<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/NCT03819634</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #45812</org_study_id>
    <nct_id>NCT03819634</nct_id>
  </id_info>
  <brief_title>Longevity of Multi-Slitted Catheter With Lantern Technology</brief_title>
  <acronym>Lantern</acronym>
  <official_title>Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ConvaTec Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
      To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec&#xD;
      Lantern) infusion set with multi-slitted catheter is worn for up to 10 days&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study to obtain preliminary data to determine the time to set failure when&#xD;
      the Lantern infusion set is worn for up to 10 days. The study is not intended for&#xD;
      registration purposes or to support a 510(k) submission. The study will be conducted at one&#xD;
      site: Stanford University.&#xD;
&#xD;
      This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of&#xD;
      Lantern infusion set wear when 80% of sets are still functional (excluding accidental&#xD;
      &quot;pull-outs&quot;). Each participant will place the set and wear it for 10 days or until set&#xD;
      failure and data will be collected on the cause of set failure. If a set is accidentally&#xD;
      pulled out, it can be replaced by the subject. Failures are based on:&#xD;
&#xD;
        1. Presence of serum ketones with hyperglycemia&#xD;
&#xD;
        2. Unexplained hyperglycemia&#xD;
&#xD;
        3. Signs of infection at the infusion site&#xD;
&#xD;
        4. Pump occlusion alarm&#xD;
&#xD;
        5. Adhesive failure&#xD;
&#xD;
      Since infusion set failures will occur after variable lengths of wear, regularly scheduled&#xD;
      visits are unlikely to capture the day of an infusion set failure. Instead the subject will&#xD;
      be taught how to insert the set, measure erythema and induration with a ruler marked in&#xD;
      millimeters and to take a picture of the infusion site. Subjects will be instructed to text&#xD;
      the study team when they remove their infusion set and to send a picture of the infusion site&#xD;
      and measurements. If there is any evidence of an infection (≥10 mm of erythema or&#xD;
      induration), they will be asked to come in that day for an unscheduled visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">April 20, 2019</completion_date>
  <primary_completion_date type="Actual">April 20, 2019</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>To determine length of infusion set wear for up to a maximum of 10 days</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Infusion Set Failure</measure>
    <time_frame>10 days of infusion set wear</time_frame>
    <description>Time to when the infusion set fails and needs to be replaced.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Insulin Dependent Diabetes Mellitus 1</condition>
  <arm_group>
    <arm_group_label>Lantern infusion set</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multi-slitted lantern infusion set</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inset II with Lantern Technology</intervention_name>
    <description>Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.</description>
    <arm_group_label>Lantern infusion set</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Type 1 Diabetes by clinical definition&#xD;
&#xD;
          1. Age 22 and over&#xD;
&#xD;
          2. On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.&#xD;
&#xD;
          3. Hemoglobin A1c level less than or equal to 9%&#xD;
&#xD;
          4. Eating more than 60 grams of carbohydrate each day&#xD;
&#xD;
          5. For females, not currently known to be pregnant&#xD;
&#xD;
          6. Understanding and willingness to follow the protocol and sign informed consent&#xD;
&#xD;
          7. Willingness to wear the experimental infusion sets&#xD;
&#xD;
          8. Willingness to have photographs taken of their infusion sites&#xD;
&#xD;
          9. Ability to speak, read and write in the language of the investigators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The presence of any of the following is an exclusion for the study:&#xD;
&#xD;
          1. Diabetic ketoacidosis in the past 3 months&#xD;
&#xD;
          2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months&#xD;
             prior to enrollment&#xD;
&#xD;
          3. Pregnant or lactating&#xD;
&#xD;
          4. Known tape allergies&#xD;
&#xD;
          5. Active infection&#xD;
&#xD;
          6. A known medical condition that in the judgment of the investigator might interfere&#xD;
             with the completion of the protocol&#xD;
&#xD;
          7. Known cardiovascular events in the last 6 months&#xD;
&#xD;
          8. Known acute proliferative diabetic retinopathy&#xD;
&#xD;
          9. Known adrenal disorder&#xD;
&#xD;
         10. Current treatment for a seizure disorder&#xD;
&#xD;
         11. Inpatient psychiatric treatment in the past 6 months&#xD;
&#xD;
         12. Lack of stability on medication 1 month prior to enrollment including&#xD;
             antihypertensive, thyroid, anti-depressant or lipid lowering medication.&#xD;
&#xD;
         13. Use of SGLT inhibitor&#xD;
&#xD;
         14. Suspected drug or alcohol abuse&#xD;
&#xD;
         15. Dialysis or end stage kidney disease&#xD;
&#xD;
        Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from&#xD;
        enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce A Buckingham, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lal RA, Hsu L, Zhang J, Schondorff PK, Heschel M, Buckingham B. Longevity of the novel ConvaTec infusion set with Lantern technology. Diabetes Obes Metab. 2021 Aug;23(8):1973-1977. doi: 10.1111/dom.14395. Epub 2021 Apr 18.</citation>
    <PMID>33822472</PMID>
  </results_reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>May 3, 2021</results_first_submitted>
  <results_first_submitted_qc>May 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2021</results_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Bruce Buckingham</investigator_full_name>
    <investigator_title>Professor of Pediatric Endocrinology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>June 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03819634/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lantern Infusion Set</title>
          <description>Multi-slitted lantern infusion set&#xD;
Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who completed the protocol are included in the analysis for baseline characteristics.</population>
      <group_list>
        <group group_id="B1">
          <title>Lantern Infusion Set</title>
          <description>Multi-slitted lantern infusion set&#xD;
Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.1" spread="14.3"/>
                  </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="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="3"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.4" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>% glcosylated HBG:total HBG</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Daily Insulin Dose (Units)</title>
          <units>units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.0" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.0" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Infusion Set Failure</title>
        <description>Time to when the infusion set fails and needs to be replaced.</description>
        <time_frame>10 days of infusion set wear</time_frame>
        <population>Participants who completed the protocol are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Lantern Infusion Set</title>
            <description>Multi-slitted lantern infusion set&#xD;
Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Infusion Set Failure</title>
          <description>Time to when the infusion set fails and needs to be replaced.</description>
          <population>Participants who completed the protocol are included in the analysis.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lantern Infusion Set</title>
          <description>Multi-slitted lantern infusion set&#xD;
Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.</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="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>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="12" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>hyperglycemia</sub_title>
                <description>hyperglycemia unresponsive to a correction dose of insulin</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>ketotosis</sub_title>
                <description>ketosis with hyperglycemia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>subcutaneous infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>adhesive failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </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>Bruce Buckingham</name_or_title>
      <organization>Stanford</organization>
      <phone>6508040476</phone>
      <email>buckingham@stanford.edu</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/NCT03819634
org study id: IRB #45812
nct id: NCT03819634
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec
      Lantern) infusion set with multi-slitted catheter is worn for up to 10 days
This is a pilot study to obtain preliminary data to determine the time to set failure when
      the Lantern infusion set is worn for up to 10 days. The study is not intended for
      registration purposes or to support a 510(k) submission. The study will be conducted at one
      site: Stanford University.

      This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of
      Lantern infusion set wear when 80% of sets are still functional (excluding accidental
      "pull-outs"). Each participant will place the set and wear it for 10 days or until set
      failure and data will be collected on the cause of set failure. If a set is accidentally
      pulled out, it can be replaced by the subject. Failures are based on:

        1. Presence of serum ketones with hyperglycemia

        2. Unexplained hyperglycemia

        3. Signs of infection at the infusion site

        4. Pump occlusion alarm

        5. Adhesive failure

      Since infusion set failures will occur after variable lengths of wear, regularly scheduled
      visits are unlikely to capture the day of an infusion set failure. Instead the subject will
      be taught how to insert the set, measure erythema and induration with a ruler marked in
      millimeters and to take a picture of the infusion site. Subjects will be instructed to text
      the study team when they remove their infusion set and to send a picture of the infusion site
      and measurements. If there is any evidence of an infection (≥10 mm of erythema or
      induration), they will be asked to come in that day for an unscheduled visit.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: To determine length of infusion set wear for up to a maximum of 10 days
primary purpose: Treatment
masking: None (Open Label)
measure: Time to Infusion Set Failure
time frame: 10 days of infusion set wear
description: Time to when the infusion set fails and needs to be replaced.
arm group label: Lantern infusion set
arm group type: Experimental
description: Multi-slitted lantern infusion set
intervention type: Device
intervention name: Inset II with Lantern Technology
description: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
arm group label: Lantern infusion set
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Bruce A Buckingham, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: Lal RA, Hsu L, Zhang J, Schondorff PK, Heschel M, Buckingham B. Longevity of the novel ConvaTec infusion set with Lantern technology. Diabetes Obes Metab. 2021 Aug;23(8):1973-1977. doi: 10.1111/dom.14395. Epub 2021 Apr 18.
PMID: 33822472
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Bruce Buckingham
investigator title: Professor of Pediatric Endocrinology
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 