<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/NCT04476472</url>
  </required_header>
  <id_info>
    <org_study_id>Horizon™ Preschool Cohort</org_study_id>
    <nct_id>NCT04476472</nct_id>
  </id_info>
  <brief_title>Omnipod Horizon™ Automated Glucose Control System Preschool Cohort</brief_title>
  <official_title>Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insulet Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insulet Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and&#xD;
      insulin data will be collected. This will be followed by a 94-day (13-week) hybrid&#xD;
      closed-loop phase conducted in an outpatient setting, and an optional 12-month extension&#xD;
      phase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study schedule will consist of a standard therapy data collection phase followed by a&#xD;
      hybrid closed-loop phase.&#xD;
&#xD;
      Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and&#xD;
      insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at&#xD;
      home per their usual routine using the study continuous glucose monitoring system (CGM) and&#xD;
      remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a&#xD;
      94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects,&#xD;
      or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated&#xD;
      Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will&#xD;
      have the option to continue using the system for an additional 12 months.&#xD;
&#xD;
      During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of&#xD;
      supervised meal and exercise challenges.&#xD;
&#xD;
      The hybrid closed-loop phase will begin on Study Day 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Actual">October 12, 2022</completion_date>
  <primary_completion_date type="Actual">January 17, 2022</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>
    <intervention_model_description>single-arm, multi-center, prospective clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of severe hypoglycemia (events per person months)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)</time_frame>
    <description>Measure of serious device-related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of diabetic ketoacidosis (DKA) (events per person months)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)</time_frame>
    <description>Measure of serious device-related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycated hemoglobin (A1C)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline</time_frame>
    <description>Measures device effectiveness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time in range 70-180 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)</time_frame>
    <description>Measures device effectiveness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycated hemoglobin (A1C)</measure>
    <time_frame>Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline</time_frame>
    <description>Measures device effectiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time in range 70-180 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time in range 70-140 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time &gt; 180 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time ≥ 250 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time ≥ 300 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time &lt; 70 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time &lt; 54 mg/dL</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean glucose</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard deviation</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coefficient of variation</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall</time_frame>
    <description>Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in hybrid closed-loop as proportion of overall device usage time</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)</time_frame>
    <description>Measure of system usage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose management indicator (GMI) based on overall mean glucose</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)</time_frame>
    <description>Measurement of glucose management using overall glucose averages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily insulin (TDI) (units)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)</time_frame>
    <description>Measure of insulin requirements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily insulin (TDI) (units/kg)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)</time_frame>
    <description>Measure of insulin requirements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily basal insulin (units)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)</time_frame>
    <description>Measure of insulin requirements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily basal insulin (units/kg)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)</time_frame>
    <description>Measure of insulin requirements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily bolus insulin (units)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)</time_frame>
    <description>Measure of insulin requirements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily bolus insulin (units/kg)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)</time_frame>
    <description>Measure of insulin requirements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI) (kg/m2)</measure>
    <time_frame>Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline</time_frame>
    <description>Measure of change in weight</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Omnipod Horizon™ Automated Glucose Control System</intervention_name>
    <description>The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age at time of consent 2.0-5.9 years&#xD;
&#xD;
          2. Living with parent/legal guardian&#xD;
&#xD;
          3. Diagnosed with type 1 diabetes. Diagnosis is based on investigator's clinical judgment&#xD;
&#xD;
          4. Deemed appropriate for pump therapy per investigator's assessment taking into account&#xD;
             previous history of severe hypoglycemic and hyperglycemic events, and other&#xD;
             comorbidities&#xD;
&#xD;
          5. Investigator has confidence that the subject and/or parent/guardian/caregiver can&#xD;
             successfully operate all study devices and is capable of adhering to the protocol&#xD;
&#xD;
          6. Willing to use only the following types of insulin during the study: Humalog, Novolog,&#xD;
             Admelog or Apidra during the study&#xD;
&#xD;
          7. Willing to wear the system continuously throughout the study&#xD;
&#xD;
          8. Willing to participate in challenges for 2 consecutive days, consisting of a minimum&#xD;
             of 3 hours of activity per day and dietary challenge by reducing the number of&#xD;
             carbohydrates entered for a given meal by 50%&#xD;
&#xD;
          9. A1C &lt;10% at screening visit&#xD;
&#xD;
         10. Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod&#xD;
             Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom&#xD;
             Follow App) during the hybrid closed-loop phase&#xD;
&#xD;
         11. Subject and/or parent/guardian is able to read and speak English fluently&#xD;
&#xD;
         12. Has a parent/legal guardian willing and able to sign the ICF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A medical condition, which in the opinion of the investigator, would put the subject&#xD;
             at an unacceptable safety risk&#xD;
&#xD;
          2. History of severe hypoglycemia in the past 6 months&#xD;
&#xD;
          3. History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion&#xD;
             set failure or initial diagnosis&#xD;
&#xD;
          4. Diagnosed with sickle cell disease&#xD;
&#xD;
          5. Diagnosed with hemophilia or any other bleeding disorders&#xD;
&#xD;
          6. Plans to receive blood transfusion over the course of the study&#xD;
&#xD;
          7. Clinical evidence of acute or chronic kidney disease (e.g. estimated GFR &lt; 45) or&#xD;
             currently on hemodialysis&#xD;
&#xD;
          8. History of adrenal insufficiency&#xD;
&#xD;
          9. Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or&#xD;
             injectable steroids during the course of the study&#xD;
&#xD;
         10. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of&#xD;
             sensor or pump placement&#xD;
&#xD;
         11. Plans to use insulin other than U-100 insulin intended for use in the study device&#xD;
             during the course of the study&#xD;
&#xD;
         12. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist,&#xD;
             SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)&#xD;
&#xD;
         13. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of&#xD;
             hypothyroidism or hyperthyroidism&#xD;
&#xD;
         14. Currently participating or plans to participate in another clinical study using an&#xD;
             investigational drug or device other than the Omnipod Horizon™ Automated Glucose&#xD;
             Control System during this study period&#xD;
&#xD;
         15. Unable to follow clinical protocol for the duration of the study or is otherwise&#xD;
             deemed unacceptable to participate in the study per the investigator's clinical&#xD;
             judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Buckingham, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Stanford School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sue Brown, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Diabetes Center</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Syracuse</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T1D</keyword>
  <keyword>Omnipod</keyword>
  <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/NCT04476472
org study id: Horizon™ Preschool Cohort
nct id: NCT04476472
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. This will be followed by a 94-day (13-week) hybrid
      closed-loop phase conducted in an outpatient setting, and an optional 12-month extension
      phase.
The study schedule will consist of a standard therapy data collection phase followed by a
      hybrid closed-loop phase.

      Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at
      home per their usual routine using the study continuous glucose monitoring system (CGM) and
      remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a
      94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects,
      or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated
      Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will
      have the option to continue using the system for an additional 12 months.

      During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of
      supervised meal and exercise challenges.

      The hybrid closed-loop phase will begin on Study Day 1.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single-arm, multi-center, prospective clinical study
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence rate of severe hypoglycemia (events per person months)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
description: Measure of serious device-related adverse events
measure: Incidence rate of diabetic ketoacidosis (DKA) (events per person months)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
description: Measure of serious device-related adverse events
measure: Glycated hemoglobin (A1C)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline
description: Measures device effectiveness
measure: Time in range 70-180 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)
description: Measures device effectiveness
measure: Glycated hemoglobin (A1C)
time frame: Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
description: Measures device effectiveness
measure: Percent of time in range 70-180 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Percent of time in range 70-140 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Percent of time > 180 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Percent of time ≥ 250 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Percent of time ≥ 300 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Percent of time < 70 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Percent of time < 54 mg/dL
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Mean glucose
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)
measure: Standard deviation
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
measure: Coefficient of variation
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
description: Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
measure: Percentage of time in hybrid closed-loop as proportion of overall device usage time
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)
description: Measure of system usage
measure: Glucose management indicator (GMI) based on overall mean glucose
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
description: Measurement of glucose management using overall glucose averages
measure: Total daily insulin (TDI) (units)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
description: Measure of insulin requirements
measure: Total daily insulin (TDI) (units/kg)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
description: Measure of insulin requirements
measure: Total daily basal insulin (units)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
description: Measure of insulin requirements
measure: Total daily basal insulin (units/kg)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
description: Measure of insulin requirements
measure: Total daily bolus insulin (units)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
description: Measure of insulin requirements
measure: Total daily bolus insulin (units/kg)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
description: Measure of insulin requirements
measure: Body Mass Index (BMI) (kg/m2)
time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline
description: Measure of change in weight
arm group label: Treatment
arm group type: Experimental
description: All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm.
intervention type: Device
intervention name: Omnipod Horizon™ Automated Glucose Control System
description: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery.
arm group label: Treatment
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
last name: Bruce Buckingham, MD
role: Study Chair
affiliation: Stanford School of Medicine
last name: Sue Brown, MD
role: Study Chair
affiliation: University of Virginia
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country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No