xml: <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/NCT05973422</url>
    </required_header>
    <id_info>
      <org_study_id>CIP-0001 Sigi FIH Study CIP</org_study_id>
      <nct_id>NCT05973422</nct_id>
    </id_info>
    <brief_title>Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes</brief_title>
    <acronym>SigiFIH</acronym>
    <official_title>Sigi Insulin Management System - First-in-Human Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tandem Diabetes Care, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tandem Diabetes Care, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This early feasibility first-in-human study is a prospective single-arm single-center study&#xD;
        of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a&#xD;
        hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1&#xD;
        diabetes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sigi Insulin Management System (Sigi) is a novel insulin patch pump intended for subcutaneous&#xD;
        delivery if insulin at set and variable rates for the management of diabetes mellitus in&#xD;
        persons requiring insulin. Sigi is offering superior delivery accuracy and precision,&#xD;
        accelerated occlusion detection, wearable patch pump, pre-filled insulin cartridges and&#xD;
        smartphone control.&#xD;
  &#xD;
        Glycemia is CGM controlled and for safety purposes, CGM data are shared with study medical&#xD;
        team during the whole study.&#xD;
  &#xD;
        Sigi FIH Study is conducted in a single clinical site in Lausanne University Hospital (CHUV)&#xD;
        in Switzerland.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 30, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Serious Adverse Events</measure>
      <time_frame>15 days</time_frame>
      <description>Number of serious adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>15 days</time_frame>
      <description>Number of adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse Device Effects</measure>
      <time_frame>15 days</time_frame>
      <description>Number of adverse device effects (ADE)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serious adverse device effects (SADE)</measure>
      <time_frame>15 days</time_frame>
      <description>Number of serious adverse device effects (ADE)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi</measure>
      <time_frame>15 days</time_frame>
      <description>Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi</measure>
      <time_frame>15 days</time_frame>
      <description>Number of diabetic ketoacidosis events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptance and confidence of PI to proceed to outpatient use</measure>
      <time_frame>1 day</time_frame>
      <description>Number of participants who pass the observed use setting as evaluated by PI and proceed to outpatient use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptance and confidence of participant to proceed to outpatient use</measure>
      <time_frame>1 day</time_frame>
      <description>Number of participants who pass the observed use setting as evaluated by participants and proceed to outpatient use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device deficiencies</measure>
      <time_frame>15 days</time_frame>
      <description>Number of device deficiencies (device issues) recorded during study use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of pad duration (days)</measure>
      <time_frame>15 days</time_frame>
      <description>Collect pad replacement dates to calculate the pad survival rate at 3 days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occlusion detection rate</measure>
      <time_frame>15 days</time_frame>
      <description>Rate of occlusions detected by the system over the total wear period (number of occlusions/total wear time in days)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of skin tolerance</measure>
      <time_frame>15 days</time_frame>
      <description>Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of overall device tolerance</measure>
      <time_frame>15 days</time_frame>
      <description>Number of reports related to discomfort at the infusion site, including discomfort related adverse events, during the 15 day wear time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>System Usability Scale (SUS) at baseline and 15 days for the PAD</measure>
      <time_frame>15 days</time_frame>
      <description>System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability, collected at baseline and 15 days for evaluation of the PAD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>System Usability Scale (SUS) at baseline and 15 days for the Pump Assembly</measure>
      <time_frame>15 days</time_frame>
      <description>System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability, collected at baseline and 15 days for evaluation of the pump assembly.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Type 1 Diabetes</condition>
    <arm_group>
      <arm_group_label>SIGI Insulin Management System Observed and At-Home Use</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Current insulin pump users with type 1 diabetes, age 18+, will use the SIGI insulin management system for 1 day observed in the hospital setting, then for 2 more weeks of outpatient use.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SIGI Insulin Management System</intervention_name>
      <description>Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.</description>
      <arm_group_label>SIGI Insulin Management System Observed and At-Home Use</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Informed consent signed&#xD;
  &#xD;
            -  Patients with T1D since more than 1 year&#xD;
  &#xD;
            -  Adults 18+years&#xD;
  &#xD;
            -  Patients under sensor augmented pump for at least 6 months&#xD;
  &#xD;
            -  Hybrid closed-loop users willing to switch to manual mode 15 days before study&#xD;
  &#xD;
            -  Patients with calculated insulin-to-carb ratio and correction factor&#xD;
  &#xD;
            -  Patients with total daily insulin above 30 insulin units&#xD;
  &#xD;
            -  Patients with correction factor below 3.5 mmol/L&#xD;
  &#xD;
            -  No severe hypoglycemic or ketoacidosis episode requiring third-party intervention&#xD;
               within the past 12 months&#xD;
  &#xD;
            -  Active users of Teflon infusion sets&#xD;
  &#xD;
            -  Patients willing to use a smartphone interface to use their pump and to answer study&#xD;
               questionnaires&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with T2D&#xD;
  &#xD;
            -  Patients with T1D under multiple daily injections&#xD;
  &#xD;
            -  Patients using Apidra and not willing to switch to NovoRapid / Fiasp / Humalog&#xD;
  &#xD;
            -  Patients with history of skin diseases (e.g. generalized eczema, plan lichen,&#xD;
               psoriasis)&#xD;
  &#xD;
            -  Patients with known allergy to some insulins&#xD;
  &#xD;
            -  Clarke's score ≥ 4 (hypoglycemia unawareness)&#xD;
  &#xD;
            -  Severe late complications of diabetes, like severe neuropathy, non-stabilized&#xD;
               proliferative retinopathy, EGF &lt; 30 mL/min, myocardial infarction or stroke within the&#xD;
               last 3 months&#xD;
  &#xD;
            -  Glycated hemoglobin HbA1c &gt; 8.5 % at screening visit&#xD;
  &#xD;
            -  Medications interacting with glucose homeostasis (e.g. steroids)&#xD;
  &#xD;
            -  Pregnant of breastfeeding women&#xD;
  &#xD;
            -  Planned operation / MRI / CT requiring removal of infusion pad over the 15 days of the&#xD;
               study&#xD;
  &#xD;
            -  Planned travel over the 15 days of the study&#xD;
  &#xD;
            -  Persons under guardianship or incapable of judgement&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anne Wojtusciszyn, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHUV Centre Hospitalier Universitaire Vaudois</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alain Woodtli</last_name>
      <phone>+41786032519</phone>
      <email>awoodtli@tandemdiabetes.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laetitia Galea</last_name>
      <phone>+41215523676</phone>
      <email>lgalea@tandemdiabetes.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Insulin patch pump</keyword>
    <keyword>CGM control</keyword>
    <keyword>Smartphone control</keyword>
    <keyword>Pre-filled insulin cartridges</keyword>
    <keyword>Occlusion detection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973422
  org study id: CIP-0001 Sigi FIH Study CIP
  nct id: NCT05973422
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This early feasibility first-in-human study is a prospective single-arm single-center study
        of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a
        hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1
        diabetes.
  Sigi Insulin Management System (Sigi) is a novel insulin patch pump intended for subcutaneous
        delivery if insulin at set and variable rates for the management of diabetes mellitus in
        persons requiring insulin. Sigi is offering superior delivery accuracy and precision,
        accelerated occlusion detection, wearable patch pump, pre-filled insulin cartridges and
        smartphone control.
  
        Glycemia is CGM controlled and for safety purposes, CGM data are shared with study medical
        team during the whole study.
  
        Sigi FIH Study is conducted in a single clinical site in Lausanne University Hospital (CHUV)
        in Switzerland.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Serious Adverse Events
  time frame: 15 days
  description: Number of serious adverse events
  measure: Adverse Events
  time frame: 15 days
  description: Number of adverse events
  measure: Adverse Device Effects
  time frame: 15 days
  description: Number of adverse device effects (ADE)
  measure: Serious adverse device effects (SADE)
  time frame: 15 days
  description: Number of serious adverse device effects (ADE)
  measure: Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi
  time frame: 15 days
  description: Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study
  measure: Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi
  time frame: 15 days
  description: Number of diabetic ketoacidosis events
  measure: Acceptance and confidence of PI to proceed to outpatient use
  time frame: 1 day
  description: Number of participants who pass the observed use setting as evaluated by PI and proceed to outpatient use.
  measure: Acceptance and confidence of participant to proceed to outpatient use
  time frame: 1 day
  description: Number of participants who pass the observed use setting as evaluated by participants and proceed to outpatient use.
  measure: Device deficiencies
  time frame: 15 days
  description: Number of device deficiencies (device issues) recorded during study use
  measure: Evaluation of pad duration (days)
  time frame: 15 days
  description: Collect pad replacement dates to calculate the pad survival rate at 3 days
  measure: Occlusion detection rate
  time frame: 15 days
  description: Rate of occlusions detected by the system over the total wear period (number of occlusions/total wear time in days)
  measure: Evaluation of skin tolerance
  time frame: 15 days
  description: Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time.
  measure: Evaluation of overall device tolerance
  time frame: 15 days
  description: Number of reports related to discomfort at the infusion site, including discomfort related adverse events, during the 15 day wear time.
  measure: System Usability Scale (SUS) at baseline and 15 days for the PAD
  time frame: 15 days
  description: System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability, collected at baseline and 15 days for evaluation of the PAD.
  measure: System Usability Scale (SUS) at baseline and 15 days for the Pump Assembly
  time frame: 15 days
  description: System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability, collected at baseline and 15 days for evaluation of the pump assembly.
  arm group label: SIGI Insulin Management System Observed and At-Home Use
  arm group type: Experimental
  description: Current insulin pump users with type 1 diabetes, age 18+, will use the SIGI insulin management system for 1 day observed in the hospital setting, then for 2 more weeks of outpatient use.
  intervention type: Device
  intervention name: SIGI Insulin Management System
  description: Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.
  arm group label: SIGI Insulin Management System Observed and At-Home Use
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anne Wojtusciszyn, MD
  role: Principal Investigator
  affiliation: CHUV Centre Hospitalier Universitaire Vaudois
  last name: Alain Woodtli
  phone: +41786032519
  email: awoodtli@tandemdiabetes.com
  last name: Laetitia Galea
  phone: +41215523676
  email: lgalea@tandemdiabetes.com
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus, Type 1
  mesh term: Insulin
  sharing ipd: No