<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/NCT02971228</url>
  </required_header>
  <id_info>
    <org_study_id>ZP4207-16051</org_study_id>
    <nct_id>NCT02971228</nct_id>
  </id_info>
  <brief_title>Feasibility Trial Testing the Bionic Pancreas With ZP4207</brief_title>
  <acronym>dasiglucagon</acronym>
  <official_title>The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beta Bionics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Zealand Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to determine whether the Bionic Pancreas with ZP4207&#xD;
      (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes&#xD;
      mellitus.&#xD;
&#xD;
      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a single-center, open-label, 2-part, randomized cross-over trial. The trial was to&#xD;
      enrol up to 20 adult patients with type 1 diabetes mellitus and assess the safety and&#xD;
      efficacy of the Bionic Pancreas (BP) using either the iLet or iPhone platform when used with&#xD;
      the glucagon analogue ZP4207 (dasiglucagon) versus Lilly glucagon.&#xD;
&#xD;
      In Part 1, patients participated in two 1-day treatment arms in random order (iPhone-based BP&#xD;
      using ZP4207 (dasiglucagon) and iPhone-based BP using Lilly glucagon) according to a&#xD;
      pre-generated randomization scheme. In Part 2, it was planned to enrol additional patients to&#xD;
      participate in two 1-day treatment arms in random order (iLet using ZP4207 (dasiglucagon) and&#xD;
      iLet using Lilly glucagon) according to a pre-generated randomization scheme. However, due to&#xD;
      unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1.&#xD;
      Part 2 of the trial using the iLet was consequently not conducted.&#xD;
&#xD;
      One day the BP will use glucagon analogue ZP4207 (dasiglucagon) and the other day the BP will&#xD;
      use Lilly glucagon. Subjects will also receive insulin lispro through the BP on both days.&#xD;
      The trial will be conducted at single center, the Massachusetts General Hospital Diabetes&#xD;
      Center in Boston, MA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 7, 2017</completion_date>
  <primary_completion_date type="Actual">May 24, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters</measure>
    <time_frame>Up to 50 days</time_frame>
    <description>Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters.&#xD;
See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section.&#xD;
Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Measured on a Visual Analog Scale (VAS)</measure>
    <time_frame>16 hours</time_frame>
    <description>The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea Measured on a Visual Analog Scale (VAS)</measure>
    <time_frame>16 hours</time_frame>
    <description>The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Regulation</measure>
    <time_frame>16 hours</time_frame>
    <description>Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose&lt;60mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.</measure>
    <time_frame>16 hours</time_frame>
    <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.</measure>
    <time_frame>16 hours</time_frame>
    <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data</measure>
    <time_frame>16 hours</time_frame>
    <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured</measure>
    <time_frame>16 hours</time_frame>
    <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM</measure>
    <time_frame>16 hours</time_frame>
    <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download</measure>
    <time_frame>16 hours</time_frame>
    <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues</measure>
    <time_frame>16 hours</time_frame>
    <description>Technical faults in terms of calibration issues were listed by patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues</measure>
    <time_frame>16 hours</time_frame>
    <description>Technical faults related to connectivity issues were listed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Treatment Satisfaction Questionnaire - Status</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This questionnaire was not assessed as per protocol amendment 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Treatment Satisfaction Questionnaire - Change</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This questionnaire was not assessed as per protocol amendment 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1-Diabetes Distress Scale</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This questionnaire was not assessed as per protocol amendment 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem Areas in Diabetes Survey</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This questionnaire was not assessed as per protocol amendment 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia Fear Survey</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This questionnaire was not assessed as per protocol amendment 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Daily Diabetes Demands</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This questionnaire was not assessed as per protocol amendment 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bionic Pancreas User Opinion Survey</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This questionnaire was not assessed as per protocol amendment 7.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Part 1, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1, ZP4207 then Lilly Glucagon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2, ZP4207 then Lilly Glucagon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Lispro</intervention_name>
    <description>Used to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.</description>
    <arm_group_label>Part 1, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 1, ZP4207 then Lilly Glucagon</arm_group_label>
    <arm_group_label>Part 2, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 2, ZP4207 then Lilly Glucagon</arm_group_label>
    <other_name>HumaLOG</other_name>
    <other_name>HumaLOG Cartridge</other_name>
    <other_name>HumaLOG KwikPen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZP4207 (dasiglucagon)</intervention_name>
    <description>A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.</description>
    <arm_group_label>Part 1, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 1, ZP4207 then Lilly Glucagon</arm_group_label>
    <arm_group_label>Part 2, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 2, ZP4207 then Lilly Glucagon</arm_group_label>
    <other_name>dasiglucagon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucagon</intervention_name>
    <description>A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.</description>
    <arm_group_label>Part 1, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 1, ZP4207 then Lilly Glucagon</arm_group_label>
    <arm_group_label>Part 2, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 2, ZP4207 then Lilly Glucagon</arm_group_label>
    <other_name>Glucagon for injection (rDNA original)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iPhone-based bionic pancreas</intervention_name>
    <description>An experimental device.</description>
    <arm_group_label>Part 1, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 1, ZP4207 then Lilly Glucagon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iLet-based bionic pancreas</intervention_name>
    <description>An experimental device.</description>
    <arm_group_label>Part 2, Lilly glucagon then ZP4207</arm_group_label>
    <arm_group_label>Part 2, ZP4207 then Lilly Glucagon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with T1DM for at least 1 year, as defined by the American Diabetes&#xD;
             Association&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Prescription medication regimen stable for &gt;1 month (except for medications not&#xD;
             expected to affect trial safety or outcome, in the judgment of the investigator)&#xD;
&#xD;
          4. Diabetes managed using an insulin pump for &gt;=6 months&#xD;
&#xD;
          5. Patients in good health according to age (medical history, physical examination, vital&#xD;
             signs, 12-lead electrocardiograms [ECGs], laboratory assessments), as judged by the&#xD;
             Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous exposure to ZP4207 or adverse reaction to glucagon&#xD;
&#xD;
          2. History of liver disease or current abnormal liver function tests (LFTs)&#xD;
&#xD;
          3. Renal failure&#xD;
&#xD;
          4. Anemia&#xD;
&#xD;
          5. History of coronary artery disease or congestive heart failure (class III or IV)&#xD;
&#xD;
          6. History of transient ischemic attack or stroke&#xD;
&#xD;
          7. Seizure disorder&#xD;
&#xD;
          8. Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM&#xD;
&#xD;
          9. Other endocrine disorders&#xD;
&#xD;
         10. Use of oral anti-diabetic medications&#xD;
&#xD;
         11. Electronically powered implants&#xD;
&#xD;
         12. Hypertension (≥160/100 mm Hg despite treatment)&#xD;
&#xD;
         13. Inadequate venous (vein) access as determined by trial nurse or physician at time of&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven J Russell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MGH Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>July 2, 2020</results_first_submitted>
  <results_first_submitted_qc>January 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2021</results_first_posted>
  <disposition_first_submitted>June 26, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>June 26, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 27, 2018</disposition_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glucagon</keyword>
  <keyword>Type 1 diabetes mellitus</keyword>
  <keyword>Bionic Pancreas</keyword>
  <keyword>diabetes</keyword>
  <keyword>iLet</keyword>
  <keyword>iPhone</keyword>
  <keyword>Beta Bionics</keyword>
  <keyword>Anti-hypoglycemia</keyword>
  <keyword>Glucagon Analog</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>Insulin Lispro</mesh_term>
    <mesh_term>Glucagon</mesh_term>
    <mesh_term>Pancrelipase</mesh_term>
    <mesh_term>Pancreatin</mesh_term>
    <mesh_term>Glucagon-Like Peptide 1</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02971228/SAP_002.pdf</document_url>
    </provided_document>
    <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 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02971228/Prot_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In Part 1, it was planned to enrol 10 patients in two 1-day treatment arms in random order (iPhone-based bionic pancreas using ZP4207 or Lilly Glucagon) according to a pre-generated randomization scheme. The trial had a crossover design. In all, 19 patients were screened and 13 were randomized, but 1 patient withdrew before treatment. Thus, 12 patients were randomized and treated.</recruitment_details>
      <pre_assignment_details>Part 2 was designed to enroll up to 10 new patients in two 1-day treatment arms in random order (iLet using ZP4207 or Lilly Glucagon). However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1 Lilly Glucagon or ZP4207</title>
          <description>1 patient was enrolled but withdrew prior to treatment with either trial drug</description>
        </group>
        <group group_id="P2">
          <title>Part 1, Lilly Glucagon Then ZP4207</title>
          <description>7 patients received Lilly Glucagon then ZP4207 in this treatment sequence (2 withdrew before receiving ZP4207). Insulin Lispro was also administered in both treatment arms.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
        </group>
        <group group_id="P3">
          <title>Part 1, ZP4207 Then Lilly Glucagon</title>
          <description>5 patients received ZP4207 then Lilly Glucagon in this treatment sequence. Insulin Lispro was also administered in both treatment arms.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
        </group>
        <group group_id="P4">
          <title>Part 2, ZP4207 Then Lilly Glucagon</title>
          <description>Part 2 of the trial was not conducted - see above.</description>
        </group>
        <group group_id="P5">
          <title>Part 2, Lilly Glucagon Then ZP4207</title>
          <description>Part 2 of the trial was not conducted - see above.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0">Due to iLet unavailability, trial was stopped upon completion of Part 1. Part 2 was not conducted.</participants>
                <participants group_id="P5" count="0">Due to iLet unavailability, trial was stopped upon completion of Part 1. Part 2 was not conducted.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized and Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0">Due to iLet unavailability, trial was stopped upon completion of Part 1. Part 2 was not conducted.</participants>
                <participants group_id="P5" count="0">Due to iLet unavailability, trial was stopped upon completion of Part 1. Part 2 was not conducted.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Logistical challenges</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Due to the crossover nature of the trial, demographic and baseline characteristics are summarized for the overall population.</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1, All Participants</title>
          <description>In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. Note: 13 patients were enrolled and 1 patient withdrew prior to treatment with either trial drug; thus, 12 patients were randomized and treated.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.5" spread="18.47"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="1"/>
                  </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="1"/>
                  </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="11"/>
                  </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="1"/>
                  </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="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.28" spread="18.357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.36" spread="5.301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.2" spread="14.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.18" spread="1.462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters</title>
        <description>Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters.&#xD;
See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section.&#xD;
Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.</description>
        <time_frame>Up to 50 days</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters</title>
          <description>Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters.&#xD;
See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section.&#xD;
Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with edema infusion site reactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with erythema infusion site reactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with investigations AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with erythrocytes &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with hematocrit &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with hemoglobin &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with lymphocytes &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with infusion site pain (VAS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with nausea (VAS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with vascular disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Measured on a Visual Analog Scale (VAS)</title>
        <description>The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Measured on a Visual Analog Scale (VAS)</title>
          <description>The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>cm</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.01" spread="0.0029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.06" spread="0.202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.02" spread="0.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit end (16 hours)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nausea Measured on a Visual Analog Scale (VAS)</title>
        <description>The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Nausea Measured on a Visual Analog Scale (VAS)</title>
          <description>The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>cm</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.379"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.348"/>
                    <measurement group_id="O2" value="0.04" spread="0.144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.063"/>
                    <measurement group_id="O2" value="0.09" spread="0.215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.917"/>
                    <measurement group_id="O2" value="0.18" spread="0.522"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit end (16 hours)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.348"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemic Regulation</title>
        <description>Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose&lt;60mg/dL)</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Regulation</title>
          <description>Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose&lt;60mg/dL)</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>percentage of time points</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.78" spread="17.262"/>
                    <measurement group_id="O2" value="17.60" spread="14.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was &lt;0.001, the non-parametric method was utilized to analyze the endpoint parameter.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.</non_inferiority_desc>
            <p_value>0.2518</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.63</ci_lower_limit>
            <ci_upper_limit>5.84</ci_upper_limit>
            <estimate_desc>The estimated mean difference is based on the difference between the mean values for 10 patients in the ZP4207 group (12.78) and the matching 10 patients in the Lilly glucagon group (19.67)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2500</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-8.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.85</ci_lower_limit>
            <ci_upper_limit>10.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.</title>
        <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.</title>
          <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>Percentage of treatment delivered</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.73" spread="4.021"/>
                    <measurement group_id="O2" value="97.01" spread="2.851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was &lt;0.001, the non-parametric method was utilized to analyze the endpoint parameter.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.</non_inferiority_desc>
            <p_value>0.8508</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.55</ci_lower_limit>
            <ci_upper_limit>2.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.12</ci_lower_limit>
            <ci_upper_limit>3.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.</title>
        <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.</title>
          <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>Percentage of treatment delivered</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.36" spread="1.114"/>
                    <measurement group_id="O2" value="97.73" spread="2.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was &lt;0.001, the non-parametric method was utilized to analyze the endpoint parameter.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.</non_inferiority_desc>
            <p_value>0.1847</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.36</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0781</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>3.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data</title>
        <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data</title>
          <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>percentage of time functioning nominally</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.41" spread="1.846"/>
                    <measurement group_id="O2" value="94.26" spread="3.966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured</title>
        <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured</title>
          <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>percentage of time functioning nominally</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.86" spread="1.125"/>
                    <measurement group_id="O2" value="96.31" spread="3.891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM</title>
        <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM</title>
          <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <units>percentage of recorded values</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.55" spread="1.219"/>
                    <measurement group_id="O2" value="97.94" spread="1.076"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download</title>
        <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download</title>
          <description>Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
          <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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" spread="4.13"/>
                    <measurement group_id="O2" value="12.7" spread="5.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues</title>
        <description>Technical faults in terms of calibration issues were listed by patient.</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues</title>
          <description>Technical faults in terms of calibration issues were listed by patient.</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues</title>
        <description>Technical faults related to connectivity issues were listed</description>
        <time_frame>16 hours</time_frame>
        <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues</title>
          <description>Technical faults related to connectivity issues were listed</description>
          <population>The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.</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 group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Treatment Satisfaction Questionnaire - Status</title>
        <description>This questionnaire was not assessed as per protocol amendment 7.</description>
        <time_frame>Up to 3 months</time_frame>
        <population>This questionnaire was not assessed as per protocol amendment 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Treatment Satisfaction Questionnaire - Status</title>
          <description>This questionnaire was not assessed as per protocol amendment 7.</description>
          <population>This questionnaire was not assessed as per protocol amendment 7.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Treatment Satisfaction Questionnaire - Change</title>
        <description>This questionnaire was not assessed as per protocol amendment 7.</description>
        <time_frame>Up to 3 months</time_frame>
        <population>This questionnaire was not assessed as per protocol amendment 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Treatment Satisfaction Questionnaire - Change</title>
          <description>This questionnaire was not assessed as per protocol amendment 7.</description>
          <population>This questionnaire was not assessed as per protocol amendment 7.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T1-Diabetes Distress Scale</title>
        <description>This questionnaire was not assessed as per protocol amendment 7.</description>
        <time_frame>Up to 3 months</time_frame>
        <population>This questionnaire was not assessed as per protocol amendment 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>T1-Diabetes Distress Scale</title>
          <description>This questionnaire was not assessed as per protocol amendment 7.</description>
          <population>This questionnaire was not assessed as per protocol amendment 7.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Problem Areas in Diabetes Survey</title>
        <description>This questionnaire was not assessed as per protocol amendment 7.</description>
        <time_frame>Up to 3 months</time_frame>
        <population>This questionnaire was not assessed as per protocol amendment 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Problem Areas in Diabetes Survey</title>
          <description>This questionnaire was not assessed as per protocol amendment 7.</description>
          <population>This questionnaire was not assessed as per protocol amendment 7.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemia Fear Survey</title>
        <description>This questionnaire was not assessed as per protocol amendment 7.</description>
        <time_frame>Up to 3 months</time_frame>
        <population>This questionnaire was not assessed as per protocol amendment 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemia Fear Survey</title>
          <description>This questionnaire was not assessed as per protocol amendment 7.</description>
          <population>This questionnaire was not assessed as per protocol amendment 7.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Impact of Daily Diabetes Demands</title>
        <description>This questionnaire was not assessed as per protocol amendment 7.</description>
        <time_frame>Up to 3 months</time_frame>
        <population>This questionnaire was not assessed as per protocol amendment 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Daily Diabetes Demands</title>
          <description>This questionnaire was not assessed as per protocol amendment 7.</description>
          <population>This questionnaire was not assessed as per protocol amendment 7.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bionic Pancreas User Opinion Survey</title>
        <description>This questionnaire was not assessed as per protocol amendment 7.</description>
        <time_frame>Up to 3 months</time_frame>
        <population>This questionnaire was not assessed as per protocol amendment 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1, ZP4207</title>
            <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
          <group group_id="O2">
            <title>Part 1, Lilly Glucagon</title>
            <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
          </group>
        </group_list>
        <measure>
          <title>Bionic Pancreas User Opinion Survey</title>
          <description>This questionnaire was not assessed as per protocol amendment 7.</description>
          <population>This questionnaire was not assessed as per protocol amendment 7.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 50 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part 1, ZP4207</title>
          <description>In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</description>
        </group>
        <group group_id="E2">
          <title>Part 1, Lilly Glucagon</title>
          <description>In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.&#xD;
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.&#xD;
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.&#xD;
iPhone-based bionic pancreas: An experimental device.</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"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="8" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <description>AEs considered as &quot;blood glucose decreased&quot; were distinct from AEs considered as &quot;hypoglycemia&quot;</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E2" events="20" subjects_affected="9" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </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>Kim Mark Knudsen</name_or_title>
      <organization>Zealand Pharma A/S</organization>
      <phone>+45 5060 3780</phone>
      <email>KMKnudsen@zealandpharma.com</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/NCT02971228
org study id: ZP4207-16051
nct id: NCT02971228
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study was to determine whether the Bionic Pancreas with ZP4207
      (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes
      mellitus.

      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
This was a single-center, open-label, 2-part, randomized cross-over trial. The trial was to
      enrol up to 20 adult patients with type 1 diabetes mellitus and assess the safety and
      efficacy of the Bionic Pancreas (BP) using either the iLet or iPhone platform when used with
      the glucagon analogue ZP4207 (dasiglucagon) versus Lilly glucagon.

      In Part 1, patients participated in two 1-day treatment arms in random order (iPhone-based BP
      using ZP4207 (dasiglucagon) and iPhone-based BP using Lilly glucagon) according to a
      pre-generated randomization scheme. In Part 2, it was planned to enrol additional patients to
      participate in two 1-day treatment arms in random order (iLet using ZP4207 (dasiglucagon) and
      iLet using Lilly glucagon) according to a pre-generated randomization scheme. However, due to
      unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1.
      Part 2 of the trial using the iLet was consequently not conducted.

      One day the BP will use glucagon analogue ZP4207 (dasiglucagon) and the other day the BP will
      use Lilly glucagon. Subjects will also receive insulin lispro through the BP on both days.
      The trial will be conducted at single center, the Massachusetts General Hospital Diabetes
      Center in Boston, MA.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
time frame: Up to 50 days
description: Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters.
See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section.
Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.
measure: Pain Measured on a Visual Analog Scale (VAS)
time frame: 16 hours
description: The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3.
measure: Nausea Measured on a Visual Analog Scale (VAS)
time frame: 16 hours
description: The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period.
measure: Glycemic Regulation
time frame: 16 hours
description: Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose<60mg/dL)
measure: Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
time frame: 16 hours
description: Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
measure: Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
time frame: 16 hours
description: Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
measure: Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data
time frame: 16 hours
description: Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
measure: Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured
time frame: 16 hours
description: Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
measure: CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM
time frame: 16 hours
description: Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
measure: CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download
time frame: 16 hours
description: Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
measure: Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues
time frame: 16 hours
description: Technical faults in terms of calibration issues were listed by patient.
measure: Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues
time frame: 16 hours
description: Technical faults related to connectivity issues were listed
measure: Diabetes Treatment Satisfaction Questionnaire - Status
time frame: Up to 3 months
description: This questionnaire was not assessed as per protocol amendment 7.
measure: Diabetes Treatment Satisfaction Questionnaire - Change
time frame: Up to 3 months
description: This questionnaire was not assessed as per protocol amendment 7.
measure: T1-Diabetes Distress Scale
time frame: Up to 3 months
description: This questionnaire was not assessed as per protocol amendment 7.
measure: Problem Areas in Diabetes Survey
time frame: Up to 3 months
description: This questionnaire was not assessed as per protocol amendment 7.
measure: Hypoglycemia Fear Survey
time frame: Up to 3 months
description: This questionnaire was not assessed as per protocol amendment 7.
measure: Impact of Daily Diabetes Demands
time frame: Up to 3 months
description: This questionnaire was not assessed as per protocol amendment 7.
measure: Bionic Pancreas User Opinion Survey
time frame: Up to 3 months
description: This questionnaire was not assessed as per protocol amendment 7.
arm group label: Part 1, Lilly glucagon then ZP4207
arm group type: Experimental
description: In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme.
arm group label: Part 1, ZP4207 then Lilly Glucagon
arm group type: Experimental
description: In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme.
arm group label: Part 2, Lilly glucagon then ZP4207
arm group type: Experimental
description: In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.
arm group label: Part 2, ZP4207 then Lilly Glucagon
arm group type: Experimental
description: In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.
intervention type: Drug
intervention name: Insulin Lispro
description: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
arm group label: Part 1, Lilly glucagon then ZP4207
arm group label: Part 1, ZP4207 then Lilly Glucagon
arm group label: Part 2, Lilly glucagon then ZP4207
arm group label: Part 2, ZP4207 then Lilly Glucagon
other name: HumaLOG
other name: HumaLOG Cartridge
other name: HumaLOG KwikPen
intervention type: Drug
intervention name: ZP4207 (dasiglucagon)
description: A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
arm group label: Part 1, Lilly glucagon then ZP4207
arm group label: Part 1, ZP4207 then Lilly Glucagon
arm group label: Part 2, Lilly glucagon then ZP4207
arm group label: Part 2, ZP4207 then Lilly Glucagon
other name: dasiglucagon
intervention type: Drug
intervention name: Glucagon
description: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
arm group label: Part 1, Lilly glucagon then ZP4207
arm group label: Part 1, ZP4207 then Lilly Glucagon
arm group label: Part 2, Lilly glucagon then ZP4207
arm group label: Part 2, ZP4207 then Lilly Glucagon
other name: Glucagon for injection (rDNA original)
intervention type: Device
intervention name: iPhone-based bionic pancreas
description: An experimental device.
arm group label: Part 1, Lilly glucagon then ZP4207
arm group label: Part 1, ZP4207 then Lilly Glucagon
intervention type: Device
intervention name: iLet-based bionic pancreas
description: An experimental device.
arm group label: Part 2, Lilly glucagon then ZP4207
arm group label: Part 2, ZP4207 then Lilly Glucagon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven J Russell, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Lispro
mesh term: Glucagon
mesh term: Pancrelipase
mesh term: Pancreatin
mesh term: Glucagon-Like Peptide 1
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 