<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/NCT04503564</url>
  </required_header>
  <id_info>
    <org_study_id>150-1072-00</org_study_id>
    <secondary_id>ACTRN12620000021976</secondary_id>
    <nct_id>NCT04503564</nct_id>
  </id_info>
  <brief_title>&quot;FEXIS&quot;: (Feasibility of an Extended Wear CSII Set in Participants With T1DM)</brief_title>
  <acronym>FEXIS</acronym>
  <official_title>Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capillary Biomedical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capillary Biomedical, Inc.</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>
      Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using&#xD;
      continuous subcutaneous insulin infusion with an infusion set that needs to be changed every&#xD;
      3 days. This study will assess the feasibility and device performance of the study device,&#xD;
      the Achilles infusion set over three periods during routine insulin infusion.&#xD;
&#xD;
      This study will include 20 participants and has 3 periods:&#xD;
&#xD;
      Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7&#xD;
      days): participants will manage their blood glucose solely with their insulin pump and the&#xD;
      Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose&#xD;
      monitoring (CGM) device.&#xD;
&#xD;
      Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles&#xD;
      infusion set and continue blood glucose management at home until infusion set failure or 7&#xD;
      days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, home-use feasibility study of device performance,&#xD;
      usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles&#xD;
      infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in&#xD;
      up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).&#xD;
&#xD;
      The CapBio Achilles infusion set is a sterile single use device designed to be used with&#xD;
      commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles&#xD;
      infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and&#xD;
      three proximal holes.&#xD;
&#xD;
      The primary objective of this study is to determine feasibility and device performance of the&#xD;
      CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each&#xD;
      during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of&#xD;
      uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</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>
    <intervention_model_description>This study is designed as a single arm device feasibility evaluation</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Infusion Set Survival at End of Day 7</measure>
    <time_frame>7 days during weeks 2 and 3</time_frame>
    <description>The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Type 1 Diabetes</condition>
  <condition>Type 1 Diabetes Mellitus</condition>
  <condition>Diabetes Mellitus, Insulin-Dependent, 1</condition>
  <arm_group>
    <arm_group_label>Achilles Infusion Set</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coil-reinforced soft polymer indwelling cannula</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>coil-reinforced soft polymer indwelling cannula</intervention_name>
    <description>This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).</description>
    <arm_group_label>Achilles Infusion Set</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant is 18 - 70 years of age inclusive&#xD;
&#xD;
          2. Participant is in generally good health, as determined by the investigator&#xD;
&#xD;
          3. Participant is willing and able to individually complete written informed consent and&#xD;
             agrees to comply with all study related testing and examinations&#xD;
&#xD;
          4. Participant must be geographically stable (e.g., expects to be available and capable&#xD;
             of returning for all study specified test and examinations) during the study period&#xD;
&#xD;
          5. Participant has been diagnosed with T1DM for at least 12 months&#xD;
&#xD;
          6. C-peptide less than 0.6 nmol per L at screening&#xD;
&#xD;
          7. Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump use&#xD;
             compliance&#xD;
&#xD;
          8. Participant is willing to perform serum ketone measurements whenever the blood glucose&#xD;
             is determined to be greater than 250 mg per dL (14 mmol per L) using a ketone meter&#xD;
             and strips provided by the sponsor&#xD;
&#xD;
          9. Participant has BMI in the range 20 - 35 kg per square metre inclusive&#xD;
&#xD;
         10. Participant has experience infusing a rapid-acting insulin analog for at least 6&#xD;
             months&#xD;
&#xD;
         11. Participant has been using an insulin pump with commercially available infusion sets&#xD;
             for at least 6 months (this includes Automated Insulin Delivery systems)&#xD;
&#xD;
         12. Participant has previous experience using a continuous glucose monitor (CGM) and is&#xD;
             willing to use a CGM for the duration of the study and perform necessary calibration&#xD;
             fingerstick glucose readings&#xD;
&#xD;
         13. Participant has ability to understand and comply with protocol procedures and to&#xD;
             provide informed consent&#xD;
&#xD;
         14. AST and ALT less than or equal to 120 U per L&#xD;
&#xD;
         15. Creatinine less than 1.8 mg per dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants whose average total daily insulin dose exceeds 85 units per day (i.e.&#xD;
             typically change insulin reservoirs more often than every 3.5 days on average)&#xD;
&#xD;
          2. Participants who routinely change their commercial insulin infusion sets twice weekly&#xD;
             or less often (wear time greater than 3.5 days)&#xD;
&#xD;
          3. Female participant is pregnant or nursing (Documented negative pregnancy test results&#xD;
             for female participants required unless participant is menopausal without any&#xD;
             spontaneous menstrual cycles for &gt;12 months or key organs have been removed.)&#xD;
&#xD;
          4. Participant has abnormal skin at intended device infusion sites (existing infection,&#xD;
             inflammation, burns, or other extensive scarring)&#xD;
&#xD;
          5. Participant has HbA1C greater than 8.5 percent at screening&#xD;
&#xD;
          6. Participant has documented history in last 6 months of severe hypoglycemia associated&#xD;
             with cognitive dysfunction sufficiently severe to require third party intervention or&#xD;
             a history of impaired awareness of hypoglycemia.&#xD;
&#xD;
          7. Participant has a history of diabetic ketoacidosis in the last 6 months&#xD;
&#xD;
          8. Participant has known cardiovascular disease considered to be clinically relevant by&#xD;
             the investigator&#xD;
&#xD;
          9. Participant has known arrhythmias considered to be clinically relevant by the&#xD;
             investigator&#xD;
&#xD;
         10. Participant has known history of:&#xD;
&#xD;
               1. Cushing's Disease,&#xD;
&#xD;
               2. pancreatic islet cell tumor, or&#xD;
&#xD;
               3. insulinoma&#xD;
&#xD;
         11. Participant has:&#xD;
&#xD;
               1. Lipodystrophy,&#xD;
&#xD;
               2. extensive lipohypertrophy, as assessed by the investigator&#xD;
&#xD;
         12. Participant is undergoing current treatment with:&#xD;
&#xD;
               1. Systemic oral or intravenous corticosteroids,&#xD;
&#xD;
               2. monoamine oxidase (MAO) inhibitors,&#xD;
&#xD;
               3. non-selective beta-blockers,&#xD;
&#xD;
               4. growth hormone,&#xD;
&#xD;
               5. thyroid hormones, unless use has been stable during the past 3 months&#xD;
&#xD;
         13. Subject has significant history of any of the following, that in the opinion of the&#xD;
             investigator would compromise the subject's safety or successful study participation:&#xD;
&#xD;
               1. Alcoholism,&#xD;
&#xD;
               2. drug abuse&#xD;
&#xD;
         14. Significant acute or chronic illness, that in the investigator's opinion, might&#xD;
             interfere with subject safety or integrity of study results&#xD;
&#xD;
         15. Planned operation, MRI or CT which require removal of infusion set or CGM sensor&#xD;
             during wear periods&#xD;
&#xD;
         16. Current participation in another clinical drug or device study&#xD;
&#xD;
         17. AST and ALT greater than 120 U per L&#xD;
&#xD;
         18. Creatinine equal to or greater than 1.8 mg per dL -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David O'Neal, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Vincent's Hospital Department of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Vincent's Hospital (Melbourne) Ltd - Fitzroy</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <results_first_submitted>March 7, 2022</results_first_submitted>
  <results_first_submitted_qc>May 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2023</results_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT04503564/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited from existing participant population at study center. First patient was screened at medical clinic on 11/13/19</recruitment_details>
      <pre_assignment_details>Screening period was up to 21 days. The study comprised of Week 1 with Achilles infusion set and saline and Weeks 2 and 3 with Achilles infusion set and insulin.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Achilles Infusion Set</title>
          <description>Subjects used their own insulin infusion pumps from week 1 to 3. During week 1, participants wore 2 pumps. They wore their own pump (with insulin) and their own commercial infusion set and an additional study pump (with saline) and the investigational Achilles infusion set. During week 2-3, participants wore one pump. They wore their own pump (with insulin) and investigational Achilles infusion set.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Achilles Infusion Set w/Saline- Week 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Achilles Infusion Set w/Insulin Week 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Achilles Infusion Set w/Insulin Week 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Achilles Infusion Set</title>
          <description>Coil-reinforced soft polymer indwelling cannula&#xD;
coil-reinforced soft polymer indwelling cannula: This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.3" spread="14.03"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.0" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Infusion Set Survival at End of Day 7</title>
        <description>The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.</description>
        <time_frame>7 days during weeks 2 and 3</time_frame>
        <population>Subjects used their own insulin infusion pumps from week 1 to 3. During week 1, participants wore 2 pumps. They wore their own pump (with insulin) and their own commercial infusion set and an additional study pump (with saline) and the investigational Achilles infusion set. During week 2-3, participants wore one pump. They wore their own pump (with insulin) and investigational Achilles infusion set.</population>
        <group_list>
          <group group_id="O1">
            <title>Achilles Infusion Set</title>
            <description>Coil-reinforced soft polymer indwelling cannula: This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Infusion Set Survival at End of Day 7</title>
          <description>The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.</description>
          <population>Subjects used their own insulin infusion pumps from week 1 to 3. During week 1, participants wore 2 pumps. They wore their own pump (with insulin) and their own commercial infusion set and an additional study pump (with saline) and the investigational Achilles infusion set. During week 2-3, participants wore one pump. They wore their own pump (with insulin) and investigational Achilles infusion set.</population>
          <units>Achilles infusion sets</units>
          <param>Count of Units</param>
          <units_analyzed>Achilles infusion sets</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Achilles infusion sets</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Achilles Infusion Set</title>
          <description>Subjects used their own insulin infusion pumps from week 1 to 3. During week 1, participants wore 2 pumps. They wore their own pump (with insulin) and their own commercial infusion set and an additional study pump (with saline) and the investigational Achilles infusion set. During week 2-3, participants wore one pump. They wore their own pump (with insulin) and investigational Achilles infusion set.</description>
        </group>
      </group_list>
      <serious_events>
        <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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Non-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="15" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dental Discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site dryness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Infusion site erythema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Infusion site pruritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Infusion site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Separation Problem</sub_title>
                <description>Infusion set got caught on door and pulled out</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infusion site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Patient-Device Incompatibility</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Skin lesion removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Clinical Affairs</name_or_title>
      <organization>Capillary BioMedical, Inc.</organization>
      <phone>949-317-1711</phone>
      <email>alayne.lehman@capillarybio.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/NCT04503564
org study id: 150-1072-00
secondary id: ACTRN12620000021976
nct id: NCT04503564
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using
      continuous subcutaneous insulin infusion with an infusion set that needs to be changed every
      3 days. This study will assess the feasibility and device performance of the study device,
      the Achilles infusion set over three periods during routine insulin infusion.

      This study will include 20 participants and has 3 periods:

      Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7
      days): participants will manage their blood glucose solely with their insulin pump and the
      Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose
      monitoring (CGM) device.

      Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles
      infusion set and continue blood glucose management at home until infusion set failure or 7
      days.
This is a prospective, non-randomized, home-use feasibility study of device performance,
      usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles
      infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in
      up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).

      The CapBio Achilles infusion set is a sterile single use device designed to be used with
      commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles
      infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and
      three proximal holes.

      The primary objective of this study is to determine feasibility and device performance of the
      CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each
      during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of
      uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study is designed as a single arm device feasibility evaluation
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Rate of Infusion Set Survival at End of Day 7
time frame: 7 days during weeks 2 and 3
description: The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.
arm group label: Achilles Infusion Set
arm group type: Experimental
description: Coil-reinforced soft polymer indwelling cannula
intervention type: Device
intervention name: coil-reinforced soft polymer indwelling cannula
description: This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).
arm group label: Achilles Infusion Set
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: David O'Neal, M.D.
role: Principal Investigator
affiliation: St Vincent's Hospital Department of Medicine
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 