<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/NCT03816761</url>
  </required_header>
  <id_info>
    <org_study_id>NN1218-4360</org_study_id>
    <secondary_id>U1111-1205-1788</secondary_id>
    <nct_id>NCT03816761</nct_id>
  </id_info>
  <brief_title>Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes</brief_title>
  <official_title>An Exploratory Trial Investigating the Safety and Efficacy of Fast-acting Insulin Aspart in a Closed-loop Insulin Delivery System (Bionic Pancreas) in Adults With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose&#xD;
      Monitoring (CGM) device. This is to give participants insulin automatically. The CGM device&#xD;
      is already available for sale. The iLet™ is not yet approved for use. Fast-acting insulin&#xD;
      aspart is a type of insulin that doctors can already prescribe for use with insulin pens, but&#xD;
      not for use in an insulin pump. This study is to test how safe fast acting insulin aspart is&#xD;
      when used with different insulin delivery settings in the iLet™ in people with type 1&#xD;
      diabetes. Participants will get fast-acting insulin aspart as participants' insulin and use&#xD;
      the iLet™ as participants' insulin pump with a CGM device. Participants' iLet™ will be set to&#xD;
      2 different insulin delivery settings for 7 days on each setting. The setting participants&#xD;
      get first is decided by chance. The study will last for about 5 to 9 weeks. Participants will&#xD;
      have 4 visits and 1 phone contact with the study or staff.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">June 10, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Sponsor staff involved in the clinical trial is masked according to company standard procedures.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage)</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Severe Hypoglycaemic Episodes</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</measure>
    <time_frame>Day 1 to day 7 (in both the treatment periods)</time_frame>
    <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</measure>
    <time_frame>Day 1 to day 7 (in both the treatment periods)</time_frame>
    <description>Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages)</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Interstitial-glucose Level</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Mean interstitial glucose level is calculated as the average of the available interstitial glucose values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Adverse Events</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Infusion Site Reactions</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Insulin Dose Per Day</measure>
    <time_frame>Day 1 to day 7</time_frame>
    <description>Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Fast-acting insulin aspart, default tmax setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fast-acting insulin aspart using the iLet™ with default tmax setting (t65 = 65 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fast-acting insulin aspart, non-default tmax setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fast-acting insulin aspart using the iLet™ with non-default tmax setting (t50 = 50 minutes, t40 = 40 minutes or t30 = 30 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fast-acting insulin aspart</intervention_name>
    <description>In each cohort, participants will receive fast-acting insulin aspart using the iLet™ in a cross-over manner for 14 days (7days per period). Dose modification will be handled autonomously by the iLet™ based on the CGM sensor readings and the user interaction with the iLet™ e.g. meal announcements.</description>
    <arm_group_label>Fast-acting insulin aspart, default tmax setting</arm_group_label>
    <arm_group_label>Fast-acting insulin aspart, non-default tmax setting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iLet™</intervention_name>
    <description>The bionic pancreas including pigtail adapters, used in insulin-only configuration</description>
    <arm_group_label>Fast-acting insulin aspart, default tmax setting</arm_group_label>
    <arm_group_label>Fast-acting insulin aspart, non-default tmax setting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activities. Trial-related&#xD;
             activities are any procedures that are carried out as part of the trial, including&#xD;
             activities to determine suitability for the trial&#xD;
&#xD;
          -  Male or female, age more than or equal to 18 years and less than or equal to 75 years&#xD;
             at the time of signing informed consent&#xD;
&#xD;
          -  Diagnosed with type 1 diabetes mellitus more than or equal to 1 year prior to the day&#xD;
             of screening&#xD;
&#xD;
          -  Treated with continuous subcutaneous insulin infusion more than or equal to 1 year&#xD;
             prior to the day of screening&#xD;
&#xD;
          -  Have a mean total daily dose of insulin more than or equal to 20 units&#xD;
&#xD;
          -  Familiar with continuous glucose monitoring as judged by the investigator&#xD;
&#xD;
          -  Has someone over 18 years of age who (i) lives with them, (ii) has access to where&#xD;
             they sleep, (iii) is willing to be in the house when the subject is sleeping, and (iv)&#xD;
             is willing to receive calls from the study staff and check the welfare of the study&#xD;
             subject&#xD;
&#xD;
          -  Body mass index (BMI) less than or equal to 35.0 kg/m^2 at screening&#xD;
&#xD;
          -  Glycated haemoglobin (HbA1c) more than or equal to 6.5% (47 mmol/mol) and less than or&#xD;
             equal to 9% (75 mmol/mol) at screening&#xD;
&#xD;
          -  Able and willing to remain in a designated place for the specified duration of the&#xD;
             'in-patient' periods&#xD;
&#xD;
          -  Lives within a 120-minute drive away from the central monitoring location (site)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected hypersensitivity to trial product(s) or related products&#xD;
&#xD;
          -  Previous participation in this trial. Participation is defined as signed informed&#xD;
             consent&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of&#xD;
             child-bearing potential and not using an adequate contraceptive method (adequate&#xD;
             contraceptive measures as required by local regulation or practice)&#xD;
&#xD;
          -  Participation in any clinical trial of an approved or non-approved investigational&#xD;
             medicinal product within 30 days before screening&#xD;
&#xD;
          -  Any disorder, except for conditions associated with diabetes mellitus, which in the&#xD;
             investigator's opinion might jeopardise subject's safety or compliance with the&#xD;
             protocol&#xD;
&#xD;
          -  Anticipated initiation or change in concomitant medications known to affect weight or&#xD;
             glucose metabolism during the trial&#xD;
&#xD;
          -  Impaired liver function, defined as Alanine Aminotransferase (ALT) more than or equal&#xD;
             to 2.5 times or Bilirubin more than 1.5 times upper normal limit at screening&#xD;
&#xD;
          -  Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR&#xD;
             less than 60 ml/min/1.73 m^2&#xD;
&#xD;
          -  Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of&#xD;
             screening&#xD;
&#xD;
          -  Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's&#xD;
             questionnaire question 8&#xD;
&#xD;
          -  Recurrent severe hypoglycaemic episodes within the last year as judged by the&#xD;
             Investigator&#xD;
&#xD;
          -  Any of the following: myocardial infarction, stroke, hospitalization for unstable&#xD;
             angina pectoris or transient ischaemic attack within the past 180 days prior to the&#xD;
             day of screening&#xD;
&#xD;
          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV&#xD;
&#xD;
          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of&#xD;
             screening&#xD;
&#xD;
          -  Inadequately treated blood pressure defined as Grade 3 hypertension or higher&#xD;
             (systolic more than or equal to 180 mmHg or diastolic more than or equal to 110 mmHg)&#xD;
             at screening&#xD;
&#xD;
          -  Unwilling or unable to avoid acetaminophen throughout the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosure (1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</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>May 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <results_first_submitted>April 20, 2020</results_first_submitted>
  <results_first_submitted_qc>May 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 11, 2020</results_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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 Aspart</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>http://novonordisk-trials.com/sharing-results</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03816761/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at one site in the United States.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: t65 First, Then t50</title>
          <description>iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. The total treatment duration for each cohort was 14 days.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1: t50 First, Then t65</title>
          <description>iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2: t65 First, Then t40</title>
          <description>iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. The total treatment duration for each cohort was 14 days.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 2: t40 First, Then t65</title>
          <description>iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days.</description>
        </group>
        <group group_id="P5">
          <title>Cohort 3: t65 First, Then t30</title>
          <description>iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. The total treatment duration for each cohort was 14 days.</description>
        </group>
        <group group_id="P6">
          <title>Cohort 3: t30 First, Then t65</title>
          <description>iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Treatment Period (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Treatment Period (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Unclassified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
          <description>Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2</title>
          <description>Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3</title>
          <description>Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="24"/>
          </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="45.5" spread="13.5"/>
                    <measurement group_id="B2" value="36.3" spread="14.8"/>
                    <measurement group_id="B3" value="47.1" spread="10.7"/>
                    <measurement group_id="B4" value="43.0" spread="13.4"/>
                  </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 group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage)</title>
        <description>Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Full analysis set: included all randomised subjects receiving treatment.Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage)</title>
          <description>Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.</description>
          <population>Full analysis set: included all randomised subjects receiving treatment.Number of participants analysed=participants with available data.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.72"/>
                    <measurement group_id="O2" value="0.89" spread="1.16"/>
                    <measurement group_id="O3" value="0.69" spread="0.50"/>
                    <measurement group_id="O4" value="0.50" spread="0.79"/>
                    <measurement group_id="O5" value="0.61" spread="0.56"/>
                    <measurement group_id="O6" value="0.37" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median</title>
        <description>Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Full analysis set: included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median</title>
          <description>Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.</description>
          <population>Full analysis set: included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Percentage</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" lower_limit="0.2" upper_limit="2.2"/>
                    <measurement group_id="O2" value="0.42" lower_limit="0.1" upper_limit="3.6"/>
                    <measurement group_id="O3" value="0.75" lower_limit="0.0" upper_limit="1.4"/>
                    <measurement group_id="O4" value="0.20" lower_limit="0.0" upper_limit="2.3"/>
                    <measurement group_id="O5" value="0.58" lower_limit="0.0" upper_limit="1.4"/>
                    <measurement group_id="O6" value="0.29" lower_limit="0.1" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Severe Hypoglycaemic Episodes</title>
        <description>Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Severe Hypoglycaemic Episodes</title>
          <description>Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day</title>
        <description>Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day</title>
          <description>Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="0.44"/>
                    <measurement group_id="O2" value="0.87" spread="0.49"/>
                    <measurement group_id="O3" value="1.06" spread="0.57"/>
                    <measurement group_id="O4" value="0.68" spread="0.43"/>
                    <measurement group_id="O5" value="0.86" spread="0.55"/>
                    <measurement group_id="O6" value="0.51" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</title>
        <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</title>
          <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severe hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="42"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudo-hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</title>
        <description>Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</title>
          <description>Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severe hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or BG confirmed symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</title>
        <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
        <time_frame>Day 1 to day 7 (in both the treatment periods)</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</title>
          <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severe hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="35"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudo-hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</title>
        <description>Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</title>
          <description>Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severe hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or BG confirmed symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</title>
        <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition</title>
          <description>ADA classification of hypoglycaemia:&#xD;
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.&#xD;
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).&#xD;
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).&#xD;
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration &gt; 3.9 mmol/L (70 mg/dL) but approaching that level.&#xD;
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severe hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudo-hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</title>
        <description>Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
        <time_frame>Day 1 to day 7 (in both the treatment periods)</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification</title>
          <description>Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:&#xD;
Severe hypoglycaemia according to the ADA classification.&#xD;
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.&#xD;
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.&#xD;
BG confirmed hypoglycaemia: The union of 2. and 3.&#xD;
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.&#xD;
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severe hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or BG confirmed symptomatic hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or BG confirmed hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages)</title>
        <description>Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages)</title>
          <description>Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold.</description>
          <population>Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.87" spread="9.35"/>
                    <measurement group_id="O2" value="66.79" spread="10.39"/>
                    <measurement group_id="O3" value="73.93" spread="6.14"/>
                    <measurement group_id="O4" value="70.44" spread="8.49"/>
                    <measurement group_id="O5" value="78.32" spread="6.96"/>
                    <measurement group_id="O6" value="73.82" spread="11.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Interstitial-glucose Level</title>
        <description>Mean interstitial glucose level is calculated as the average of the available interstitial glucose values.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Interstitial-glucose Level</title>
          <description>Mean interstitial glucose level is calculated as the average of the available interstitial glucose values.</description>
          <population>Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.3" spread="7.8"/>
                    <measurement group_id="O2" value="157.7" spread="11.0"/>
                    <measurement group_id="O3" value="150.1" spread="8.5"/>
                    <measurement group_id="O4" value="157.6" spread="11.5"/>
                    <measurement group_id="O5" value="144.1" spread="7.1"/>
                    <measurement group_id="O6" value="152.5" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Adverse Events</title>
        <description>Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Adverse Events</title>
          <description>Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Infusion Site Reactions</title>
        <description>Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Infusion Site Reactions</title>
          <description>Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.</description>
          <population>Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>Infusion site reaction</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Insulin Dose Per Day</title>
        <description>Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days.</description>
        <time_frame>Day 1 to day 7</time_frame>
        <population>Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>t50 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O2">
            <title>t65 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O3">
            <title>t40 Faster Aspart Cohort 1</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O4">
            <title>t65 Faster Aspart Cohort 2</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O5">
            <title>t30 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
          <group group_id="O6">
            <title>t65 Faster Aspart Cohort 3</title>
            <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Insulin Dose Per Day</title>
          <description>Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days.</description>
          <population>Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.</population>
          <units>U/Kg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" spread="0.12"/>
                    <measurement group_id="O2" value="0.63" spread="0.12"/>
                    <measurement group_id="O3" value="0.65" spread="0.13"/>
                    <measurement group_id="O4" value="0.67" spread="0.16"/>
                    <measurement group_id="O5" value="0.63" spread="0.12"/>
                    <measurement group_id="O6" value="0.64" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first trial-related activity (screening, day -14) after obtaining informed consent and until the follow up visit (treatment days 7 in both periiods+7 days follow-up)</time_frame>
      <desc>All adverse events listed are treatment emergent. Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>t50 Faster Aspart Cohort 1</title>
          <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="E2">
          <title>t65 Faster Aspart Cohort 1</title>
          <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="E3">
          <title>t40 Faster Aspart Cohort 2</title>
          <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="E4">
          <title>t65 Faster Aspart Cohort 2</title>
          <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="E5">
          <title>t30 Faster Aspart Cohort 3</title>
          <description>Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</description>
        </group>
        <group group_id="E6">
          <title>t65 Faster Aspart Cohort 3</title>
          <description>Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22</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="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </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>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Reporting Anchor and Disclosure (1452)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.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/NCT03816761
org study id: NN1218-4360
secondary id: U1111-1205-1788
nct id: NCT03816761
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose
      Monitoring (CGM) device. This is to give participants insulin automatically. The CGM device
      is already available for sale. The iLet™ is not yet approved for use. Fast-acting insulin
      aspart is a type of insulin that doctors can already prescribe for use with insulin pens, but
      not for use in an insulin pump. This study is to test how safe fast acting insulin aspart is
      when used with different insulin delivery settings in the iLet™ in people with type 1
      diabetes. Participants will get fast-acting insulin aspart as participants' insulin and use
      the iLet™ as participants' insulin pump with a CGM device. Participants' iLet™ will be set to
      2 different insulin delivery settings for 7 days on each setting. The setting participants
      get first is decided by chance. The study will last for about 5 to 9 weeks. Participants will
      have 4 visits and 1 phone contact with the study or staff.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
measure: Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage)
time frame: Day 1 to day 7
description: Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.
measure: Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median
time frame: Day 1 to day 7
description: Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.
measure: Number of Treatment Emergent Severe Hypoglycaemic Episodes
time frame: Day 1 to day 7
description: Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.
measure: Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day
time frame: Day 1 to day 7
description: Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.
measure: Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
time frame: Day 1 to day 7
description: ADA classification of hypoglycaemia:
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration > 3.9 mmol/L (70 mg/dL) but approaching that level.
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
measure: Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
time frame: Day 1 to day 7
description: Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
Severe hypoglycaemia according to the ADA classification.
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.
BG confirmed hypoglycaemia: The union of 2. and 3.
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
measure: Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
time frame: Day 1 to day 7 (in both the treatment periods)
description: ADA classification of hypoglycaemia:
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration > 3.9 mmol/L (70 mg/dL) but approaching that level.
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
measure: Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
time frame: Day 1 to day 7
description: Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
Severe hypoglycaemia according to the ADA classification.
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.
BG confirmed hypoglycaemia: The union of 2. and 3.
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
measure: Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
time frame: Day 1 to day 7
description: ADA classification of hypoglycaemia:
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration > 3.9 mmol/L (70 mg/dL) but approaching that level.
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
measure: Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
time frame: Day 1 to day 7 (in both the treatment periods)
description: Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
Severe hypoglycaemia according to the ADA classification.
Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.
BG confirmed hypoglycaemia: The union of 2. and 3.
Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.
Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
measure: Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages)
time frame: Day 1 to day 7
description: Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold.
measure: Mean Interstitial-glucose Level
time frame: Day 1 to day 7
description: Mean interstitial glucose level is calculated as the average of the available interstitial glucose values.
measure: Number of Treatment Emergent Adverse Events
time frame: Day 1 to day 7
description: Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.
measure: Number of Treatment Emergent Infusion Site Reactions
time frame: Day 1 to day 7
description: Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.
measure: Total Insulin Dose Per Day
time frame: Day 1 to day 7
description: Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days.
arm group label: Fast-acting insulin aspart, default tmax setting
arm group type: Experimental
description: Participants will receive fast-acting insulin aspart using the iLet™ with default tmax setting (t65 = 65 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort.
arm group label: Fast-acting insulin aspart, non-default tmax setting
arm group type: Experimental
description: Participants will receive fast-acting insulin aspart using the iLet™ with non-default tmax setting (t50 = 50 minutes, t40 = 40 minutes or t30 = 30 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort.
intervention type: Drug
intervention name: Fast-acting insulin aspart
description: In each cohort, participants will receive fast-acting insulin aspart using the iLet™ in a cross-over manner for 14 days (7days per period). Dose modification will be handled autonomously by the iLet™ based on the CGM sensor readings and the user interaction with the iLet™ e.g. meal announcements.
arm group label: Fast-acting insulin aspart, default tmax setting
arm group label: Fast-acting insulin aspart, non-default tmax setting
intervention type: Device
intervention name: iLet™
description: The bionic pancreas including pigtail adapters, used in insulin-only configuration
arm group label: Fast-acting insulin aspart, default tmax setting
arm group label: Fast-acting insulin aspart, non-default tmax setting
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Aspart
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: http://novonordisk-trials.com/sharing-results
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 