<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/NCT04417270</url>
  </required_header>
  <id_info>
    <org_study_id>20-0455</org_study_id>
    <nct_id>NCT04417270</nct_id>
  </id_info>
  <brief_title>Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge</brief_title>
  <official_title>Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The FDA has provided an emergency waiver for the use of non-invasive continuous glucose&#xD;
      monitors (CGM) in hospitals, so frontline health care providers (in hospitals) can remotely&#xD;
      monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to&#xD;
      COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre&#xD;
      14-day system is a continuous glucose monitoring system consisting of a handheld reader&#xD;
      (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. In&#xD;
      order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a&#xD;
      study which will examine the correlation between the libre CGM data and capillary blood&#xD;
      glucose test - the current standard of care taken by the Accuchek Inform II platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In hospitalized patients diagnosed with COVID-19, diabetes mellitus is associated with a&#xD;
      higher mortality. Patients with controlled blood glucose have a lower mortality rate than&#xD;
      those who are uncontrolled. However, a rigid blood glucose control - which may lead to&#xD;
      hypoglycemia- is associated with higher mortality rates. Thus, adequate glucose monitoring is&#xD;
      important for hospitalized diabetic patients.&#xD;
&#xD;
      Previous studies have shown that CGMS, in the outpatient setting, engender better glycemic&#xD;
      control thereby reducing risk of hypoglycemia. CGMS offer a replacement for finger stick&#xD;
      blood glucose monitoring which may not identify an incidence of hypoglycemia until symptoms&#xD;
      drive the patient to test. Furthermore, finger stick blood glucose monitoring is painful and&#xD;
      time consuming thus causing many patients to avoid this aspect of diabetes self-care&#xD;
      management.&#xD;
&#xD;
      Freestyle Libre CGMs sample interstitial fluid glucose subcutaneously. Measurement&#xD;
      frequencies typically range from 1 to 15 minutes and most commonly are every 5 minutes.&#xD;
&#xD;
      Previous studies in hospitalized patients living with diabetes mellitus on basal bolus&#xD;
      regimen have shown:&#xD;
&#xD;
      • Use of the CGM increased detection of both hypoglycemic and hyperglycemic events versus&#xD;
      those sensed by POCT.&#xD;
&#xD;
      One investigation identified 88 postprandial hyperglycemic excursions in patients with CGM&#xD;
      use as opposed to 61 in those with POCT. Another noted that when comparing the CGM use with&#xD;
      that of POCT, the former identified 55 hypoglycemic events whereas the latter only found 12.&#xD;
&#xD;
      • No difference in mean daily glucose CGM and POCT readings. In a study of 38 patients, the&#xD;
      investigators noted no difference in mean daily glucose between the CGM and POCT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Patients will use the Freestyle 14 day CGM reader or their phone to check their glucose. A clinical staff member will check the patient's blood sugar by performing a glucose finger stick with the Accuchek inform II meter.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of values between two devices</measure>
    <time_frame>Through end of patient hospitalization, an average of 14 days</time_frame>
    <description>Correlation between blood glucose results from the Freestlye Libre 14-day CGM and Accuchek Inform II platform using the Bland-Altman method to determine whether the two glucose methods agree</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Freestyle Libre 14-day CGM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Accuchek Inform II meter</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ACCU-CHEK INFORM II system quantitatively measures glucose in fresh venous, arterial, neonatal heel stick and capillary whole blood from the finger and is used as an aid in monitoring the effectiveness of glucose control</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Freestyle Libre 14 day CGM system</intervention_name>
    <description>The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.</description>
    <arm_group_label>Accuchek Inform II meter</arm_group_label>
    <arm_group_label>Freestyle Libre 14-day CGM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accuchek Inform II platform</intervention_name>
    <description>The Accu-Chek Inform II system is designed to deliver data with speed and efficiency, helping to provide optimal care. Wireless meter quickly transfers data. The Accu-Chek Inform II system is the first point-of-care blood glucose device to offer truly wireless technology at the meter level.</description>
    <arm_group_label>Accuchek Inform II meter</arm_group_label>
    <arm_group_label>Freestyle Libre 14-day CGM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants acquired from among all non-critical care in patients who are living with&#xD;
             Diabetes Mellitus. Because the patients will have to be instructed on the use of the&#xD;
             CGM, this study will be limited to English speaking/reading adults (18 years of age or&#xD;
             older), who possess the cognitive and physical ability to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors, pregnant women, and critically ill.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renee Murray-Bachmann, Ed.D, MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://doi.org/10.1007/s13300-016-0223-6</url>
    <description>Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: A Multicenter, Open-Label Randomize</description>
  </link>
  <link>
    <url>http://doi.org/10.1016/j.cmet.2020.04.021</url>
    <description>Zhu, L., Zhi-Gang, S., Cheng, S., Guo, J., Bing-Hong, Z.,Hongliang, L. (2020).Association of blood glucose control and outcomes in patients with COVID-19 and pre-existing Type 2 Diabetes Cell Metabolism, 31, (2020).pp.1-10</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The team has not decided whether to share the results with other researchers. The team will consider publishing results after study completion</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>February 14, 2022</submitted>
    <returned>February 17, 2022</returned>
    <submitted>March 22, 2023</submitted>
    <returned>April 13, 2023</returned>
    <submitted>April 24, 2023</submitted>
    <returned>May 17, 2023</returned>
  </pending_results>
  <!-- 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/NCT04417270
org study id: 20-0455
nct id: NCT04417270
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The FDA has provided an emergency waiver for the use of non-invasive continuous glucose
      monitors (CGM) in hospitals, so frontline health care providers (in hospitals) can remotely
      monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to
      COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre
      14-day system is a continuous glucose monitoring system consisting of a handheld reader
      (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. In
      order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a
      study which will examine the correlation between the libre CGM data and capillary blood
      glucose test - the current standard of care taken by the Accuchek Inform II platform.
In hospitalized patients diagnosed with COVID-19, diabetes mellitus is associated with a
      higher mortality. Patients with controlled blood glucose have a lower mortality rate than
      those who are uncontrolled. However, a rigid blood glucose control - which may lead to
      hypoglycemia- is associated with higher mortality rates. Thus, adequate glucose monitoring is
      important for hospitalized diabetic patients.

      Previous studies have shown that CGMS, in the outpatient setting, engender better glycemic
      control thereby reducing risk of hypoglycemia. CGMS offer a replacement for finger stick
      blood glucose monitoring which may not identify an incidence of hypoglycemia until symptoms
      drive the patient to test. Furthermore, finger stick blood glucose monitoring is painful and
      time consuming thus causing many patients to avoid this aspect of diabetes self-care
      management.

      Freestyle Libre CGMs sample interstitial fluid glucose subcutaneously. Measurement
      frequencies typically range from 1 to 15 minutes and most commonly are every 5 minutes.

      Previous studies in hospitalized patients living with diabetes mellitus on basal bolus
      regimen have shown:

      • Use of the CGM increased detection of both hypoglycemic and hyperglycemic events versus
      those sensed by POCT.

      One investigation identified 88 postprandial hyperglycemic excursions in patients with CGM
      use as opposed to 61 in those with POCT. Another noted that when comparing the CGM use with
      that of POCT, the former identified 55 hypoglycemic events whereas the latter only found 12.

      • No difference in mean daily glucose CGM and POCT readings. In a study of 38 patients, the
      investigators noted no difference in mean daily glucose between the CGM and POCT.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: Patients will use the Freestyle 14 day CGM reader or their phone to check their glucose. A clinical staff member will check the patient's blood sugar by performing a glucose finger stick with the Accuchek inform II meter.
primary purpose: Other
masking: None (Open Label)
measure: Comparison of values between two devices
time frame: Through end of patient hospitalization, an average of 14 days
description: Correlation between blood glucose results from the Freestlye Libre 14-day CGM and Accuchek Inform II platform using the Bland-Altman method to determine whether the two glucose methods agree
arm group label: Freestyle Libre 14-day CGM
arm group type: Other
description: The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.
arm group label: Accuchek Inform II meter
arm group type: Other
description: ACCU-CHEK INFORM II system quantitatively measures glucose in fresh venous, arterial, neonatal heel stick and capillary whole blood from the finger and is used as an aid in monitoring the effectiveness of glucose control
intervention type: Device
intervention name: Freestyle Libre 14 day CGM system
description: The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.
arm group label: Accuchek Inform II meter
arm group label: Freestyle Libre 14-day CGM
intervention type: Device
intervention name: Accuchek Inform II platform
description: The Accu-Chek Inform II system is designed to deliver data with speed and efficiency, helping to provide optimal care. Wireless meter quickly transfers data. The Accu-Chek Inform II system is the first point-of-care blood glucose device to offer truly wireless technology at the meter level.
arm group label: Accuchek Inform II meter
arm group label: Freestyle Libre 14-day CGM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Renee Murray-Bachmann, Ed.D, MSN
role: Principal Investigator
affiliation: Northwell Health
facility: 
country: United States
url: http://doi.org/10.1007/s13300-016-0223-6
description: Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: A Multicenter, Open-Label Randomize
url: http://doi.org/10.1016/j.cmet.2020.04.021
description: Zhu, L., Zhi-Gang, S., Cheng, S., Guo, J., Bing-Hong, Z.,Hongliang, L. (2020).Association of blood glucose control and outcomes in patients with COVID-19 and pre-existing Type 2 Diabetes Cell Metabolism, 31, (2020).pp.1-10
responsible party type: Sponsor
sharing ipd: No
ipd description: The team has not decided whether to share the results with other researchers. The team will consider publishing results after study completion
submitted: February 14, 2022
returned: February 17, 2022
submitted: March 22, 2023
returned: April 13, 2023
submitted: April 24, 2023
returned: May 17, 2023