<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/NCT03242005</url>
  </required_header>
  <id_info>
    <org_study_id>DBC-17SCARL23</org_study_id>
    <nct_id>NCT03242005</nct_id>
  </id_info>
  <brief_title>The PSIQS Study - User Experience With Pro-Set</brief_title>
  <official_title>The PSIQS Study - User Experience With the Pro-Set Over Intended Wear of 3 Days With New Instructions and Requirement to be Inserted With the Quick-Serter</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open label, randomized 2-period cross-over study comparing two continuous subcutaneous&#xD;
      insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed®&#xD;
      Quick-set®&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision to not proceed with study - no subjects enrolled&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia</measure>
    <time_frame>6 hours from time of insertion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; &gt; 400mg/dl.</measure>
    <time_frame>6 hours from time of insertion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia &gt;250mg/dl.</measure>
    <time_frame>72 hours of set wear that occurs at 6 hours or later after insertion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.</measure>
    <time_frame>60 hours post insertion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Pro-set® vs. Quick- set® for duration of wear</measure>
    <time_frame>% reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Pro-set® vs. Quick-set®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MiniMed® Pro-set®</intervention_name>
    <description>Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.</description>
    <arm_group_label>Pro-set® vs. Quick-set®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MiniMed® Quick-set®</intervention_name>
    <description>Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.</description>
    <arm_group_label>Pro-set® vs. Quick-set®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be between 13 and 70 years of age (inclusive)&#xD;
&#xD;
          -  Must have been previously diagnosed with type 1 diabetes mellitus&#xD;
&#xD;
          -  Must be using one of the following Medtronic insulin pumps with the Paradigm connector&#xD;
             (note 670G excluded) for at least 6 months prior to enrollment. These pumps must have&#xD;
             the ability to upload data to Medtronic CareLink Therapy Management software.&#xD;
&#xD;
               1. MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3&#xD;
                  mL reservoir)&#xD;
&#xD;
               2. MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir)&#xD;
&#xD;
               3. MiniMed 630G System&#xD;
&#xD;
          -  Must have been using the Medtronic Enlite CGM for at least 3 months prior to&#xD;
             enrollment, and are currently doing so&#xD;
&#xD;
          -  Must routinely insert their own infusion set (may be inserted manually or with an&#xD;
             inserter or with an integrated set/inserter, i.e. Mio)&#xD;
&#xD;
          -  If instructed, must be willing to insert all assigned infusion sets with a mechanical&#xD;
             inserter&#xD;
&#xD;
          -  Must have another form of insulin delivery available (i.e. vial and syringe or pen and&#xD;
             pen needle)&#xD;
&#xD;
          -  Must agree to continue using current Medtronic Enlite CGM throughout the study&#xD;
&#xD;
          -  Willing to have insulin pump, BGM and CGM data downloaded into Medtronic CareLink&#xD;
             Therapy Management Software (requires subject CareLink logon ID and password)&#xD;
&#xD;
          -  In stable health status with no acute or significant illness, in the opinion of the&#xD;
             investigator or designee&#xD;
&#xD;
          -  Able to read, write and follow instructions in English&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
          -  Able and willing to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant (self-attestation) or nursing&#xD;
&#xD;
          -  Currently using a body-worn patch insulin infusion pump, e.g. Omnipod or V-Go&#xD;
&#xD;
          -  Currently using the Medtronic Model 670G pump and associated CGM&#xD;
&#xD;
          -  Current or past participation in previous BD Study DBC-16SCARL21&#xD;
&#xD;
          -  History of bleeding disorder or easy bruising.&#xD;
&#xD;
          -  Currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day&#xD;
             of aspirin is permitted).&#xD;
&#xD;
          -  Known blood borne infections.&#xD;
&#xD;
          -  History of recurrent dermatological condition or skin disorder (e.g. psoriasis,&#xD;
             eczema, pre-existing dermatitis).&#xD;
&#xD;
          -  Skin abnormalities, anomalies or conditions (e.g. sunburn, tattoos, extensive&#xD;
             scarring, lipohypertrophy) located at or very close to the intended insertion site.&#xD;
&#xD;
          -  Physical condition that restricts dexterity and may limit ability to perform study&#xD;
             procedures (i.e. severe neuropathy or arthritis of the hands; self-reported)&#xD;
&#xD;
          -  Currently participating in any other clinical investigation that conflicts with this&#xD;
             study&#xD;
&#xD;
          -  Employed by, or currently serving as a contractor or consultant to BD, Medtronic or&#xD;
             study site&#xD;
&#xD;
          -  Any other condition the investigator or designee deems to pose an unacceptable risk to&#xD;
             the subject in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</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, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242005
org study id: DBC-17SCARL23
nct id: NCT03242005
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Open label, randomized 2-period cross-over study comparing two continuous subcutaneous
      insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed®
      Quick-set®
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia
time frame: 6 hours from time of insertion
measure: Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.
time frame: 6 hours from time of insertion
measure: Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl.
time frame: 72 hours of set wear that occurs at 6 hours or later after insertion
measure: Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.
time frame: 60 hours post insertion
measure: Compare Pro-set® vs. Quick- set® for duration of wear
time frame: % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)
arm group label: Pro-set® vs. Quick-set®
arm group type: Experimental
description: Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design.
intervention type: Device
intervention name: MiniMed® Pro-set®
description: Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.
arm group label: Pro-set® vs. Quick-set®
intervention type: Device
intervention name: MiniMed® Quick-set®
description: Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.
arm group label: Pro-set® vs. Quick-set®
criteria: 
gender: All
minimum age: 13 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No