<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/NCT03249974</url>
  </required_header>
  <id_info>
    <org_study_id>JessaH_B243201732756</org_study_id>
    <nct_id>NCT03249974</nct_id>
  </id_info>
  <brief_title>Comparison Between Enlite and Flash Glucose Monitoring</brief_title>
  <official_title>A Comparative Study on the Accuracy, Ease of Use and Skin Reactions Between the Enlite Sensor With Guardian 2 Link Transmitter and the FreeStyle Libre Flash Glucose Sensor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jessa Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with&#xD;
           a standardized breakfast test. Patients receive a standardized breakfast. The usual&#xD;
           insulin bolus will be administered at breakfast. After breakfast, a venous blood sample&#xD;
           is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time,&#xD;
           the glucose value shown by the sensors will be noted. A comparison of the blood glucose&#xD;
           value with the data recorded by the sensor can evaluate the accuracy of the sensor and&#xD;
           also estimate the lag-time between the sensor glucose and the venous glucose.&#xD;
&#xD;
        2. Patient satisfaction will be evaluated using a questionnaire that will be completed&#xD;
           after the Enlite sensor has been worn for 1 month.&#xD;
&#xD;
        3. The development of skin reactions will be checked by a short questionnaire, supplemented&#xD;
           with a picture of possible skin phenomena.&#xD;
&#xD;
        4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within&#xD;
           target,% under target, amount of hypoglycemia) in the month prior to sensor switching&#xD;
           will be compared to the same data recorded by the Enlite sensor during the first month&#xD;
           of use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">July 4, 2018</completion_date>
  <primary_completion_date type="Actual">July 4, 2018</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>Accuracy of Enlite sensor</measure>
    <time_frame>2 hours</time_frame>
    <description>The accuracy of the sensors (flash vs enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability of Enlite sensor</measure>
    <time_frame>1 month</time_frame>
    <description>Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin reactions wih Enlite sensor</measure>
    <time_frame>1 month</time_frame>
    <description>The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Type1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Target group</arm_group_label>
    <description>Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Enlite sensor communicating with Minimed 640G pump</intervention_name>
    <description>Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump</description>
    <arm_group_label>Target group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and&#xD;
        wearing a FreeStyle Flash Libre glucosesensor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children (5 to 18 years)&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes mellitus&#xD;
&#xD;
          -  Treatment is an insulin pump and wearing a FreeStyle Flash Libre glucosesensor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guy Massa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jessa Hospital, hasselt, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>July 10, 2018</last_update_submitted>
  <last_update_submitted_qc>July 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Enlite glucose monitoring</keyword>
  <keyword>accuracy</keyword>
  <keyword>usability</keyword>
  <keyword>skin reactions</keyword>
  <keyword>type 1 diabetes mellitus</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>
  <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/NCT03249974
org study id: JessaH_B243201732756
nct id: NCT03249974
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with
           a standardized breakfast test. Patients receive a standardized breakfast. The usual
           insulin bolus will be administered at breakfast. After breakfast, a venous blood sample
           is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time,
           the glucose value shown by the sensors will be noted. A comparison of the blood glucose
           value with the data recorded by the sensor can evaluate the accuracy of the sensor and
           also estimate the lag-time between the sensor glucose and the venous glucose.

        2. Patient satisfaction will be evaluated using a questionnaire that will be completed
           after the Enlite sensor has been worn for 1 month.

        3. The development of skin reactions will be checked by a short questionnaire, supplemented
           with a picture of possible skin phenomena.

        4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within
           target,% under target, amount of hypoglycemia) in the month prior to sensor switching
           will be compared to the same data recorded by the Enlite sensor during the first month
           of use.
observational model: Case-Only
time perspective: Prospective
measure: Accuracy of Enlite sensor
time frame: 2 hours
description: The accuracy of the sensors (flash vs enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose.
measure: Usability of Enlite sensor
time frame: 1 month
description: Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month.
measure: skin reactions wih Enlite sensor
time frame: 1 month
description: The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena.
arm group label: Target group
description: Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump
intervention type: Device
intervention name: Enlite sensor communicating with Minimed 640G pump
description: Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump
arm group label: Target group
blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Guy Massa, MD, PhD
role: Principal Investigator
affiliation: Jessa Hospital, hasselt, Belgium
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No