<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/NCT01697150</url>
  </required_header>
  <id_info>
    <org_study_id>JDRF 22-2011-649 SB</org_study_id>
    <nct_id>NCT01697150</nct_id>
  </id_info>
  <brief_title>Outpatient Control-to-Range: System and Monitoring Testing</brief_title>
  <official_title>Systems Approach to Closed-Loop Control of Type 1 Diabetes at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Santa Barbara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sansum Diabetes Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Automated closed-loop control (CLC) of blood glucose, known as &quot;artificial pancreas&quot; (AP) can&#xD;
      have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The&#xD;
      investigators inter-institutional and international research team has been on the forefront&#xD;
      of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006.&#xD;
      Thus far, the investigators have conducted three closed-loop control clinical trials&#xD;
      (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable&#xD;
      &quot;target&quot; blood glucose range during CLC, and significantly fewer hypoglycemic events during&#xD;
      CLC compared to open loop. The investigators overall objective is to sequentially test,&#xD;
      validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range&#xD;
      (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a&#xD;
      Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's&#xD;
      continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also&#xD;
      monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations&#xD;
      or loss of sensitivity. The HMM will be responsible for the optimal regulation of&#xD;
      postprandial hyperglycemic excursions through correction boluses.&#xD;
&#xD;
      This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and&#xD;
      (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who&#xD;
      are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local&#xD;
      hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for&#xD;
      validation that remote system monitoring can successfully occur. During the study, study&#xD;
      subject will be responsible for. operating the CTR system with nursing and technicians&#xD;
      available&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      I.A. PURPOSE/OBJECTIVES&#xD;
&#xD;
        1. Primary objective The purpose of this pilot study is to test a closed-loop&#xD;
           Control-to-Range (CTR) system in a semi-controlled environment and especially to&#xD;
           evaluate if the system can accurately collect data coming from patient inputs, insulin&#xD;
           pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use.&#xD;
&#xD;
        2. Secondary objectives&#xD;
&#xD;
      This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based&#xD;
      system to test an outpatient controller and remote monitoring as follows:&#xD;
&#xD;
        -  test that the CTR system can be remotely monitored by nurses/physicians/ technicians to&#xD;
           confirm appropriate functioning outside of the hospital setting&#xD;
&#xD;
        -  test that the CTR system can be deployed, with appropriate subject response, outside of&#xD;
           the hospital setting&#xD;
&#xD;
      I.B. STUDY DESIGN&#xD;
&#xD;
      This study is an early feasibility pilot trial with the principal goal is to validate an&#xD;
      initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is&#xD;
      an unblinded pilot study and no control group will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent time of active CTR</measure>
    <time_frame>42 hours</time_frame>
    <description>The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency analysis of failed data caused by system components</measure>
    <time_frame>42 hours</time_frame>
    <description>The failed data records will be compared to failure/missing data records from our past in-clinic studies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of inaccurate data caused by system components</measure>
    <time_frame>42 hours</time_frame>
    <description>Continuous glucose sensor data will be compared with Hemocue data for accuracy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency analysis of lost data caused by system components</measure>
    <time_frame>42 hours</time_frame>
    <description>The failure/missing data records will be compared to missing data records from our past in-clinic studies</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Control to Range Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will spend two nights in a non hospital setting while the DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is remotely monitored from an adjacent room. DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DiAs Diabetes Assistant Wearable Artificial Pancreas Platform</intervention_name>
    <description>Subjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.</description>
    <arm_group_label>Control to Range Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥21 and &lt;65 years old&#xD;
&#xD;
          2. Clinical diagnosis of type 1 diabetes mellitus:&#xD;
&#xD;
             Criteria for documented hyperglycemia (at least 1 criterion must be met):&#xD;
&#xD;
               -  Fasting glucose ≥126 mg/dL - confirmed&#xD;
&#xD;
               -  Two-hour OGTT glucose ≥200 mg/dL - confirmed&#xD;
&#xD;
               -  HbA1c ≥6.5% documented by history - confirmed&#xD;
&#xD;
               -  Random glucose ≥200 mg/dL with symptoms&#xD;
&#xD;
               -  No data at diagnosis is available but the participant has a convincing history of&#xD;
                  hyperglycemia consistent with diabetes&#xD;
&#xD;
             Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):&#xD;
&#xD;
               -  Participant required insulin at diagnosis and continually thereafter&#xD;
&#xD;
               -  Participant did not start insulin at diagnosis but upon investigator review&#xD;
                  likely needed insulin (significant hyperglycemia that did not respond to oral&#xD;
                  agents) and did require insulin eventually and used continually&#xD;
&#xD;
               -  Participant did not start insulin at diagnosis but continued to be hyperglycemic,&#xD;
                  had positive islet cell antibodies - consistent with latent autoimmune diabetes&#xD;
                  in adults (LADA) and did require insulin eventually and used continually&#xD;
&#xD;
          3. Use of an insulin pump to treat his/her diabetes for at least 1 year&#xD;
&#xD;
          4. Actively using an insulin pump with bolus calculator feature including predefined&#xD;
             parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active&#xD;
             insulin.&#xD;
&#xD;
          5. HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device&#xD;
&#xD;
          6. Not currently known to be pregnant, breast feeding, or intending to become pregnant&#xD;
             (females)&#xD;
&#xD;
          7. Demonstration of proper mental status and cognition for the study&#xD;
&#xD;
          8. Willingness to avoid consumption of acetaminophen-containing products during the study&#xD;
             interventions involving DexCom use&#xD;
&#xD;
          9. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have&#xD;
             stability on the medication for at least 2 months prior to enrollment in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ≥21 and &lt;65 years old&#xD;
&#xD;
          2. Clinical diagnosis of type 1 diabetes mellitus:&#xD;
&#xD;
               -  Criteria for documented hyperglycemia (at least 1 criterion must be met):&#xD;
&#xD;
                    -  Fasting glucose ≥126 mg/dL - confirmed&#xD;
&#xD;
                    -  Two-hour OGTT glucose ≥200 mg/dL - confirmed&#xD;
&#xD;
                    -  HbA1c ≥6.5% documented by history - confirmed&#xD;
&#xD;
                    -  Random glucose ≥200 mg/dL with symptoms&#xD;
&#xD;
                    -  No data at diagnosis is available but the participant has a convincing&#xD;
                       history of hyperglycemia consistent with diabetes&#xD;
&#xD;
               -  Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):&#xD;
&#xD;
                    -  Participant required insulin at diagnosis and continually thereafter&#xD;
&#xD;
                    -  Participant did not start insulin at diagnosis but upon investigator review&#xD;
                       likely needed insulin (significant hyperglycemia that did not respond to&#xD;
                       oral agents) and did require insulin eventually and used continually&#xD;
&#xD;
                    -  Participant did not start insulin at diagnosis but continued to be&#xD;
                       hyperglycemic, had positive islet cell antibodies - consistent with latent&#xD;
                       autoimmune diabetes in adults (LADA) and did require insulin eventually and&#xD;
                       used continually&#xD;
&#xD;
          3. Use of an insulin pump to treat his/her diabetes for at least 1 year&#xD;
&#xD;
          4. Actively using an insulin pump with bolus calculator feature including predefined&#xD;
             parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active&#xD;
             insulin.&#xD;
&#xD;
          5. HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device&#xD;
&#xD;
          6. Not currently known to be pregnant, breast feeding, or intending to become pregnant&#xD;
             (females)&#xD;
&#xD;
          7. Demonstration of proper mental status and cognition for the study&#xD;
&#xD;
          8. Willingness to avoid consumption of acetaminophen-containing products during the study&#xD;
             interventions involving DexCom use&#xD;
&#xD;
          9. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have&#xD;
             stability on the medication for at least 2 months prior to enrollment in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Howard Zisser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sansum Diabetes Research Institute</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sansum.org</url>
    <description>http://www.sansum.org/research-trials/current-trials/</description>
  </link>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>April 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>April 20, 2016</last_update_submitted>
  <last_update_submitted_qc>April 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sansum Diabetes Research Institute</investigator_affiliation>
    <investigator_full_name>Jordan Pinsker</investigator_full_name>
    <investigator_title>Director of Clinical Research and Diabetes Technology</investigator_title>
  </responsible_party>
  <keyword>Type 1 diabetes mellitus</keyword>
  <keyword>closed loop artificial pancreas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01697150
org study id: JDRF 22-2011-649 SB
nct id: NCT01697150
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can
      have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The
      investigators inter-institutional and international research team has been on the forefront
      of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006.
      Thus far, the investigators have conducted three closed-loop control clinical trials
      (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable
      "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during
      CLC compared to open loop. The investigators overall objective is to sequentially test,
      validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range
      (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a
      Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's
      continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also
      monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations
      or loss of sensitivity. The HMM will be responsible for the optimal regulation of
      postprandial hyperglycemic excursions through correction boluses.

      This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and
      (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who
      are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local
      hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for
      validation that remote system monitoring can successfully occur. During the study, study
      subject will be responsible for. operating the CTR system with nursing and technicians
      available
I.A. PURPOSE/OBJECTIVES

        1. Primary objective The purpose of this pilot study is to test a closed-loop
           Control-to-Range (CTR) system in a semi-controlled environment and especially to
           evaluate if the system can accurately collect data coming from patient inputs, insulin
           pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use.

        2. Secondary objectives

      This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based
      system to test an outpatient controller and remote monitoring as follows:

        -  test that the CTR system can be remotely monitored by nurses/physicians/ technicians to
           confirm appropriate functioning outside of the hospital setting

        -  test that the CTR system can be deployed, with appropriate subject response, outside of
           the hospital setting

      I.B. STUDY DESIGN

      This study is an early feasibility pilot trial with the principal goal is to validate an
      initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is
      an unblinded pilot study and no control group will be used.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent time of active CTR
time frame: 42 hours
description: The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation.
measure: Frequency analysis of failed data caused by system components
time frame: 42 hours
description: The failed data records will be compared to failure/missing data records from our past in-clinic studies
measure: Frequency of inaccurate data caused by system components
time frame: 42 hours
description: Continuous glucose sensor data will be compared with Hemocue data for accuracy.
measure: Frequency analysis of lost data caused by system components
time frame: 42 hours
description: The failure/missing data records will be compared to missing data records from our past in-clinic studies
arm group label: Control to Range Testing
arm group type: Experimental
description: Subjects will spend two nights in a non hospital setting while the DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is remotely monitored from an adjacent room. DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.
intervention type: Device
intervention name: DiAs Diabetes Assistant Wearable Artificial Pancreas Platform
description: Subjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.
arm group label: Control to Range Testing
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Howard Zisser, MD
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
facility: 
country: United States
url: http://www.sansum.org
description: http://www.sansum.org/research-trials/current-trials/
responsible party type: Principal Investigator
investigator affiliation: Sansum Diabetes Research Institute
investigator full name: Jordan Pinsker
investigator title: Director of Clinical Research and Diabetes Technology
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Pancrelipase