<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/NCT04464772</url>
  </required_header>
  <id_info>
    <org_study_id>ADC-US-VAL-20192</org_study_id>
    <nct_id>NCT04464772</nct_id>
  </id_info>
  <brief_title>FreeStyle Libre Continuous Glucose Monitoring System Accuracy Study</brief_title>
  <official_title>FreeStyle Libre Continuous Glucose Monitoring System 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to characterize the Freestyle Libre Glucose Monitoring System in&#xD;
      pediatric and adult subjects with respect to YSI reference venous plasma sample measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 100 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. Subjects will be asked to perform at least 4 capillary Blood Glucose&#xD;
      (BG) tests per day using the primary Reader.&#xD;
&#xD;
      Interstitial glucose readings from each Sensor will be obtained with the corresponding&#xD;
      Readers immediately following each BG test. Subjects will be instructed to report any&#xD;
      problems with the device. Subjects will make up to six (6) scheduled visits to the clinical&#xD;
      study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age&#xD;
      and&#xD;
&#xD;
      /or weight, subjects will have up to three (3) in- clinic visits during which intravenous&#xD;
      blood draws and YSI reference testing will occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Actual">September 22, 2020</completion_date>
  <primary_completion_date type="Actual">September 14, 2020</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">85</enrollment>
  <condition>Diabetes Mellitus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FreeStyle Libre 3</intervention_name>
    <description>FreeStyle Libre 3 Continuous Glucose Monitoring System</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult and pediatric subjects with type 1 or type 2 diabetes requiring multiple daily&#xD;
        insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be at least 4 years of age.&#xD;
&#xD;
          2. Subject must have type 1 or type 2 diabetes.&#xD;
&#xD;
          3. Subject must require insulin therapy through an insulin pump and/or multiple daily&#xD;
             insulin injections (at least 3 injections daily).&#xD;
&#xD;
          4. Willing to perform a minimum of 4 finger sticks per day while wearing the sensor in&#xD;
             the study.&#xD;
&#xD;
          5. Subject must be able to read and understand English.&#xD;
&#xD;
          6. 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 samples to be obtained per the study&#xD;
             protocol.&#xD;
&#xD;
          7. 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;
          8. At the time of enrollment, subject must be available to participate in all study&#xD;
             visits.&#xD;
&#xD;
          9. Subjects aged 18 years and older must be willing and able to provide written signed&#xD;
             and dated informed consent.&#xD;
&#xD;
         10. Subjects aged 17 years and younger must have a parent, guardian or legally authorized&#xD;
             representative willing and able to provide written informed consent.&#xD;
&#xD;
         11. Subjects aged 7 - 17 years of age must be willing and able to provide written signed&#xD;
             and dated informed assent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to&#xD;
             disinfect skin.&#xD;
&#xD;
          2. Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive or&#xD;
             is not willing and able to practice birth control during the study duration&#xD;
             (applicable to only to female subjects age 18 and older).&#xD;
&#xD;
          3. Subjects age 17 and younger: Subject is known to be pregnant or becomes pregnant&#xD;
             during the study (only applicable to female subjects age 17 years and younger)&#xD;
&#xD;
          4. 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;
          5. Subject is currently participating in another clinical trial.&#xD;
&#xD;
          6. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the&#xD;
             study activities.&#xD;
&#xD;
          7. For subjects age 6 and older: subject has a hemoglobin (Hb) level that is below the&#xD;
             normal range (for reference the low end of the normal range for Hb for adult males is&#xD;
             14 g/dL and for adult females is 12 g/dL; for pediatric males and pediatric 13.0 g/dL;&#xD;
             for pediatric females aged 12 - 17 it is 12.0 g/dL2).&#xD;
&#xD;
          8. Subject has a known concomitant medical condition which, in the opinion of the&#xD;
             investigator, could present a risk to the safety or welfare of the subject or study&#xD;
             staff.&#xD;
&#xD;
          9. 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;
         10. 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>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shridhara A Karinka, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Diabetes Care</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>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>Rocky Mountain Diabetes &amp; Osteoporosis Center</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research</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>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04464772
org study id: ADC-US-VAL-20192
nct id: NCT04464772
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to characterize the Freestyle Libre Glucose Monitoring System in
      pediatric and adult subjects with respect to YSI reference venous plasma sample measurements.
Up to 100 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. 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 up to six (6) scheduled visits to the clinical
      study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age
      and

      /or weight, subjects will have up to three (3) 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 3
description: FreeStyle Libre 3 Continuous Glucose Monitoring System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: No
last name: Shridhara A Karinka, PhD
role: Study Director
affiliation: Abbott Diabetes Care
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided