<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/NCT04492566</url>
  </required_header>
  <id_info>
    <org_study_id>G200099/S001</org_study_id>
    <nct_id>NCT04492566</nct_id>
  </id_info>
  <brief_title>Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home</brief_title>
  <official_title>Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</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>
      This clinical trial is a safety and feasibility study to assess the performance of an&#xD;
      artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health&#xD;
      Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with&#xD;
      type 1 diabetes (T1D).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age&#xD;
      18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic&#xD;
      Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour&#xD;
      closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
      During the session, subjects will bolus for all meals and snacks, and will perform their&#xD;
      usual daily activities while being accompanied by study medical staff.&#xD;
&#xD;
      For subjects who wish to continue use of the system, they will be offered the option of&#xD;
      continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">October 5, 2022</completion_date>
  <primary_completion_date type="Actual">October 5, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time in Target Glucose Range</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overnight Time in Target Glucose Range</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Sensor glucose time within the target range of 63-140 mg/dl overnight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial Time in Target Glucose Range</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following meals and 2 hours following meals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &lt; 63 mg/dL</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Percent time CGM glucose &lt; 63 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &lt; 54 mg/dL</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Percent time CGM glucose &lt; 54 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &gt; 140 mg/dL</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Percent time GGM glucose &gt; 140 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &gt; 180 mg/dL</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Percent time GGM glucose &gt; 180 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemic Events Per Week</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of hypoglycemic events per week, defined as time &lt;54 mg/dL for 15 consecutive minutes followed by time &gt;70 mg/dL for 15 consecutive minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Hypoglycemic Events</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of hypoglycemic events that events that require active assistance of another individual</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperglycemic Events</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of episodes with ketones &gt;1 mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &gt; 250 mg/dL</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Percent time GGM glucose &gt; 250 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events (SAE)</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>The total number of serious adverse events during the clinical trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Device Events (SADE)</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>The total number of serious adverse events related to the study device use during the clinical trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Device Effects (ADE)</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>The total number of adverse device effects (ADE) during the clinical trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unanticipated Adverse Device Effects (UADE)</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>The total number of unanticipated adverse device effects (UADE) during the clinical trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean CGM Glucose Level</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Mean CGM glucose level during AID use</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Closed-Loop Active Time</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Percent time (hours/day) of closed-loop use during the clinical trial</description>
  </other_outcome>
  <other_outcome>
    <measure>Sensor Use Time</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Percent Time CGM during the clinical trial</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Outcomes: Gestational Hypertension</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of subjects who develop gestational hypertension during pregnancy</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Outcomes: Pre-eclampsia</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of subjects who develop pre-eclampsia during pregnancy</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Outcomes: Eclampsia</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of subjects who develop eclampsia during pregnancy</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Outcomes: Oligo/Polyhydramnios</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of subjects who develop oligo/polyhydramnios during pregnancy</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Outcomes: Pre Term Labor</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of subjects who develop pre term labor during pregnancy</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Outcomes: Primary Caesarian Section</measure>
    <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
    <description>Number of subjects who underwent primary caesarian section</description>
  </other_outcome>
  <other_outcome>
    <measure>Fetal Outcomes: Large for Gestational Age</measure>
    <time_frame>At Delivery</time_frame>
    <description>Number of infants born large for gestational age</description>
  </other_outcome>
  <other_outcome>
    <measure>Fetal Outcomes: Neonatal Hypoglycemia</measure>
    <time_frame>At delivery and up to 48 hours afterwards</time_frame>
    <description>Number of infants who develop neonatal hypoglycemia. Neonatal hypoglycemia is defined as treatment requiring IV dextrose, treatment of the newborn with glucose gel is also reported, however protocols for use of glucose gel varied by delivery location.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fetal Outcomes: Neonatal Intensive Care Unit Admission</measure>
    <time_frame>At delivery and up to 7 days afterwards</time_frame>
    <description>Number of infants who are admitted to the neonatal intensive care unit</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>AID Evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated Insulin Delivery</intervention_name>
    <description>Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
    <arm_group_label>AID Evaluation</arm_group_label>
    <other_name>Interoperable Artificial Pancreas System (iAPS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 45 years at the time of screening.&#xD;
&#xD;
          -  Clinical diagnosis of type 1 diabetes&#xD;
&#xD;
          -  Currently using an insulin pump at the time of screening.&#xD;
&#xD;
          -  HbA1c ≤ 9%, as performed by point of care or central laboratory testing.&#xD;
&#xD;
          -  Pregnant 14+0/7 to 32+6/7 weeks gestation.&#xD;
&#xD;
          -  Singleton pregnancy without any other significant known complications, such as&#xD;
             preeclampsia, premature rupture of membranes, 2nd/3rd trimester bleeding, fetal growth&#xD;
             or fluid abnormalities.&#xD;
&#xD;
          -  No proven or suspected fetal malformations diagnosed in the current pregnancy.&#xD;
&#xD;
          -  Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.&#xD;
&#xD;
          -  Willing to switch to, or continue Novolog or Humalog for the closed-loop session.&#xD;
&#xD;
          -  Willingness not to start any new non-insulin glucose-lowering agent during the course&#xD;
             of the trial.&#xD;
&#xD;
          -  Willing to abide by the study protocol and use study-provided devices.&#xD;
&#xD;
          -  Have a care partner with the following responsibilities: knowing subject whereabouts&#xD;
             and being promptly available for contact by study staff during the day and night,&#xD;
             residing in the same dwelling as subject during the night, being agreeable to all&#xD;
             device training during the supervised HCL session and additional training on hyper-&#xD;
             and hypoglycemia treatment, and assisting with emergency care if needed, such as&#xD;
             transportation to the hospital or emergency department.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known unstable cardiac disease or untreated cardiac disease, as revealed by history or&#xD;
             physical examination.&#xD;
&#xD;
          -  Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than&#xD;
             metformin (including GLP-1 agonists, Pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors,&#xD;
             sulfonylureas).&#xD;
&#xD;
          -  Hemophilia or any other bleeding disorder&#xD;
&#xD;
          -  Prior history of Preterm Premature Rupture of Membranes (PPROM)&#xD;
&#xD;
          -  Significant hyperemesis interfering with carbohydrate intake&#xD;
&#xD;
          -  Laboratory results:&#xD;
&#xD;
               1. A1C &gt; 9%&#xD;
&#xD;
               2. Abnormal liver or renal function (Transaminase &gt;2 times the upper limit of&#xD;
                  normal, creatinine &gt; 1.5 mg/dL)&#xD;
&#xD;
               3. Liver and renal function testing drawn at screening visit or within three months&#xD;
                  prior to screening (for other purposes) will suffice for enrollment purposes&#xD;
&#xD;
          -  Dermatological conditions that would preclude wearing a CGM sensor or infusion site.&#xD;
&#xD;
          -  Any condition that could interfere with participating in the trial, based on&#xD;
             investigator judgment.&#xD;
&#xD;
          -  Participation in another pharmaceutical or device trial at the time of enrollment or&#xD;
             during the study.&#xD;
&#xD;
          -  Having a direct supervisor at place of employment who is also directly involved in&#xD;
             conducting the clinical trial (as a study investigator, coordinator, etc.); or having&#xD;
             a first-degree relative who is directly involved in conducting the clinical trial&#xD;
&#xD;
          -  History of severe hypoglycemia in the past 6 months&#xD;
&#xD;
          -  History of DKA requiring hospitalization in the past 6 months&#xD;
&#xD;
          -  Significant chronic kidney disease (eGFR &lt; 60) or hemodialysis&#xD;
&#xD;
          -  Significant liver disease&#xD;
&#xD;
          -  History of adrenal insufficiency&#xD;
&#xD;
          -  History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not&#xD;
             appropriately treated&#xD;
&#xD;
          -  History of high dose steroid use in the past 8 weeks&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eyal Dassau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard University John A Paulson School of Engineering and Applied Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yogish Kudva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carol Levy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barak Rosenn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Grenye O'Malley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristin Castorino, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordan Pinsker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</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>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>Levy CJ, Kudva YC, Ozaslan B, Castorino K, O'Malley G, Kaur RJ, Levister CM, Church MM, Desjardins D, McCrady-Spitzer S, Ogyaadu S, Trinidad MC, Reid C, Rizvi S, Deshpande S, Zaniletti I, Kremers WK, Pinsker JE, Doyle FJ, Dassau E; LOIS-P Diabetes and Pregnancy Consortium. At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study. Diabetes Care. 2023 Jul 1;46(7):1425-1431. doi: 10.2337/dc23-0173.</citation>
    <PMID>37196353</PMID>
  </results_reference>
  <results_reference>
    <citation>Ozaslan B, Levy CJ, Kudva YC, Pinsker JE, O'Malley G, Kaur RJ, Castorino K, Levister C, Trinidad MC, Desjardins D, Church MM, Plesser M, McCrady-Spitzer S, Ogyaadu S, Nelson K, Reid C, Deshpande S, Kremers WK, Doyle FJ , III, Rosenn B, Dassau E. Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm. Diabetes Technol Ther. 2022 Jul;24(7):471-480. doi: 10.1089/dia.2021.0521. Epub 2022 Apr 26.</citation>
    <PMID>35230138</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <results_first_submitted>May 17, 2023</results_first_submitted>
  <results_first_submitted_qc>July 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 4, 2023</results_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>pregnancy</keyword>
  <keyword>artificial pancreas</keyword>
  <keyword>automated insulin delivery</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>No</sharing_ipd>
  </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>November 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT04492566/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 30, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT04492566/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AID Evaluation</title>
          <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Ten participants were enrolled in the study and used the system from their enrollment until delivery of the baby.</population>
      <group_list>
        <group group_id="B1">
          <title>AID Evaluation</title>
          <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="32.6" spread="4.3"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycated Hemoglobin</title>
          <units>percentage of glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.8" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time in Target Glucose Range</title>
        <description>Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Target Glucose Range</title>
          <description>Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system</description>
          <units>percent 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.6" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overnight Time in Target Glucose Range</title>
        <description>Sensor glucose time within the target range of 63-140 mg/dl overnight</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Overnight Time in Target Glucose Range</title>
          <description>Sensor glucose time within the target range of 63-140 mg/dl overnight</description>
          <units>percent 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postprandial Time in Target Glucose Range</title>
        <description>Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following meals and 2 hours following meals</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Postprandial Time in Target Glucose Range</title>
          <description>Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following meals and 2 hours following meals</description>
          <units>percent 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.4" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose &lt; 63 mg/dL</title>
        <description>Percent time CGM glucose &lt; 63 mg/dL</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose &lt; 63 mg/dL</title>
          <description>Percent time CGM glucose &lt; 63 mg/dL</description>
          <units>percent time</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.4" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose &lt; 54 mg/dL</title>
        <description>Percent time CGM glucose &lt; 54 mg/dL</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose &lt; 54 mg/dL</title>
          <description>Percent time CGM glucose &lt; 54 mg/dL</description>
          <units>percent time</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose &gt; 140 mg/dL</title>
        <description>Percent time GGM glucose &gt; 140 mg/dL</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose &gt; 140 mg/dL</title>
          <description>Percent time GGM glucose &gt; 140 mg/dL</description>
          <units>percent 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose &gt; 180 mg/dL</title>
        <description>Percent time GGM glucose &gt; 180 mg/dL</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose &gt; 180 mg/dL</title>
          <description>Percent time GGM glucose &gt; 180 mg/dL</description>
          <units>percent time</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="3.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemic Events Per Week</title>
        <description>Number of hypoglycemic events per week, defined as time &lt;54 mg/dL for 15 consecutive minutes followed by time &gt;70 mg/dL for 15 consecutive minutes.</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemic Events Per Week</title>
          <description>Number of hypoglycemic events per week, defined as time &lt;54 mg/dL for 15 consecutive minutes followed by time &gt;70 mg/dL for 15 consecutive minutes.</description>
          <units>events per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Hypoglycemic Events</title>
        <description>Number of hypoglycemic events that events that require active assistance of another individual</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Hypoglycemic Events</title>
          <description>Number of hypoglycemic events that events that require active assistance of another individual</description>
          <units>Number of Events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hyperglycemic Events</title>
        <description>Number of episodes with ketones &gt;1 mmol/L</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperglycemic Events</title>
          <description>Number of episodes with ketones &gt;1 mmol/L</description>
          <units>Number of Events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose &gt; 250 mg/dL</title>
        <description>Percent time GGM glucose &gt; 250 mg/dL</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose &gt; 250 mg/dL</title>
          <description>Percent time GGM glucose &gt; 250 mg/dL</description>
          <units>percent time</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serious Adverse Events (SAE)</title>
        <description>The total number of serious adverse events during the clinical trial</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Serious Adverse Events (SAE)</title>
          <description>The total number of serious adverse events during the clinical trial</description>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serious Adverse Device Events (SADE)</title>
        <description>The total number of serious adverse events related to the study device use during the clinical trial</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Serious Adverse Device Events (SADE)</title>
          <description>The total number of serious adverse events related to the study device use during the clinical trial</description>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Device Effects (ADE)</title>
        <description>The total number of adverse device effects (ADE) during the clinical trial</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <population>Infusion Set Failure</population>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Device Effects (ADE)</title>
          <description>The total number of adverse device effects (ADE) during the clinical trial</description>
          <population>Infusion Set Failure</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unanticipated Adverse Device Effects (UADE)</title>
        <description>The total number of unanticipated adverse device effects (UADE) during the clinical trial</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Unanticipated Adverse Device Effects (UADE)</title>
          <description>The total number of unanticipated adverse device effects (UADE) during the clinical trial</description>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean CGM Glucose Level</title>
        <description>Mean CGM glucose level during AID use</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean CGM Glucose Level</title>
          <description>Mean CGM glucose level during AID use</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.1" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Closed-Loop Active Time</title>
        <description>Percent time (hours/day) of closed-loop use during the clinical trial</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Closed-Loop Active Time</title>
          <description>Percent time (hours/day) of closed-loop use during the clinical trial</description>
          <units>percent 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.1" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Sensor Use Time</title>
        <description>Percent Time CGM during the clinical trial</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Sensor Use Time</title>
          <description>Percent Time CGM during the clinical trial</description>
          <units>percent 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Outcomes: Gestational Hypertension</title>
        <description>Number of subjects who develop gestational hypertension during pregnancy</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Outcomes: Gestational Hypertension</title>
          <description>Number of subjects who develop gestational hypertension during pregnancy</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Outcomes: Pre-eclampsia</title>
        <description>Number of subjects who develop pre-eclampsia during pregnancy</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Outcomes: Pre-eclampsia</title>
          <description>Number of subjects who develop pre-eclampsia during pregnancy</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Outcomes: Eclampsia</title>
        <description>Number of subjects who develop eclampsia during pregnancy</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Outcomes: Eclampsia</title>
          <description>Number of subjects who develop eclampsia during pregnancy</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Outcomes: Oligo/Polyhydramnios</title>
        <description>Number of subjects who develop oligo/polyhydramnios during pregnancy</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Outcomes: Oligo/Polyhydramnios</title>
          <description>Number of subjects who develop oligo/polyhydramnios during pregnancy</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Outcomes: Pre Term Labor</title>
        <description>Number of subjects who develop pre term labor during pregnancy</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Outcomes: Pre Term Labor</title>
          <description>Number of subjects who develop pre term labor during pregnancy</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Outcomes: Primary Caesarian Section</title>
        <description>Number of subjects who underwent primary caesarian section</description>
        <time_frame>Duration of iAPS Use During Pregnancy up to 40 weeks of Use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Outcomes: Primary Caesarian Section</title>
          <description>Number of subjects who underwent primary caesarian section</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fetal Outcomes: Large for Gestational Age</title>
        <description>Number of infants born large for gestational age</description>
        <time_frame>At Delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Fetal Outcomes: Large for Gestational Age</title>
          <description>Number of infants born large for gestational age</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fetal Outcomes: Neonatal Hypoglycemia</title>
        <description>Number of infants who develop neonatal hypoglycemia. Neonatal hypoglycemia is defined as treatment requiring IV dextrose, treatment of the newborn with glucose gel is also reported, however protocols for use of glucose gel varied by delivery location.</description>
        <time_frame>At delivery and up to 48 hours afterwards</time_frame>
        <population>No IV glucose was given, all treated with glucose gel.</population>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Fetal Outcomes: Neonatal Hypoglycemia</title>
          <description>Number of infants who develop neonatal hypoglycemia. Neonatal hypoglycemia is defined as treatment requiring IV dextrose, treatment of the newborn with glucose gel is also reported, however protocols for use of glucose gel varied by delivery location.</description>
          <population>No IV glucose was given, all treated with glucose gel.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fetal Outcomes: Neonatal Intensive Care Unit Admission</title>
        <description>Number of infants who are admitted to the neonatal intensive care unit</description>
        <time_frame>At delivery and up to 7 days afterwards</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AID Evaluation</title>
            <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
          </group>
        </group_list>
        <measure>
          <title>Fetal Outcomes: Neonatal Intensive Care Unit Admission</title>
          <description>Number of infants who are admitted to the neonatal intensive care unit</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Pregnancy through delivery, up to 40 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AID Evaluation</title>
          <description>After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.&#xD;
Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.&#xD;
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.</description>
        </group>
      </group_list>
      <serious_events>
        <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="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>SNOMED CT</default_vocab>
        <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="6" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ketosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>gestational hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>exacerbation of pre-pregnancy hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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>Dr. Kristin Castorino</name_or_title>
      <organization>Sansum Diabetes Research Institute</organization>
      <phone>805-682-7638</phone>
      <email>info@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/NCT04492566
org study id: G200099/S001
nct id: NCT04492566
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This clinical trial is a safety and feasibility study to assess the performance of an
      artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health
      Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with
      type 1 diabetes (T1D).
The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age
      18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic
      Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour
      closed-loop (CL) session in a supervised outpatient environment with medical staff present.
      During the session, subjects will bolus for all meals and snacks, and will perform their
      usual daily activities while being accompanied by study medical staff.

      For subjects who wish to continue use of the system, they will be offered the option of
      continuing use of the system at home in an extension phase, for the rest of their pregnancy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time in Target Glucose Range
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system
measure: Overnight Time in Target Glucose Range
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Sensor glucose time within the target range of 63-140 mg/dl overnight
measure: Postprandial Time in Target Glucose Range
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following meals and 2 hours following meals
measure: Glucose < 63 mg/dL
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Percent time CGM glucose < 63 mg/dL
measure: Glucose < 54 mg/dL
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Percent time CGM glucose < 54 mg/dL
measure: Glucose > 140 mg/dL
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Percent time GGM glucose > 140 mg/dL
measure: Glucose > 180 mg/dL
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Percent time GGM glucose > 180 mg/dL
measure: Hypoglycemic Events Per Week
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of hypoglycemic events per week, defined as time <54 mg/dL for 15 consecutive minutes followed by time >70 mg/dL for 15 consecutive minutes.
measure: Severe Hypoglycemic Events
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of hypoglycemic events that events that require active assistance of another individual
measure: Hyperglycemic Events
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of episodes with ketones >1 mmol/L
measure: Glucose > 250 mg/dL
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Percent time GGM glucose > 250 mg/dL
measure: Serious Adverse Events (SAE)
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: The total number of serious adverse events during the clinical trial
measure: Serious Adverse Device Events (SADE)
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: The total number of serious adverse events related to the study device use during the clinical trial
measure: Adverse Device Effects (ADE)
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: The total number of adverse device effects (ADE) during the clinical trial
measure: Unanticipated Adverse Device Effects (UADE)
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: The total number of unanticipated adverse device effects (UADE) during the clinical trial
measure: Mean CGM Glucose Level
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Mean CGM glucose level during AID use
measure: Closed-Loop Active Time
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Percent time (hours/day) of closed-loop use during the clinical trial
measure: Sensor Use Time
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Percent Time CGM during the clinical trial
measure: Maternal Outcomes: Gestational Hypertension
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of subjects who develop gestational hypertension during pregnancy
measure: Maternal Outcomes: Pre-eclampsia
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of subjects who develop pre-eclampsia during pregnancy
measure: Maternal Outcomes: Eclampsia
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of subjects who develop eclampsia during pregnancy
measure: Maternal Outcomes: Oligo/Polyhydramnios
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of subjects who develop oligo/polyhydramnios during pregnancy
measure: Maternal Outcomes: Pre Term Labor
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of subjects who develop pre term labor during pregnancy
measure: Maternal Outcomes: Primary Caesarian Section
time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
description: Number of subjects who underwent primary caesarian section
measure: Fetal Outcomes: Large for Gestational Age
time frame: At Delivery
description: Number of infants born large for gestational age
measure: Fetal Outcomes: Neonatal Hypoglycemia
time frame: At delivery and up to 48 hours afterwards
description: Number of infants who develop neonatal hypoglycemia. Neonatal hypoglycemia is defined as treatment requiring IV dextrose, treatment of the newborn with glucose gel is also reported, however protocols for use of glucose gel varied by delivery location.
measure: Fetal Outcomes: Neonatal Intensive Care Unit Admission
time frame: At delivery and up to 7 days afterwards
description: Number of infants who are admitted to the neonatal intensive care unit
arm group label: AID Evaluation
arm group type: Experimental
description: After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
intervention type: Device
intervention name: Automated Insulin Delivery
description: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
arm group label: AID Evaluation
other name: Interoperable Artificial Pancreas System (iAPS)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Eyal Dassau, PhD
role: Principal Investigator
affiliation: Harvard University John A Paulson School of Engineering and Applied Sciences
last name: Yogish Kudva, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Carol Levy, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Barak Rosenn, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Grenye O'Malley, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Kristin Castorino, DO
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
last name: Jordan Pinsker, MD
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
facility: 
facility: 
facility: 
country: United States
citation: Levy CJ, Kudva YC, Ozaslan B, Castorino K, O'Malley G, Kaur RJ, Levister CM, Church MM, Desjardins D, McCrady-Spitzer S, Ogyaadu S, Trinidad MC, Reid C, Rizvi S, Deshpande S, Zaniletti I, Kremers WK, Pinsker JE, Doyle FJ, Dassau E; LOIS-P Diabetes and Pregnancy Consortium. At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study. Diabetes Care. 2023 Jul 1;46(7):1425-1431. doi: 10.2337/dc23-0173.
PMID: 37196353
citation: Ozaslan B, Levy CJ, Kudva YC, Pinsker JE, O'Malley G, Kaur RJ, Castorino K, Levister C, Trinidad MC, Desjardins D, Church MM, Plesser M, McCrady-Spitzer S, Ogyaadu S, Nelson K, Reid C, Deshpande S, Kremers WK, Doyle FJ , III, Rosenn B, Dassau E. Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm. Diabetes Technol Ther. 2022 Jul;24(7):471-480. doi: 10.1089/dia.2021.0521. Epub 2022 Apr 26.
PMID: 35230138
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Pancrelipase
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 