<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/NCT03808376</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-0036</org_study_id>
    <nct_id>NCT03808376</nct_id>
  </id_info>
  <brief_title>PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days</brief_title>
  <acronym>PROMISE</acronym>
  <official_title>PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Senseonics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Senseonics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical investigation is to evaluate the accuracy of the Eversense®&#xD;
      continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared&#xD;
      with reference standard measurements up to 180 days of sensor use.&#xD;
&#xD;
      The investigation will also evaluate safety of the Eversense® 180 CGM System usage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">May 8, 2020</completion_date>
  <primary_completion_date type="Actual">May 8, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness Measure - mean absolute relative difference (MARD)</measure>
    <time_frame>180 days</time_frame>
    <description>The effectiveness endpoint will be mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Endpoint - Incidence of device-related or sensor insertion/removal procedure-related serious adverse</measure>
    <time_frame>180 days</time_frame>
    <description>Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 180 days post-Sensor insertion or removal and follow-up.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Continuous Glucose Monitoring Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Eversense® 180 CGM System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitoring System</intervention_name>
    <description>The Eversense® 180 CGM System</description>
    <arm_group_label>Continuous Glucose Monitoring Device</arm_group_label>
    <other_name>Eversense CGM system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult subjects, age ≥18 years&#xD;
&#xD;
          2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year&#xD;
&#xD;
          3. Subject has signed an informed consent form and is willing to comply with protocol&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of unexplained severe hypoglycemia in the previous 6 months. Severe&#xD;
             hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure&#xD;
&#xD;
          2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in&#xD;
             the previous 6 months&#xD;
&#xD;
          3. Subjects with gastroparesis&#xD;
&#xD;
          4. Female subjects of childbearing capacity (defined as not surgically sterile or not&#xD;
             menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant,&#xD;
             or not practicing birth control during the course of the study.&#xD;
&#xD;
          5. A condition preventing or complicating the placement,operation, or removal of the&#xD;
             Sensor or wearing of transmitter, including upper extremity deformities or skin&#xD;
             condition.&#xD;
&#xD;
          6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient&#xD;
             ischemic attack or stroke in the past 6 months; uncontrolled hypertension&#xD;
             (systolic&gt;160 mm Hg or diastolic &gt;100 mm Hg at time of screening); current congestive&#xD;
             heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects&#xD;
             with asymptomatic coronary artery disease (e.g. CABG, stent placement or angioplasty)&#xD;
             may participate if negative stress test within 1 year prior to screening and written&#xD;
             clearance from Cardiologist documented.&#xD;
&#xD;
          7. Hematocrit &lt;30% or &gt;60%&#xD;
&#xD;
          8. History of hepatitis B, hepatitis C, or HIV&#xD;
&#xD;
          9. Current treatment for a seizure disorder unless written clearance by neurologist to&#xD;
             participate in study&#xD;
&#xD;
         10. History of adrenal insufficiency&#xD;
&#xD;
         11. 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 exclusion does include the use&#xD;
             of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site&#xD;
             only); antibiotic for chronic infection (e.g. osteomyelitis, endocarditis)&#xD;
&#xD;
         12. A condition requiring or likely to require magnetic resonance imaging (MRI)&#xD;
&#xD;
         13. Known topical or local anesthetic allergy&#xD;
&#xD;
         14. Known allergy to glucocorticoids&#xD;
&#xD;
         15. Any condition that in the investigator's opinion would make the subject unable to&#xD;
             complete the study or would make it not in the subject's best interest to participate&#xD;
             in the study. Conditions include but are not limited to psychiatric conditions, known&#xD;
             current or recent alcohol abuse or drug abuse by subject history, a condition that may&#xD;
             increase the risk of induced hypoglycemia or risk related to repeated blood testing.&#xD;
             Investigator will supply rationale for exclusion&#xD;
&#xD;
         16. Participation in another clinical investigation (drug or device) within 2 weeks prior&#xD;
             to screening or intent to participate during the study period&#xD;
&#xD;
         17. The presence of any other active implanted device (as defined further in protocol)&#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>Satish Garg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barbara Davis Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Muir Physician Network Clinical Research Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMCR Institute Inc.</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Davis Center for Diabetes</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes Care</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky mountain Diabetes Center C/O Research Department</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03808376
org study id: CTP-0036
nct id: NCT03808376
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense®
      continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared
      with reference standard measurements up to 180 days of sensor use.

      The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Effectiveness Measure - mean absolute relative difference (MARD)
time frame: 180 days
description: The effectiveness endpoint will be mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL.
measure: Safety Endpoint - Incidence of device-related or sensor insertion/removal procedure-related serious adverse
time frame: 180 days
description: Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 180 days post-Sensor insertion or removal and follow-up.
arm group label: Continuous Glucose Monitoring Device
arm group type: Experimental
description: The Eversense® 180 CGM System
intervention type: Device
intervention name: Continuous Glucose Monitoring System
description: The Eversense® 180 CGM System
arm group label: Continuous Glucose Monitoring Device
other name: Eversense CGM system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Satish Garg, MD
role: Principal Investigator
affiliation: Barbara Davis Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No