<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/NCT02985866</url>
  </required_header>
  <id_info>
    <org_study_id>iDCL</org_study_id>
    <secondary_id>UC4DK108483</secondary_id>
    <nct_id>NCT02985866</nct_id>
  </id_info>
  <brief_title>The International Diabetes Closed Loop (iDCL) Trial: Protocol 1</brief_title>
  <acronym>iDCL</acronym>
  <official_title>Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TypeZero Technologies, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roche Diagnostic Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ascensia Diabetes Care</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</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>
      The objective of the study is to assess the efficacy and safety of home use of a&#xD;
      Control-to-Range (CTR) closed-loop (CL) system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol is a 3-month parallel group multi-center randomized trial designed to compare&#xD;
      Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP).&#xD;
      Approximately 126 subjects will be entered into the randomized trial at approximately seven&#xD;
      clinical sites in the United States, such that at least 110 subjects complete the randomized&#xD;
      trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of&#xD;
      randomizing 126 subjects.&#xD;
&#xD;
      In order to have a broad range of glycemic control among the subjects, a study goal will be&#xD;
      to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c &lt; 7.5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">September 4, 2018</completion_date>
  <primary_completion_date type="Actual">September 4, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time Below 70 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time Above 180 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time Below 54 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>Percent time CGM readings were below 54 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Below 60 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured % time below 60 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Range 70-180 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured % in range 70-180 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Range 70-140 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured % time in range 70-140 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Above 250 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured % time above 250 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Above 300 mg/dL</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured % time above 300 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coefficient of Variation</measure>
    <time_frame>Post randomization (final 11 weeks)</time_frame>
    <description>CGM-measured coefficient of variation (CV)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Type1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Artificial Pancreas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensor Augmented Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Artificial Pancreas</intervention_name>
    <description>Use of CTR at home for 3 months</description>
    <arm_group_label>Artificial Pancreas</arm_group_label>
    <other_name>Control-to-Range (CTR) closed-loop (CL)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sensor Augmented Therapy</intervention_name>
    <description>Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
    <arm_group_label>Sensor Augmented Therapy</arm_group_label>
    <other_name>SAP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least&#xD;
             one year and using insulin for at least 1 year&#xD;
&#xD;
          2. Use of an insulin pump for at least 6 months&#xD;
&#xD;
          3. Age ≥14 years old&#xD;
&#xD;
          4. HbA1c level &lt;10.5% at screening&#xD;
&#xD;
          5. For females, not currently known to be pregnant&#xD;
&#xD;
          6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1&#xD;
             analogs, SGLT2 inhibitors) during the study&#xD;
&#xD;
          7. Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop&#xD;
             control system for the duration of the clinical trial&#xD;
&#xD;
          8. Willingness to suspend use of any personal CGM for the duration of the clinical trial&#xD;
             once the unblinded study CGM is in use&#xD;
&#xD;
          9. Willingness to establish network connectivity on at least a weekly basis either via&#xD;
             local Wifi network or via a study-provided cellular service&#xD;
&#xD;
         10. Currently using no insulins other than one of the following rapid-acting insulins at&#xD;
             the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin&#xD;
             glulisine (Apidra)&#xD;
&#xD;
         11. Investigator has confidence that the subject can successfully operate all study&#xD;
             devices and is capable of adhering to the protocol&#xD;
&#xD;
         12. For subjects less than 18 years old, living with one or more parent/legal guardian&#xD;
             (referred to subsequently as diabetes care partner) committed to participating in&#xD;
             study training for emergency procedures for severe hypoglycemia and able to contact&#xD;
             the subject in case of an emergency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical need for chronic acetaminophen&#xD;
&#xD;
          2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs,&#xD;
             SGLT2 inhibitors) in the 3 months prior to enrollment&#xD;
&#xD;
          3. Hemophilia or any other bleeding disorder&#xD;
&#xD;
          4. A condition, which in the opinion of the investigator or designee, would put the&#xD;
             participant or study at risk including any contraindication to the use of any of the&#xD;
             study devices per FDA labeling&#xD;
&#xD;
          5. Participation in another pharmaceutical or device trial at the time of enrollment or&#xD;
             during the study&#xD;
&#xD;
          6. Use of a closed-loop system within the last month prior to enrollment&#xD;
&#xD;
          7. Employed by, or having immediate family members employed by TypeZero Technologies, LLC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris P. Kovatchev, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia Center for Diabetes Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stacey M. Anderson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Virginia Center for Diabetes Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Sansum Diabetes Center</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Davis Center, University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard University (Joslin Diabetes Center)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Center for Diabetes Technology</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Netherlands</country>
  </removed_countries>
  <reference>
    <citation>Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615. Diabetes Care. 2020 Jun;43(6):1366. doi: 10.2337/dc20-er06. Epub 2020 Apr 3. No abstract available.</citation>
    <PMID>32245747</PMID>
  </reference>
  <results_reference>
    <citation>Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care. 2020 Mar;43(3):607-615. doi: 10.2337/dc19-1310. Epub 2020 Jan 14. Erratum In: Diabetes Care. 2020 Jun;43(6):1366.</citation>
    <PMID>31937608</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>August 15, 2022</results_first_submitted>
  <results_first_submitted_qc>November 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 5, 2022</results_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Artificial Pancreas</keyword>
  <keyword>Closed Loop Control</keyword>
  <keyword>Continuous Glucose Monitor (CGM)</keyword>
  <keyword>inControl Diabetes Management Platform</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <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>Pancrelipase</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series, meal content, boluses, &amp; exercise will be deidentified &amp; retrievable only by subject ID number. Individual patterns of demographic &amp; insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes &amp; not to identify participants; (2) a commitment to securing the data using appropriate computer technology; &amp; (3) a commitment to destroying or returning the data after analyses are completed.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT02985866/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT02985866/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This parallel-group, multicenter, randomized unblinded clinical trial was conducted at 7 US university centers. Participants were diagnosed with type 1 diabetes, treated with insulin for at least 1 year, using pump therapy for at least 6 months, age 14 and above, &amp; HbA1c &lt;10.5% (91 mmol/mol). A study goal was to have at least 50 participants with HbA1c&lt;7.5% (58 mmol/mol) and at least 50 participants with HbA1c &gt;7.5% (58 mmol/mol). Participants were screened October 2017 - May 2018.</recruitment_details>
      <pre_assignment_details>Participants who used a personal Dexcom G4 or G5 CGM pre-study for at least 21 of the prior 28 days proceeded directly to randomization. For these participants, the data downloaded from the personal CGM provided the 2-week baseline data. All others wore a blinded study CGM for 2 weeks to collect baseline data, followed by 2 weeks of training using an unblinded study CGM. Successful completion of the run-in was followed by randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Artificial Pancreas (Closed Loop Control)</title>
          <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
        </group>
        <group group_id="P2">
          <title>Sensor Augmented Therapy</title>
          <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Poor CGM data</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Artificial Pancreas (Closed Loop Control)</title>
          <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
        </group>
        <group group_id="B2">
          <title>Sensor Augmented Therapy</title>
          <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="65"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>21 to &lt;35</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>35 to &lt;65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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="32"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes duration at randomization (years)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1 to &lt;5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 to &lt;10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 to &lt;20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 to &lt;30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 to &lt;40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior CGM use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>In past, but not current</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI at enrollment (kg/m2)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 to &lt;25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 to &lt;30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c at randomization: laboratory</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;7.0% (53 mmol/ml)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7.0% to &lt;7.5% (53 to &lt;58 mmol/mol)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7.5% to &lt;8.0% (58 to &lt;64 mmol/mol)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8.0% to ≤10.5% (64 to ≤91 mmol/mol)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>C-Peptide at randomization (nmol/L): Laboratory</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;0.003</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0.003 to &lt;0.1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0.1 to &lt;0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes ketoacidosis events in the last 12 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Severe hypoglycemic events in past 12 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time Below 70 mg/dL</title>
        <description>CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time Below 70 mg/dL</title>
          <description>CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)</description>
          <units>percentage of total CGM time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.7"/>
                    <measurement group_id="O2" value="4.0" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The first co-primary end point was superiority of CLC over SAP in terms of CGM-measured time below 70 mg/dL. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time Above 180 mg/dL</title>
        <description>CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time Above 180 mg/dL</title>
          <description>CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)</description>
          <units>percentage of total CGM time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" spread="11"/>
                    <measurement group_id="O2" value="39" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Below 54 mg/dL</title>
        <description>Percent time CGM readings were below 54 mg/dL</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time Below 54 mg/dL</title>
          <description>Percent time CGM readings were below 54 mg/dL</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.6"/>
                    <measurement group_id="O2" value="1.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Same as for the primary outcomes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Same as for primary outcome 1</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Below 60 mg/dL</title>
        <description>CGM-measured % time below 60 mg/dL</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time Below 60 mg/dL</title>
          <description>CGM-measured % time below 60 mg/dL</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.0"/>
                    <measurement group_id="O2" value="1.9" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Same as for the primary outcomes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Same as for primary outcome 1</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Range 70-180 mg/dL</title>
        <description>CGM-measured % in range 70-180 mg/dL</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Range 70-180 mg/dL</title>
          <description>CGM-measured % in range 70-180 mg/dL</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64" spread="11"/>
                    <measurement group_id="O2" value="57" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Same as for the primary outcomes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Same as for primary outcome 1</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Range 70-140 mg/dL</title>
        <description>CGM-measured % time in range 70-140 mg/dL</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Range 70-140 mg/dL</title>
          <description>CGM-measured % time in range 70-140 mg/dL</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" spread="10"/>
                    <measurement group_id="O2" value="35" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Same as for the primary outcomes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Same as for primary outcome 1</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Above 250 mg/dL</title>
        <description>CGM-measured % time above 250 mg/dL</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time Above 250 mg/dL</title>
          <description>CGM-measured % time above 250 mg/dL</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="7.4"/>
                    <measurement group_id="O2" value="13.7" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Same as for the primary outcomes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Same as for primary outcome 1</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Above 300 mg/dL</title>
        <description>CGM-measured % time above 300 mg/dL</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Time Above 300 mg/dL</title>
          <description>CGM-measured % time above 300 mg/dL</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="4.2"/>
                    <measurement group_id="O2" value="5.7" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Same as for the primary outcomes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Same as for primary outcome 1</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coefficient of Variation</title>
        <description>CGM-measured coefficient of variation (CV)</description>
        <time_frame>Post randomization (final 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas (Closed Loop Control)</title>
            <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Therapy</title>
            <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation</title>
          <description>CGM-measured coefficient of variation (CV)</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" spread="5"/>
                    <measurement group_id="O2" value="38" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Same as for the primary outcomes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Same as for primary outcome 1</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>13 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Artificial Pancreas (Closed Loop Control)</title>
          <description>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
Artificial Pancreas: Use of CTR at home for 3 months</description>
        </group>
        <group group_id="E2">
          <title>Sensor Augmented Therapy</title>
          <description>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.&#xD;
Sensor Augmented Therapy: Use of personal pump with study CGM &amp; glucometer at home for 3 months</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <description>Participant ran 100k race on 5/12/18.Felt overheated &amp; vomiting x2 after 52.8 miles (13.5h run time). Admitted to the ER for dehydration &amp; DKA risk. BG in 200s &amp; ketones were negative. Complete recovery.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemic seizure</sub_title>
                <description>Severe hypoglycemia on 2/26/18 at ~5:30PM. Spouse noticed convulsion during sleep CGM reading = 50 mg/dl. Spouse provided two boxes of juice &amp; glucose tablets. Participant doesn't recall episode. Complete recovery after rescue carbohydrates.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <description>Nausea &amp; vomiting started 02/13/18. No fever. Exposed GI illness day before. Blood glucose=99 mg/dl; serum ketones=1.2 mmol/L. In follow up call, ketones=1.1 mmol/L one hour later. On 02/14/18, ketones=0.3 mmol/L. Complete recovery.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgery</sub_title>
                <description>Planned in-patient surgery on 4/10/18. Removal of Whartin growth behind left ear. Complete recovery.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boris Kovatchev, PhD</name_or_title>
      <organization>University of Virginia Center for Diabetes Technology</organization>
      <phone>434-982-0602</phone>
      <email>mc7m@virginia.edu</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/NCT02985866
org study id: iDCL
secondary id: UC4DK108483
nct id: NCT02985866
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The objective of the study is to assess the efficacy and safety of home use of a
      Control-to-Range (CTR) closed-loop (CL) system.
The protocol is a 3-month parallel group multi-center randomized trial designed to compare
      Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP).
      Approximately 126 subjects will be entered into the randomized trial at approximately seven
      clinical sites in the United States, such that at least 110 subjects complete the randomized
      trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of
      randomizing 126 subjects.

      In order to have a broad range of glycemic control among the subjects, a study goal will be
      to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c < 7.5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time Below 70 mg/dL
time frame: Post randomization (final 11 weeks)
description: CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)
measure: Time Above 180 mg/dL
time frame: Post randomization (final 11 weeks)
description: CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)
measure: Time Below 54 mg/dL
time frame: Post randomization (final 11 weeks)
description: Percent time CGM readings were below 54 mg/dL
measure: Time Below 60 mg/dL
time frame: Post randomization (final 11 weeks)
description: CGM-measured % time below 60 mg/dL
measure: Time in Range 70-180 mg/dL
time frame: Post randomization (final 11 weeks)
description: CGM-measured % in range 70-180 mg/dL
measure: Time in Range 70-140 mg/dL
time frame: Post randomization (final 11 weeks)
description: CGM-measured % time in range 70-140 mg/dL
measure: Time Above 250 mg/dL
time frame: Post randomization (final 11 weeks)
description: CGM-measured % time above 250 mg/dL
measure: Time Above 300 mg/dL
time frame: Post randomization (final 11 weeks)
description: CGM-measured % time above 300 mg/dL
measure: Coefficient of Variation
time frame: Post randomization (final 11 weeks)
description: CGM-measured coefficient of variation (CV)
arm group label: Artificial Pancreas
arm group type: Experimental
description: Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.
arm group label: Sensor Augmented Therapy
arm group type: Active Comparator
description: Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.
intervention type: Device
intervention name: Artificial Pancreas
description: Use of CTR at home for 3 months
arm group label: Artificial Pancreas
other name: Control-to-Range (CTR) closed-loop (CL)
intervention type: Other
intervention name: Sensor Augmented Therapy
description: Use of personal pump with study CGM & glucometer at home for 3 months
arm group label: Sensor Augmented Therapy
other name: SAP
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Boris P. Kovatchev, PhD
role: Principal Investigator
affiliation: University of Virginia Center for Diabetes Technology
last name: Stacey M. Anderson, MD
role: Study Chair
affiliation: University of Virginia Center for Diabetes Technology
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: France
country: Italy
country: Netherlands
citation: Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615. Diabetes Care. 2020 Jun;43(6):1366. doi: 10.2337/dc20-er06. Epub 2020 Apr 3. No abstract available.
PMID: 32245747
citation: Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care. 2020 Mar;43(3):607-615. doi: 10.2337/dc19-1310. Epub 2020 Jan 14. Erratum In: Diabetes Care. 2020 Jun;43(6):1366.
PMID: 31937608
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Pancrelipase
sharing ipd: Yes
ipd description: NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series, meal content, boluses, & exercise will be deidentified & retrievable only by subject ID number. Individual patterns of demographic & insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes & not to identify participants; (2) a commitment to securing the data using appropriate computer technology; & (3) a commitment to destroying or returning the data after analyses are completed.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 