<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/NCT02969863</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002450</org_study_id>
    <nct_id>NCT02969863</nct_id>
  </id_info>
  <brief_title>The Monitoring Study</brief_title>
  <official_title>The Monitoring Study: Evaluating the Effect of Remote Monitoring For Hypoglycemia on Bionic Pancreas Safety and Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal&#xD;
      and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years&#xD;
      of age) subjects with type 1 diabetes in a random-order crossover study versus usual care&#xD;
      with an insulin pump with and without remote monitoring of hypoglycemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rationale for this study is to measure the safety of eliminating the glycemic monitoring&#xD;
      that the investigators have done in all of the previous outpatient studies under both insulin&#xD;
      only and bihormonal bionic pancreas control. The investigators are planning to transition the&#xD;
      outpatient studies to an integrated bionic pancreas, the iLet, in the near future. The&#xD;
      intended use of this device does not include remote monitoring, which would not be feasible&#xD;
      on a commercial scale. Therefore, in this trial the investigators will test the effects on&#xD;
      hypoglycemia of eliminating blood glucose related monitoring. In addition, the investigators&#xD;
      will perform a pilot trial testing the effects of the bionic pancreas on food intake,&#xD;
      exercise, weight and body composition. The primary purpose of this pilot is to assess the&#xD;
      feasibility of performing these measurements in the context of a larger trial and to collect&#xD;
      data that can be used to power sub-studies of pivotal trials looking at these outcomes.&#xD;
      Finally, the investigators will test the accuracy of two new CGM devices to see if they have&#xD;
      sufficient accuracy to provide glucose data to the bionic pancreas. If so, this would provide&#xD;
      new options for users who may have difficulties with the only currently validated CGM for&#xD;
      this purpose, the Dexcom G4 AP / G5 platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 28, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</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 Spent With Dexcom CGMG &lt; 60 mg/dl</measure>
    <time_frame>days 2-7</time_frame>
    <description>A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>Usual Care Arm - Monitored</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Arm - Unmonitored</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bihormonal Bionic Pancreas - Monitored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bihormonal Bionic Pancreas - Unmonitored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin Only Bionic Pancreas - Monitored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin Only Bionic Pancreas - Unmonitored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bihormonal Bionic Pancreas</intervention_name>
    <description>Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.</description>
    <arm_group_label>Bihormonal Bionic Pancreas - Monitored</arm_group_label>
    <arm_group_label>Bihormonal Bionic Pancreas - Unmonitored</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insulin Only Bionic Pancreas</intervention_name>
    <description>Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.</description>
    <arm_group_label>Insulin Only Bionic Pancreas - Monitored</arm_group_label>
    <arm_group_label>Insulin Only Bionic Pancreas - Unmonitored</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Monitored for Hypoglycemia</intervention_name>
    <description>During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.</description>
    <arm_group_label>Bihormonal Bionic Pancreas - Monitored</arm_group_label>
    <arm_group_label>Insulin Only Bionic Pancreas - Monitored</arm_group_label>
    <arm_group_label>Usual Care Arm - Monitored</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Not Monitored for Hypoglycemia</intervention_name>
    <description>During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.</description>
    <arm_group_label>Bihormonal Bionic Pancreas - Unmonitored</arm_group_label>
    <arm_group_label>Insulin Only Bionic Pancreas - Unmonitored</arm_group_label>
    <arm_group_label>Usual Care Arm - Unmonitored</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years and have had clinical type 1 diabetes for at least one year managed&#xD;
             using an insulin pump for ≥ 6 months&#xD;
&#xD;
          -  Prescription medication regimen stable for &gt; 1 month (except for medications that will&#xD;
             not affect the safety of the study and are not expected to affect any outcome of the&#xD;
             study, in the judgment of the principal investigator)&#xD;
&#xD;
          -  Live within a 60 minute drive-time radius of the central monitoring location&#xD;
&#xD;
          -  Willing to remain within a 120 minute drive-time radius of the central monitoring&#xD;
             location throughout the study&#xD;
&#xD;
          -  Have someone over 18 years of age who lives with them, has access to where they sleep,&#xD;
             is willing to be in the house when the subject is sleeping, and is willing to receive&#xD;
             calls from the study staff and check the welfare of the study subject if telemetry&#xD;
             shows a technical problem or severe biochemical hypoglycemia without subject response&#xD;
             and the subject does not answer their telephone (up to two individuals can share this&#xD;
             role, but they must be willing to carefully coordinate with each other and the subject&#xD;
             so that one of them is clearly designated as having this responsibility at any given&#xD;
             time)&#xD;
&#xD;
          -  Willing to wear one or two infusion sets and one Dexcom CGM sensor and change sets&#xD;
             frequently (at least one new glucagon infusion set daily during bi-hormonal arms, and&#xD;
             insulin infusion set every other day throughout the study)&#xD;
&#xD;
          -  Willing to wear two additional CGM sensors that must be placed in the upper arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent (e.g. impaired cognition or judgment)&#xD;
&#xD;
          -  Unable to safely comply with study procedures and reporting requirements (e.g.&#xD;
             impairment of vision or dexterity that prevents safe operation of the bionic pancreas,&#xD;
             impaired memory, unable to speak and read English)&#xD;
&#xD;
          -  Current participation in another diabetes-related clinical trial that, in the judgment&#xD;
             of the principal investigator, will compromise the results of this study or the safety&#xD;
             of the subject&#xD;
&#xD;
          -  Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the&#xD;
             immediate future, or sexually active without use of contraception Subjects must use&#xD;
             acceptable contraception for the two weeks prior to the study, throughout the study&#xD;
             and for the two weeks following the study.&#xD;
&#xD;
        Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine&#xD;
        Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap&#xD;
        with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as&#xD;
        Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as&#xD;
        Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis&#xD;
&#xD;
          -  Need to go outside of the designated geographic boundaries during the study&#xD;
&#xD;
          -  Current alcohol abuse (intake averaging &gt; 3 drinks daily in last 30 days), use of&#xD;
             marijuana within 1 month of enrollment, or other substance abuse (use within the last&#xD;
             6 months of controlled substances other than marijuana without a prescription)&#xD;
&#xD;
          -  Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more&#xD;
             than 4 drinks in a day or use of marijuana 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 period&#xD;
             of participation in the study (use of beta blockers will be allowed as long as the&#xD;
             dose is stable and the subject does not meet the criteria for hypoglycemia unawareness&#xD;
             while taking that stable dose, but use of benzodiazepines or narcotics, even if by&#xD;
             prescription, may be excluded according to the judgment of the principal investigator)&#xD;
&#xD;
          -  History of liver disease that is expected to interfere with the anti-hypoglycemia&#xD;
             action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active&#xD;
             hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis,&#xD;
             glycogen storage disease) may exclude the subject if it causes significant compromise&#xD;
             to liver function or may do so in an unpredictable fashion.&#xD;
&#xD;
          -  Renal failure on dialysis&#xD;
&#xD;
          -  Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other&#xD;
             pancreatic disease&#xD;
&#xD;
          -  Any known history of coronary artery disease including, but not limited to, history of&#xD;
             myocardial infarction, stress test showing ischemia, history of angina, or history of&#xD;
             intervention such as coronary artery bypass grafting, percutaneous coronary&#xD;
             intervention, or enzymatic lysis of a presumed coronary occlusion)&#xD;
&#xD;
          -  Abnormal EKG consistent with coronary artery disease or increased risk of malignant&#xD;
             arrhythmia including, but not limited to, evidence of active ischemia, prior&#xD;
             myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT&#xD;
             interval (&gt; 440 ms). Non-specific ST segment and T wave changes are not grounds for&#xD;
             exclusion in the absence of symptoms or history of heart disease. A reassuring&#xD;
             evaluation by a cardiologist after an abnormal EKG finding may allow participation.&#xD;
&#xD;
          -  Congestive heart failure (established history of CHF, lower extremity edema,&#xD;
             paroxysmal nocturnal dyspnea, or orthopnea)&#xD;
&#xD;
          -  History of TIA or stroke&#xD;
&#xD;
          -  Seizure disorder, history of any non-hypoglycemic seizure within the last two years,&#xD;
             or ongoing treatment with anticonvulsants&#xD;
&#xD;
          -  History of hypoglycemic seizures (grand-mal) or coma in the last year&#xD;
&#xD;
          -  History of pheochromocytoma: fractionated metanephrines will be tested in patients&#xD;
             with history increasing the risk for a catecholamine secreting tumor:&#xD;
&#xD;
               -  Episodic or treatment refractory (requiring 4 or more medications to achieve&#xD;
                  normotension) hypertension&#xD;
&#xD;
               -  Paroxysms of tachycardia, pallor, or headache&#xD;
&#xD;
               -  Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von&#xD;
                  Hippel-Lindau disease&#xD;
&#xD;
          -  History of adrenal disease or tumor&#xD;
&#xD;
          -  Hypertension with systolic BP ≥160 mm Hg or diastolic BP ≥100 despite treatment&#xD;
&#xD;
          -  Untreated or inadequately treated mental illness (indicators would include symptoms&#xD;
             such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the&#xD;
             last year), or treatment with anti-psychotic medications that are known to affect&#xD;
             glucose regulation.&#xD;
&#xD;
          -  Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be&#xD;
             susceptible to RF interference&#xD;
&#xD;
          -  The presence of any other active implanted device&#xD;
&#xD;
          -  Unable to completely avoid acetaminophen for duration of study&#xD;
&#xD;
          -  Unable to completely avoid ascorbic acid (Vitamin C) for duration of study&#xD;
&#xD;
          -  Unable to completely avoid salicylic acid (used in some pain relievers such as Aspirin&#xD;
             and some skin care products)&#xD;
&#xD;
          -  History of adverse reaction to glucagon (including allergy) besides nausea and&#xD;
             vomiting&#xD;
&#xD;
          -  Established history of allergy or severe reaction to adhesive or tape that must be&#xD;
             used in the study&#xD;
&#xD;
          -  History of eating disorder within the last 2 years, such as anorexia, bulimia, or&#xD;
             diabulemia or omission of insulin to manipulate weight&#xD;
&#xD;
          -  History of intentional, inappropriate administration of insulin leading to severe&#xD;
             hypoglycemia requiring treatment&#xD;
&#xD;
          -  Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4&#xD;
             inhibitors, SGLT-2 inhibitors) anti-diabetic medications&#xD;
&#xD;
          -  Lives in or frequents areas with poor Verizon wireless network coverage (which would&#xD;
             prevent remote monitoring)&#xD;
&#xD;
          -  Any factors that, in the opinion of the principal investigator would interfere with&#xD;
             the safe completion of the study&#xD;
&#xD;
          -  A condition preventing or complicating the placement, operation or removal of the&#xD;
             Senseonics sensor or wearing of transmitter, including upper extremity deformities or&#xD;
             skin condition&#xD;
&#xD;
          -  Currently receiving (or likely to need during the study period): immunosuppressant&#xD;
             therapy, chemotherapy, anticoagulant/antithrombotic therapy (excluding aspirin),&#xD;
             glucocorticoids (excluding ophthalmic or nasal). This does include the use of inhaled&#xD;
             and topical glucocorticoids and antibiotics for chronic infection&#xD;
&#xD;
          -  A condition requiring or likely requiring magnetic resonance imaging (MRI), Computed&#xD;
             Tomography (CT) scan, or high-frequency electrical heat (diathermy)&#xD;
&#xD;
          -  A known topical or local anesthetic allergy&#xD;
&#xD;
          -  A known glucocorticoids allergy&#xD;
&#xD;
          -  The presence of any other CGM sensor or transmitter located in the upper arm (other&#xD;
             location is acceptable)&#xD;
&#xD;
          -  Hemoglobin &lt; 12 g/dl&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven J Russell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MGH Diabetes Research Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>February 7, 2018</results_first_submitted>
  <results_first_submitted_qc>July 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 30, 2018</results_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Steven J. Russell, MD, PhD</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>bionic pancreas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
    <mesh_term>Pancreatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02969863/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>27 subjects were enrolled, but only 24 participated in the study. 2 subjects were ineligible, and 1 could not participate for scheduling reasons. 1 of the 24 was terminated by the investigator during the first arm of the study, so that 1 subject only started 1 arm. 23 subjects finished that arm, and 23 subjects started and finished the other arms</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>BBPM First, Then BBP, Then UCM, Then UC, Then IOBPM, Then IOBP</title>
          <description>UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week&#xD;
IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.&#xD;
BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm&#xD;
M-arm includes real-time remote monitoring for hypoglycemia</description>
        </group>
        <group group_id="P2">
          <title>UCM First, Then UC, Then IOBPM, Then IOBP, Then BBPM, Then BBP</title>
          <description>UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week&#xD;
IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.&#xD;
BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm&#xD;
M-arm includes real-time remote monitoring for hypoglycemia</description>
        </group>
        <group group_id="P3">
          <title>IOBPM First, Then IOBP, Then BBPM, Then BBP, Then UCM, Then UC</title>
          <description>UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week&#xD;
IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.&#xD;
BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm&#xD;
M-arm includes real-time remote monitoring for hypoglycemia</description>
        </group>
        <group group_id="P4">
          <title>UC First, Then UCM, Then BBP, Then BBPM, Then IOBP, Then IOBPM</title>
          <description>UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week&#xD;
IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.&#xD;
BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm&#xD;
M-arm includes real-time remote monitoring for hypoglycemia</description>
        </group>
        <group group_id="P5">
          <title>IOBP First, Then IOBPM, Then UC, Then UCM, Then BBP, Then BBPM</title>
          <description>UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week&#xD;
IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.&#xD;
BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm&#xD;
M-arm includes real-time remote monitoring for hypoglycemia</description>
        </group>
        <group group_id="P6">
          <title>BBP First, Then BBPM, Then IOBP, Then IOBPM, Then UC, Then UCM</title>
          <description>UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week&#xD;
IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.&#xD;
BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm&#xD;
M-arm includes real-time remote monitoring for hypoglycemia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All participants who began participating in the study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.5" spread="13.5"/>
                  </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="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c</title>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Time Spent With Dexcom CGMG &lt; 60 mg/dl</title>
        <description>A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl</description>
        <time_frame>days 2-7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care Arm - Monitored</title>
            <description>Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia&#xD;
Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Arm - Unmonitored</title>
            <description>Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia&#xD;
Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.</description>
          </group>
          <group group_id="O3">
            <title>Bihormonal Bionic Pancreas - Monitored</title>
            <description>Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia&#xD;
Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.</description>
          </group>
          <group group_id="O4">
            <title>Bihormonal Bionic Pancreas - Unmonitored</title>
            <description>Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia&#xD;
Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.</description>
          </group>
          <group group_id="O5">
            <title>Insulin Only Bionic Pancreas - Monitored</title>
            <description>Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia&#xD;
Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.</description>
          </group>
          <group group_id="O6">
            <title>Insulin Only Bionic Pancreas - Unmonitored</title>
            <description>Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia&#xD;
Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Spent With Dexcom CGMG &lt; 60 mg/dl</title>
          <description>A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl</description>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="1.39"/>
                    <measurement group_id="O2" value="1.95" spread="2.11"/>
                    <measurement group_id="O3" value="1.05" spread="1.01"/>
                    <measurement group_id="O4" value="0.99" spread="0.93"/>
                    <measurement group_id="O5" value="1.55" spread="1.16"/>
                    <measurement group_id="O6" value="1.66" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Usual Care Arm - Monitored</title>
          <description>Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia&#xD;
Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care Arm - Unmonitored</title>
          <description>Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia&#xD;
Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.</description>
        </group>
        <group group_id="E3">
          <title>Bihormonal Bionic Pancreas - Monitored</title>
          <description>Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia&#xD;
Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.</description>
        </group>
        <group group_id="E4">
          <title>Bihormonal Bionic Pancreas - Unmonitored</title>
          <description>Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia&#xD;
Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.</description>
        </group>
        <group group_id="E5">
          <title>Insulin Only Bionic Pancreas - Monitored</title>
          <description>Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.&#xD;
Monitored for hypoglycemia&#xD;
Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.</description>
        </group>
        <group group_id="E6">
          <title>Insulin Only Bionic Pancreas - Unmonitored</title>
          <description>Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.&#xD;
Not monitored for hypoglycemia&#xD;
Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.&#xD;
Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <description>The subject reported a hypoglycemic event that he was not called for. Remote monitoring did not see this or notify study staff. The subject reported that he treated using oral carbohydrates, and it resolved without incident.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </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>Courtney Balliro, BS RN CDE</name_or_title>
      <organization>MGH</organization>
      <phone>617-726-1242</phone>
      <email>cballiro@partners.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02969863
org study id: 2016P002450
nct id: NCT02969863
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal
      and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years
      of age) subjects with type 1 diabetes in a random-order crossover study versus usual care
      with an insulin pump with and without remote monitoring of hypoglycemia.
The rationale for this study is to measure the safety of eliminating the glycemic monitoring
      that the investigators have done in all of the previous outpatient studies under both insulin
      only and bihormonal bionic pancreas control. The investigators are planning to transition the
      outpatient studies to an integrated bionic pancreas, the iLet, in the near future. The
      intended use of this device does not include remote monitoring, which would not be feasible
      on a commercial scale. Therefore, in this trial the investigators will test the effects on
      hypoglycemia of eliminating blood glucose related monitoring. In addition, the investigators
      will perform a pilot trial testing the effects of the bionic pancreas on food intake,
      exercise, weight and body composition. The primary purpose of this pilot is to assess the
      feasibility of performing these measurements in the context of a larger trial and to collect
      data that can be used to power sub-studies of pivotal trials looking at these outcomes.
      Finally, the investigators will test the accuracy of two new CGM devices to see if they have
      sufficient accuracy to provide glucose data to the bionic pancreas. If so, this would provide
      new options for users who may have difficulties with the only currently validated CGM for
      this purpose, the Dexcom G4 AP / G5 platform.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Time Spent With Dexcom CGMG < 60 mg/dl
time frame: days 2-7
description: A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl
arm group label: Usual Care Arm - Monitored
arm group type: Active Comparator
description: Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia.
Monitored for hypoglycemia
arm group label: Usual Care Arm - Unmonitored
arm group type: Active Comparator
description: Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia.
Not monitored for hypoglycemia
arm group label: Bihormonal Bionic Pancreas - Monitored
arm group type: Experimental
description: Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.
Monitored for hypoglycemia
arm group label: Bihormonal Bionic Pancreas - Unmonitored
arm group type: Experimental
description: Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.
Not monitored for hypoglycemia
arm group label: Insulin Only Bionic Pancreas - Monitored
arm group type: Experimental
description: Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.
Monitored for hypoglycemia
arm group label: Insulin Only Bionic Pancreas - Unmonitored
arm group type: Experimental
description: Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.
Not monitored for hypoglycemia
intervention type: Device
intervention name: Bihormonal Bionic Pancreas
description: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.
arm group label: Bihormonal Bionic Pancreas - Monitored
arm group label: Bihormonal Bionic Pancreas - Unmonitored
intervention type: Device
intervention name: Insulin Only Bionic Pancreas
description: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.
arm group label: Insulin Only Bionic Pancreas - Monitored
arm group label: Insulin Only Bionic Pancreas - Unmonitored
intervention type: Other
intervention name: Monitored for Hypoglycemia
description: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.
arm group label: Bihormonal Bionic Pancreas - Monitored
arm group label: Insulin Only Bionic Pancreas - Monitored
arm group label: Usual Care Arm - Monitored
intervention type: Other
intervention name: Not Monitored for Hypoglycemia
description: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.
arm group label: Bihormonal Bionic Pancreas - Unmonitored
arm group label: Insulin Only Bionic Pancreas - Unmonitored
arm group label: Usual Care Arm - Unmonitored
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven J Russell, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Steven J. Russell, MD, PhD
investigator title: Assistant Professor of Medicine
mesh term: Diabetes Mellitus, Type 1
mesh term: Pancrelipase
mesh term: Pancreatin
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 