<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/NCT01667185</url>
  </required_header>
  <id_info>
    <org_study_id>PTL900803</org_study_id>
    <nct_id>NCT01667185</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus</brief_title>
  <official_title>Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DexCom, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to evaluate the safety and effectiveness of the G4&#xD;
      System (System) when used as an adjuvant to blood glucose testing over a 7-day period in&#xD;
      pediatric subjects with diabetes mellitus.&#xD;
&#xD;
      System effectiveness will be primarily evaluated with comparison to laboratory reference&#xD;
      Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be&#xD;
      evaluated in terms of point and rate accuracy of the system in reference to YSI. The point&#xD;
      accuracy is measured as the proportion of G4 System values that are within ±20% of YSI&#xD;
      reference value for glucose levels &gt;80 mg/dL and ±20 mg/dL at YSI glucose levels &lt;80 mg/dL.&#xD;
      The trend accuracy of the device performance, i.e., continuous glucose error grid analysis,&#xD;
      will be evaluated as well as the temporal accuracy at different glucose rates of changes and&#xD;
      different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary&#xD;
      matched paired (Sensor-YSI) measurements will be collected during one in-clinic session.&#xD;
      System effectiveness will also be evaluated with SMBG measurements similarly.&#xD;
&#xD;
      Safety data of the system will also be collected and safety will be characterized by the&#xD;
      incidence of Adverse Device Effects (ADE) experienced by study participants.&#xD;
&#xD;
      Other objectives include the evaluation of device performance at an alternate site (the upper&#xD;
      buttocks).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>System Performance Effectiveness</measure>
    <time_frame>7 days</time_frame>
    <description>The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>System Performance at Alternate Wear Site</measure>
    <time_frame>7 days</time_frame>
    <description>An additional objective is to evaluate System performance at an alternate wear site. The System performance will be assessed, using the same statistical methodology as the primary wear site.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">176</enrollment>
  <condition>Pediatric Subjects With Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Pediatric subjects with diabetes mellitus</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric subjects with diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 2 to 17 years ;&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus;&#xD;
&#xD;
          -  Willing to participate in one 7-day Sensor wear period;&#xD;
&#xD;
          -  Willing to wear 2 systems simultaneously;&#xD;
&#xD;
          -  Willing to take a minimum of 7 fingersticks per day during home use with a blood&#xD;
             glucose meter provided;&#xD;
&#xD;
          -  Willing to attend one in-clinic session of up to 6 hours duration. Clinic procedures&#xD;
             where blood sampling via SMBG and/or venous YSI method, depending on age;&#xD;
&#xD;
          -  Subject or guardian is able to speak, read, and write English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extensive skin changes/diseases at sensor wear site that preclude wearing the Sensor&#xD;
             on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive&#xD;
             eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis);&#xD;
&#xD;
          -  Known allergy to medical-grade adhesives;&#xD;
&#xD;
          -  Require a magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, or&#xD;
             diathermy during the wear period. If any of these procedures are required urgently&#xD;
             during the study, subjects will notify the study staff, end their continuous glucose&#xD;
             monitoring (CGM) session, and remove their sensor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Advanced Metabolic Care and Research</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHOC Children's</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</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>Rocky Mountain Diabetes and Osteoporosis Center, PA</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>February 7, 2013</last_update_submitted>
  <last_update_submitted_qc>February 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>diabetes mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667185
org study id: PTL900803
nct id: NCT01667185
lead sponsor: 
has dmc: No
The primary objective of the study is to evaluate the safety and effectiveness of the G4
      System (System) when used as an adjuvant to blood glucose testing over a 7-day period in
      pediatric subjects with diabetes mellitus.

      System effectiveness will be primarily evaluated with comparison to laboratory reference
      Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be
      evaluated in terms of point and rate accuracy of the system in reference to YSI. The point
      accuracy is measured as the proportion of G4 System values that are within ±20% of YSI
      reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL.
      The trend accuracy of the device performance, i.e., continuous glucose error grid analysis,
      will be evaluated as well as the temporal accuracy at different glucose rates of changes and
      different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary
      matched paired (Sensor-YSI) measurements will be collected during one in-clinic session.
      System effectiveness will also be evaluated with SMBG measurements similarly.

      Safety data of the system will also be collected and safety will be characterized by the
      incidence of Adverse Device Effects (ADE) experienced by study participants.

      Other objectives include the evaluation of device performance at an alternate site (the upper
      buttocks).
observational model: Cohort
time perspective: Prospective
measure: System Performance Effectiveness
time frame: 7 days
description: The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.
measure: System Performance at Alternate Wear Site
time frame: 7 days
description: An additional objective is to evaluate System performance at an alternate wear site. The System performance will be assessed, using the same statistical methodology as the primary wear site.
arm group label: Pediatric subjects with diabetes mellitus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus