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/NCT06011473</url>
    </required_header>
    <id_info>
      <org_study_id>NKBBN/780/2022</org_study_id>
      <nct_id>NCT06011473</nct_id>
    </id_info>
    <brief_title>Continuous Glucose Monitoring for Colorectal Cancer</brief_title>
    <acronym>CGM-CRC</acronym>
    <official_title>Continuous Glucose Monitoring for Colorectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Gdansk</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Gdansk</source>
    <oversight_info>
      <has_dmc>No</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>
        Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and&#xD;
        trauma. It has been shown that improper glycemia control leads to impaired wound healing and&#xD;
        a higher risk of other postoperative complications.&#xD;
  &#xD;
        The primary aim of our project is to assess the feasibility of the use of continuous glucose&#xD;
        monitoring in measuring blood glucose levels in patients undergoing colorectal cancer&#xD;
        surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to&#xD;
        understand the effects of stress and intraoperative interventions on the blood glucose level.&#xD;
        The tertiary goal is to assess the predictive value of hyperglycemia for surgical site&#xD;
        infection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and&#xD;
        trauma. It has been shown that improper glycemia control leads to impaired wound healing and&#xD;
        a higher risk of other postoperative complications. However, glucose levels measured in&#xD;
        patients before surgery are taken infrequently, and there remains controversy regarding&#xD;
        optimal management. Usually, a blood glucose meter is used to measure non-fasted blood&#xD;
        glucose concentrations, and a single-point measurement can easily misrepresent the actual&#xD;
        glycemic control. Continuous glucose monitoring allows for a minimally invasive real-time&#xD;
        remote glycemia control and is providing insights into glucose regulation in patients,&#xD;
        demonstrating significant periods of clinically silent hypoglycemia and hyperglycemia.&#xD;
  &#xD;
        The primary aim of our project is to assess the feasibility of the use of CGM in measuring&#xD;
        blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is&#xD;
        to analyze changes in perioperative blood glucose levels to understand the effects of stress&#xD;
        and intraoperative interventions on the blood glucose level. The tertiary goal is to assess&#xD;
        the predictive value of hyperglycemia for surgical site infection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 27, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>feasibility of CGM system</measure>
      <time_frame>10 days</time_frame>
      <description>measured as the drop-out rate caused by non-adherence of both patients and medical staff due to system detaching, problems with the receiving device (low battery. distance beyond Bluetooth communication range) etc.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>perioperative glycemia</measure>
      <time_frame>10 days</time_frame>
      <description>number of hyperglycemia episodes impact of stress and intraoperative interventions on the blood glucose level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SSI rate</measure>
      <time_frame>30 days</time_frame>
      <description>Surgical Site Infection according to Centre for Disease Control criteria:&#xD;
  Infection occurring within the first 30 post-operative days with at least one of the following:&#xD;
  Purulent drainage from the incision Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision&#xD;
  Incision is deliberately opened by a surgeon AND at least one of the following signs/symptoms of infection:&#xD;
  Pain or tenderness Localized swelling Redness Heat Diagnosis of SSI by the surgeon or attending physician</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Continuous Glucose Monitoring</condition>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study subjects submitted to the General Surgery Clinic for colorectal surgery. On admission day, patients will have a CGM sensor placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Glycemia will be continuously monitored for 10 days. The CGM sensor will be taken off during visit in Outpatient Clinic.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CGM (FreeStyle Libre 3)</intervention_name>
      <description>FreeStyle Libre 3 system consists of a sensor that measures interstitial glycemia every minute and a dedicated application on mobile phone. Measurements are transmitted via Bluetooth to a mobile phone, that collects the data in the mobile application. Moreover, the study subject's application is connected to the doctor's application which allows remote real-time glycemia monitoring on another device.&#xD;
  Other Name: continuous glucose monitoring, CGM, FreeStyle Libre 3</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  written informed consent&#xD;
  &#xD;
            -  confirmed colorectal cancer qualified for surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients who will be unable or will refuse to express informed concern&#xD;
  &#xD;
            -  pregnant women&#xD;
  &#xD;
            -  people undergoing dialysis treatment&#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>Magdalena Antoszewska, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>MUG Division of Dermatology, Venereology and Allergology</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Piotr Spychalski, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>MUG Division of General Surgery</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jarosław Kobiela, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>MUG Division of General Surgery</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Magdalena Antoszewska, MD</last_name>
      <phone>+48698748705</phone>
      <email>magdalena.antoszewska@gumed.edu.pl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Piotr Spychalski, MD, PhD</last_name>
      <phone>+48 667 843 555</phone>
      <email>piotr.spychalski@gumed.edu.pl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UCC Division of Oncological, Transplant and General Surgery</name>
        <address>
          <city>Gdańsk</city>
          <state>Pomeranian</state>
          <zip>80-214</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Magdalena Antoszewska, MD</last_name>
        <phone>+48698748705</phone>
        <email>magdalena.antoszewska@gumed.edu.pl</email>
      </contact>
      <investigator>
        <last_name>Magdalena Antoszewska, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Piotr Spychalski, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jarosław Kobiela, Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <reference>
      <citation>McConnell YJ, Johnson PM, Porter GA. Surgical site infections following colorectal surgery in patients with diabetes: association with postoperative hyperglycemia. J Gastrointest Surg. 2009 Mar;13(3):508-15. doi: 10.1007/s11605-008-0734-1. Epub 2008 Nov 11.</citation>
      <PMID>19002535</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cgm</keyword>
    <keyword>Colorectal Cancer</keyword>
    <keyword>continuous glucose monitoring</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <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/NCT06011473
  org study id: NKBBN/780/2022
  nct id: NCT06011473
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and
        trauma. It has been shown that improper glycemia control leads to impaired wound healing and
        a higher risk of other postoperative complications.
  
        The primary aim of our project is to assess the feasibility of the use of continuous glucose
        monitoring in measuring blood glucose levels in patients undergoing colorectal cancer
        surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to
        understand the effects of stress and intraoperative interventions on the blood glucose level.
        The tertiary goal is to assess the predictive value of hyperglycemia for surgical site
        infection.
  Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and
        trauma. It has been shown that improper glycemia control leads to impaired wound healing and
        a higher risk of other postoperative complications. However, glucose levels measured in
        patients before surgery are taken infrequently, and there remains controversy regarding
        optimal management. Usually, a blood glucose meter is used to measure non-fasted blood
        glucose concentrations, and a single-point measurement can easily misrepresent the actual
        glycemic control. Continuous glucose monitoring allows for a minimally invasive real-time
        remote glycemia control and is providing insights into glucose regulation in patients,
        demonstrating significant periods of clinically silent hypoglycemia and hyperglycemia.
  
        The primary aim of our project is to assess the feasibility of the use of CGM in measuring
        blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is
        to analyze changes in perioperative blood glucose levels to understand the effects of stress
        and intraoperative interventions on the blood glucose level. The tertiary goal is to assess
        the predictive value of hyperglycemia for surgical site infection.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: feasibility of CGM system
  time frame: 10 days
  description: measured as the drop-out rate caused by non-adherence of both patients and medical staff due to system detaching, problems with the receiving device (low battery. distance beyond Bluetooth communication range) etc.
  measure: perioperative glycemia
  time frame: 10 days
  description: number of hyperglycemia episodes impact of stress and intraoperative interventions on the blood glucose level
  measure: SSI rate
  time frame: 30 days
  description: Surgical Site Infection according to Centre for Disease Control criteria:
  Infection occurring within the first 30 post-operative days with at least one of the following:
  Purulent drainage from the incision Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision
  Incision is deliberately opened by a surgeon AND at least one of the following signs/symptoms of infection:
  Pain or tenderness Localized swelling Redness Heat Diagnosis of SSI by the surgeon or attending physician
  arm group label: Experimental
  arm group type: Experimental
  description: Study subjects submitted to the General Surgery Clinic for colorectal surgery. On admission day, patients will have a CGM sensor placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Glycemia will be continuously monitored for 10 days. The CGM sensor will be taken off during visit in Outpatient Clinic.
  intervention type: Device
  intervention name: CGM (FreeStyle Libre 3)
  description: FreeStyle Libre 3 system consists of a sensor that measures interstitial glycemia every minute and a dedicated application on mobile phone. Measurements are transmitted via Bluetooth to a mobile phone, that collects the data in the mobile application. Moreover, the study subject's application is connected to the doctor's application which allows remote real-time glycemia monitoring on another device.
  Other Name: continuous glucose monitoring, CGM, FreeStyle Libre 3
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Magdalena Antoszewska, MD
  role: Principal Investigator
  affiliation: MUG Division of Dermatology, Venereology and Allergology
  last name: Piotr Spychalski, MD, PhD
  role: Principal Investigator
  affiliation: MUG Division of General Surgery
  last name: Jarosław Kobiela, Prof.
  role: Principal Investigator
  affiliation: MUG Division of General Surgery
  last name: Magdalena Antoszewska, MD
  phone: +48698748705
  email: magdalena.antoszewska@gumed.edu.pl
  last name: Piotr Spychalski, MD, PhD
  phone: +48 667 843 555
  email: piotr.spychalski@gumed.edu.pl
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Poland
  citation: McConnell YJ, Johnson PM, Porter GA. Surgical site infections following colorectal surgery in patients with diabetes: association with postoperative hyperglycemia. J Gastrointest Surg. 2009 Mar;13(3):508-15. doi: 10.1007/s11605-008-0734-1. Epub 2008 Nov 11.
  PMID: 19002535
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  sharing ipd: No