<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/NCT04436796</url>
  </required_header>
  <id_info>
    <org_study_id>G200047</org_study_id>
    <secondary_id>UC4DK108483</secondary_id>
    <nct_id>NCT04436796</nct_id>
  </id_info>
  <brief_title>The International Diabetes Closed Loop (iDCL) Trial: Protocol 4</brief_title>
  <acronym>DCLP4</acronym>
  <official_title>The International Diabetes Closed Loop (iDCL) Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control (MPC) Artificial Pancreas Versus Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes (DCLP4)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <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>
  </sponsors>
  <source>Sansum Diabetes Research Institute</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 investigators aim to compare the efficacy and safety of an AID system using an adaptive&#xD;
      MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in&#xD;
      people with type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized crossover trial will compare the efficacy and safety of an automated insulin&#xD;
      delivery (AID) study system using an adaptive Model Predictive Control (MPC) algorithm versus&#xD;
      SAP (which may or may not include PLGS; to be referred to as SAP) therapy in people with type&#xD;
      1 diabetes for 13 weeks in each arm of the study. A Pilot Phase using the study system for&#xD;
      10-14 days will be conducted prior to the crossover trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Actual">May 10, 2021</completion_date>
  <primary_completion_date type="Actual">May 10, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent CGM Time in Range 70-180 mg/dL</measure>
    <time_frame>13 weeks</time_frame>
    <description>This results shown is mean percent time in range 70-180 mg/dL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-inferiority for CGM Time &lt;54 mg/dL</measure>
    <time_frame>13 weeks</time_frame>
    <description>Superiority for time in range 70-180 mg/dL and non-inferiority for time &lt;54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CGM Mean Glucose</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM-measured mean glucose (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Time &gt; 180</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM time &gt; 180 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Time &gt; 250</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM time &gt; 250 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Time &lt; 70</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM time &lt; 70 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Time &lt; 54 (Superiority)</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM time &lt; 54 mg/dL (Superiority)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coefficient of Variation</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM measured glucose variability measured with the coefficient of variation (CV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Time in Range 70-140 mg/dL</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM-measured % in range 70-140 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard Deviation</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM measured glucose variability measured with the standard deviation (SD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Time &lt; 60</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM time &lt; 60 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LBGI</measure>
    <time_frame>13 weeks</time_frame>
    <description>Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 &lt; LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 &lt; LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI &gt; 5.0 is associated with high risk of hypoglycemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Time &gt; 300</measure>
    <time_frame>13 weeks</time_frame>
    <description>CGM time &gt; 300 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBGI</measure>
    <time_frame>13 weeks</time_frame>
    <description>High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI &lt; 4.5 is associated with lower risk of hyperglycemia, 4.5 &lt; HBGI &lt; 9 is associated with a moderate risk of hyperglycemia and HBGI &gt; 9 is associated with high risk of hyperglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c at 13 Weeks</measure>
    <time_frame>13 weeks</time_frame>
    <description>Hemiglobin A1c measured after completing each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HbA1c &lt;7.0% at 13 Weeks</measure>
    <time_frame>13 weeks</time_frame>
    <description>Number of participants HbA1c &lt;7.0% after completing each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HbA1c &lt;7.5% at 13 Weeks</measure>
    <time_frame>3 months</time_frame>
    <description>Number of participants HbA1c &lt;7.5% after completing each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Distress Scale at 13 Weeks - Total Score</measure>
    <time_frame>13 weeks</time_frame>
    <description>Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Monitoring Satisfaction Survey (Total Scale)</measure>
    <time_frame>13 weeks</time_frame>
    <description>The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia Confidence Scale</measure>
    <time_frame>13 weeks</time_frame>
    <description>Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INSPIRE Survey Scores - Following Study System Period Only</measure>
    <time_frame>13 weeks</time_frame>
    <description>The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SUS Survey Scores - Following Study System Period</measure>
    <time_frame>13 weeks</time_frame>
    <description>System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Daily Insulin</measure>
    <time_frame>13 weeks</time_frame>
    <description>Total Daily Insulin (units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal: Bolus Insulin Ratio</measure>
    <time_frame>13 weeks</time_frame>
    <description>Basal: bolus insulin ratio</description>
  </secondary_outcome>
  <other_outcome>
    <measure>CGM Metrics by Time of Day</measure>
    <time_frame>13 weeks</time_frame>
    <description>Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Severe Hypoglycemia (Per Protocol)</measure>
    <time_frame>13 weeks</time_frame>
    <description>Severe hypoglycemia (per protocol)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Diabetic Ketoacidosis (Per Protocol)</measure>
    <time_frame>13 weeks</time_frame>
    <description>Diabetic ketoacidosis (per protocol)</description>
  </other_outcome>
  <other_outcome>
    <measure>Ketone Events Defined as Day With Ketone Level &gt;1.0 mmol/L</measure>
    <time_frame>13 weeks</time_frame>
    <description>Ketone events defined as day with ketone level &gt;1.0 mmol/L</description>
  </other_outcome>
  <other_outcome>
    <measure>CGM-measured Hypoglycemic Events (&gt;15 Minutes With Glucose Concentration &lt;54 mg/dL)</measure>
    <time_frame>3 months</time_frame>
    <description>CGM-measured hypoglycemic events (&gt;15 minutes with glucose concentration &lt;54 mg/dL) in each arm.</description>
  </other_outcome>
  <other_outcome>
    <measure>CGM-measured Hyperglycemic Events (&gt;15 Minutes With Glucose Concentration &gt;300 mg/dL)</measure>
    <time_frame>3 months</time_frame>
    <description>CGM-measured hyperglycemic events (&gt;15 minutes with glucose concentration &gt;300 mg/dL) in each arm.</description>
  </other_outcome>
  <other_outcome>
    <measure>BG-measured Hypoglycemic Events (One BG Record &lt;54 mg/dL</measure>
    <time_frame>13 weeks</time_frame>
    <description>BG-measured Hypoglycemic Events (One BG Record &lt;54 mg/dL</description>
  </other_outcome>
  <other_outcome>
    <measure>Worsening of HbA1c From Baseline to 26 Weeks by &gt;0.5%</measure>
    <time_frame>13 weeks</time_frame>
    <description>Worsening of HbA1c from baseline to 26 weeks by &gt;0.5%</description>
  </other_outcome>
  <other_outcome>
    <measure>Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)</measure>
    <time_frame>13 weeks</time_frame>
    <description>Other serious adverse events (SAE) and serious adverse device events (SADE)</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Device Effects (ADE)</measure>
    <time_frame>13 weeks</time_frame>
    <description>Adverse device effects (ADE)</description>
  </other_outcome>
  <other_outcome>
    <measure>Unanticipated Adverse Device Effects (UADE)</measure>
    <time_frame>13 weeks</time_frame>
    <description>Unanticipated adverse device effects (UADE)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With SH Events</measure>
    <time_frame>13 weeks</time_frame>
    <description>For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group</description>
  </other_outcome>
  <other_outcome>
    <measure>SH Event Rate Per 100 Person-years</measure>
    <time_frame>13 weeks</time_frame>
    <description>For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With DKA Events</measure>
    <time_frame>13 weeks</time_frame>
    <description>For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.</description>
  </other_outcome>
  <other_outcome>
    <measure>DKA Event Rate Per 100 Person-years</measure>
    <time_frame>13 weeks</time_frame>
    <description>For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Any Adverse Event Rate Per 100 Person-years</measure>
    <time_frame>13 weeks</time_frame>
    <description>For this outcome, the adverse event rate per 100 person-years calculated as a rate.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Artificial Pancreas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensor Augmented Pump/Predictive Low Glucose Suspend</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>interoperable Artificial Pancreas System (iAPS)</intervention_name>
    <description>Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
    <arm_group_label>Artificial Pancreas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)</intervention_name>
    <description>Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
    <arm_group_label>Sensor Augmented Pump/Predictive Low Glucose Suspend</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  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;
          -  Using an insulin pump for at least 3 months (which may include use of automated&#xD;
             features)&#xD;
&#xD;
          -  Familiarity and use of a carbohydrate ratio for meal boluses&#xD;
&#xD;
          -  Age ≥18.0 years old&#xD;
&#xD;
          -  For females, not currently known to be pregnant. If female and sexually active, must&#xD;
             agree to use a form of contraception to prevent pregnancy while a participant in the&#xD;
             study. A negative serum or urine pregnancy test will be required for all females of&#xD;
             child-bearing potential. Participants who become pregnant will be discontinued from&#xD;
             the study. Also, participants who during the study develop and express the intention&#xD;
             to become pregnant within the timespan of the study will be discontinued.&#xD;
&#xD;
          -  If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal&#xD;
             CGM use during the study&#xD;
&#xD;
          -  Willing not to begin use of, or not to continue use of if currently using, a personal&#xD;
             AID (closed loop control) system during the study; note if the system offers an&#xD;
             open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom&#xD;
             G6, the system may be used during the study in these modes only&#xD;
&#xD;
          -  Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already,&#xD;
             and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the&#xD;
             study&#xD;
&#xD;
          -  Willingness not to start any new non-insulin glucose-lowering agent during the course&#xD;
             of the trial, and not to use Afrezza during the trial&#xD;
&#xD;
          -  Investigator believes that the participant can successfully and safely operate all&#xD;
             study devices and is capable of adhering to the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of Afrezza or any non-insulin glucose-lowering agent other than metformin&#xD;
             (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless&#xD;
             participant is willing to discontinue during the trial.&#xD;
&#xD;
          -  Two or more episodes of DKA requiring an emergency room visit or hospitalization in&#xD;
             the past 6 months&#xD;
&#xD;
          -  Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in&#xD;
             the last 6 months&#xD;
&#xD;
          -  Hemophilia or any other bleeding disorder&#xD;
&#xD;
          -  A medical or other condition that in the opinion of the investigator could create a&#xD;
             safety concern for the participant or put the study at risk. History of frequent&#xD;
             severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis,&#xD;
             without emergency room visit or hospitalization, due to poor diabetes self-management&#xD;
             may be disqualifying per investigator judgment&#xD;
&#xD;
          -  Participation in another pharmaceutical or device trial at the time of enrollment or&#xD;
             during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eyal Dassau, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Harvard University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordan Pinsker, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francis J Doyle III, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sansum Diabetes Research Institute</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>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_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Pinsker JE, Dassau E, Deshpande S, Raghinaru D, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Church MM, Desrochers H, Ekhlaspour L, Kaur RJ, Levister C, Shi D, Lum JW, Kollman C, Doyle FJ; iDCL Trial Research Group. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4. Diabetes Technol Ther. 2022 Sep;24(9):635-642. doi: 10.1089/dia.2022.0084. Epub 2022 Jun 2.</citation>
    <PMID>35549708</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <results_first_submitted>May 4, 2022</results_first_submitted>
  <results_first_submitted_qc>November 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 2, 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 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Artificial Pancreas</keyword>
  <keyword>Automated Insulin Delivery</keyword>
  <keyword>Closed Loop Control</keyword>
  <keyword>Continuous Glucose Monitor (CGM)</keyword>
  <keyword>interoperable Artificial Pancreas System (iAPS)</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 &amp; boluses, 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>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The dataset from each iDCL protocol will be made public after publication of all manuscripts written by the study group using the dataset and any regulatory submission/completion of review by the regulatory agency, but no later than 3 years after the completion of the protocol even if additional manuscripts or regulatory submissions are planned.</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04436796/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04436796/SAP_001.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>July 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04436796/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Artificial Pancreas First, Then Sensor-Augmented Pump/Predicitive Low Glucose Suspend</title>
          <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.&#xD;
Subjects will then continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas</title>
          <description>Subjects will then continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.&#xD;
Then subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Artificial Pancreas First, Then Sensor-Augmented Pump/Predictive Low Glucose Suspend</title>
          <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.&#xD;
After 13 weeks, participants then crossed over to the other arm.</description>
        </group>
        <group group_id="B2">
          <title>Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas</title>
          <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.&#xD;
After 13 weeks, participants then crossed over to the other arm.</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="19"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41" spread="16"/>
                    <measurement group_id="B2" value="37" spread="15"/>
                    <measurement group_id="B3" value="39" spread="16"/>
                  </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="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent CGM Time in Range 70-180 mg/dL</title>
        <description>This results shown is mean percent time in range 70-180 mg/dL.</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent CGM Time in Range 70-180 mg/dL</title>
          <description>This results shown is mean percent time in range 70-180 mg/dL.</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="14"/>
                    <measurement group_id="O2" value="66" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-inferiority for CGM Time &lt;54 mg/dL</title>
        <description>Superiority for time in range 70-180 mg/dL and non-inferiority for time &lt;54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Non-inferiority for CGM Time &lt;54 mg/dL</title>
          <description>Superiority for time in range 70-180 mg/dL and non-inferiority for time &lt;54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.39"/>
                    <measurement group_id="O2" value="0.71" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Mean Glucose</title>
        <description>CGM-measured mean glucose (mg/dL)</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Mean Glucose</title>
          <description>CGM-measured mean glucose (mg/dL)</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158" spread="22"/>
                    <measurement group_id="O2" value="156" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Time &gt; 180</title>
        <description>CGM time &gt; 180 mg/dL</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Time &gt; 180</title>
          <description>CGM time &gt; 180 mg/dL</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" spread="15"/>
                    <measurement group_id="O2" value="30" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Time &gt; 250</title>
        <description>CGM time &gt; 250 mg/dL</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Time &gt; 250</title>
          <description>CGM time &gt; 250 mg/dL</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="8"/>
                    <measurement group_id="O2" value="8" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Time &lt; 70</title>
        <description>CGM time &lt; 70 mg/dL</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Time &lt; 70</title>
          <description>CGM time &lt; 70 mg/dL</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.7"/>
                    <measurement group_id="O2" value="3.5" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Time &lt; 54 (Superiority)</title>
        <description>CGM time &lt; 54 mg/dL (Superiority)</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Time &lt; 54 (Superiority)</title>
          <description>CGM time &lt; 54 mg/dL (Superiority)</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.39"/>
                    <measurement group_id="O2" value="0.71" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coefficient of Variation</title>
        <description>CGM measured glucose variability measured with the coefficient of variation (CV)</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation</title>
          <description>CGM measured glucose variability measured with the coefficient of variation (CV)</description>
          <units>percentage SD of Mean</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" spread="5.3"/>
                    <measurement group_id="O2" value="34.9" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Time in Range 70-140 mg/dL</title>
        <description>CGM-measured % in range 70-140 mg/dL</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Time in Range 70-140 mg/dL</title>
          <description>CGM-measured % in range 70-140 mg/dL</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" spread="14"/>
                    <measurement group_id="O2" value="43" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Standard Deviation</title>
        <description>CGM measured glucose variability measured with the standard deviation (SD)</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Standard Deviation</title>
          <description>CGM measured glucose variability measured with the standard deviation (SD)</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" spread="5.3"/>
                    <measurement group_id="O2" value="34.9" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Time &lt; 60</title>
        <description>CGM time &lt; 60 mg/dL</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Time &lt; 60</title>
          <description>CGM time &lt; 60 mg/dL</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="0.73"/>
                    <measurement group_id="O2" value="1.39" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LBGI</title>
        <description>Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 &lt; LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 &lt; LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI &gt; 5.0 is associated with high risk of hypoglycemia.</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>LBGI</title>
          <description>Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 &lt; LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 &lt; LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI &gt; 5.0 is associated with high risk of hypoglycemia.</description>
          <units>index score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.4"/>
                    <measurement group_id="O2" value="1.0" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Time &gt; 300</title>
        <description>CGM time &gt; 300 mg/dL</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Time &gt; 300</title>
          <description>CGM time &gt; 300 mg/dL</description>
          <units>percentage of 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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="4"/>
                    <measurement group_id="O2" value="3" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HBGI</title>
        <description>High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI &lt; 4.5 is associated with lower risk of hyperglycemia, 4.5 &lt; HBGI &lt; 9 is associated with a moderate risk of hyperglycemia and HBGI &gt; 9 is associated with high risk of hyperglycemia</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>HBGI</title>
          <description>High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI &lt; 4.5 is associated with lower risk of hyperglycemia, 4.5 &lt; HBGI &lt; 9 is associated with a moderate risk of hyperglycemia and HBGI &gt; 9 is associated with high risk of hyperglycemia</description>
          <units>index score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="3.6"/>
                    <measurement group_id="O2" value="6.8" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HbA1c at 13 Weeks</title>
        <description>Hemiglobin A1c measured after completing each study arm</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c at 13 Weeks</title>
          <description>Hemiglobin A1c measured after completing each study arm</description>
          <units>percentage of glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="0.8"/>
                    <measurement group_id="O2" value="6.8" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HbA1c &lt;7.0% at 13 Weeks</title>
        <description>Number of participants HbA1c &lt;7.0% after completing each study arm</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HbA1c &lt;7.0% at 13 Weeks</title>
          <description>Number of participants HbA1c &lt;7.0% after completing each study arm</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HbA1c &lt;7.5% at 13 Weeks</title>
        <description>Number of participants HbA1c &lt;7.5% after completing each study arm</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HbA1c &lt;7.5% at 13 Weeks</title>
          <description>Number of participants HbA1c &lt;7.5% after completing each study arm</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Distress Scale at 13 Weeks - Total Score</title>
        <description>Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Distress Scale at 13 Weeks - Total Score</title>
          <description>Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="0.5"/>
                    <measurement group_id="O2" value="1.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose Monitoring Satisfaction Survey (Total Scale)</title>
        <description>The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Monitoring Satisfaction Survey (Total Scale)</title>
          <description>The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.8"/>
                    <measurement group_id="O2" value="4.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemia Confidence Scale</title>
        <description>Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemia Confidence Scale</title>
          <description>Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.5"/>
                    <measurement group_id="O2" value="3.5" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>INSPIRE Survey Scores - Following Study System Period Only</title>
        <description>The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.</description>
        <time_frame>13 weeks</time_frame>
        <population>following study system period only</population>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>INSPIRE Survey Scores - Following Study System Period Only</title>
          <description>The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.</description>
          <population>following study system period only</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.7" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SUS Survey Scores - Following Study System Period</title>
        <description>System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability</description>
        <time_frame>13 weeks</time_frame>
        <population>following study system period</population>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>SUS Survey Scores - Following Study System Period</title>
          <description>System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability</description>
          <population>following study system period</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Daily Insulin</title>
        <description>Total Daily Insulin (units)</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Daily Insulin</title>
          <description>Total Daily Insulin (units)</description>
          <units>units/kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" lower_limit="0.43" upper_limit="0.68"/>
                    <measurement group_id="O2" value="0.52" lower_limit="0.42" upper_limit="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Basal: Bolus Insulin Ratio</title>
        <description>Basal: bolus insulin ratio</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Artificial Pancreas</title>
            <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
          </group>
          <group group_id="O2">
            <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
            <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Basal: Bolus Insulin Ratio</title>
          <description>Basal: bolus insulin ratio</description>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" lower_limit="0.64" upper_limit="1.94"/>
                    <measurement group_id="O2" value="1.13" lower_limit="0.84" upper_limit="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CGM Metrics by Time of Day</title>
        <description>Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Severe Hypoglycemia (Per Protocol)</title>
        <description>Severe hypoglycemia (per protocol)</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Diabetic Ketoacidosis (Per Protocol)</title>
        <description>Diabetic ketoacidosis (per protocol)</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ketone Events Defined as Day With Ketone Level &gt;1.0 mmol/L</title>
        <description>Ketone events defined as day with ketone level &gt;1.0 mmol/L</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CGM-measured Hypoglycemic Events (&gt;15 Minutes With Glucose Concentration &lt;54 mg/dL)</title>
        <description>CGM-measured hypoglycemic events (&gt;15 minutes with glucose concentration &lt;54 mg/dL) in each arm.</description>
        <time_frame>3 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CGM-measured Hyperglycemic Events (&gt;15 Minutes With Glucose Concentration &gt;300 mg/dL)</title>
        <description>CGM-measured hyperglycemic events (&gt;15 minutes with glucose concentration &gt;300 mg/dL) in each arm.</description>
        <time_frame>3 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>BG-measured Hypoglycemic Events (One BG Record &lt;54 mg/dL</title>
        <description>BG-measured Hypoglycemic Events (One BG Record &lt;54 mg/dL</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Worsening of HbA1c From Baseline to 26 Weeks by &gt;0.5%</title>
        <description>Worsening of HbA1c from baseline to 26 weeks by &gt;0.5%</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)</title>
        <description>Other serious adverse events (SAE) and serious adverse device events (SADE)</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adverse Device Effects (ADE)</title>
        <description>Adverse device effects (ADE)</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Unanticipated Adverse Device Effects (UADE)</title>
        <description>Unanticipated adverse device effects (UADE)</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With SH Events</title>
        <description>For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>SH Event Rate Per 100 Person-years</title>
        <description>For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With DKA Events</title>
        <description>For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>DKA Event Rate Per 100 Person-years</title>
        <description>For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Any Adverse Event Rate Per 100 Person-years</title>
        <description>For this outcome, the adverse event rate per 100 person-years calculated as a rate.</description>
        <time_frame>13 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From protocol entry through last study date which is approximately 26-28 weeks per participant.</time_frame>
      <desc>Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.</desc>
      <group_list>
        <group group_id="E1">
          <title>Artificial Pancreas</title>
          <description>Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.&#xD;
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.</description>
        </group>
        <group group_id="E2">
          <title>Sensor Augmented Pump/Predictive Low Glucose Suspend</title>
          <description>Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.&#xD;
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM &amp; glucometer at home for 13 weeks.</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="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Severe Hypoglycemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </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="4" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Medical Device Site Bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Jordan Pinsker</name_or_title>
      <organization>Sansum Diabetes Research Institute</organization>
      <phone>805-682-7640</phone>
      <email>jpinsker@sansum.org</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/NCT04436796
org study id: G200047
secondary id: UC4DK108483
nct id: NCT04436796
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The investigators aim to compare the efficacy and safety of an AID system using an adaptive
      MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in
      people with type 1 diabetes.
A randomized crossover trial will compare the efficacy and safety of an automated insulin
      delivery (AID) study system using an adaptive Model Predictive Control (MPC) algorithm versus
      SAP (which may or may not include PLGS; to be referred to as SAP) therapy in people with type
      1 diabetes for 13 weeks in each arm of the study. A Pilot Phase using the study system for
      10-14 days will be conducted prior to the crossover trial.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent CGM Time in Range 70-180 mg/dL
time frame: 13 weeks
description: This results shown is mean percent time in range 70-180 mg/dL.
measure: Non-inferiority for CGM Time <54 mg/dL
time frame: 13 weeks
description: Superiority for time in range 70-180 mg/dL and non-inferiority for time <54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure
measure: CGM Mean Glucose
time frame: 13 weeks
description: CGM-measured mean glucose (mg/dL)
measure: CGM Time > 180
time frame: 13 weeks
description: CGM time > 180 mg/dL
measure: CGM Time > 250
time frame: 13 weeks
description: CGM time > 250 mg/dL
measure: CGM Time < 70
time frame: 13 weeks
description: CGM time < 70 mg/dL
measure: CGM Time < 54 (Superiority)
time frame: 13 weeks
description: CGM time < 54 mg/dL (Superiority)
measure: Coefficient of Variation
time frame: 13 weeks
description: CGM measured glucose variability measured with the coefficient of variation (CV)
measure: CGM Time in Range 70-140 mg/dL
time frame: 13 weeks
description: CGM-measured % in range 70-140 mg/dL
measure: Standard Deviation
time frame: 13 weeks
description: CGM measured glucose variability measured with the standard deviation (SD)
measure: CGM Time < 60
time frame: 13 weeks
description: CGM time < 60 mg/dL
measure: LBGI
time frame: 13 weeks
description: Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia.
measure: CGM Time > 300
time frame: 13 weeks
description: CGM time > 300 mg/dL
measure: HBGI
time frame: 13 weeks
description: High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia
measure: HbA1c at 13 Weeks
time frame: 13 weeks
description: Hemiglobin A1c measured after completing each study arm
measure: Number of Participants With HbA1c <7.0% at 13 Weeks
time frame: 13 weeks
description: Number of participants HbA1c <7.0% after completing each study arm
measure: Number of Participants With HbA1c <7.5% at 13 Weeks
time frame: 3 months
description: Number of participants HbA1c <7.5% after completing each study arm
measure: Diabetes Distress Scale at 13 Weeks - Total Score
time frame: 13 weeks
description: Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.
measure: Glucose Monitoring Satisfaction Survey (Total Scale)
time frame: 13 weeks
description: The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)
measure: Hypoglycemia Confidence Scale
time frame: 13 weeks
description: Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.
measure: INSPIRE Survey Scores - Following Study System Period Only
time frame: 13 weeks
description: The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.
measure: SUS Survey Scores - Following Study System Period
time frame: 13 weeks
description: System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
measure: Total Daily Insulin
time frame: 13 weeks
description: Total Daily Insulin (units)
measure: Basal: Bolus Insulin Ratio
time frame: 13 weeks
description: Basal: bolus insulin ratio
measure: CGM Metrics by Time of Day
time frame: 13 weeks
description: Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).
measure: Number of Participants With Severe Hypoglycemia (Per Protocol)
time frame: 13 weeks
description: Severe hypoglycemia (per protocol)
measure: Number of Participants With Diabetic Ketoacidosis (Per Protocol)
time frame: 13 weeks
description: Diabetic ketoacidosis (per protocol)
measure: Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
time frame: 13 weeks
description: Ketone events defined as day with ketone level >1.0 mmol/L
measure: CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
time frame: 3 months
description: CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL) in each arm.
measure: CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
time frame: 3 months
description: CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL) in each arm.
measure: BG-measured Hypoglycemic Events (One BG Record <54 mg/dL
time frame: 13 weeks
description: BG-measured Hypoglycemic Events (One BG Record <54 mg/dL
measure: Worsening of HbA1c From Baseline to 26 Weeks by >0.5%
time frame: 13 weeks
description: Worsening of HbA1c from baseline to 26 weeks by >0.5%
measure: Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)
time frame: 13 weeks
description: Other serious adverse events (SAE) and serious adverse device events (SADE)
measure: Adverse Device Effects (ADE)
time frame: 13 weeks
description: Adverse device effects (ADE)
measure: Unanticipated Adverse Device Effects (UADE)
time frame: 13 weeks
description: Unanticipated adverse device effects (UADE)
measure: Number of Participants With SH Events
time frame: 13 weeks
description: For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group
measure: SH Event Rate Per 100 Person-years
time frame: 13 weeks
description: For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.
measure: Number of Participants With DKA Events
time frame: 13 weeks
description: For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.
measure: DKA Event Rate Per 100 Person-years
time frame: 13 weeks
description: For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.
measure: Any Adverse Event Rate Per 100 Person-years
time frame: 13 weeks
description: For this outcome, the adverse event rate per 100 person-years calculated as a rate.
arm group label: Artificial Pancreas
arm group type: Experimental
description: Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.
arm group label: Sensor Augmented Pump/Predictive Low Glucose Suspend
arm group type: Active Comparator
description: Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.
intervention type: Device
intervention name: interoperable Artificial Pancreas System (iAPS)
description: Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
arm group label: Artificial Pancreas
intervention type: Other
intervention name: Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
description: Use of personal pump with study CGM & glucometer at home for 13 weeks.
arm group label: Sensor Augmented Pump/Predictive Low Glucose Suspend
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eyal Dassau, PhD
role: Study Chair
affiliation: Harvard University
last name: Jordan Pinsker, MD
role: Study Chair
affiliation: Sansum Diabetes Research Institute
last name: Francis J Doyle III, PhD
role: Principal Investigator
affiliation: Harvard University
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Pinsker JE, Dassau E, Deshpande S, Raghinaru D, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Church MM, Desrochers H, Ekhlaspour L, Kaur RJ, Levister C, Shi D, Lum JW, Kollman C, Doyle FJ; iDCL Trial Research Group. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4. Diabetes Technol Ther. 2022 Sep;24(9):635-642. doi: 10.1089/dia.2022.0084. Epub 2022 Jun 2.
PMID: 35549708
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 & boluses, 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.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: The dataset from each iDCL protocol will be made public after publication of all manuscripts written by the study group using the dataset and any regulatory submission/completion of review by the regulatory agency, but no later than 3 years after the completion of the protocol even if additional manuscripts or regulatory submissions are planned.
provided document: 
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 