<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/NCT03262116</url>
  </required_header>
  <id_info>
    <org_study_id>2017P001778</org_study_id>
    <nct_id>NCT03262116</nct_id>
  </id_info>
  <brief_title>Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas</brief_title>
  <official_title>Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</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>
      Subjects will participate in three weeks of the bionic pancreas in the insulin-only&#xD;
      configuration. Each week, subjects will use a different rapid acting insulin analog --&#xD;
      Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that differences in the PK characteristics of insulin analogs&#xD;
      will lead to differences in glycemic outcomes when delivered by the insulin-only&#xD;
      configuration of the bionic pancreas. Specifically, the investigators predict that insulin&#xD;
      analogs that have faster absorption (numerically lower Tmax and/or T½max) and insulin analogs&#xD;
      that have faster clearance (numerically lower terminal half-life) will result in lower mean&#xD;
      glucose and/or a lower percentage of time in the hypoglycemic range.&#xD;
&#xD;
      Up to 30 subjects will participate in three 7-day study arms using insulin lispro, insulin&#xD;
      aspart, and BC222 lispro in the bionic pancreas in random order. The co-primary outcomes will&#xD;
      be mean CGMG and fraction of time spent with CGMG &lt;54 mg/dl with comparisons made between&#xD;
      arms for individual participants. Secondary analyses will include time in glycemic ranges&#xD;
      (&lt;50, &lt;60, &lt;70, 70-120, 70-180, &gt;180, &gt;250 mg/dl), coefficient of variation, mean&#xD;
      postprandial excursion (difference in CGMG from the time of meal announcement to the peak&#xD;
      CGMG in the first 4 hours after the meal announcement) for both mixed meal challenges, number&#xD;
      of symptomatic hypoglycemic events, grams of carbohydrate consumed to treat hypoglycemia, and&#xD;
      TDD of insulin, between arms for individual subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Devices are not available&#xD;
  </why_stopped>
  <start_date type="Actual">March 19, 2019</start_date>
  <completion_date type="Actual">July 23, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will be blinded to the type of insulin used in the iLet bionic pancreas each arm of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Average Continuous Glucose Monitor (CGM) Glucose</measure>
    <time_frame>7 days</time_frame>
    <description>The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Time Spent With CGM Glucose &lt; 54 mg/dl</measure>
    <time_frame>7 days</time_frame>
    <description>The amount of time the subject spent in the hypoglycemic range &lt; 54 mg/dl as measured by the continuous glucose monitor during each arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time Spent Within Each of the Following Ranges:</measure>
    <time_frame>7 days</time_frame>
    <description>The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within Day Coefficient of Variation</measure>
    <time_frame>7 days</time_frame>
    <description>A measure of dispersion of glucose values around the mean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Post Prandial Excursion</measure>
    <time_frame>7 days</time_frame>
    <description>Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Symptomatic Hypoglycemic Events Per Day</measure>
    <time_frame>7 days</time_frame>
    <description>The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day</measure>
    <time_frame>7 days</time_frame>
    <description>The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Daily Dose of Insulin</measure>
    <time_frame>7 days</time_frame>
    <description>The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Bionic Pancreas - Humalog</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bionic Pancreas - Novolog</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bionic Pancreas - BC222 insulin lispro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Humalog</intervention_name>
    <description>Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.</description>
    <arm_group_label>Bionic Pancreas - Humalog</arm_group_label>
    <other_name>insulin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Novolog</intervention_name>
    <description>Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.</description>
    <arm_group_label>Bionic Pancreas - Novolog</arm_group_label>
    <other_name>insulin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BC222 insulin lispro</intervention_name>
    <description>Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.</description>
    <arm_group_label>Bionic Pancreas - BC222 insulin lispro</arm_group_label>
    <other_name>insulin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bionic Pancreas</intervention_name>
    <description>The insulin-only bionic pancreas will be used in all three arms of the study</description>
    <arm_group_label>Bionic Pancreas - BC222 insulin lispro</arm_group_label>
    <arm_group_label>Bionic Pancreas - Humalog</arm_group_label>
    <arm_group_label>Bionic Pancreas - Novolog</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years and have had clinical type 1 diabetes for at least one year&#xD;
&#xD;
          -  Diabetes managed using an insulin pump for ≥ 6 months&#xD;
&#xD;
          -  Have used a CGM for at least one cumulative month over the last 12 months&#xD;
&#xD;
          -  Prescription medication regimen stable for &gt; 1 month (except for medications that will&#xD;
             not affect the safety of the study and are not expected to affect any outcome of the&#xD;
             study, in the judgment of the principal investigator)&#xD;
&#xD;
          -  Willing to remain within a 250 mile radius of MGH. No air travel will be allowed, and&#xD;
             subjects will still be expected to follow the visit schedule as described.&#xD;
&#xD;
          -  Willing to wear one Dexcom CGM sensor, and one leur-lock compatible infusion set that&#xD;
             must be replaced every other day&#xD;
&#xD;
          -  Have a mobile phone they will have access to at all times during the study for making&#xD;
             contact with study staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent (e.g. impaired cognition or judgment)&#xD;
&#xD;
          -  Unable to safely comply with study procedures and reporting requirements (e.g.&#xD;
             impairment of vision or dexterity that prevents safe operation of the bionic pancreas,&#xD;
             impaired memory, unable to speak and read English)&#xD;
&#xD;
          -  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 subject&#xD;
&#xD;
          -  Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the&#xD;
             immediate future, or sexually active without use of contraception Subjects must use&#xD;
             acceptable contraception for the two weeks prior to the study, throughout the study&#xD;
             and for the two weeks following the study.&#xD;
&#xD;
        Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine&#xD;
        Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap&#xD;
        with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as&#xD;
        Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as&#xD;
        Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis&#xD;
&#xD;
          -  Current alcohol abuse (intake averaging &gt; 3 drinks daily in last 30 days) or other&#xD;
             substance abuse (use within the last 6 months of controlled substances other than&#xD;
             marijuana without a prescription)&#xD;
&#xD;
          -  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 beta blockers will be allowed as long as the&#xD;
             dose is stable and the subject does not meet the criteria for hypoglycemia unawareness&#xD;
             while taking that stable dose, but use of benzodiazepines or narcotics or other&#xD;
             central nervous system depressants, even if by prescription, may be excluded according&#xD;
             to the judgment of the principal investigator)&#xD;
&#xD;
          -  Renal failure requiring dialysis&#xD;
&#xD;
          -  Estimated Glomerular filtration rate &lt;15 mL/min/1.732&#xD;
&#xD;
          -  Personal history of cystic fibrosis, severe pancreatitis, pancreatic tumor,&#xD;
             pancreatectomy or any other pancreatic disease leading to diabetes mellitus.&#xD;
&#xD;
          -  Any known history of coronary artery disease including, but not limited to, history of&#xD;
             myocardial infarction, stress test showing ischemia, history of angina, or history of&#xD;
             intervention such as coronary artery bypass grafting, percutaneous coronary&#xD;
             intervention, or enzymatic lysis of a presumed coronary occlusion)&#xD;
&#xD;
          -  Abnormal EKG consistent with coronary artery disease or increased risk of malignant&#xD;
             arrhythmia including, but not limited to, evidence of active ischemia, prior&#xD;
             myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT&#xD;
             interval (&gt; 440 ms). Non-specific ST segment and T wave changes are not grounds for&#xD;
             exclusion in the absence of symptoms or history of heart disease. A reassuring&#xD;
             evaluation by a cardiologist after an abnormal EKG finding may allow participation.&#xD;
&#xD;
          -  Congestive heart failure (established history of CHF, lower extremity edema,&#xD;
             paroxysmal nocturnal dyspnea, or orthopnea)&#xD;
&#xD;
          -  History of TIA or stroke15. Recent history of diabetic ketoacidosis (DKA) or severe&#xD;
             hypoglycemia in the last 6 months. Severe hypoglycemia is defined as an event that&#xD;
             required assistance of another person due to altered consciousness, and required&#xD;
             another person to actively administer carbohydrate, glucagon, or other resuscitative&#xD;
             actions. This means that the participant was impaired cognitively to the point that&#xD;
             he/she was unable to treat himself/herself, was unable to verbalize his/ her needs,&#xD;
             was incoherent, disoriented, and/or combative, or experienced seizure or coma.&#xD;
&#xD;
          -  History of more than 1 episode of DKA requiring hospitalization in the last 2 years&#xD;
&#xD;
          -  History of more than 1 episode of severe hypoglycemia in the last year.&#xD;
&#xD;
          -  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;
          -  Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be&#xD;
             susceptible to RF interference&#xD;
&#xD;
          -  Unable to completely avoid acetaminophen for duration of study&#xD;
&#xD;
          -  Established history of allergy or severe reaction to adhesive or tape that must be&#xD;
             used in the study&#xD;
&#xD;
          -  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;
          -  History of intentional, inappropriate administration of insulin leading to severe&#xD;
             hypoglycemia requiring treatment&#xD;
&#xD;
          -  Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4&#xD;
             inhibitors, SGLT-2 inhibitors) or non-insulin injectable (GLP-1 agonists, amylin)&#xD;
             anti-diabetic medications&#xD;
&#xD;
          -  Any diagnosed allergy to insulin lispro or insulin aspart&#xD;
&#xD;
          -  Lives in or frequents areas with poor Verizon wireless network coverage (which would&#xD;
             prevent study staff from contacting subjects)&#xD;
&#xD;
          -  Any factors that, in the opinion of the principal investigator would interfere with&#xD;
             the safe completion of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>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 2022</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>February 24, 2022</results_first_submitted>
  <results_first_submitted_qc>November 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 9, 2022</results_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2022</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>insulin</keyword>
  <keyword>continuous glucose monitor</keyword>
  <keyword>type 1 diabetes</keyword>
  <keyword>insulin pharmacokinetics</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>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Lispro</mesh_term>
    <mesh_term>Insulin Aspart</mesh_term>
    <mesh_term>Pancrelipase</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>June 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03262116/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>20 subjects signed the consent form and screened into the study. 2 subjects were found to be ineligible after they were enrolled. 13 pariticpants were randomized. The numbers listed here, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No relevant data was collected from designated contacts.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Lispro, Then Insulin Aspart</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="P2">
          <title>Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Aspart, Then Insulin Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="P3">
          <title>Insulin-only Bionic Pancreas With Insulin Lispro, Then BC222 Lispro, Then Insulin Aspart</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="P4">
          <title>Insulin-only Bionic Pancreas With Insulin Lispro, Then Insulin Aspart, Then BC222 Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="P5">
          <title>Insulin-only Bionic Pancreas With Insulin Aspart, Then BC222 Lispro, Then Insulin Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="P6">
          <title>Insulin-only Bionic Pancreas With Insulin Aspart, Then Insulin Lispro, Then BC222 Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>20 participants consented to participate. 13 participants were randomized to complete three weeks using the insulin-only bionic pancreas. Only 6 completed all three arms.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts that is relevant to this protocol.</population>
      <group_list>
        <group group_id="B1">
          <title>Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Lispro, Then Insulin Aspart</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="B2">
          <title>Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Aspart, Then Insulin Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="B3">
          <title>Insulin-only Bionic Pancreas With Insulin Lispro, Then BC222 Lispro, Then Insulin Aspart</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="B4">
          <title>Insulin-only Bionic Pancreas With Insulin Lispro, Then Insulin Aspart, Then BC222 Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="B5">
          <title>Insulin-only Bionic Pancreas With Insulin Aspart, Then BC222 Lispro, Then Insulin Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="B6">
          <title>Insulin-only Bionic Pancreas With Insulin Aspart, Then Insulin Lispro, Then BC222 Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="B7">
          <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="2"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="2"/>
            <count group_id="B5" value="2"/>
            <count group_id="B6" value="2"/>
            <count group_id="B7" value="13"/>
          </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="30.0" spread="14.1"/>
                    <measurement group_id="B2" value="40.7" spread="17.6"/>
                    <measurement group_id="B3" value="70.5" spread="14.8"/>
                    <measurement group_id="B4" value="33.0" spread="9.9"/>
                    <measurement group_id="B5" value="47.0" spread="14.1"/>
                    <measurement group_id="B6" value="50.0" spread="15.6"/>
                    <measurement group_id="B7" value="47.8" spread="15.9"/>
                  </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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="7"/>
                  </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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" 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 group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="12"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" 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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c</title>
          <units>percent of glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.7" spread="0.8"/>
                    <measurement group_id="B2" value="6.9" spread="0.9"/>
                    <measurement group_id="B3" value="6.9" spread="0.2"/>
                    <measurement group_id="B4" value="6.2" spread="0.5"/>
                    <measurement group_id="B5" value="7.2" spread="0.8"/>
                    <measurement group_id="B6" value="6.4" spread="0.5"/>
                    <measurement group_id="B7" value="6.7" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Continuous Glucose Monitor (CGM) Glucose</title>
        <description>The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Continuous Glucose Monitor (CGM) Glucose</title>
          <description>The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.0" spread="9.2"/>
                    <measurement group_id="O2" value="151.4" spread="13.1"/>
                    <measurement group_id="O3" value="151.2" spread="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Time Spent With CGM Glucose &lt; 54 mg/dl</title>
        <description>The amount of time the subject spent in the hypoglycemic range &lt; 54 mg/dl as measured by the continuous glucose monitor during each arm</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Spent With CGM Glucose &lt; 54 mg/dl</title>
          <description>The amount of time the subject spent in the hypoglycemic range &lt; 54 mg/dl as measured by the continuous glucose monitor during each arm</description>
          <units>percentage of CGM glucose values</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="0.53"/>
                    <measurement group_id="O2" value="0.55" spread="0.26"/>
                    <measurement group_id="O3" value="1.01" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time Spent Within Each of the Following Ranges:</title>
        <description>The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Spent Within Each of the Following Ranges:</title>
          <description>The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm</description>
          <units>percentage of CGM glucose values</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>% time CGM glcuose &lt; 50 mg/dl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.42"/>
                    <measurement group_id="O2" value="0.24" spread="0.21"/>
                    <measurement group_id="O3" value="0.63" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% time CGM glcuose &lt; 60 mg/dl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.88"/>
                    <measurement group_id="O2" value="1.31" spread="0.55"/>
                    <measurement group_id="O3" value="1.85" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% time CGM glcuose &lt; 70 mg/dl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.65" spread="1.71"/>
                    <measurement group_id="O2" value="3.59" spread="1.71"/>
                    <measurement group_id="O3" value="4.31" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% time CGM glcuose 70-120 mg/dl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.49" spread="5.04"/>
                    <measurement group_id="O2" value="27.20" spread="5.53"/>
                    <measurement group_id="O3" value="30.44" spread="5.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% time CGM glcuose 70-180 mg/dl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.77" spread="8.57"/>
                    <measurement group_id="O2" value="72.16" spread="10.34"/>
                    <measurement group_id="O3" value="70.06" spread="10.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% time CGM glcuose &gt;180 mg/dl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.58" spread="7.79"/>
                    <measurement group_id="O2" value="24.26" spread="9.29"/>
                    <measurement group_id="O3" value="25.63" spread="9.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% time CGM glcuose &gt; 250 mg/dl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.67" spread="3.55"/>
                    <measurement group_id="O2" value="5.21" spread="5.24"/>
                    <measurement group_id="O3" value="7.11" spread="6.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Within Day Coefficient of Variation</title>
        <description>A measure of dispersion of glucose values around the mean</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Within Day Coefficient of Variation</title>
          <description>A measure of dispersion of glucose values around the mean</description>
          <units>percentage of CGM glucose values</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.4" spread="4.1"/>
                    <measurement group_id="O2" value="35.5" spread="7.8"/>
                    <measurement group_id="O3" value="38.6" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Post Prandial Excursion</title>
        <description>Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges.</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Post Prandial Excursion</title>
          <description>Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges.</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.06" spread="37.49"/>
                    <measurement group_id="O2" value="103.13" spread="47.37"/>
                    <measurement group_id="O3" value="104.07" spread="36.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Symptomatic Hypoglycemic Events Per Day</title>
        <description>The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Symptomatic Hypoglycemic Events Per Day</title>
          <description>The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm</description>
          <units>number of events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.43"/>
                    <measurement group_id="O2" value="0.60" spread="0.43"/>
                    <measurement group_id="O3" value="1.02" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day</title>
        <description>The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day</title>
          <description>The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia</description>
          <units>grams of carbohydrates</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.42" spread="11.59"/>
                    <measurement group_id="O2" value="9.27" spread="6.94"/>
                    <measurement group_id="O3" value="14.00" spread="11.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Daily Dose of Insulin</title>
        <description>The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm.</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O2">
            <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
          <group group_id="O3">
            <title>Insulin-only Bionic Pancreas With Insulin Aspart</title>
            <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Daily Dose of Insulin</title>
          <description>The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm.</description>
          <units>units per kilogram 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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="0.16"/>
                    <measurement group_id="O2" value="0.60" spread="0.21"/>
                    <measurement group_id="O3" value="0.61" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 week of study participation using each insulin, for a total of up to three weeks of study intervention</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Insulin-only Bionic Pancreas With BC222 Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="E2">
          <title>Insulin-only Bionic Pancreas With Insulin Lispro</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</description>
        </group>
        <group group_id="E3">
          <title>Insulin-only Bionic Pancreas With Insulin-aspart</title>
          <description>Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.&#xD;
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.&#xD;
The study had be terminated before all participants could complete all interventions. All available data are reported here.</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="9"/>
              </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="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other 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="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>The study was terminated, so only a limited number of participants completed all three interventions.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Steven J. Russell, MD, PhD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617.726.1848</phone>
      <email>sjrussell@mgh.harvard.edu</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/NCT03262116
org study id: 2017P001778
nct id: NCT03262116
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
Subjects will participate in three weeks of the bionic pancreas in the insulin-only
      configuration. Each week, subjects will use a different rapid acting insulin analog --
      Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.
The investigators hypothesize that differences in the PK characteristics of insulin analogs
      will lead to differences in glycemic outcomes when delivered by the insulin-only
      configuration of the bionic pancreas. Specifically, the investigators predict that insulin
      analogs that have faster absorption (numerically lower Tmax and/or T½max) and insulin analogs
      that have faster clearance (numerically lower terminal half-life) will result in lower mean
      glucose and/or a lower percentage of time in the hypoglycemic range.

      Up to 30 subjects will participate in three 7-day study arms using insulin lispro, insulin
      aspart, and BC222 lispro in the bionic pancreas in random order. The co-primary outcomes will
      be mean CGMG and fraction of time spent with CGMG <54 mg/dl with comparisons made between
      arms for individual participants. Secondary analyses will include time in glycemic ranges
      (<50, <60, <70, 70-120, 70-180, >180, >250 mg/dl), coefficient of variation, mean
      postprandial excursion (difference in CGMG from the time of meal announcement to the peak
      CGMG in the first 4 hours after the meal announcement) for both mixed meal challenges, number
      of symptomatic hypoglycemic events, grams of carbohydrate consumed to treat hypoglycemia, and
      TDD of insulin, between arms for individual subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants will be blinded to the type of insulin used in the iLet bionic pancreas each arm of the study.
measure: Average Continuous Glucose Monitor (CGM) Glucose
time frame: 7 days
description: The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm
measure: Percentage of Time Spent With CGM Glucose < 54 mg/dl
time frame: 7 days
description: The amount of time the subject spent in the hypoglycemic range < 54 mg/dl as measured by the continuous glucose monitor during each arm
measure: Percentage of Time Spent Within Each of the Following Ranges:
time frame: 7 days
description: The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm
measure: Within Day Coefficient of Variation
time frame: 7 days
description: A measure of dispersion of glucose values around the mean
measure: Mean Post Prandial Excursion
time frame: 7 days
description: Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges.
measure: Number of Symptomatic Hypoglycemic Events Per Day
time frame: 7 days
description: The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm
measure: Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day
time frame: 7 days
description: The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia
measure: Total Daily Dose of Insulin
time frame: 7 days
description: The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm.
arm group label: Bionic Pancreas - Humalog
arm group type: Experimental
description: Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
arm group label: Bionic Pancreas - Novolog
arm group type: Experimental
description: Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
arm group label: Bionic Pancreas - BC222 insulin lispro
arm group type: Experimental
description: Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
intervention type: Drug
intervention name: Humalog
description: Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
arm group label: Bionic Pancreas - Humalog
other name: insulin
intervention type: Drug
intervention name: Novolog
description: Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
arm group label: Bionic Pancreas - Novolog
other name: insulin
intervention type: Drug
intervention name: BC222 insulin lispro
description: Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
arm group label: Bionic Pancreas - BC222 insulin lispro
other name: insulin
intervention type: Device
intervention name: Bionic Pancreas
description: The insulin-only bionic pancreas will be used in all three arms of the study
arm group label: Bionic Pancreas - BC222 insulin lispro
arm group label: Bionic Pancreas - Humalog
arm group label: Bionic Pancreas - Novolog
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: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Lispro
mesh term: Insulin Aspart
mesh term: Pancrelipase
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated, so only a limited number of participants completed all three interventions.
point of contact: 