<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/NCT04473001</url>
  </required_header>
  <id_info>
    <org_study_id>H-20002220</org_study_id>
    <nct_id>NCT04473001</nct_id>
  </id_info>
  <brief_title>Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring</brief_title>
  <acronym>WARD-CGM</acronym>
  <official_title>Continuous Glucose Measurements to Detect Hypoglycemia in Patients Undergoing Major Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Bispebjerg and Frederiksberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Bispebjerg and Frederiksberg</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>
      The applicant and research team partners have over the last years developed the WARD project&#xD;
      (Wireless Assessment of Respiratory and circulatory Distress), using wireless continuous&#xD;
      monitoring of vital signs in high-risk patients undergoing major abdominal surgery. An&#xD;
      important perioperative indicator not currently included in the WARD project is continuous&#xD;
      glucose monitoring (CGM), which may not only predict and identify hypo- and hyperglycemia,&#xD;
      but also utilize the information from variations in blood glucose in combination with other&#xD;
      changes in vital signs to predict surgical complications in all patients.&#xD;
&#xD;
      The current study involves the inclusion of 80 patients, scheduled for major abdominal,&#xD;
      orthopedic or vascular surgery, to be monitored with CGM in addition to the currently&#xD;
      measured vital signs. The project is a prospective, observational, clinical study, describing&#xD;
      and analyzing variations in perioperative blood glucose levels and vital signs, and the&#xD;
      relation to adverse clinical outcomes.&#xD;
&#xD;
      Patients scheduled for elective surgery will preferentially be recruited at the preoperative&#xD;
      assessment at a maximum of 30 days before surgery. CGM and monitoring of the remaining vital&#xD;
      sign modalities will commence on the day of surgery. Patients admitted for acute surgery will&#xD;
      be recruited preoperatively and CGM as well monitoring of the remaining vital sign modalities&#xD;
      will commence as soon as possible. The patients will be monitored with CGM for up to 10 days&#xD;
      and with the remaining modalities for up to 5 days or for all modalities until discharge or&#xD;
      withdrawal of consent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</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>Hypoglycemia</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Duration of glucose levels &lt; 3.9 mmol/L as measured by continuous glucose monitoring (CGM)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active CGM</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>% of study time with active CGM and data stored on the secure server</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Glycemic variability (%CV, SD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean glucose</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Mean glucose (mmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycemic events</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Median number of hypoglycemic events per patient per day; glucose &lt; 3.9 mmol/L, &gt;15 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severe hypoglycemic events</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Median number of severe hypoglycemic events per patient per day; glucose &lt; 3.0 mmol/L, &gt;15 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of fasting hypoglycemia events</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Median number of hypoglycemia events during perioperative fasting; glucose &lt; 3.9 mmol/L, &gt;15 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of fasting hypoglycemia events</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Duration of hypoglycemia events during perioperative fasting, glucose &lt; 3.9 mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of readings and time below range (TBR)</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>% of readings and time in range 3.0-3.8 mmol/L&#xD;
% of readings and time &lt;3.0 mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of readings and time in range (TIR)</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>○ % of readings and time in range 3.9-10.0 mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of readings and time above range (TAR)</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>% of readings and time in range 10.1-13.9 mmol/L.&#xD;
% of readings and time &gt;13.9 mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse clinical outcomes</measure>
    <time_frame>Until 30 days after monitoring is commenced</time_frame>
    <description>Occurrence and severity of a range of predefined adverse clinical outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission or death</measure>
    <time_frame>Until 6 months after monitoring is commenced</time_frame>
    <description>Occurrence of readmission and/or death.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Agreement between CGM and plasma glucose (PG)</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Level of agreement between CGM and concomitant PG measurements.</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of hypoglycemia as measured by PG</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Duration of glucose levels &lt; 3.9 mmol/L as measured by plasma glucose (defined as time from first measurement &lt; 3.9 mmol/L, until first measurement &gt; 3.9 mmol/L).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of PG measurements</measure>
    <time_frame>Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)</time_frame>
    <description>Median number of bedside PG measurements.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Hypoglycemia</condition>
  <condition>Perioperative Complication</condition>
  <arm_group>
    <arm_group_label>Surgical patients</arm_group_label>
    <description>Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous vital signs and glucose monitoring</intervention_name>
    <description>The patients will have the following parameters and vital signs continuously monitored using wireless equipment:&#xD;
Glucose measurements (quasi-continuous, every 5 minutes)&#xD;
Heart rate&#xD;
Heart rhythm (single-lead ECG; quasi-continuous, 10 seconds every minute)&#xD;
Signs of cardiac ischemia (single-lead ECG; quasi-continuous, 10 seconds every minute)&#xD;
Respiration rate&#xD;
Oxygen saturation of arterial hemoglobin (%SpO2)&#xD;
Perfusion index (ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue)&#xD;
Blood pressure (quasi-continuous; every 30-60 minutes)&#xD;
Skin temperature&#xD;
Electrodermal activity&#xD;
Ambulatory activity (accelerometry)</description>
    <arm_group_label>Surgical patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years) admitted to Rigshospitalet or Bispebjerg Hospital for major&#xD;
             abdominal surgery (e.g. colonic resections, gastrectomy, hepatic resection etc.) or&#xD;
             major orthopedic surgery (e.g. hip-fracture, hip and knee-arthroplasty) or major&#xD;
             arterial vascular surgery (e.g. aortic aneurysm, iliac or femoral bypass etc.)&#xD;
&#xD;
          -  Estimated duration of surgery ≥1 hour and at least one expected overnight stay&#xD;
             postoperatively&#xD;
&#xD;
        AND&#xD;
&#xD;
        ● Type 1 diabetes (Clinically defined: insulin initiated at diabetes onset and treatment&#xD;
        with multiple doses of insulin or continuous subcutaneous insulin infusion) (n=20)&#xD;
&#xD;
        OR&#xD;
&#xD;
        ● Type 2 diabetes treated with insulin (Clinically defined: treatment with diet or oral&#xD;
        antidiabetic drugs for at least 6 months before insulin was started) (n =20)&#xD;
&#xD;
        OR&#xD;
&#xD;
        ● Type 2 diabetes treated with oral antihyperglycemic drugs and/or GLP-1 analogs (n=20)&#xD;
&#xD;
        OR&#xD;
&#xD;
        ● No diabetes mellitus (excluded by an admission HbA1c &lt;48 mmol/mol) (n=20)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient expected not to cooperate with study procedures.&#xD;
&#xD;
          -  Patient allergic to plaster or silicone.&#xD;
&#xD;
          -  Patients with impaired cognitive function (assessed by a Mini Mental State Examination&#xD;
             [MMSE] score &lt;24)&#xD;
&#xD;
          -  Patients admitted for palliative care only.&#xD;
&#xD;
          -  Previous or currently scheduled for pancreatectomy (complete or partial)&#xD;
&#xD;
          -  Patients with pacemaker or implantable cardioverter defibrillator (ICD) device&#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>Eske K Aasvang, MD, DMSc</last_name>
    <role>Study Director</role>
    <affiliation>Rigshospitalet, Centre for Cancer and Organ Diseases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Danmark</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <state>Danmark</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Bispebjerg and Frederiksberg</investigator_affiliation>
    <investigator_full_name>Christian Jakob Carlsson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</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/NCT04473001
org study id: H-20002220
nct id: NCT04473001
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The applicant and research team partners have over the last years developed the WARD project
      (Wireless Assessment of Respiratory and circulatory Distress), using wireless continuous
      monitoring of vital signs in high-risk patients undergoing major abdominal surgery. An
      important perioperative indicator not currently included in the WARD project is continuous
      glucose monitoring (CGM), which may not only predict and identify hypo- and hyperglycemia,
      but also utilize the information from variations in blood glucose in combination with other
      changes in vital signs to predict surgical complications in all patients.

      The current study involves the inclusion of 80 patients, scheduled for major abdominal,
      orthopedic or vascular surgery, to be monitored with CGM in addition to the currently
      measured vital signs. The project is a prospective, observational, clinical study, describing
      and analyzing variations in perioperative blood glucose levels and vital signs, and the
      relation to adverse clinical outcomes.

      Patients scheduled for elective surgery will preferentially be recruited at the preoperative
      assessment at a maximum of 30 days before surgery. CGM and monitoring of the remaining vital
      sign modalities will commence on the day of surgery. Patients admitted for acute surgery will
      be recruited preoperatively and CGM as well monitoring of the remaining vital sign modalities
      will commence as soon as possible. The patients will be monitored with CGM for up to 10 days
      and with the remaining modalities for up to 5 days or for all modalities until discharge or
      withdrawal of consent.
observational model: Cohort
time perspective: Prospective
measure: Hypoglycemia
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Duration of glucose levels < 3.9 mmol/L as measured by continuous glucose monitoring (CGM)
measure: Active CGM
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: % of study time with active CGM and data stored on the secure server
measure: Glycemic variability
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Glycemic variability (%CV, SD)
measure: Mean glucose
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Mean glucose (mmol/L).
measure: Number of hypoglycemic events
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Median number of hypoglycemic events per patient per day; glucose < 3.9 mmol/L, >15 minutes
measure: Number of severe hypoglycemic events
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Median number of severe hypoglycemic events per patient per day; glucose < 3.0 mmol/L, >15 minutes
measure: Number of fasting hypoglycemia events
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Median number of hypoglycemia events during perioperative fasting; glucose < 3.9 mmol/L, >15 minutes
measure: Duration of fasting hypoglycemia events
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Duration of hypoglycemia events during perioperative fasting, glucose < 3.9 mmol/L
measure: % of readings and time below range (TBR)
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: % of readings and time in range 3.0-3.8 mmol/L
% of readings and time <3.0 mmol/L
measure: % of readings and time in range (TIR)
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: ○ % of readings and time in range 3.9-10.0 mmol/L.
measure: % of readings and time above range (TAR)
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: % of readings and time in range 10.1-13.9 mmol/L.
% of readings and time >13.9 mmol/L.
measure: Adverse clinical outcomes
time frame: Until 30 days after monitoring is commenced
description: Occurrence and severity of a range of predefined adverse clinical outcomes.
measure: Readmission or death
time frame: Until 6 months after monitoring is commenced
description: Occurrence of readmission and/or death.
measure: Agreement between CGM and plasma glucose (PG)
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Level of agreement between CGM and concomitant PG measurements.
measure: Duration of hypoglycemia as measured by PG
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Duration of glucose levels < 3.9 mmol/L as measured by plasma glucose (defined as time from first measurement < 3.9 mmol/L, until first measurement > 3.9 mmol/L).
measure: Number of PG measurements
time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
description: Median number of bedside PG measurements.
arm group label: Surgical patients
description: Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.
intervention type: Other
intervention name: Continuous vital signs and glucose monitoring
description: The patients will have the following parameters and vital signs continuously monitored using wireless equipment:
Glucose measurements (quasi-continuous, every 5 minutes)
Heart rate
Heart rhythm (single-lead ECG; quasi-continuous, 10 seconds every minute)
Signs of cardiac ischemia (single-lead ECG; quasi-continuous, 10 seconds every minute)
Respiration rate
Oxygen saturation of arterial hemoglobin (%SpO2)
Perfusion index (ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue)
Blood pressure (quasi-continuous; every 30-60 minutes)
Skin temperature
Electrodermal activity
Ambulatory activity (accelerometry)
arm group label: Surgical patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eske K Aasvang, MD, DMSc
role: Study Director
affiliation: Rigshospitalet, Centre for Cancer and Organ Diseases
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital Bispebjerg and Frederiksberg
investigator full name: Christian Jakob Carlsson
investigator title: Principal Investigator
mesh term: Hypoglycemia