<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/NCT03267264</url>
  </required_header>
  <id_info>
    <org_study_id>DBC-17NUCL07</org_study_id>
    <nct_id>NCT03267264</nct_id>
  </id_info>
  <brief_title>Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle</brief_title>
  <official_title>Nucleus Claims Study: Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Becton, Dickinson and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Becton, Dickinson and Company</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-site, prospective, open-label, randomized, 2 period cross over study&#xD;
      comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus&#xD;
      pen needle. The study will consist of two 15 day periods ( in which the subject will use each&#xD;
      pen needle [BD Nucleus pen needle or subject's current pen needle, order randomized] for&#xD;
      injection. At the end of the last study period, each subject will be asked to evaluate his or&#xD;
      her perceptions using a 150mm relative VAS scale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">April 24, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall User Preference -Combined Groups</measure>
    <time_frame>30 Days</time_frame>
    <description>This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall User Preference - Each Comparator Group</measure>
    <time_frame>30 Days</time_frame>
    <description>This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Experience - All Study Groups Combined</measure>
    <time_frame>30 Days</time_frame>
    <description>This is a combined endpoint for all study subjects. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Experience - Each Individual Study Group</measure>
    <time_frame>30 Days</time_frame>
    <description>This endpoint analyzes data for individual groups. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">248</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BD Nano™ vs Nucleus</intervention_name>
    <description>Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or&#xD;
subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NovoFine® vs Nucleus</intervention_name>
    <description>Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or&#xD;
subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NovoTwist®/NovoFine® Plus vs Nucleus</intervention_name>
    <description>Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or&#xD;
subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus</intervention_name>
    <description>Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or&#xD;
subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (18 - 75 inclusive)&#xD;
&#xD;
          2. Diagnosed Type 1 or Type 2 diabetes&#xD;
&#xD;
          3. Every effort will be made to recruit approximately 25% Type 1 patients (of the total&#xD;
             population, not of each subgroup) (minimum: 10%, maximum: 50%)&#xD;
&#xD;
          4. Every effort will be made to recruit a minimum of 30 subjects with Asian ethnicity (of&#xD;
             the total population, not of each subgroup). Ideally, 60 Asian subjects are needed for&#xD;
             the study&#xD;
&#xD;
          5. Minimum within the last 4 months experience self-injecting insulin with a pen injector&#xD;
&#xD;
          6. Minimum within the last 2 months experience self-injecting consistently with one of&#xD;
             the following available pen needles OR a subject may be enrolled that is using a&#xD;
             31G/32G pen needle that is not longer than 6mm in length who is willing to transfer to&#xD;
             one of the following 32G pen needle with a 14 day wash-in period:&#xD;
&#xD;
               -  BD Nano™ 32Gx4mm&#xD;
&#xD;
               -  NovoFine® 32Gx6mm&#xD;
&#xD;
               -  NovoTwist® 32Gx5mm or&#xD;
&#xD;
               -  NovoFine® Plus 32Gx4mm&#xD;
&#xD;
               -  Owen Mumford PenTips 32Gx4mm or&#xD;
&#xD;
               -  Perrigo / Ypsomed ClickFine 32Gx4mm or&#xD;
&#xD;
               -  Other 32G such as UltiMed, MHC, or other private label.&#xD;
&#xD;
          7. Able and willing to provide informed consent/participant form&#xD;
&#xD;
          8. Able and willing to complete all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Self-injecting insulin with a pen injector for less than 3 months&#xD;
&#xD;
          2. Planned changes in insulin regimen (increasing or decreasing number of injections per&#xD;
             day).&#xD;
&#xD;
          3. Positive pregnancy test (urine)&#xD;
&#xD;
          4. Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day&#xD;
             of aspirin is permitted).&#xD;
&#xD;
          5. History of a bleeding disorder or easy bruising&#xD;
&#xD;
          6. Blood borne infection(s)&#xD;
&#xD;
          7. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis,&#xD;
             eczema)&#xD;
&#xD;
          8. Gross skin anomalies and abnormalities (e.g., scars, stretch marks, discolorations,&#xD;
             tattoos, superficial masses, acne, inflammation) located at or very close to the&#xD;
             injection sites&#xD;
&#xD;
          9. Fear of needles, history of symptomatic low blood pressure or history of fainting&#xD;
             (syncope) during hypodermic injections.&#xD;
&#xD;
         10. Use of any prescription analgesic medications within 24 hours of first study&#xD;
             injection, and during the study.&#xD;
&#xD;
         11. A current or previous medical or physical condition that, in the opinion of the&#xD;
             investigator, would place the patient at risk or make them unable to perform study&#xD;
             procedures or has the potential to confound interpretation of the study results.&#xD;
&#xD;
         12. Currently participating in another study&#xD;
&#xD;
         13. Employed by, or currently serving as a contractor or consultant to BD or any insulin,&#xD;
             insulin pen, or insulin pen needle manufacturer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>East West Medical Research Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid Medical Research, Inc.</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporation Lane Internal Medicine and Research Center</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Whooley S, Briskin T, Gibney M, Blank L, Berube J, Pflug B. Evaluation the User Performance and Experience of a New Pen Needle with Advanced Hub Face Geometry. Poster presented at: American Association of Diabetes Education Annual Conference; 2018 Aug 17-20; Baltimore, MD.</citation>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <results_first_submitted>April 10, 2019</results_first_submitted>
  <results_first_submitted_qc>June 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 16, 2019</results_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03267264/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03267264/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1</title>
          <description>BD Nano™ vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or&#xD;
subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
        <group group_id="P2">
          <title>Group 2</title>
          <description>NovoFine® vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or&#xD;
subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
        <group group_id="P3">
          <title>Group 3</title>
          <description>NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or&#xD;
subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
        <group group_id="P4">
          <title>Group 4</title>
          <description>Other Commercially Available Pen Needles (MHC Easy Touch, Simple Diagnostics Comfor EZ) vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or&#xD;
subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="68"/>
                <participants group_id="P4" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sequence A(Nucleus)</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sequence B(Comparator)</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>BD Nano™ vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or&#xD;
subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>NovoFine® vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or&#xD;
subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or&#xD;
subject's current pen needle (NovoTwist®/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
        <group group_id="B4">
          <title>Group 4</title>
          <description>Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus: Subjects will be randomized to&#xD;
Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or&#xD;
subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="66"/>
            <count group_id="B2" value="49"/>
            <count group_id="B3" value="68"/>
            <count group_id="B4" value="65"/>
            <count group_id="B5" value="248"/>
          </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="55.5" spread="13.3"/>
                    <measurement group_id="B2" value="56.6" spread="12.8"/>
                    <measurement group_id="B3" value="55.4" spread="12.2"/>
                    <measurement group_id="B4" value="55.2" spread="11.2"/>
                    <measurement group_id="B5" value="55.6" spread="12.3"/>
                  </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="34"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="120"/>
                  </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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="64"/>
                    <measurement group_id="B5" value="237"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall User Preference -Combined Groups</title>
        <description>This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).</description>
        <time_frame>30 Days</time_frame>
        <population>Per-protocol population; note that one VAS data point was missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Groups</title>
            <description>Nucleus vs all groups combined</description>
          </group>
        </group_list>
        <measure>
          <title>Overall User Preference -Combined Groups</title>
          <description>This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).</description>
          <population>Per-protocol population; note that one VAS data point was missing.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="225"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" lower_limit="10.3" upper_limit="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>17.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.3</ci_lower_limit>
            <ci_upper_limit>24.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall User Preference - Each Comparator Group</title>
        <description>This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).</description>
        <time_frame>30 Days</time_frame>
        <population>Per-protocol population; note that one VAS data point was missing</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>BD Nano™ vs Nucleus</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>NovoFine® vs Nucleus</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>NovoTwist®/NovoFine® Plus vs Nucleus</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Other Commercially Available Pen Needles</description>
          </group>
        </group_list>
        <measure>
          <title>Overall User Preference - Each Comparator Group</title>
          <description>This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).</description>
          <population>Per-protocol population; note that one VAS data point was missing</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.5" lower_limit="16.8" upper_limit="44.3"/>
                    <measurement group_id="O2" value="20.6" lower_limit="4.1" upper_limit="37.1"/>
                    <measurement group_id="O3" value="6.2" lower_limit="-7.2" upper_limit="19.5"/>
                    <measurement group_id="O4" value="12.8" lower_limit="-1.1" upper_limit="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>30.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.8</ci_lower_limit>
            <ci_upper_limit>44.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall</param_type>
            <param_value>20.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.1</ci_lower_limit>
            <ci_upper_limit>37.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>overal mean</param_type>
            <param_value>6.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.2</ci_lower_limit>
            <ci_upper_limit>19.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>12.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>26.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>User Experience - All Study Groups Combined</title>
        <description>This is a combined endpoint for all study subjects. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.</description>
        <time_frame>30 Days</time_frame>
        <population>Per-protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>All Groups Combined</title>
            <description>Resutls from comparator pen needle groups combined and compared to NUCLEUS</description>
          </group>
        </group_list>
        <measure>
          <title>User Experience - All Study Groups Combined</title>
          <description>This is a combined endpoint for all study subjects. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.</description>
          <population>Per-protocol population</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="226"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Comfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" lower_limit="11.3" upper_limit="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Associated with a Needle Stick Injury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" lower_limit="9.9" upper_limit="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" lower_limit="8.9" upper_limit="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" lower_limit="13.8" upper_limit="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Overall Comfort</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall mean</param_type>
            <param_value>18.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.3</ci_lower_limit>
            <ci_upper_limit>24.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Anxiety Associated with a Needle Stick Injury</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>15.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.9</ci_lower_limit>
            <ci_upper_limit>21.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Injection Pain</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>15.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.9</ci_lower_limit>
            <ci_upper_limit>22.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Ease of Use</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>19.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.8</ci_lower_limit>
            <ci_upper_limit>25.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>User Experience - Each Individual Study Group</title>
        <description>This endpoint analyzes data for individual groups. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.</description>
        <time_frame>30 Days</time_frame>
        <population>Per-protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>BD Nano™ vs Nucleus</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>NovoFine® vs Nucleus</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>NovoTwist®/NovoFine® Plus vs Nucleus</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Other Commercially Available Pen Needles</description>
          </group>
        </group_list>
        <measure>
          <title>User Experience - Each Individual Study Group</title>
          <description>This endpoint analyzes data for individual groups. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.</description>
          <population>Per-protocol population</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Comfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="14.9" upper_limit="40.7"/>
                    <measurement group_id="O2" value="20.7" lower_limit="5.3" upper_limit="36.1"/>
                    <measurement group_id="O3" value="8.4" lower_limit="-4" upper_limit="20.9"/>
                    <measurement group_id="O4" value="15.1" lower_limit="2.1" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Associated with a Needle Stick Injury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" lower_limit="8.9" upper_limit="31.6"/>
                    <measurement group_id="O2" value="19.4" lower_limit="6" upper_limit="32.8"/>
                    <measurement group_id="O3" value="12.9" lower_limit="1.9" upper_limit="23.8"/>
                    <measurement group_id="O4" value="11.0" lower_limit="-0.5" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" lower_limit="3.4" upper_limit="28.8"/>
                    <measurement group_id="O2" value="18.6" lower_limit="3.6" upper_limit="33.7"/>
                    <measurement group_id="O3" value="7.0" lower_limit="-5.3" upper_limit="19.4"/>
                    <measurement group_id="O4" value="20.2" lower_limit="7.4" upper_limit="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.7" lower_limit="19.3" upper_limit="42.1"/>
                    <measurement group_id="O2" value="18.4" lower_limit="4.9" upper_limit="31.9"/>
                    <measurement group_id="O3" value="17.7" lower_limit="6.7" upper_limit="28.8"/>
                    <measurement group_id="O4" value="12.0" lower_limit="0.5" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Overall Comfort</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>27.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.9</ci_lower_limit>
            <ci_upper_limit>40.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Anxiety Associated with a needle stick injury</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>20.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.9</ci_lower_limit>
            <ci_upper_limit>31.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Injection Pain</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>16.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.4</ci_lower_limit>
            <ci_upper_limit>28.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Ease of Use</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>30.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.3</ci_lower_limit>
            <ci_upper_limit>42.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall Comfort</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>20.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>36.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anxiety Associated with a needle stick</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>19.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6</ci_lower_limit>
            <ci_upper_limit>32.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Injection Pain</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>18.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.6</ci_lower_limit>
            <ci_upper_limit>33.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Ease of Use</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>18.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.9</ci_lower_limit>
            <ci_upper_limit>31.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Overall Comfort</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>8.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.0</ci_lower_limit>
            <ci_upper_limit>20.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Associated with a Needle stick injury</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>12.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.9</ci_lower_limit>
            <ci_upper_limit>23.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Injection Pain</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>7.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.3</ci_lower_limit>
            <ci_upper_limit>19.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Ease of Use</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>17.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.7</ci_lower_limit>
            <ci_upper_limit>28.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Overall Comfort</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>15.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.1</ci_lower_limit>
            <ci_upper_limit>28.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Anxiety Associated with a Needle Stick Injury</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>11.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>22.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Injection Pain</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>20.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.4</ci_lower_limit>
            <ci_upper_limit>33.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Eae of Use</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value &lt; 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is &gt; -10mm, we can conclude in non-inferiority.</non_inferiority_desc>
            <param_type>Overall Mean</param_type>
            <param_value>12.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5</ci_lower_limit>
            <ci_upper_limit>23.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected over 6 week period.</time_frame>
      <desc>Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions</desc>
      <group_list>
        <group group_id="E1">
          <title>Nucleus</title>
          <description>This arm contains every subject in the study. Because every subject regardless of group recieved Nucleus</description>
        </group>
        <group group_id="E2">
          <title>BD Nano</title>
          <description>This arm contains only those subjects that recieve BD Nano, included in results section described in group 1.</description>
        </group>
        <group group_id="E3">
          <title>NovoFine®</title>
          <description>This arm contains only those subjects that recieved NovoFine®, included in results section described in group 2.</description>
        </group>
        <group group_id="E4">
          <title>NovoTwist®/NovoFine®</title>
          <description>This arm contains only those subjects that recieved NovoTwist®/NovoFine®, included in results section described in group 3.</description>
        </group>
        <group group_id="E5">
          <title>Other Commercially Available Pen Needles (Unifine® Pentips®/M</title>
          <description>This arm contains only those subjects that recieved Other Commercial Pen Needles, included in results section described in group 4.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection of L Hand Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Broken Right Ankle</sub_title>
                <description>Subject broke their ankle</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="50" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Worsening of Type 2 Diabetes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Stomach Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abcess under chin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <description>Experience exceeds that normally associated with the procedure, as judged by the Subject</description>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="241"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <description>Experience exceeds that normally associated with the procedure, as judged by the Subject</description>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Swelling/Pain at injection site</sub_title>
                <description>Experience exceeds that normally associated with the procedure, as judged by the Subject</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Common Cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Respiratory Illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>L hand Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </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>Michael Gibney</name_or_title>
      <organization>Becton Dickinson</organization>
      <phone>201-847-6170</phone>
      <email>michael_gibney@bd.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/NCT03267264
org study id: DBC-17NUCL07
nct id: NCT03267264
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This is a multi-site, prospective, open-label, randomized, 2 period cross over study
      comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus
      pen needle. The study will consist of two 15 day periods ( in which the subject will use each
      pen needle [BD Nucleus pen needle or subject's current pen needle, order randomized] for
      injection. At the end of the last study period, each subject will be asked to evaluate his or
      her perceptions using a 150mm relative VAS scale.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Overall User Preference -Combined Groups
time frame: 30 Days
description: This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).
measure: Overall User Preference - Each Comparator Group
time frame: 30 Days
description: This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).
measure: User Experience - All Study Groups Combined
time frame: 30 Days
description: This is a combined endpoint for all study subjects. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.
measure: User Experience - Each Individual Study Group
time frame: 30 Days
description: This endpoint analyzes data for individual groups. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.
arm group label: Group 1
arm group type: Experimental
arm group label: Group 2
arm group type: Experimental
arm group label: Group 3
arm group type: Experimental
arm group label: Group 4
arm group type: Experimental
intervention type: Device
intervention name: BD Nano™ vs Nucleus
description: Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or
subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
arm group label: Group 1
intervention type: Device
intervention name: NovoFine® vs Nucleus
description: Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or
subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period
arm group label: Group 2
intervention type: Device
intervention name: NovoTwist®/NovoFine® Plus vs Nucleus
description: Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or
subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period
arm group label: Group 3
intervention type: Device
intervention name: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus
description: Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or
subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period
arm group label: Group 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Whooley S, Briskin T, Gibney M, Blank L, Berube J, Pflug B. Evaluation the User Performance and Experience of a New Pen Needle with Advanced Hub Face Geometry. Poster presented at: American Association of Diabetes Education Annual Conference; 2018 Aug 17-20; Baltimore, MD.
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 