<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/NCT03017482</url>
  </required_header>
  <id_info>
    <org_study_id>670Gstartup</org_study_id>
    <nct_id>NCT03017482</nct_id>
  </id_info>
  <brief_title>Clinical Startup of the 670G Closed Loop Insulin Delivery System</brief_title>
  <acronym>670Gstartup</acronym>
  <official_title>Clinical Startup of the 670G Closed Loop Insulin Delivery System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to track initiation and the first year of clinical use of the&#xD;
      newly FDA approved 670G closed loop insulin delivery system by patients who have requested&#xD;
      this system. Our goal is to evaluate our clinical approach to starting this newly approved&#xD;
      system. Since the investigators are only following patients who have already decided to start&#xD;
      the 670G, the investigator does not assign specific interventions to the subjects of the&#xD;
      study; thus this is a Observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      3.1 Initial Procedures After reviewing the patient's interest and eligibility, the&#xD;
      investigators will obtain informed consent and assent as appropriate. The investigators will&#xD;
      start the clinical process for starting an insulin infusion pump. This typically involves&#xD;
      attending a pre-pump class (for those patients naïve to insulin pump therapy) and starting&#xD;
      the process to obtain insurance coverage for the 670G system.&#xD;
&#xD;
      The investigators plan to track the insurance approval process, typically the number of calls&#xD;
      and faxes required, as well as the result - approved vs not approved.&#xD;
&#xD;
      3.2 Pump Run-in (for those patients new to insulin infusion pumps) For patients who are&#xD;
      insulin pump naïve the investigators will start on 670G insulin pump without the glucose&#xD;
      sensor activation as per our existing clinical protocol. This may occur at a group visit.&#xD;
&#xD;
      3.3 Initial Visit&#xD;
&#xD;
      During at an initial visit, the following procedures will be performed:&#xD;
&#xD;
        -  A clinically obtained HbA1c assessment, typically done via fingerstick and DCA2000 (but&#xD;
           any equivalent NGSP-certified point-of-care or laboratory based measurement within 2&#xD;
           weeks prior to enrollment acceptable)&#xD;
&#xD;
        -  Collection of medical history information including&#xD;
&#xD;
             -  Demographics (date of birth, gender, race and ethnicity), diabetes history, medical&#xD;
                history, concomitant medications&#xD;
&#xD;
             -  Collect data for diabetes devices (eg meters, sensors, pumps)&#xD;
&#xD;
             -  Brief clinical physical exam including vital signs and skin assessment&#xD;
&#xD;
             -  CareLink account creation and sharing of access if this is not already done At this&#xD;
                visit, patients will be taught how to insert and use the system glucose sensor.&#xD;
&#xD;
      3.3.1 Initial Week on the 670G System During the following week, the system (with both pump&#xD;
      and sensor active) will be active with the PLGS on.&#xD;
&#xD;
      3.4 System Start Visit After the initial PLGS week, patients will be taught, perhaps as a&#xD;
      group, the closed loop system and the system activated. (Note: multiple days of system data&#xD;
      are required using the pump and sensor prior to the 670G system being capable of delivering&#xD;
      additional insulin for hyperglycemia. Therefore, this stage of the start-up is a function of&#xD;
      the system requirements.)&#xD;
&#xD;
      3.5 Weekly CareLink Download and Calls For each of the next four weeks, the patient/family&#xD;
      will upload data into the CareLink system and the data will be reviewed by a member of the&#xD;
      clinical team. Adjustments to system settings will be suggested to the family as clinically&#xD;
      appropriate.&#xD;
&#xD;
      3.6 Routine 3, 6, 9 and 12 Month Clinical visits At a routine clinical visits the&#xD;
      investigators will obtain an interval medical history, physical examination, collect and&#xD;
      review of diabetes management data from all diabetes devices with an eye towards improving&#xD;
      glycemic control. The investigators will collect adverse event information regarding severe&#xD;
      hypoglycemia and diabetic ketoacidosis. Patients will be advised of suggested changes in pump&#xD;
      settings&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percent of time patients are on the closed loop system</measure>
    <time_frame>6 month</time_frame>
    <description>percent of time patients are on the closed loop system at 6 months after start of closed loop activation with a goal of &gt;70%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent time in range</measure>
    <time_frame>6 months</time_frame>
    <description>Percent time in range (70 to 180 mg/dL) &quot;Week 1 before closed loop but with predictive low glucose suspend (PLGS)&quot; vs &quot;Week 24 on full closed loop control.&quot;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Severe Hypoglycemia</measure>
    <time_frame>12 months</time_frame>
    <description>Number of severe hypoglycemic events in 12 months on closed loop compared with the up to 12 months before by history before closed loop control</description>
  </other_outcome>
  <other_outcome>
    <measure>Diabetic Ketoacidosis</measure>
    <time_frame>12 months</time_frame>
    <description>Number of diabetic ketoacidosis (DKA) events in 12 months on closed loop compared with the up to 12 months before by history before closed loop control</description>
  </other_outcome>
  <enrollment type="Actual">85</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic 670G</intervention_name>
    <description>This is an open labeled follow up of a clinical startup of a newly approved FDA closed loop insulin delivery system. It is essentially a &quot;prospective&quot; chart review of the clinically startup of a FDA closed loop system and has many elements of a quality improvement project with additional features of:&#xD;
Questionnaires about the utility and impact of the device&#xD;
Use of the device in children younger than the current FDA approval range</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with the clinical diagnosis of type 1 diabetes planning to start the 670G system&#xD;
        clinically.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of type 1 diabetes The diagnosis of type 1 diabetes is based on the&#xD;
             investigator's judgment; C peptide level and antibody determinations are not required.&#xD;
&#xD;
          2. Clinically planning to and be able to start the Medtronic 670G closed loop system&#xD;
&#xD;
          3. Age greater than 7.00 years at the initiation of the 670G system&#xD;
&#xD;
          4. Total daily insulin use of great than 8.0 units per day over a 1 week period&#xD;
&#xD;
          5. Willing and able (access to internet from home) to download information into the&#xD;
             Medtronic CareLink software&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Current or planned pregnancy (for the next 12 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darrell M Wilson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Darrell M Wilson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share</ipd_description>
  </patient_data>
  <!-- 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/NCT03017482
org study id: 670Gstartup
nct id: NCT03017482
lead sponsor: 
has dmc: No
The purpose of this project is to track initiation and the first year of clinical use of the
      newly FDA approved 670G closed loop insulin delivery system by patients who have requested
      this system. Our goal is to evaluate our clinical approach to starting this newly approved
      system. Since the investigators are only following patients who have already decided to start
      the 670G, the investigator does not assign specific interventions to the subjects of the
      study; thus this is a Observational study.
3.1 Initial Procedures After reviewing the patient's interest and eligibility, the
      investigators will obtain informed consent and assent as appropriate. The investigators will
      start the clinical process for starting an insulin infusion pump. This typically involves
      attending a pre-pump class (for those patients naïve to insulin pump therapy) and starting
      the process to obtain insurance coverage for the 670G system.

      The investigators plan to track the insurance approval process, typically the number of calls
      and faxes required, as well as the result - approved vs not approved.

      3.2 Pump Run-in (for those patients new to insulin infusion pumps) For patients who are
      insulin pump naïve the investigators will start on 670G insulin pump without the glucose
      sensor activation as per our existing clinical protocol. This may occur at a group visit.

      3.3 Initial Visit

      During at an initial visit, the following procedures will be performed:

        -  A clinically obtained HbA1c assessment, typically done via fingerstick and DCA2000 (but
           any equivalent NGSP-certified point-of-care or laboratory based measurement within 2
           weeks prior to enrollment acceptable)

        -  Collection of medical history information including

             -  Demographics (date of birth, gender, race and ethnicity), diabetes history, medical
                history, concomitant medications

             -  Collect data for diabetes devices (eg meters, sensors, pumps)

             -  Brief clinical physical exam including vital signs and skin assessment

             -  CareLink account creation and sharing of access if this is not already done At this
                visit, patients will be taught how to insert and use the system glucose sensor.

      3.3.1 Initial Week on the 670G System During the following week, the system (with both pump
      and sensor active) will be active with the PLGS on.

      3.4 System Start Visit After the initial PLGS week, patients will be taught, perhaps as a
      group, the closed loop system and the system activated. (Note: multiple days of system data
      are required using the pump and sensor prior to the 670G system being capable of delivering
      additional insulin for hyperglycemia. Therefore, this stage of the start-up is a function of
      the system requirements.)

      3.5 Weekly CareLink Download and Calls For each of the next four weeks, the patient/family
      will upload data into the CareLink system and the data will be reviewed by a member of the
      clinical team. Adjustments to system settings will be suggested to the family as clinically
      appropriate.

      3.6 Routine 3, 6, 9 and 12 Month Clinical visits At a routine clinical visits the
      investigators will obtain an interval medical history, physical examination, collect and
      review of diabetes management data from all diabetes devices with an eye towards improving
      glycemic control. The investigators will collect adverse event information regarding severe
      hypoglycemia and diabetic ketoacidosis. Patients will be advised of suggested changes in pump
      settings
observational model: Case-Only
time perspective: Prospective
measure: percent of time patients are on the closed loop system
time frame: 6 month
description: percent of time patients are on the closed loop system at 6 months after start of closed loop activation with a goal of >70%.
measure: Percent time in range
time frame: 6 months
description: Percent time in range (70 to 180 mg/dL) "Week 1 before closed loop but with predictive low glucose suspend (PLGS)" vs "Week 24 on full closed loop control."
measure: Severe Hypoglycemia
time frame: 12 months
description: Number of severe hypoglycemic events in 12 months on closed loop compared with the up to 12 months before by history before closed loop control
measure: Diabetic Ketoacidosis
time frame: 12 months
description: Number of diabetic ketoacidosis (DKA) events in 12 months on closed loop compared with the up to 12 months before by history before closed loop control
intervention type: Device
intervention name: Medtronic 670G
description: This is an open labeled follow up of a clinical startup of a newly approved FDA closed loop insulin delivery system. It is essentially a "prospective" chart review of the clinically startup of a FDA closed loop system and has many elements of a quality improvement project with additional features of:
Questionnaires about the utility and impact of the device
Use of the device in children younger than the current FDA approval range
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Darrell M Wilson, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Darrell M Wilson
investigator title: Professor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
ipd description: No plan to share