xml: <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/NCT06012799</url>
    </required_header>
    <id_info>
      <org_study_id>SNUH-CGM-KT-V1.2</org_study_id>
      <nct_id>NCT06012799</nct_id>
    </id_info>
    <brief_title>Continuous Glucose Monitoring in Peri-operative Period in Kidney Transplant Recipients</brief_title>
    <official_title>Prospective Observational Study for Efficacy of Perioperative Serum Glucose Level Evaluated by Continuous Glucose Monitoring System in Kidney Transplantation Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        his study aims to utilize Continuous Glucose Monitoring (CGM) to observe glucose fluctuations&#xD;
        in kidney transplant recipients and predict New-Onset Diabetes After Transplantation (NODAT)&#xD;
        based on these patterns. Additionally, it seeks to investigate glucose variability resulting&#xD;
        from medications and surgeries such as immunosuppressants and steroid regimens post-kidney&#xD;
        transplantation. This prospective observational study anticipates identifying factors&#xD;
        influencing blood glucose levels and contributing to future research on blood glucose&#xD;
        management using CGM monitoring in kidney transplant patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2021</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of NODAT</measure>
      <time_frame>6 months after kidney transplantation</time_frame>
      <description>rate of new onset diabetes after transplantation</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>New Onset Diabetes After Transplantation</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>continuous glucose monitoring</intervention_name>
      <description>FreeStyle Libre Flash Glucose Monitoring System</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Kidney transplant patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The study will target 100 kidney transplant patients who have provided consent, among&#xD;
               those who underwent the procedure at Seoul National University Hospital after March&#xD;
               2021.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  multi-organ transplant&#xD;
  &#xD;
            -  history of previous kidney transplant&#xD;
  &#xD;
            -  less than 18 years old&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Jiyoung Sin, MD</last_name>
      <phone>82-10-6593-6503</phone>
      <email>taddy11119@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>110-744</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sang-Il Min, MD</last_name>
        <phone>82-2-2072-2330</phone>
        <email>surgeonmsi@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012799
  org study id: SNUH-CGM-KT-V1.2
  nct id: NCT06012799
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  his study aims to utilize Continuous Glucose Monitoring (CGM) to observe glucose fluctuations
        in kidney transplant recipients and predict New-Onset Diabetes After Transplantation (NODAT)
        based on these patterns. Additionally, it seeks to investigate glucose variability resulting
        from medications and surgeries such as immunosuppressants and steroid regimens post-kidney
        transplantation. This prospective observational study anticipates identifying factors
        influencing blood glucose levels and contributing to future research on blood glucose
        management using CGM monitoring in kidney transplant patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Rate of NODAT
  time frame: 6 months after kidney transplantation
  description: rate of new onset diabetes after transplantation
  intervention type: Diagnostic Test
  intervention name: continuous glucose monitoring
  description: FreeStyle Libre Flash Glucose Monitoring System
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Jiyoung Sin, MD
  phone: 82-10-6593-6503
  email: taddy11119@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  sharing ipd: No