<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/NCT03257501</url>
  </required_header>
  <id_info>
    <org_study_id>ADC-US-VAL-17166</org_study_id>
    <nct_id>NCT03257501</nct_id>
  </id_info>
  <brief_title>FreeStyle Libre Flash Accuracy Study</brief_title>
  <official_title>FreeStyle Libre Flash 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>
      This is a non-randomized, single arm, multi-center, prospective, non-significant risk study&#xD;
      to evaluate the FreeStyle Libre Flash Glucose Monitoring System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 150 subjects will be enrolled at four (4) clinical research sites in the United States.&#xD;
      Subjects will wear two Sensors of three unique sensor lots. Each Sensor will have a paired&#xD;
      Reader that will be given to the subject. All Readers will be masked during the study (i.e.&#xD;
      subjects will not be able to view glucose results obtained from the Sensor on the Reader&#xD;
      screen). Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per&#xD;
      day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained&#xD;
      with the corresponding Readers immediately following each BG test. Subjects will be&#xD;
      instructed to report any problems with the device. Subjects will make eight (8) scheduled&#xD;
      visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1).&#xD;
      Subjects will have five (5) in-clinic visits during which intravenous blood draws and YSI&#xD;
      reference testing will occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">January 8, 2018</completion_date>
  <primary_completion_date type="Actual">January 8, 2018</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 with respect to YSI reference venous plasma sample measurements.</measure>
    <time_frame>Approximately 35 hours</time_frame>
    <description>System performance will be characterized with respect to YSI reference venous plasma sample measurements.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System Related adverse device effects</measure>
    <time_frame>Up to 51 days</time_frame>
    <description>System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.</description>
  </primary_outcome>
  <enrollment type="Actual">104</enrollment>
  <condition>Diabetes Mellitus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FreeStyle Libre Flash Glucose Monitoring System</intervention_name>
    <description>Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI)&#xD;
        or continuous subcutaneous insulin infusion (CSII).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be at least 18 years of age.&#xD;
&#xD;
          -  Subject must have type 1 or type 2 diabetes.&#xD;
&#xD;
          -  Subject must require insulin therapy through an insulin pump and/or multiple daily&#xD;
             insulin injections (at least 3 injections daily).&#xD;
&#xD;
          -  Willing to perform a minimum of 8 finger sticks per day during the study.&#xD;
&#xD;
          -  Subject must be willing to fast five individual times prior to in-clinic visits, each&#xD;
             fast lasting a minimum of eight hours.&#xD;
&#xD;
          -  Subject must be able to read and understand English.&#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;
          -  Subject must be available to participate in all study visits.&#xD;
&#xD;
          -  Subject must be willing and able to provide written signed and dated informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has known allergy to medical grade adhesive or isopropyl alcohol used to&#xD;
             disinfect skin.&#xD;
&#xD;
          -  Subject is pregnant, attempting to conceive or not willing and able to practice birth&#xD;
             control during the study duration (applicable to 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 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.&#xD;
&#xD;
          -  Subject is anemic as determined by the Investigator.&#xD;
&#xD;
          -  Subject has concomitant medical condition which, in the opinion of the investigator,&#xD;
             could interfere with the study or present a risk to the safety or welfare of the&#xD;
             subject or study staff. Such conditions include but are not limited to History of HIV,&#xD;
             Hepatitis B or C.&#xD;
&#xD;
          -  Subject has X-ray, MRI or CT appointment scheduled during the period of study&#xD;
             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>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shridhara K Alva, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Diabetes Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Sansum Diabetes Center</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>January 2018</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</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/NCT03257501
org study id: ADC-US-VAL-17166
nct id: NCT03257501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a non-randomized, single arm, multi-center, prospective, non-significant risk study
      to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
Up to 150 subjects will be enrolled at four (4) clinical research sites in the United States.
      Subjects will wear two Sensors of three unique sensor lots. 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 8 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 eight (8) scheduled
      visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1).
      Subjects will have five (5) in-clinic visits during which intravenous blood draws and YSI
      reference testing will occur.
observational model: Cohort
time perspective: Prospective
measure: System Performance with respect to YSI reference venous plasma sample measurements.
time frame: Approximately 35 hours
description: System performance will be characterized with respect to YSI reference venous plasma sample measurements.
measure: System Related adverse device effects
time frame: Up to 51 days
description: System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
intervention type: Device
intervention name: FreeStyle Libre Flash Glucose Monitoring System
description: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shridhara K Alva, PhD
role: Study Director
affiliation: Abbott Diabetes Care
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No