<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/NCT01726621</url>
  </required_header>
  <id_info>
    <org_study_id>CEP267</org_study_id>
    <nct_id>NCT01726621</nct_id>
  </id_info>
  <brief_title>User Evaluation of the MiniMed 620G and 640G Insulin Pumps</brief_title>
  <official_title>A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Diabetes</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Diabetes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This six center international study will include two United Kingdom National Health Service&#xD;
      centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The&#xD;
      objective of the study is to evaluate subject acceptance of the a new insulin pump and&#xD;
      transmitter together with the accompanying training materials. Descriptive data from&#xD;
      participant questionnaires and device uploads will be evaluated.&#xD;
&#xD;
      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of&#xD;
      age upwards, who currently use an insulin pump in the management of their type 1 or type 2&#xD;
      diabetes, will be invited to participate. Each subject will be trained on the study device&#xD;
      and then use it for approximately six weeks. During this time there will be three in-clinic&#xD;
      visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of&#xD;
      this period, they will revert back to their original insulin pump and complete a&#xD;
      questionnaire on the study pump training materials, features and usability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter</measure>
    <time_frame>Four weeks of pump wear</time_frame>
    <description>Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Insulin dependent diabetics</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic MiniMed 620G or 640G Insulin Pump</intervention_name>
    <description>Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.</description>
    <arm_group_label>Insulin dependent diabetics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is 7 years or older at time of screening&#xD;
&#xD;
          -  Subject is current insulin pump user for at least 3 months&#xD;
&#xD;
          -  Subject has the following Continuous Glucose Monitoring experience as determined by&#xD;
             the Investigator:&#xD;
&#xD;
               -  Has experience and is able to insert/change sensor by herself/himself and&#xD;
&#xD;
               -  Has experience and can recharge the transmitter and&#xD;
&#xD;
               -  Has experience and can read sensor data in real-time on her/his pump screen&#xD;
&#xD;
          -  Subject has signed a Patient Informed Consent form and is willing to comply with the&#xD;
             study procedures;&#xD;
&#xD;
          -  Subject is willing to complete study questionnaires throughout the study&#xD;
&#xD;
          -  Must have one of the following clinical diagnosis:&#xD;
&#xD;
               -  Type 1 diabetes, for a minimum of 6 months prior to enrollment&#xD;
&#xD;
               -  Insulin requiring type 2 diabetes, for a minimum of 6 months prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subject has a positive urine pregnancy screening test.&#xD;
&#xD;
          -  Female subject who plans to become pregnant during the course of study. If a woman&#xD;
             becomes pregnant during participation, she will be withdrawn&#xD;
&#xD;
          -  Subject has any condition that, in the opinion of the Investigator or qualified&#xD;
             Investigational Center staff, may preclude him/her from participating in the study and&#xD;
             completing study related procedures.&#xD;
&#xD;
          -  Subject has impaired vision or hearing problems that could compromise the handling of&#xD;
             the device as determined by Investigator or qualified Investigational Center staff&#xD;
&#xD;
          -  Subject is actively participating in an investigational study (drug or device) wherein&#xD;
             he/she has received treatment from an investigational study drug or investigational&#xD;
             study device in the last 2 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pratik Choudhary, MBBS, MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Vincent Hospital and The University of Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital</name>
      <address>
        <city>Patkville</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barcelona University Hospital</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE5 9NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Denmark</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>July 2, 2015</results_first_submitted>
  <results_first_submitted_qc>March 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 18, 2016</results_first_posted>
  <last_update_submitted>March 17, 2016</last_update_submitted>
  <last_update_submitted_qc>March 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Insulin Dependent Diabetics</title>
          <description>Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Insulin Depedent Diabetics</title>
          <description>Subject is current insulin pump user and has CGM experience as determined by the investigator.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.3" spread="16.91"/>
                  </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="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter</title>
        <description>Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.</description>
        <time_frame>Four weeks of pump wear</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin Depedent Diabetics</title>
            <description>Subject is current insulin pump user and has CGM experience as determined by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter</title>
          <description>Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.88" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Insulin Dependent Diabetics</title>
          <description>Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter&#xD;
Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Ketonemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Severe hypoglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough with sputum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding cannula site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Insulin infusion set insertion site - bruising</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Skin irritation from Enlite sensor tape</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research Manager</name_or_title>
      <organization>Medtronic MiniMed, Inc</organization>
      <phone>8185765171</phone>
      <email>julie.sekella@medtronic.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/NCT01726621
org study id: CEP267
nct id: NCT01726621
lead sponsor: 
has dmc: No
This six center international study will include two United Kingdom National Health Service
      centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The
      objective of the study is to evaluate subject acceptance of the a new insulin pump and
      transmitter together with the accompanying training materials. Descriptive data from
      participant questionnaires and device uploads will be evaluated.

      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of
      age upwards, who currently use an insulin pump in the management of their type 1 or type 2
      diabetes, will be invited to participate. Each subject will be trained on the study device
      and then use it for approximately six weeks. During this time there will be three in-clinic
      visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of
      this period, they will revert back to their original insulin pump and complete a
      questionnaire on the study pump training materials, features and usability.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter
time frame: Four weeks of pump wear
description: Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
arm group label: Insulin dependent diabetics
arm group type: Other
description: Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
intervention type: Device
intervention name: Medtronic MiniMed 620G or 640G Insulin Pump
description: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.
arm group label: Insulin dependent diabetics
criteria: 
gender: All
minimum age: 7 Years
maximum age: 99 Years
healthy volunteers: No
last name: Pratik Choudhary, MBBS, MRCP
role: Principal Investigator
affiliation: King's College London
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Denmark
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Insulin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 