<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/NCT03820050</url>
  </required_header>
  <id_info>
    <org_study_id>ADC-US-VAL-18175</org_study_id>
    <nct_id>NCT03820050</nct_id>
  </id_info>
  <brief_title>FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study</brief_title>
  <official_title>FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Diabetes Care</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Diabetes Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 characterize the Freestyle Libre Flash Glucose Monitoring&#xD;
      System in pediatric subjects with respect to YSI reference venous plasma sample measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 250 subjects will be enrolled at up to six (6) clinical research sites in the United&#xD;
      States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be&#xD;
      given to the subject. All Readers will be masked during the study (i.e. subjects will not be&#xD;
      able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be&#xD;
      asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary&#xD;
      Reader. Interstitial glucose readings from each Sensor will be obtained with the&#xD;
      corresponding Readers immediately following each BG test. Subjects will be instructed to&#xD;
      report any problems with the device. Subjects will make three (3), four (4) or five (5)&#xD;
      scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit&#xD;
      1). Based on the subjects weight, subjects will have up to two (2) in-clinic visits during&#xD;
      which intravenous blood draws and YSI reference testing will occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 2019</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</measure>
    <time_frame>45 days</time_frame>
    <description>System Performance will be characterized with respect to YSI reference venous plasma measurements</description>
  </primary_outcome>
  <enrollment type="Actual">144</enrollment>
  <condition>Diabetes Mellitus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Freestyle LIbre Flash Glucose Monitoring System</intervention_name>
    <description>System Performance will be characterized with respect to YSI reference venous plasma measurements</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric subjects aged 4-17 with Type 1 or Type 2 diabetes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be between the ages of 4 and 17 years of age at the time of study&#xD;
             enrollment.&#xD;
&#xD;
          -  Subject must have type 1 or type 2 diabetes.&#xD;
&#xD;
          -  Subjects age 11 and older must require insulin therapy through an insulin pump and/or&#xD;
             multiple daily insulin injections (at least 3 injections daily).&#xD;
&#xD;
          -  Willing to perform a minimum of 4 finger sticks per day while wearing the sensor in&#xD;
             the study.&#xD;
&#xD;
          -  Subject and/or guardian must be able to read and understand English.&#xD;
&#xD;
          -  For subjects age 6 and older: willing to allow medical personnel to insert an IV&#xD;
             catheter in the arm to allow for venous blood flow samples to be obtained per the&#xD;
             study protocol.&#xD;
&#xD;
          -  For subjects age 11 and older: subject is willing to have their blood sugar&#xD;
             manipulated during one or more in-clinic sessions.&#xD;
&#xD;
          -  In the investigator's opinion, the subject must be able to follow the instructions&#xD;
             provided to him/her by the study site and perform all study tasks as specified by the&#xD;
             protocol.&#xD;
&#xD;
          -  At the time of enrollment, subject must be available to participate in all study&#xD;
             visits.&#xD;
&#xD;
          -  Known insulin sensitivity factor (only applicable to subjects age 11 and older).&#xD;
&#xD;
          -  Subject's parent, guardian or legally authorized representative must be willing and&#xD;
             able to provide written informed consent.&#xD;
&#xD;
          -  Subject must be willing and able to provide written signed and dated informed assent&#xD;
             when appropriate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is 18 years of age or older.&#xD;
&#xD;
          -  Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11&#xD;
             and older).&#xD;
&#xD;
          -  Subject has known allergy to medical grade adhesive or isopropyl alcohol used to&#xD;
             disinfect skin.&#xD;
&#xD;
          -  Subject is known to be pregnant or becomes pregnant during the study (applicable to&#xD;
             female subjects only).&#xD;
&#xD;
          -  Subject has extensive skin changes/diseases at the proposed application sites that&#xD;
             could interfere with device placement or the accuracy of interstitial glucose&#xD;
             measurements. Such conditions include, but are not limited to extensive psoriasis,&#xD;
             recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis&#xD;
             herpetiformis, skin lesions, redness, infection or edema.&#xD;
&#xD;
          -  Subject has had an episode of severe hypoglycemia requiring intervention from a health&#xD;
             care professional(i.e. EMT assistance, emergency room visit, or hospital admission)&#xD;
             within the last six (6) months (only applicable to subjects age 11 or older).&#xD;
&#xD;
          -  Subject has had an episode of diabetic ketoacidosis (DKA) within the last (3) months&#xD;
             (only applicable to subjects age 11 or older).&#xD;
&#xD;
          -  Subject is currently participating in another clinical trial.&#xD;
&#xD;
          -  Subject has donated blood within 112 days (3.7 months) prior to the beginning of the&#xD;
             study activities (only applicable to subjects age 6 and older).&#xD;
&#xD;
          -  Subject has both hemoglobin (Hb) and hematocrit levels that are below the normal&#xD;
             ranges (only applicable to subjects age 6 and older). The low end of the normal range&#xD;
             for Hb is as follows: for males and females aged 6-12 years old it is 11.5 g/dL; for&#xD;
             males aged 12-17 it is 13.0 g/dL; for females aged 12-17 it is 12.0 g/dL. The low end&#xD;
             of the normal hematocrit for males and females aged 6-12 is 35%; 37% for males aged&#xD;
             12-17 and 36% for females aged 12- 17).&#xD;
&#xD;
          -  Subject has X-ray, MRI, CT or diathermy appointment scheduled during the period of&#xD;
             study participation, and the appointment cannot be rescheduled for a time before study&#xD;
             participation starts or after study participation ends.&#xD;
&#xD;
          -  Subject is unsuitable for participation due to any other cause as determined by the&#xD;
             Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shridhara Karinka, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Diabetes Care</affiliation>
  </overall_official>
  <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>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>Rocky Mountain Diabetes and Osteoporosis Center</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>94502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes and Glandular Disease Clinic</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03820050
org study id: ADC-US-VAL-18175
nct id: NCT03820050
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring
      System in pediatric subjects with respect to YSI reference venous plasma sample measurements.
Up to 250 subjects will be enrolled at up to six (6) clinical research sites in the United
      States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be
      given to the subject. All Readers will be masked during the study (i.e. subjects will not be
      able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be
      asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary
      Reader. Interstitial glucose readings from each Sensor will be obtained with the
      corresponding Readers immediately following each BG test. Subjects will be instructed to
      report any problems with the device. Subjects will make three (3), four (4) or five (5)
      scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit
      1). Based on the subjects weight, subjects will have up to two (2) in-clinic visits during
      which intravenous blood draws and YSI reference testing will occur.
observational model: Cohort
time perspective: Prospective
measure: System Performance
time frame: 45 days
description: System Performance will be characterized with respect to YSI reference venous plasma measurements
intervention type: Device
intervention name: Freestyle LIbre Flash Glucose Monitoring System
description: System Performance will be characterized with respect to YSI reference venous plasma measurements
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: No
last name: Shridhara Karinka, Ph.D.
role: Study Director
affiliation: Abbott Diabetes Care
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No