<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/NCT04479826</url>
  </required_header>
  <id_info>
    <org_study_id>Sheba-19-5955-at-ctil</org_study_id>
    <nct_id>NCT04479826</nct_id>
  </id_info>
  <brief_title>Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition</brief_title>
  <official_title>Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheba Medical Center</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will follow participants for the periods of 3 months while using an advanced hybrid&#xD;
      closed loop algorithm in free living conditions . Each period will have a different meal&#xD;
      handling protocols. The objective is to identify the mitigation of the algorithm with&#xD;
      different meal handling approaches.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">July 16, 2021</completion_date>
  <primary_completion_date type="Actual">July 16, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time in ranges</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>type1diabetes</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Advanced hybrid closed loop system</intervention_name>
    <description>Free living follow-up of meal handelling</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Subject is 20 to 70 years of age at time of screening&#xD;
&#xD;
          2. Subject's weight is between 50 and 120 kg&#xD;
&#xD;
          3. A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a&#xD;
             minimum of 36 months prior to enrollment&#xD;
&#xD;
          4. Subject has ongoing use of an insulin pump and rtCGM ≥ 6 months prior to screening&#xD;
&#xD;
          5. Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.&#xD;
&#xD;
          6. Subject uses a rapid-acting analogue insulin in his/her pump&#xD;
&#xD;
          7. Patient is willing to undergo all study procedures&#xD;
&#xD;
          8. English proficiency&#xD;
&#xD;
          9. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8&#xD;
             units&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Female subject who has a positive serum pregnancy screening test, or who plans to&#xD;
             become pregnant during the course of the study&#xD;
&#xD;
          2. Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in&#xD;
             the area of sensor placement or device replacement (e.g., psoriasis, rash,&#xD;
             Staphylococcus infection)&#xD;
&#xD;
          3. Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12&#xD;
             months&#xD;
&#xD;
          4. Subjects currently taking adjunct therapy with SGLT2-inhibitors, GLP-1 mimetics,&#xD;
             Amylin.&#xD;
&#xD;
          5. Subject has a history of seizure disorder unrelated to diabetes within the past 12&#xD;
             months&#xD;
&#xD;
          6. Gastroparesis, uncontrolled thyroid disorder, Addison dis. , Pituitary insufficiency&#xD;
&#xD;
          7. Subject has a history of myocardial infarction, unstable angina, coronary artery&#xD;
             bypass surgery, coronary artery stenting, transient ischemic attack (TIA),&#xD;
             cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm&#xD;
             disturbances, or thromboembolic disease within the past 6 months&#xD;
&#xD;
          8. Subject has a presence of a cardiac pacemaker or any other device that may be&#xD;
             sensitive to radio frequency telemetry&#xD;
&#xD;
          9. Subject has any condition, including screening lab values that in the opinion of the&#xD;
             Investigator may preclude him/her from participating in the study and completing study&#xD;
             related procedures&#xD;
&#xD;
         10. Subject is actively participating in other investigational study (drug or device)&#xD;
&#xD;
         11. Subjects who consume alcohol daily&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel-Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Prof. Amir Tirosh</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04479826
org study id: Sheba-19-5955-at-ctil
nct id: NCT04479826
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The study will follow participants for the periods of 3 months while using an advanced hybrid
      closed loop algorithm in free living conditions . Each period will have a different meal
      handling protocols. The objective is to identify the mitigation of the algorithm with
      different meal handling approaches.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time in ranges
time frame: 3 months
intervention type: Device
intervention name: Advanced hybrid closed loop system
description: Free living follow-up of meal handelling
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Prof. Amir Tirosh
investigator title: Clinical Professor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No