duration as determined via medical&#xD;
                  record/ source documentation by an individual qualified to make a medical&#xD;
                  diagnosis.&#xD;
&#xD;
               2. If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or&#xD;
                  type 2 diabetes as determined via medical record/ source documentation by an&#xD;
                  individual qualified to make a medical diagnosis.&#xD;
&#xD;
          3. If subject is participating in YSI™* FST , subject has adequate venous access as&#xD;
             assessed by investigator or appropriate staff.&#xD;
&#xD;
          4. Subjects participating in the high and low glucose challenges must have an insulin&#xD;
             carbohydrate ratio(s) and insulin sensitivity factor(s). Subjects without ratios may&#xD;
             participate under observation only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject will not tolerate tape adhesive in the area of sensor placement as assessed by&#xD;
             a qualified individual.&#xD;
&#xD;
          2. Subject has any unresolved adverse skin condition in the area of sensor or device&#xD;
             placement (e.g., psoriasis, rash, Staphylococcus infection).&#xD;
&#xD;
          3. Subject is actively participating in an investigational study (e.g., drug or device)&#xD;
             wherein he/she has received treatment from an investigational study (drug or device)&#xD;
             in the last 2 weeks prior to Visit 1. (Please note participation in an observational&#xD;
             study is acceptable.)&#xD;
&#xD;
          4. Subject is female of child-bearing potential and has a pregnancy screening test that&#xD;
             is positive.&#xD;
&#xD;
          5. Subject is a sexually active female of child-bearing potential and is not using a form&#xD;
             of contraception deemed reliable by 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 prior to enrollment.&#xD;
&#xD;
          8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6&#xD;
             months prior to enrollment.&#xD;
&#xD;
          9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months&#xD;
             prior to enrollment.&#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. If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below&#xD;
             the lower limit of normal reference range (please note that patients may use prior&#xD;
             blood draw from routine care as long as done within 6 months of screening and report&#xD;
             of lab placed with subject source documents).&#xD;
&#xD;
         14. Subject has a history of adrenal insufficiency.&#xD;
&#xD;
         15. Subject is a member of the research staff involved with the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AMCR Institute</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sansum Diabetes Research Institute</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SoCal Diabetes</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research, Inc.</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 for Diabetes</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</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>Rocky Mountain Diabetes and Osteoporosis Center</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AM Diabetes and Endocrinology Center</name>
      <address>
        <city>Bartlett</city>
        <state>Tennessee</state>
        <zip>38133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes &amp; Endocrinology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78749</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Center for Diabetes Technology</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research Center, Inc.</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalian Municiple Central Hospital</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116089</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Sixth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200233</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <results_first_submitted>April 4, 2023</results_first_submitted>
  <results_first_submitted_qc>May 4, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 2, 2023</results_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 31, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04436822/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 31, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04436822/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>317 subjects (175 adult subjects, 141 pediatric subjects, and 1 age-unknown subject) consented and enrolled in the overall study. Of them, 7 subjects were screening failure and 310 subjects (172 adult subjects and 138 pediatric subjects) participated in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adult Subjects (Age 18-80) Wearing DS5</title>
          <description>Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing</description>
        </group>
        <group group_id="P2">
          <title>Pediatric Subjects (Age 2-17) Wearing DS5</title>
          <description>Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor request</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by parent/guardian</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unsuccessful procedure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal due to Covid-19</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>The sponsor was not able to provide the investigational product</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographics and other baseline characteristics were documented for eligible subjects (i.e., subjects who passed screening).</population>
      <group_list>
        <group group_id="B1">
          <title>Adult Subjects (Age 18-80) Wearing DS5</title>
          <description>Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing</description>
        </group>
        <group group_id="B2">
          <title>Pediatric Subjects (Age 2-17) Wearing DS5</title>
          <description>Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="172"/>
            <count group_id="B2" value="138"/>
            <count group_id="B3" value="310"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="46.3" spread="16.8"/>
                    <measurement group_id="B2" value="10.5" spread="4.8"/>
                    <measurement group_id="B3" value="30.3" spread="22.0"/>
                  </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="78"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="204"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="76"/>
                  </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="121"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (kg/m2)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.7" spread="6.4"/>
                    <measurement group_id="B2" value="19.8" spread="4.2"/>
                    <measurement group_id="B3" value="24.8" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Readings Within 20% Agreement</title>
        <description>Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL [1.1 mmol/L] when sensor values &lt; 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.</description>
        <time_frame>7 days (170 hours)</time_frame>
        <population>Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear</population>
        <group_list>
          <group group_id="O1">
            <title>Adult Subjects (Age 18-80) Wearing DS5 on the Arm</title>
            <description>Adult subjects (age 18-80) wearing DS5 on the arm over 7 days: Continuous Glucose Monitoring and frequent sample testing. Zero calibration sensor algorithm applied to raw sensor data.</description>
          </group>
          <group group_id="O2">
            <title>Pediatric Subjects (Age 2-17) Wearing DS5 on the Arm</title>
            <description>Pediatric subjects (age 2-17) wearing DS5 on the arm over 7 days: Continuous Glucose Monitoring and frequent sample testing. Zero calibration sensor algorithm applied to raw sensor data.</description>
          </group>
          <group group_id="O3">
            <title>Pediatric Subjects (Age 2-17) Wearing DS5 on the Buttock</title>
            <description>Pediatric subjects (age 2-17) wearing DS5 on the buttock over 7 days: Continuous Glucose Monitoring and frequent sample testing. Zero calibration sensor algorithm applied to raw sensor data.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Readings Within 20% Agreement</title>
          <description>Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL [1.1 mmol/L] when sensor values &lt; 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.</description>
          <population>Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear</population>
          <units>percentage of readings</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" lower_limit="87.1" upper_limit="90.7"/>
                    <measurement group_id="O2" value="87.5" lower_limit="85.4" upper_limit="89.7"/>
                    <measurement group_id="O3" value="87.9" lower_limit="85.8" upper_limit="89.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANCOVA</method>
            <method_desc>A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).</method_desc>
            <param_type>Intercept from ANCOVA as agreement rate</param_type>
            <param_value>88.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>87.1</ci_lower_limit>
            <ci_upper_limit>90.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANCOVA</method>
            <method_desc>A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).</method_desc>
            <param_type>Intercept from ANCOVA as agreement rate</param_type>
            <param_value>87.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>85.4</ci_lower_limit>
            <ci_upper_limit>89.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANCOVA</method>
            <method_desc>A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).</method_desc>
            <param_type>Intercept from ANCOVA as agreement rate</param_type>
            <param_value>87.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>85.8</ci_lower_limit>
            <ci_upper_limit>89.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Adult Subjects (Age 18-80) Wearing DS5</title>
          <description>Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing</description>
        </group>
        <group group_id="E2">
          <title>Pediatric Subjects (Age 2-17) Wearing DS5</title>
          <description>Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>BILATERAL HYDRONEPHROSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA25.0</default_vocab>
        <default_assessment>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="27" subjects_at_risk="172"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Left atrial enlargement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune thyroiditis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Thyroid mass</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Medical device site bruise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Medical device site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Medical device site rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hepatic cyst</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hepatic mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Non-alcoholic fatty liver</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Asymptomatic bacteriuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Helicobacter gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Infusion site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Serum ferritin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Alcoholic ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Diabetic ketosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Ketosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Growth retardation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Giant cell tumour of tendon sheath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Pleural mesothelioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid arteriosclerosis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Cerebral artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Cerebral artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic nephropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Prostatic calcification</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="172"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
              </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>Robin Mottackel</name_or_title>
      <organization>Medtronic Diabetes</organization>
      <phone>8185764886</phone>
      <email>robin.e.mottackel@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/NCT04436822
org study id: CIP330
nct id: NCT04436822
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in
      subjects age 2 - 80 years, for the span of 170 hours (7 days).
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in
      subjects age 2 - 80 years, for the span of 170 hours (7 days).

      This is a multi-center study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of Readings Within 20% Agreement
time frame: 7 days (170 hours)
description: Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL [1.1 mmol/L] when sensor values < 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
arm group label: Subjects with diabetes wearing DS5
arm group type: Experimental
description: Subjects wearing DS5 over 7 days and participating in FSTs.
intervention type: Device
intervention name: Continuous Glucose Monitoring
description: CGM and frequent sample testing
arm group label: Subjects with diabetes wearing DS5
criteria: 
gender: All
minimum age: 2 Years
maximum age: 80 Years
healthy volunteers: No
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country: China
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 