<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/NCT04430608</url>
  </required_header>
  <id_info>
    <org_study_id>H-20025305</org_study_id>
    <nct_id>NCT04430608</nct_id>
  </id_info>
  <brief_title>Remote Continues Glucose Monitoring During the COVID-19 Pandemic in Quarantined Hospitalized Patients</brief_title>
  <acronym>CGM-ISO</acronym>
  <official_title>Remote Glucose Monitoring of Patients With Diabetes Quarantined During the COVID-19 Pandemic - a Hospital-Based Randomized Controlled Trial of the Effect of Remote Continuous Glucose Monitoring Compared to Usual Glucose Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordsjaellands Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nordsjaellands Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial of isolated patients with diabetes admitted to&#xD;
      Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring&#xD;
      (CGM) based system with transmission of glucose data to a central system is used for remote&#xD;
      monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to&#xD;
      patients) CGM is mounted in the finger-prick group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemics and pandemics are a constant threat to health care systems globally. This stresses&#xD;
      the importance of preparedness for a large amount of hospitalized quarantined patients in&#xD;
      isolation, with the extra challenges it brings. The COVID-19 pandemic challenges the Danish&#xD;
      health care system in many aspects: An increased number of citizens are expected to be&#xD;
      admitted to hospital due to COVID-19 infected pneumonia and this will demand extra workforce&#xD;
      resources, extra use of protective equipment (gowns, masks, gloves, etc) and extra time used&#xD;
      for taking protective equipment on and off. In concert these extra demands will drain the&#xD;
      health care system and any initiative to reduce these challenges is needed.&#xD;
&#xD;
      In this randomized controlled trial, isolated patients with diabetes will be randomized to&#xD;
      either standard care fingerprick glucose + blinded CGM or Dexcom G6 only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">May 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients are randomized 1:1 to either CGM or Fingerprick group</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time In Range (TIR) for blood glucose</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Saved patient-personnel contacts related to blood glucose measurements.</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose variations during hospitalization</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Additional glucose outcomes based on data from Dexcom G6 are for example Time Above Range (TAR), Time Below Range (TBR), average glucose, variance in glucose (CV), etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose lowering interventions</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>That is: Tablet-based and insulin-based regimens and number of times that sliding scale insulin (including dose of insulin) has been administered for each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM sensor performance</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Number of techincal errors during the sensors lifetime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Course of hospital stay.</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Hospital death (yes/no), length of stay at hospital, need for respiratory support (yes/no) and intensive care (yes/no), recovered vs. fatal (death within 60 days from admission).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Diabetes</condition>
  <condition>Covid-19</condition>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Fingerprick glucose</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard care with fingerprick glucose + blinded CGM stratification on COVID-19 status</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open continous glucose monitoring (CGM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard care with fingerprick glucose + un-blinded CGM stratification on COVID-19 status</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom G6</intervention_name>
    <description>The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. The Dexcom G6 sensor can last for 10 days without calibration and is approved for diabetes treatment decision making. Dexcom G6 has been extensively tested and is safe and approved even for pregnant women.&#xD;
The CE Marking confirms that the G6 system meets the Essential Requirements of the Medical Device Directive MDD 93/42/EEC as amended by 2007/47/EC.</description>
    <arm_group_label>Fingerprick glucose</arm_group_label>
    <arm_group_label>Open continous glucose monitoring (CGM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hospitalized with confirmed COVID-19 infection by real-time PCR or another validated&#xD;
             method OR hospitalized with a non-COVID-19 diagnosis AND in isolation at time of&#xD;
             inclusion.&#xD;
&#xD;
          2. A documented clinically relevant history of diabetes or newly discovered during&#xD;
             hospitalization.&#xD;
&#xD;
          3. Written informed consent obtained before any trial related procedures are performed.&#xD;
&#xD;
          4. Male or female aged over 18 years of age.&#xD;
&#xD;
          5. Must be able to communicate with the study personnel.&#xD;
&#xD;
          6. The subject must be willing and able to comply with trial protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Known hypersensitivity to the band-aid of the Dexcom G6 sensors&#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>Peter L. Kristensen, MD, ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nordsjællands Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carina Klarskov, MD</last_name>
    <phone>004548294829</phone>
    <email>carina.kirstine.klarskov@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peter L. Kristensen, MD, ph.D</last_name>
    <phone>004548294829</phone>
    <email>peter.lommer.kristensen.01@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nordsjællands Hospital</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter L. Kristensen, MD, ph.D</last_name>
      <phone>004548294829</phone>
      <email>peter.lommer.kristensen.01@regionh.dk</email>
    </contact>
    <contact_backup>
      <last_name>Carina Klarskov, MD</last_name>
      <phone>004548284829</phone>
      <email>carina.kirstine.klarskov@regionh.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endocrinology</keyword>
  <keyword>diabetes</keyword>
  <keyword>quarentine</keyword>
  <keyword>isolation</keyword>
  <keyword>CGM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Undecided, will be updated</ipd_description>
  </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/NCT04430608
org study id: H-20025305
nct id: NCT04430608
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a randomized controlled trial of isolated patients with diabetes admitted to
      Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring
      (CGM) based system with transmission of glucose data to a central system is used for remote
      monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to
      patients) CGM is mounted in the finger-prick group.
Epidemics and pandemics are a constant threat to health care systems globally. This stresses
      the importance of preparedness for a large amount of hospitalized quarantined patients in
      isolation, with the extra challenges it brings. The COVID-19 pandemic challenges the Danish
      health care system in many aspects: An increased number of citizens are expected to be
      admitted to hospital due to COVID-19 infected pneumonia and this will demand extra workforce
      resources, extra use of protective equipment (gowns, masks, gloves, etc) and extra time used
      for taking protective equipment on and off. In concert these extra demands will drain the
      health care system and any initiative to reduce these challenges is needed.

      In this randomized controlled trial, isolated patients with diabetes will be randomized to
      either standard care fingerprick glucose + blinded CGM or Dexcom G6 only.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomized 1:1 to either CGM or Fingerprick group
primary purpose: Other
masking: None (Open Label)
measure: Time In Range (TIR) for blood glucose
time frame: 1-2 weeks
description: TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges.
measure: Saved patient-personnel contacts related to blood glucose measurements.
time frame: 1-2 weeks
description: Saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization.
measure: Glucose variations during hospitalization
time frame: 1-2 weeks
description: Additional glucose outcomes based on data from Dexcom G6 are for example Time Above Range (TAR), Time Below Range (TBR), average glucose, variance in glucose (CV), etc.
measure: Blood glucose lowering interventions
time frame: 1-2 weeks
description: That is: Tablet-based and insulin-based regimens and number of times that sliding scale insulin (including dose of insulin) has been administered for each patient.
measure: CGM sensor performance
time frame: 1-2 weeks
description: Number of techincal errors during the sensors lifetime.
measure: Course of hospital stay.
time frame: 1-2 weeks
description: Hospital death (yes/no), length of stay at hospital, need for respiratory support (yes/no) and intensive care (yes/no), recovered vs. fatal (death within 60 days from admission).
arm group label: Fingerprick glucose
arm group type: Other
description: Standard care with fingerprick glucose + blinded CGM stratification on COVID-19 status
arm group label: Open continous glucose monitoring (CGM)
arm group type: Experimental
description: Standard care with fingerprick glucose + un-blinded CGM stratification on COVID-19 status
intervention type: Device
intervention name: Dexcom G6
description: The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. The Dexcom G6 sensor can last for 10 days without calibration and is approved for diabetes treatment decision making. Dexcom G6 has been extensively tested and is safe and approved even for pregnant women.
The CE Marking confirms that the G6 system meets the Essential Requirements of the Medical Device Directive MDD 93/42/EEC as amended by 2007/47/EC.
arm group label: Fingerprick glucose
arm group label: Open continous glucose monitoring (CGM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter L. Kristensen, MD, ph.D
role: Principal Investigator
affiliation: Nordsjællands Hospital
last name: Carina Klarskov, MD
phone: 004548294829
email: carina.kirstine.klarskov@regionh.dk
last name: Peter L. Kristensen, MD, ph.D
phone: 004548294829
email: peter.lommer.kristensen.01@regionh.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: Undecided, will be updated