<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/NCT03258853</url>
  </required_header>
  <id_info>
    <org_study_id>2020P003452</org_study_id>
    <nct_id>NCT03258853</nct_id>
  </id_info>
  <brief_title>Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes</brief_title>
  <official_title>Feasibility of Outpatient Automated Blood Glucose Control With the iLet Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beta Bionics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study is designed to test the feasibility of the a wearable bionic pancreas&#xD;
      system that automatically delivers insulin and glucagon can provide superior regulation of&#xD;
      glycemia versus usual care for adults and children with cystic fibrosis related diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2021</start_date>
  <completion_date type="Actual">June 29, 2022</completion_date>
  <primary_completion_date type="Actual">June 29, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Percentage of time spent with CGM glucose values between 70 and 180 mg/dl</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time Spent With CGM Glucose: &lt; 54 mg/dl</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Percentage of time spent with CGM glucose in this range</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean CGM Glucose</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Average CGM glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time Spent With CGM Glucose &lt; 70 mg/dl</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Percent of time the participant spent with CGM glucose in this range</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time Spent With CGM Glucose &gt;180 mg/dL</measure>
    <time_frame>Days 3-14</time_frame>
    <description>The percent of time the participant spent with CGM glucose in this range</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time Spent With CGM Glucose &gt; 250mg/dL</measure>
    <time_frame>Days 3-14</time_frame>
    <description>The percent of time the participant spent with CGM glucose in this range</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard Deviation</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Standard deviation of participants' mean CGM glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coefficient of Variation</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Coefficient of variation of CGM glucose values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Episodes of Self-reported Symptomatic Hypoglycemia</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Mean CGMG &lt;154 mg/dl</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Number of subjects who achieve a mean CGM glucose &lt; 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Percentage of Time &lt; 54 mg/dl &lt; 1%</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Number of subjects who have less than 1% percent of CGM glucose values &lt; 54 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Percentage of Time &lt; 54 mg/dl &lt; 1% and Mean CGM Glucose &lt; or Equal to 154 mg/dl</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Number of subjects who have less than 1% percent of CGM glucose values &lt; 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater</measure>
    <time_frame>Days 3-14</time_frame>
    <description>Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Cystic Fibrosis-related Diabetes</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin only bionic pancreas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bionic Pancreas</intervention_name>
    <description>Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
    <arm_group_label>Insulin only bionic pancreas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Age &gt;/= 10 years and have had a diagnosis of cystic fibrosis related diabetes (CFRD)&#xD;
             managed using either an insulin pump or multiple daily injections (MDI).&#xD;
&#xD;
          -  Mean continuous glucose monitoring (CGM) glucose &gt;/=125 mg/dl as determined by the&#xD;
             participant's personal CGM 30-day download if CGM is used as part of their usual care.&#xD;
             If the participant does not use CGM, hemoglobin A1c &gt;/= 6% within the last 6-months&#xD;
             from available medical records will be required.&#xD;
&#xD;
          -  Minimum insulin requirement of &gt;/=0.1u/kg/day. To ensure that participants with a wide&#xD;
             range of insulin requirements are included, participants whose insulin requirement is&#xD;
             &lt;0.3u/kg/day will be limited to approximately 1/3 of the enrolled &gt;/=18 year old adult&#xD;
             cohort.&#xD;
&#xD;
          -  Willing to wear iLet infusion sets and one Dexcom CGM sensor and change sets at least&#xD;
             every other day in the iLet arm&#xD;
&#xD;
          -  Assent will be obtained for patients &lt;18 of age&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Diabetes from etiologies other than CFRD&#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 clinical trial that, in the judgment of the principal&#xD;
             investigator, will compromise the results of this study or the safety of the&#xD;
             participant&#xD;
&#xD;
          -  Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the next&#xD;
             3-months, or sexually active without use of contraception&#xD;
&#xD;
             o Participants must use acceptable contraception for the two weeks prior to the study,&#xD;
             throughout the study and for the two weeks following the study.&#xD;
&#xD;
          -  History of hypoglycemic seizures (grand-mal) or coma 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;
          -  Unable to avoid hydroxyurea for duration of study (interferes with accuracy of Dexcom&#xD;
             G6 CGM)&#xD;
&#xD;
          -  Unable to avoid taking higher than the maximum dose of acetaminophen from all sources&#xD;
             for the duration of the study (interferes with accuracy of Dexcom G6 CGM)&#xD;
&#xD;
               -  Adult: 1 g every 6 hours, up to 4 g every 24 hours&#xD;
&#xD;
               -  Pediatric: 75 mg/kg/day in up to 5 doses, not to exceed 4000 mg/day&#xD;
&#xD;
          -  Have started or stopped a cystic fibrosis transmembrane conductance regulator (CFTR)&#xD;
             modulator in the past 4 weeks.&#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;
          -  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;
          -  History of lung or liver transplant&#xD;
&#xD;
          -  Anticipated lung transplant (on transplant list)&#xD;
&#xD;
          -  No acute pulmonary exacerbation or hospitalizations within the past 4 weeks or&#xD;
             treatment with IV antibiotics in the past 4 weeks.&#xD;
&#xD;
          -  Any factors that, in the opinion of the principal investigator would interfere with&#xD;
             the safe completion of the study&#xD;
&#xD;
          -  History of severe liver disease, including cirrhosis or portal hypertension&#xD;
&#xD;
          -  Presence of a medical condition or use of a medication that, in the judgment of the&#xD;
             investigator, could compromise the results of the study or the safety of the&#xD;
             participant. Conditions to be considered by the investigator may include the&#xD;
             following:&#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 to refrain from drinking more than 2 drinks in an hour or&#xD;
                  more than 4 drinks in a day during the trial&#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&#xD;
                  period of participation in the study (use of beta blockers will be allowed as&#xD;
                  long as the dose is stable and the participant does not meet the criteria for&#xD;
                  hypoglycemia unawareness while taking that stable dose, but use of&#xD;
                  benzodiazepines or narcotics, even if by prescription, may be excluded according&#xD;
                  to the judgment of the principal investigator)&#xD;
&#xD;
               -  Renal failure requiring dialysis&#xD;
&#xD;
               -  Any known history of coronary artery disease including, but not limited to,&#xD;
                  history of myocardial infarction, stress test showing ischemia, history of&#xD;
                  angina, or history of intervention such as coronary artery bypass grafting,&#xD;
                  percutaneous coronary intervention, or enzymatic lysis of a presumed coronary&#xD;
                  occlusion)&#xD;
&#xD;
               -  Congestive heart failure (established history of CHF, lower extremity edema,&#xD;
                  paroxysmal nocturnal dyspnea, or orthopnea) oHistory of TIA or stroke&#xD;
&#xD;
               -  Seizure disorder, history of any non-hypoglycemic seizure within the last two&#xD;
                  years, or ongoing treatment with anticonvulsants&#xD;
&#xD;
               -  History of intentional, inappropriate administration of insulin leading to severe&#xD;
                  hypoglycemia requiring treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa S Putman, MD</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>July 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>May 24, 2023</results_first_submitted>
  <results_first_submitted_qc>July 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 20, 2023</results_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Melissa Susan Putman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cystic fibrosis</keyword>
  <keyword>insulin</keyword>
  <keyword>glucagon</keyword>
  <keyword>continuous glucose monitor</keyword>
  <keyword>bionic pancreas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De identified glucose data and microbiome data will be shared with research collaborators.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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>November 3, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03258853/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 28, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03258853/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment occurred between April 2021 and June 2022</recruitment_details>
      <pre_assignment_details>30 adults were consented and screened for study participation. Of these, 3 did not meet inclusion criteria, 3 declined to participate, and 2 were lost to follow-up prior to randomization. The remaining 22 subjects were randomized. 2 subjects were assigned to a study arm but withdrew prior to any study procedures. No baseline or outcome data were collected in these 2 subjects, and they were excluded from all analyses. The remaining 20 subjects completed the study and are included in the analyses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Usual Care First, Then Insulin Only Bionic Pancreas</title>
          <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.&#xD;
After completing 14 days of Usual Care, participants then crossed over to the insulin only bionic pancreas for another 14 days.&#xD;
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
        </group>
        <group group_id="P2">
          <title>Insulin Only Bionic Pancreas First, Then Usual Care</title>
          <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.&#xD;
After completing 14 days of the insulin only bionic pancreas, participants then crossed over to Usual Care for another 14 days:&#xD;
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (14 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Intervention (14 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usual Care First, Then Insulin Only Bionic Pancreas</title>
          <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.&#xD;
After 14 days of Usual Care, participants then crossed over to the Insulin only bionic pancreas arm for anther 14 days.&#xD;
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
        </group>
        <group group_id="B2">
          <title>Insulin Only Bionic Pancreas First, Then Usual Care</title>
          <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.&#xD;
After 14 days of the insulin only bionic pancreas, participants then crossed over to the usual care arm for another 14 days.&#xD;
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
        </group>
        <group group_id="B3">
          <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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </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="40" spread="17"/>
                    <measurement group_id="B2" value="39" spread="10"/>
                    <measurement group_id="B3" value="40" spread="13"/>
                  </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="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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_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_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.6" spread="3.2"/>
                    <measurement group_id="B2" value="23.8" spread="4.9"/>
                    <measurement group_id="B3" value="23.7" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>% of glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.0" spread="1.5"/>
                    <measurement group_id="B2" value="6.2" spread="2.7"/>
                    <measurement group_id="B3" value="7.4" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean CGM glucose</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="173" spread="35"/>
                    <measurement group_id="B2" value="163" spread="25"/>
                    <measurement group_id="B3" value="167" spread="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cystic fibrosis related diabetes (CFRD) duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13" spread="9"/>
                    <measurement group_id="B2" value="17" spread="10"/>
                    <measurement group_id="B3" value="15" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insulin Total Daily Dose</title>
          <units>units/kg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.62" spread="0.26"/>
                    <measurement group_id="B2" value="0.46" spread="0.30"/>
                    <measurement group_id="B3" value="0.54" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent predicted forced expiratory volume in 1 second (FEV1)</title>
          <units>% of predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="26"/>
                    <measurement group_id="B2" value="65" spread="21"/>
                    <measurement group_id="B3" value="70" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pancreatic insufficiency</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Continuous glucose monitor (CGM) Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Multiple Daily Injection Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insulin Pump Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14</title>
        <description>Percentage of time spent with CGM glucose values between 70 and 180 mg/dl</description>
        <time_frame>Days 3-14</time_frame>
        <population>This was a random-order cross-over design clinical trial. Each participant completed each study arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14</title>
          <description>Percentage of time spent with CGM glucose values between 70 and 180 mg/dl</description>
          <population>This was a random-order cross-over design clinical trial. Each participant completed each study arm.</population>
          <units>percentage of time spent in target range</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" spread="22"/>
                    <measurement group_id="O2" value="75" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>paired 2-sided t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time Spent With CGM Glucose: &lt; 54 mg/dl</title>
        <description>Percentage of time spent with CGM glucose in this range</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Spent With CGM Glucose: &lt; 54 mg/dl</title>
          <description>Percentage of time spent with CGM glucose in this range</description>
          <units>percentage of time spent &lt;54mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" lower_limit="0" upper_limit="0.82"/>
                    <measurement group_id="O2" value="0.27" lower_limit="0.06" upper_limit="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0</p_value>
            <p_value_desc>Secondary outcomes were adjusted for multiple comparisons</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean CGM Glucose</title>
        <description>Average CGM glucose</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean CGM Glucose</title>
          <description>Average CGM glucose</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171" spread="45"/>
                    <measurement group_id="O2" value="150" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <p_value_desc>Secondary outcomes are adjusted for multiple comparisons</p_value_desc>
            <method>paired 2-sided t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time Spent With CGM Glucose &lt; 70 mg/dl</title>
        <description>Percent of time the participant spent with CGM glucose in this range</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Spent With CGM Glucose &lt; 70 mg/dl</title>
          <description>Percent of time the participant spent with CGM glucose in this range</description>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.13" upper_limit="3.5"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.0" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0</p_value>
            <p_value_desc>Adjusted for multiple comparisons</p_value_desc>
            <method>Wicoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time Spent With CGM Glucose &gt;180 mg/dL</title>
        <description>The percent of time the participant spent with CGM glucose in this range</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Spent With CGM Glucose &gt;180 mg/dL</title>
          <description>The percent of time the participant spent with CGM glucose in this range</description>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="17" upper_limit="52"/>
                    <measurement group_id="O2" value="18" lower_limit="14" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <p_value_desc>Adjusted for multiple comparisons</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time Spent With CGM Glucose &gt; 250mg/dL</title>
        <description>The percent of time the participant spent with CGM glucose in this range</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Spent With CGM Glucose &gt; 250mg/dL</title>
          <description>The percent of time the participant spent with CGM glucose in this range</description>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="2.5" upper_limit="22"/>
                    <measurement group_id="O2" value="3.9" lower_limit="2.0" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <p_value_desc>Adjusted for multiple comparisons</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Standard Deviation</title>
        <description>Standard deviation of participants' mean CGM glucose</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Standard Deviation</title>
          <description>Standard deviation of participants' mean CGM glucose</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="16"/>
                    <measurement group_id="O2" value="54" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.14</p_value>
            <p_value_desc>Adjusted for multiple comparisons</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coefficient of Variation</title>
        <description>Coefficient of variation of CGM glucose values</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation</title>
          <description>Coefficient of variation of CGM glucose values</description>
          <units>percentage of variability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" spread="6"/>
                    <measurement group_id="O2" value="35" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0</p_value>
            <p_value_desc>Adjusted for multiple comparisons</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Episodes of Self-reported Symptomatic Hypoglycemia</title>
        <description>Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Episodes of Self-reported Symptomatic Hypoglycemia</title>
          <description>Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)</description>
          <units>Episodes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.7" lower_limit="0.4" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Mean CGMG &lt;154 mg/dl</title>
        <description>Number of subjects who achieve a mean CGM glucose &lt; 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Mean CGMG &lt;154 mg/dl</title>
          <description>Number of subjects who achieve a mean CGM glucose &lt; 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Percentage of Time &lt; 54 mg/dl &lt; 1%</title>
        <description>Number of subjects who have less than 1% percent of CGM glucose values &lt; 54 mg/dl</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Percentage of Time &lt; 54 mg/dl &lt; 1%</title>
          <description>Number of subjects who have less than 1% percent of CGM glucose values &lt; 54 mg/dl</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.56</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Percentage of Time &lt; 54 mg/dl &lt; 1% and Mean CGM Glucose &lt; or Equal to 154 mg/dl</title>
        <description>Number of subjects who have less than 1% percent of CGM glucose values &lt; 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Percentage of Time &lt; 54 mg/dl &lt; 1% and Mean CGM Glucose &lt; or Equal to 154 mg/dl</title>
          <description>Number of subjects who have less than 1% percent of CGM glucose values &lt; 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.56</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater</title>
        <description>Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl</description>
        <time_frame>Days 3-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
          </group>
          <group group_id="O2">
            <title>Insulin Only Bionic Pancreas</title>
            <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater</title>
          <description>Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm&#xD;
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.</description>
        </group>
        <group group_id="E2">
          <title>Insulin Only Bionic Pancreas</title>
          <description>Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.&#xD;
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia without ketosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperglycemia with ketosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoglycemia unawareness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea and vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary exacerbation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Melissa Putman</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-1847</phone>
      <email>msputman@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/NCT03258853
org study id: 2020P003452
nct id: NCT03258853
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The current study is designed to test the feasibility of the a wearable bionic pancreas
      system that automatically delivers insulin and glucagon can provide superior regulation of
      glycemia versus usual care for adults and children with cystic fibrosis related diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
time frame: Days 3-14
description: Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
measure: Percentage of Time Spent With CGM Glucose: < 54 mg/dl
time frame: Days 3-14
description: Percentage of time spent with CGM glucose in this range
measure: Mean CGM Glucose
time frame: Days 3-14
description: Average CGM glucose
measure: Percentage of Time Spent With CGM Glucose < 70 mg/dl
time frame: Days 3-14
description: Percent of time the participant spent with CGM glucose in this range
measure: Percentage of Time Spent With CGM Glucose >180 mg/dL
time frame: Days 3-14
description: The percent of time the participant spent with CGM glucose in this range
measure: Percentage of Time Spent With CGM Glucose > 250mg/dL
time frame: Days 3-14
description: The percent of time the participant spent with CGM glucose in this range
measure: Standard Deviation
time frame: Days 3-14
description: Standard deviation of participants' mean CGM glucose
measure: Coefficient of Variation
time frame: Days 3-14
description: Coefficient of variation of CGM glucose values
measure: Number of Episodes of Self-reported Symptomatic Hypoglycemia
time frame: Days 3-14
description: Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)
measure: Number of Subjects With Mean CGMG <154 mg/dl
time frame: Days 3-14
description: Number of subjects who achieve a mean CGM glucose < 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)
measure: Number of Subjects With Percentage of Time < 54 mg/dl < 1%
time frame: Days 3-14
description: Number of subjects who have less than 1% percent of CGM glucose values < 54 mg/dl
measure: Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl
time frame: Days 3-14
description: Number of subjects who have less than 1% percent of CGM glucose values < 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl
measure: Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater
time frame: Days 3-14
description: Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl
arm group label: Usual Care
arm group type: Active Comparator
description: Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
arm group label: Insulin only bionic pancreas
arm group type: Experimental
description: Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
intervention type: Device
intervention name: Bionic Pancreas
description: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
arm group label: Insulin only bionic pancreas
intervention type: Other
intervention name: Usual Care
description: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa S Putman, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Melissa Susan Putman
investigator title: Principal Investigator
mesh term: Cystic Fibrosis
mesh term: Diabetes Mellitus
mesh term: Fibrosis
mesh term: Pancrelipase
sharing ipd: Yes
ipd description: De identified glucose data and microbiome data will be shared with research collaborators.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 