<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/NCT03815552</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-FNH-01</org_study_id>
    <nct_id>NCT03815552</nct_id>
  </id_info>
  <brief_title>Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth</brief_title>
  <acronym>FNH</acronym>
  <official_title>An Investigator Initiated Pilot Study to Evaluate the Impact on Glucose Control and Safety of the Eversense Continuous Glucose Monitoring System in Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kinderkrankenhaus auf der Bult</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Senseonics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kinderkrankenhaus auf der Bult</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical investigation is to provide pilot clinical data to direct&#xD;
      pivotal study development for the pediatric indication of the Senseonics Continuous Glucose&#xD;
      Monitoring System (CGM) measurements when compared with finger stick blood glucose monitoring&#xD;
      in an outpatient setting. (The investigation will also evaluate safety of the Senseonics CGM&#xD;
      System usage, get feedback regarding subject and caregiver acceptability of the device and&#xD;
      the mobile medical application (MMA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-randomized, non-blinded, prospective, single-arm, single-center pilot study,&#xD;
      enrolling up to 15 pediatric subjects in two cohorts (5 subjects age 6-12 and 10 subjects age&#xD;
      13-17) with diabetes mellitus for up to 180 days. Study will evaluate the system at home with&#xD;
      comparison to SMBG with clinic check visits and downloading of stored data every 30 days.&#xD;
      Subjects will have one Sensor inserted subcutaneous by trained Investigators. The System will&#xD;
      be set to provide real-time glucose information, including alarms and alerts in the home&#xD;
      settings. The system is for adjunctive use. All diabetes care decisions will be based on SMBG&#xD;
      values rather than System CGM results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2018</start_date>
  <completion_date type="Actual">September 11, 2019</completion_date>
  <primary_completion_date type="Actual">September 11, 2019</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>time in range</measure>
    <time_frame>90 days</time_frame>
    <description>Reduction of time in range of Glucose &lt; 70-mg/dL when using the Senseonics CGM System</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time of hypoglycemia</measure>
    <time_frame>three weeks of the blinded phase compared to the last three weeks before 90 days visit</time_frame>
    <description>Percentage time of hypoglycemia (Glucose &lt;70 mg/dL</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Self Care</condition>
  <arm_group>
    <arm_group_label>Eversense Continuous Glucose Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with type 1 Diabetes.The System will be set to provide realtime glucose information, including alarms and alerts in the home settings für 180 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eversense Continuous Glucose Monitoring</intervention_name>
    <description>The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with diabetes for the operating life of the sensor.The System comprises a sensor and a transmitter. The small sensor will be subcutaneously inserted in the arm.The transmitter reads glucose data from the subcutaneous sensor.</description>
    <arm_group_label>Eversense Continuous Glucose Monitoring</arm_group_label>
    <other_name>Senseonics Continuous Glucose Monitoring System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pediatric subjects ≥6 and &lt; 18 years with Type 1 Diabetes&#xD;
&#xD;
          2. HbA1c &lt; 11 % at Screening&#xD;
&#xD;
          3. Subject/legal guardian has signed an informed consent form before any study related&#xD;
             activities and is willing to comply with protocol requirements&#xD;
&#xD;
          4. Clinically confirmed diagnosis of diabetes mellitus for ≥ 1 year&#xD;
&#xD;
          5. Pretreated with CSII or ICT with a minimum duration of 3 month&#xD;
&#xD;
          6. Patient and parents are physically and mental able to exercise as determined the&#xD;
             &quot;Eversense&quot; System&#xD;
&#xD;
          7. Patient must be willing to document every diabetes relevant information (meals, carbs,&#xD;
             physical activity, extraordinary stress,…)&#xD;
&#xD;
          8. Patient is willing to follow protocol and procedures for study&#xD;
&#xD;
          9. Patient has the possibility to use a smartphone which is compatible with the system in&#xD;
             daily life&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients are unwilling to follow the study procedures&#xD;
&#xD;
          2. Patient is absent for a longer time (no possibility for visits)&#xD;
&#xD;
          3. Patient is unable to tolerate tape adhesive in the area of sensor placement&#xD;
&#xD;
          4. Patient has any unresolved adverse skin condition in the area of sensor placement&#xD;
             (e.g. atopic dermatitis, psoriasis, rash,…)&#xD;
&#xD;
          5. Patient is allergic to components of sensor material (Polymethylmethacrylate,&#xD;
             dexamethasone, local anesthesia)&#xD;
&#xD;
          6. Eating disorder: e.g. bulimia, anorexia&#xD;
&#xD;
          7. Infections with hepatitis B, C or HIV&#xD;
&#xD;
          8. Coagulation disorder, wound healing disorder&#xD;
&#xD;
          9. Pregnancy&#xD;
&#xD;
         10. Mental incapacity or psychiatric disorders (Major Depression, anxiety disorders,&#xD;
             schizophrenia)&#xD;
&#xD;
         11. Language barriers&#xD;
&#xD;
         12. Medication which is influencing metabolic control as systemic steroids, other&#xD;
             non-Routine hormones&#xD;
&#xD;
         13. Medication influencing coagulation as Marcumar or systemic Xa-Antagonists as well as&#xD;
             known bleeding disorders&#xD;
&#xD;
         14. People known to M. Addison&#xD;
&#xD;
         15. Untreated coeliac disease (Transglutaminase at screening elevated 2x&gt;upper limit)&#xD;
&#xD;
         16. Severe diseases as cancer, heart failure, M. Parkinson, diabetic nephropathy or&#xD;
             neuropathy or cardiomyopathy&#xD;
&#xD;
         17. Severe hypoglycemia in the past 3 months (defined as seizure or loss of consciousness)&#xD;
&#xD;
         18. Alcohol or drug abuse other than nicotine&#xD;
&#xD;
         19. Precluding adequate understanding or cooperation&#xD;
&#xD;
         20. A condition requiring or likely to require magnetic resonance imaging (MRI) during the&#xD;
             study duration.&#xD;
&#xD;
         21. Any condition that in the investigator's opinion would make the subject unable to&#xD;
             complete the study&#xD;
&#xD;
         22. Participation in another clinical investigation within 30 days or intent to&#xD;
             participate during the study period&#xD;
&#xD;
         23. Patients with Diabetes mellitus Type 2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Danne, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kinder- und Jugendkrankenhaus AUF DER BULT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kinder- und Jugendkrankenhaus AUF DER BULT</name>
      <address>
        <city>Hannover</city>
        <state>Lower Saxony</state>
        <zip>30173</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>pediatrics</keyword>
  <keyword>blood sugar devices</keyword>
  <!-- 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/NCT03815552
org study id: IIT-FNH-01
nct id: NCT03815552
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this clinical investigation is to provide pilot clinical data to direct
      pivotal study development for the pediatric indication of the Senseonics Continuous Glucose
      Monitoring System (CGM) measurements when compared with finger stick blood glucose monitoring
      in an outpatient setting. (The investigation will also evaluate safety of the Senseonics CGM
      System usage, get feedback regarding subject and caregiver acceptability of the device and
      the mobile medical application (MMA).
This is a non-randomized, non-blinded, prospective, single-arm, single-center pilot study,
      enrolling up to 15 pediatric subjects in two cohorts (5 subjects age 6-12 and 10 subjects age
      13-17) with diabetes mellitus for up to 180 days. Study will evaluate the system at home with
      comparison to SMBG with clinic check visits and downloading of stored data every 30 days.
      Subjects will have one Sensor inserted subcutaneous by trained Investigators. The System will
      be set to provide real-time glucose information, including alarms and alerts in the home
      settings. The system is for adjunctive use. All diabetes care decisions will be based on SMBG
      values rather than System CGM results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time in range
time frame: 90 days
description: Reduction of time in range of Glucose < 70-mg/dL when using the Senseonics CGM System
measure: time of hypoglycemia
time frame: three weeks of the blinded phase compared to the last three weeks before 90 days visit
description: Percentage time of hypoglycemia (Glucose <70 mg/dL
arm group label: Eversense Continuous Glucose Monitoring
arm group type: Experimental
description: The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with type 1 Diabetes.The System will be set to provide realtime glucose information, including alarms and alerts in the home settings für 180 days.
intervention type: Device
intervention name: Eversense Continuous Glucose Monitoring
description: The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with diabetes for the operating life of the sensor.The System comprises a sensor and a transmitter. The small sensor will be subcutaneously inserted in the arm.The transmitter reads glucose data from the subcutaneous sensor.
arm group label: Eversense Continuous Glucose Monitoring
other name: Senseonics Continuous Glucose Monitoring System
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Thomas Danne, MD
role: Study Chair
affiliation: Kinder- und Jugendkrankenhaus AUF DER BULT
facility: 
country: Germany
responsible party type: Sponsor