<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/NCT03296995</url>
  </required_header>
  <id_info>
    <org_study_id>SHRJ001</org_study_id>
    <nct_id>NCT03296995</nct_id>
  </id_info>
  <brief_title>Accuracy, Feasibility and Acceptance of CGM Lupus</brief_title>
  <official_title>Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective monocenter, non-randomised, open-lable single-group intervention&#xD;
      diagnostic trial on the accuracy, reliability and feasibility of the continuous glucose&#xD;
      monitoring system in critically systemic lupus erythematosus (SLE). Newly developed&#xD;
      technologies for continuous glucose monitoring in critically SLE patients may improve&#xD;
      glycemic control and reduce glucose variability. Critically SLE patients will be performed by&#xD;
      continuous glucose monitoring. The subcutaneous glucose will be continuously monitored in&#xD;
      critical SLE patients by freestyle libre glucose monitoring system for 14 days. The aim of&#xD;
      this study is to evaluate accuracy feasibility and acceptance of these methods. To analyze&#xD;
      accuracy sensor glucose levels will be validated due to venous blood measurements with&#xD;
      glucose oxidase methods. The influence of several factors like oedema, perspiration, BMI,&#xD;
      body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the&#xD;
      particular system would be evaluated. Furthermore the acceptance of physicians and Nursing&#xD;
      staff would be evaluated by a questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of continuous glucose monitoring compared to glucose oxidase method</measure>
    <time_frame>7 d</time_frame>
    <description>Difference between glucose values of continuous glucose monitoring and blood gas analyses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of continuous glucose monitoring</measure>
    <time_frame>7 d</time_frame>
    <description>Problems within the application of sensor and monitoring during ward routine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of continuous glucose monitoring by physicians and nursing staff</measure>
    <time_frame>7 d</time_frame>
    <description>Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Technical problems with the monitoring</measure>
    <time_frame>7 d</time_frame>
    <description>Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Critical Illness</condition>
  <condition>Diabetic Blood Glucose Monitoring</condition>
  <arm_group>
    <arm_group_label>flash glucose monitoring system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the arm measure blood glucose by flash glucose monitoring system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flash glucose monitoring system</intervention_name>
    <description>Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.</description>
    <arm_group_label>flash glucose monitoring system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11&#xD;
             classification criteria of American College of Rheumatology for the classification of&#xD;
             systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria&#xD;
             doesn't need to be present at the time of study enrollment;&#xD;
&#xD;
          -  critically SLE patients&#xD;
&#xD;
          -  informed consent by the patients or legal proxy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18&#xD;
&#xD;
          -  no informed consent by the patients or legal proxy&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  infaust prognosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shuang Ye, MD</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuang Ye, MD</last_name>
      <phone>+8613817615871</phone>
      <email>ye_shuang2000@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Huijing Wang, postgraduate</last_name>
      <phone>+8618267851823</phone>
      <email>whj30813@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glucose</keyword>
  <keyword>systemic lupus erythematosus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_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/NCT03296995
org study id: SHRJ001
nct id: NCT03296995
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective monocenter, non-randomised, open-lable single-group intervention
      diagnostic trial on the accuracy, reliability and feasibility of the continuous glucose
      monitoring system in critically systemic lupus erythematosus (SLE). Newly developed
      technologies for continuous glucose monitoring in critically SLE patients may improve
      glycemic control and reduce glucose variability. Critically SLE patients will be performed by
      continuous glucose monitoring. The subcutaneous glucose will be continuously monitored in
      critical SLE patients by freestyle libre glucose monitoring system for 14 days. The aim of
      this study is to evaluate accuracy feasibility and acceptance of these methods. To analyze
      accuracy sensor glucose levels will be validated due to venous blood measurements with
      glucose oxidase methods. The influence of several factors like oedema, perspiration, BMI,
      body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the
      particular system would be evaluated. Furthermore the acceptance of physicians and Nursing
      staff would be evaluated by a questionnaire.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Accuracy of continuous glucose monitoring compared to glucose oxidase method
time frame: 7 d
description: Difference between glucose values of continuous glucose monitoring and blood gas analyses
measure: Feasibility of continuous glucose monitoring
time frame: 7 d
description: Problems within the application of sensor and monitoring during ward routine
measure: Acceptance of continuous glucose monitoring by physicians and nursing staff
time frame: 7 d
description: Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire
measure: Technical problems with the monitoring
time frame: 7 d
description: Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.
arm group label: flash glucose monitoring system
arm group type: Experimental
description: Subjects in the arm measure blood glucose by flash glucose monitoring system.
intervention type: Device
intervention name: Flash glucose monitoring system
description: Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.
arm group label: flash glucose monitoring system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
mesh term: Critical Illness