<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/NCT03840278</url>
  </required_header>
  <id_info>
    <org_study_id>2019P000252</org_study_id>
    <secondary_id>19-002</secondary_id>
    <nct_id>NCT03840278</nct_id>
  </id_info>
  <brief_title>The Bihormonal iLet Bionic Pancreas Feasibility Study</brief_title>
  <official_title>The Bihormonal iLet Bionic Pancreas Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beta Bionics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zealand Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic&#xD;
      pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet&#xD;
      bionic pancreas in a home-use study in adults with type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our objective is to conduct a home-use study testing the Gen 3.2 iLet bionic pancreas system&#xD;
      in the insulin-only configuration and the bihormonal configuration with dasiglucagion in 10&#xD;
      adult subjects (≥ 18 years old) with type 1 diabetes in a random-order crossover study under&#xD;
      real-world conditions. The study will assess the safety and reliability of both iLet&#xD;
      configurations. Our primary objective is to assess whether the iLet operates as designed&#xD;
      comparing the insulin-only configuration of the Gen 3.2 iLet bionic pancreas system with the&#xD;
      bihormonal configuration of the device using dasiglucagon at a concentration of 4 mg/ml. Our&#xD;
      secondary objective is to assess the impact of both configurations of the Gen 3.2 iLet bionic&#xD;
      pancreas system on glycemic control, quality of life, and treatment satisfaction among study&#xD;
      participants, their caregivers, partners, and/or family members. The study follows a&#xD;
      2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random&#xD;
      order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and&#xD;
      dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin&#xD;
      aspart.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Actual">July 3, 2019</completion_date>
  <primary_completion_date type="Actual">July 3, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas</measure>
    <time_frame>Days 1-7</time_frame>
    <description>Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available</measure>
    <time_frame>Days 1-7</time_frame>
    <description>Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon</measure>
    <time_frame>Days 1-7</time_frame>
    <description>Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Time With CGM Glucose &lt; 54 mg/dl</measure>
    <time_frame>Days 2-7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Continuous Glucose Monitor Glucose Concentration</measure>
    <time_frame>Days 2-7</time_frame>
    <description>Mean continuous glucose monitor glucose concentration measured days 2-7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl</measure>
    <time_frame>Days 2-7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)</measure>
    <time_frame>Days 1-7</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Bihormonal iLet first, then Insulin-Only iLet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).&#xD;
For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin-Only iLet first, then Bihormonal iLet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).&#xD;
For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bihormonal iLet Bionic Pancreas</intervention_name>
    <description>Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon</description>
    <arm_group_label>Bihormonal iLet first, then Insulin-Only iLet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insulin-only Bionic Pancreas</intervention_name>
    <description>Insulin-only iLet Bionic Pancreas using just insulin</description>
    <arm_group_label>Insulin-Only iLet first, then Bihormonal iLet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dasiglucagon</intervention_name>
    <description>Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
    <arm_group_label>Bihormonal iLet first, then Insulin-Only iLet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years and have had clinical type 1 diabetes for at least one year&#xD;
&#xD;
          2. Diabetes managed using an insulin pump for ≥ 3 months&#xD;
&#xD;
          3. Prescription medication regimen stable for &gt; 1 month (except for medications that will&#xD;
             not affect the safety of the participant and are not expected to affect any outcome of&#xD;
             the study, in the judgement of the principal investigator)&#xD;
&#xD;
          4. Willing to wear one Dexcom CGM sensor, and up to two steel cannula infusion sets (6 mm&#xD;
             Contact Detach) and change infusion sets frequently (if the subject is known not to&#xD;
             tolerate steel infusion sets then a plastic set may be used)&#xD;
&#xD;
          5. Have used a CGM for at least one cumulative month over the last 24 months&#xD;
&#xD;
          6. Willing to stay within a 250-mile radius of the designated base throughout the study.&#xD;
             Air travel is not permitted.&#xD;
&#xD;
          7. Informed consent obtained before any trial-related activities&#xD;
&#xD;
          8. Have a designated contact (an adult ≥ 18 years of age) willing to serve as an&#xD;
             emergency contact for them throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to provide informed consent (e.g. impaired cognition or judgment)&#xD;
&#xD;
          2. Unable to safely comply with study procedures and reporting requirements (e.g.&#xD;
             impairment of vision or dexterity that prevents safe operation of the iLet, impaired&#xD;
             memory, unable to speak and read English)&#xD;
&#xD;
          3. Current participation in another clinical trial with administration of investigational&#xD;
             drug.&#xD;
&#xD;
          4. Current participation in another diabetes-related clinical trial that, in the judgment&#xD;
             of the principal investigator, will compromise the results of this study or the safety&#xD;
             of the participant&#xD;
&#xD;
          5. Previous exposure to dasiglucagon (otherwise known as ZP4207)&#xD;
&#xD;
          6. Pregnant (positive urine HCG), breast feeding, plan to become pregnant in the next 12&#xD;
             months, or sexually active without use of contraception&#xD;
&#xD;
               1. Subjects must use acceptable contraception for the two weeks prior to the study,&#xD;
                  throughout the study and for the two weeks following the study.&#xD;
&#xD;
               2. Acceptable contraception methods include:Oral contraceptive pills (OCP),&#xD;
                  Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms,&#xD;
                  Diaphragm or cervical cap with spermicide, Contraceptive patch (such as&#xD;
                  OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring&#xD;
                  (such as Nuvaring), Progestin shot (such as Depo-Provera), Male partner with a&#xD;
                  vasectomy proven to be effective by semen analysis&#xD;
&#xD;
          7. Current alcohol abuse (intake averaging &gt;4 drinks daily in last 30 days) or other&#xD;
             substance abuse (use within the last 3 months of controlled substances other than&#xD;
             marijuana without a prescription)&#xD;
&#xD;
          8. Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce&#xD;
             sensitivity to symptoms of hypoglycemia, or hinder decision making during the period&#xD;
             of participation in the study (use of benzodiazepines or narcotics, even if by&#xD;
             prescription, may be excluded according to the judgment of the principal investigator)&#xD;
&#xD;
          9. Renal failure on dialysis&#xD;
&#xD;
         10. History of cystic fibrosis, pancreatitis, or other pancreatic disease, including&#xD;
             pancreatic tumor or insulinoma, or history of complete pancreatectomy&#xD;
&#xD;
         11. Coronary artery disease that is not stable with medical management, including unstable&#xD;
             angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6&#xD;
             METS) despite medical management, or within the last 12 months before screening a&#xD;
             history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis&#xD;
             of a presumed coronary occlusion, or coronary artery bypass grafting&#xD;
&#xD;
         12. Abnormal EKG consistent with increased risk of malignant arrhythmia including, but not&#xD;
             limited to, evidence of active ischemia, proximal LAD critical stenosis (Wellen's&#xD;
             sign), or prolonged QT interval (&gt; 440 ms). Other EKG findings, including stable Q&#xD;
             waves, are not grounds for exclusion as long as the participant is not excluded&#xD;
             according to other criteria. A reassuring evaluation by a cardiologist after an&#xD;
             abnormal EKG finding may allow participation.&#xD;
&#xD;
         13. Congestive heart failure with New York Heart Association (NYHA) Functional&#xD;
             Classification III or IV&#xD;
&#xD;
         14. History of TIA or stroke in the last 12 months&#xD;
&#xD;
         15. History of liver disease that is expected to interfere with the anti-hypoglycemic&#xD;
             action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (e.g. active&#xD;
             hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis,&#xD;
             glycogen storage disease) may exclude the subject if it causes significant compromise&#xD;
             to liver function or may do so in an unpredictable fashion.&#xD;
&#xD;
         16. Personal history of pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von&#xD;
             Hippel-Lindau disease&#xD;
&#xD;
             a.Fractionated metanephrines will be tested to rule out pheochromocytoma in patients&#xD;
             with symptoms that could be related to a catecholamine secreting tumor, including&#xD;
             those with: Episodic or treatment refractory (requiring 4 or more medications to&#xD;
             achieve normotension) hypertension, Paroxyms of tachycardia, pallor or headache&#xD;
&#xD;
         17. History of adrenal disease or tumor that has not undergone characterization for&#xD;
             endocrine function&#xD;
&#xD;
         18. Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100&#xD;
             mm Hg despite treatment&#xD;
&#xD;
         19. Recent history of diabetic ketoacidosis (DKA) or severe hypoglycemia in the last 6&#xD;
             months. Severe hypoglycemia is defined as an event that required assistance of another&#xD;
             person due to altered consciousness, and required another person to actively&#xD;
             administer carbohydrate, glucagon, or other resuscitative actions. This means that the&#xD;
             participant was impaired cognitively to the point that he/she was unable to treat&#xD;
             himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented,&#xD;
             and/or combative, or experienced seizure or coma.&#xD;
&#xD;
         20. History of more than 1 episode of DKA requiring hospitalization in the last 2 years&#xD;
&#xD;
         21. History of more than 1 episode of severe hypoglycemia in the last year.&#xD;
&#xD;
         22. Untreated or inadequately treated mental illness (indicators would include symptoms&#xD;
             such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the&#xD;
             last year), or treatment with anti-psychotic medications that are known to affect&#xD;
             glucose regulation.&#xD;
&#xD;
         23. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be&#xD;
             susceptible to RF interference&#xD;
&#xD;
         24. Unable or unwilling to completely avoid acetaminophen for duration of study&#xD;
&#xD;
         25. Established history of allergy or severe reaction to adhesive or tape that must be&#xD;
             used in the study&#xD;
&#xD;
         26. History of adverse reaction to glucagon (including allergy) besides nausea or vomiting&#xD;
&#xD;
         27. History of severe hypersensitivity to milk proteins or lactose&#xD;
&#xD;
         28. History of eating disorder within the last 2 years, such as anorexia, bulimia, or&#xD;
             diabulemia or omission of insulin to manipulate weight&#xD;
&#xD;
         29. Current or planned use of SGLT2 inhibitors (prior use more than 3 months prior to&#xD;
             enrollment is acceptable; SGLT2 inhibitors should not be initiated during the trial)&#xD;
&#xD;
         30. If using GLP1, pramlintide, or metformin must be on a stable dose for 3 months prior&#xD;
             to enrollment (these agents should not be initiated during the trial)&#xD;
&#xD;
         31. Required use of 2 or more steroid bursts in the 6 months prior to the trial&#xD;
&#xD;
         32. History of intentional, inappropriate administration of insulin leading to severe&#xD;
             hypoglycemia requiring treatment&#xD;
&#xD;
         33. Any factors that, in the opinion of the site principal investigator or clinical&#xD;
             protocol chair, would interfere with the safe completion of the study, including&#xD;
             medical conditions that may require hospitalization during the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven J Russell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</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>November 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>October 22, 2019</results_first_submitted>
  <results_first_submitted_qc>November 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 16, 2019</results_first_posted>
  <last_update_submitted>November 27, 2019</last_update_submitted>
  <last_update_submitted_qc>November 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Steven J. Russell, MD, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>bionic pancreas</keyword>
  <keyword>closed loop</keyword>
  <keyword>glucagon</keyword>
  <keyword>insulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
    <mesh_term>Pancreatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03840278/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>2 were ineligible due to lacking a designated contact or were taking arrhythmogenic medications</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bihormonal iLet Bionic Pancreas First, Then Insulin-Only</title>
          <description>Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).&#xD;
For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week without a washout period.</description>
        </group>
        <group group_id="P2">
          <title>Insulin-Only iLet Bionic Pancreas First, Then Bihormonal</title>
          <description>Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).&#xD;
For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week without a washout period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).&#xD;
Participants were randomized to either first use the bihormonal iLet bionic pancreas for 1 week followed by the insulin-only iLet bionic pancreas for 1 week or to first use the insulin-only iLet bionic pancreas for 1 week followed by the bihormonal iLet for 1 week.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" spread="18"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas</title>
        <description>Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.</description>
        <time_frame>Days 1-7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bihormonal iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
          </group>
          <group group_id="O2">
            <title>Insulin-Only iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas</title>
          <description>Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.</description>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2" spread="6.4"/>
                    <measurement group_id="O2" value="91.0" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available</title>
        <description>Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.</description>
        <time_frame>Days 1-7</time_frame>
        <population>Percent of time that insulin channel available measured in both groups. Percent of time that glucagon channel available measured only in bihormonal group.</population>
        <group_list>
          <group group_id="O1">
            <title>Bihormonal iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
          </group>
          <group group_id="O2">
            <title>Insulin-Only iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available</title>
          <description>Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.</description>
          <population>Percent of time that insulin channel available measured in both groups. Percent of time that glucagon channel available measured only in bihormonal group.</population>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>% of time that insulin channel available</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.1" spread="1.3"/>
                    <measurement group_id="O2" value="99.7" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% of time that glucagon channel available</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon</title>
        <description>Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.</description>
        <time_frame>Days 1-7</time_frame>
        <population>Ratio of cumulative insulin doses delivered to cumulative insulin doses attempted was measured in both groups. Ratio of cumulative glucagon doses delivered to cumulative glucagon doses attempted only measured in bihormonal arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Bihormonal iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
          </group>
          <group group_id="O2">
            <title>Insulin-Only iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
          </group>
        </group_list>
        <measure>
          <title>The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon</title>
          <description>Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.</description>
          <population>Ratio of cumulative insulin doses delivered to cumulative insulin doses attempted was measured in both groups. Ratio of cumulative glucagon doses delivered to cumulative glucagon doses attempted only measured in bihormonal arm.</population>
          <units>ratio of dose delivered:dose attempted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ratio for insulin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.999" spread="0.006"/>
                    <measurement group_id="O2" value="1.002" spread="0.004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ratio for glucagon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.019" spread="0.002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Time With CGM Glucose &lt; 54 mg/dl</title>
        <time_frame>Days 2-7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bihormonal iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
          </group>
          <group group_id="O2">
            <title>Insulin-Only iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Time With CGM Glucose &lt; 54 mg/dl</title>
          <units>proportion of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.2" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Continuous Glucose Monitor Glucose Concentration</title>
        <description>Mean continuous glucose monitor glucose concentration measured days 2-7</description>
        <time_frame>Days 2-7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bihormonal iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
          </group>
          <group group_id="O2">
            <title>Insulin-Only iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Continuous Glucose Monitor Glucose Concentration</title>
          <description>Mean continuous glucose monitor glucose concentration measured days 2-7</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139" spread="11"/>
                    <measurement group_id="O2" value="149" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl</title>
        <time_frame>Days 2-7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bihormonal iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
          </group>
          <group group_id="O2">
            <title>Insulin-Only iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl</title>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79" spread="9"/>
                    <measurement group_id="O2" value="71" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)</title>
        <time_frame>Days 1-7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bihormonal iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
          </group>
          <group group_id="O2">
            <title>Insulin-Only iLet Bionic Pancreas</title>
            <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)</title>
          <units>grams of carbs per 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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="21"/>
                    <measurement group_id="O2" value="16" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>After the 14-day treatment period, two follow-up visits were required; the first in 10 (±3) days and the second in 25 (±4) days after the end of the intervention period (day 14).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bihormonal iLet Bionic Pancreas</title>
          <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.&#xD;
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon&#xD;
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas</description>
        </group>
        <group group_id="E2">
          <title>Insulin-Only iLet Bionic Pancreas</title>
          <description>Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.&#xD;
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Emesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Courtney A Balliro, BS, RN, CDE</name_or_title>
      <organization>Massachusetts General Hospital Diabetes Research Center</organization>
      <phone>617-726-1242</phone>
      <email>cballiro@partners.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840278
org study id: 2019P000252
secondary id: 19-002
nct id: NCT03840278
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic
      pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet
      bionic pancreas in a home-use study in adults with type 1 diabetes.
Our objective is to conduct a home-use study testing the Gen 3.2 iLet bionic pancreas system
      in the insulin-only configuration and the bihormonal configuration with dasiglucagion in 10
      adult subjects (≥ 18 years old) with type 1 diabetes in a random-order crossover study under
      real-world conditions. The study will assess the safety and reliability of both iLet
      configurations. Our primary objective is to assess whether the iLet operates as designed
      comparing the insulin-only configuration of the Gen 3.2 iLet bionic pancreas system with the
      bihormonal configuration of the device using dasiglucagon at a concentration of 4 mg/ml. Our
      secondary objective is to assess the impact of both configurations of the Gen 3.2 iLet bionic
      pancreas system on glycemic control, quality of life, and treatment satisfaction among study
      participants, their caregivers, partners, and/or family members. The study follows a
      2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random
      order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and
      dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin
      aspart.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas
time frame: Days 1-7
description: Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.
measure: Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available
time frame: Days 1-7
description: Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.
measure: The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon
time frame: Days 1-7
description: Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.
measure: Proportion of Time With CGM Glucose < 54 mg/dl
time frame: Days 2-7
measure: Mean Continuous Glucose Monitor Glucose Concentration
time frame: Days 2-7
description: Mean continuous glucose monitor glucose concentration measured days 2-7
measure: Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl
time frame: Days 2-7
measure: Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)
time frame: Days 1-7
arm group label: Bihormonal iLet first, then Insulin-Only iLet
arm group type: Experimental
description: Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).
For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week.
arm group label: Insulin-Only iLet first, then Bihormonal iLet
arm group type: Experimental
description: Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).
For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week.
intervention type: Device
intervention name: Bihormonal iLet Bionic Pancreas
description: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
arm group label: Bihormonal iLet first, then Insulin-Only iLet
intervention type: Device
intervention name: Insulin-only Bionic Pancreas
description: Insulin-only iLet Bionic Pancreas using just insulin
arm group label: Insulin-Only iLet first, then Bihormonal iLet
intervention type: Drug
intervention name: Dasiglucagon
description: Experimental stable glucagon for use in the iLet Bionic Pancreas
arm group label: Bihormonal iLet first, then Insulin-Only iLet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven J Russell, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Steven J. Russell, MD, PhD
investigator title: Principal Investigator
mesh term: Diabetes Mellitus, Type 1
mesh term: Pancrelipase
mesh term: Pancreatin
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 