<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/NCT03827434</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00084458</org_study_id>
    <nct_id>NCT03827434</nct_id>
  </id_info>
  <brief_title>CGM/Clarity Use, Glycemic Control and Clinical Outcomes</brief_title>
  <official_title>Improving Glycemic Control and Clinical Outcomes in Insulin Treated DM2 Patients Managed With CGM Devices and Clarity, a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baltimore VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</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>
      The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or&#xD;
      9.4% of the US population has DM. Several large scale randomized clinical trials have found&#xD;
      that improved glycemic control reduces the development of complications in patients with DM.&#xD;
      However intensive glucose management carries an increased risk of hypoglycemia, a condition&#xD;
      that may lead to neurological damage and is associated with increased incidence of&#xD;
      cardiovascular events and mortality.&#xD;
&#xD;
      Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important&#xD;
      objective, as may decrease the direct and indirect impact that diabetes has in our health&#xD;
      care system. Achieving optimal glycemic control requires frequent blood glucose monitoring by&#xD;
      the patients and recurrent clinic visits,which is often difficult to achieve, as access to&#xD;
      typical DM clinic is at least sub optimal.&#xD;
&#xD;
      m-Health and telemedicine health solutions represent alternative ways to manage patients in&#xD;
      the outpatient setting and have been applied in different medical areas, among them in&#xD;
      diabetes. However, almost all the telemedicine studies that have been previously performed&#xD;
      and recruited DM patients used telemedicine solutions which were based on point of care (POC)&#xD;
      finger-stick glucose testing, which are checked infrequently , usually 4-6 times/day.&#xD;
&#xD;
      Continuous glucose monitoring (CGM) devices offer additional ways to monitor blood glucose&#xD;
      values and can provide numerous glucose measurements (as frequent as every 5 min). By using&#xD;
      software applications, such as the Clarity (Dexcom), which highlights glucose patterns,&#xD;
      trends and statistics in standardized reports, providers can make safe recommendations of&#xD;
      adjusting DM medications, especially insulin titration. In this randomized clinical trial&#xD;
      investigators propose to use CGM devices and Clarity software as a telemedicine platform in&#xD;
      order to improve glycemic control and improve health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We did not receive funding to conduct the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hemoglobin A1c (HbA1c) among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)</measure>
    <time_frame>Through study completion, 6 months after randomization</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of hypoglycemic episodes among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)</measure>
    <time_frame>Through study completion, 6 months after randomization</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of hospitalizations among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)</measure>
    <time_frame>Through study completion, 6 months after randomization</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of ED visits among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)</measure>
    <time_frame>Through study completion, 6 months after randomization</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mortality among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)</measure>
    <time_frame>Through study completion, 6 months after randomization</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Hyperglycemia</condition>
  <condition>Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Continuous glucose Monitoring and Clarity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with DM2 and abnormal glycemic control followed by Continuous glucose Monitoring, using Clarity software</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Point of Care Fingerstick Glucose values</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients with DM2 and abnormal glycemic control followed by Point of Care Fingerstick Glucose values</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous glucose Monitoring Devices and Clarity Software</intervention_name>
    <description>Patients with DM2 at the intervention group will be managed by Continuous glucose Monitoring and Clarity software</description>
    <arm_group_label>Continuous glucose Monitoring and Clarity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Point of Care (POC) blood glucose</intervention_name>
    <description>Testing Blood Glucose levels with Point of Care (POC) blood glucose</description>
    <arm_group_label>Point of Care Fingerstick Glucose values</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of Diabetes Mellitus type 2 (DM2) on insulin&#xD;
&#xD;
          -  Uncontrolled glycemic control [hyperglycemia defined as Hba1c≥9% in the last 3 months&#xD;
             or clinically important hypoglycemia (any reported glucose values less than 54 mg/dl)&#xD;
             or severe hypoglycemia (low glucose value that led to a severe event characterized by&#xD;
             altered mental status and or physical status requiring assistance)]&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects that have a history of type 1 DM&#xD;
&#xD;
          -  History of type 2 DM, not treated or required to be treated with basal/bolus insulin&#xD;
             (i.e diet only, any combination of non insulin antidiabetic drugs only, basal only&#xD;
             insulin or bolus/short acting only insulin, or pre-mixed insulins) as these patients&#xD;
             are less likely to benefit from CGM use.&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Use of Clarity/ Share or follow applications as telehealth/telemedicine to improve DM&#xD;
             management during the last 3 months prior to study entry.&#xD;
&#xD;
          -  Extensive skin changes/disease or allergies that preclude wearing the CGM sensor&#xD;
&#xD;
          -  Significant psychiatric illness or any mental condition rendering the subject&#xD;
             incapable of understanding the objectives and potential consequences of the study.&#xD;
&#xD;
          -  Subjects without personal computer and internet network access.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Baltimore VA Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 23, 2021</last_update_submitted>
  <last_update_submitted_qc>April 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Ilias Spanakis</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine, VA Staff Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No, only de-identified data are going to be shared.</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/NCT03827434
org study id: HP-00084458
nct id: NCT03827434
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or
      9.4% of the US population has DM. Several large scale randomized clinical trials have found
      that improved glycemic control reduces the development of complications in patients with DM.
      However intensive glucose management carries an increased risk of hypoglycemia, a condition
      that may lead to neurological damage and is associated with increased incidence of
      cardiovascular events and mortality.

      Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important
      objective, as may decrease the direct and indirect impact that diabetes has in our health
      care system. Achieving optimal glycemic control requires frequent blood glucose monitoring by
      the patients and recurrent clinic visits,which is often difficult to achieve, as access to
      typical DM clinic is at least sub optimal.

      m-Health and telemedicine health solutions represent alternative ways to manage patients in
      the outpatient setting and have been applied in different medical areas, among them in
      diabetes. However, almost all the telemedicine studies that have been previously performed
      and recruited DM patients used telemedicine solutions which were based on point of care (POC)
      finger-stick glucose testing, which are checked infrequently , usually 4-6 times/day.

      Continuous glucose monitoring (CGM) devices offer additional ways to monitor blood glucose
      values and can provide numerous glucose measurements (as frequent as every 5 min). By using
      software applications, such as the Clarity (Dexcom), which highlights glucose patterns,
      trends and statistics in standardized reports, providers can make safe recommendations of
      adjusting DM medications, especially insulin titration. In this randomized clinical trial
      investigators propose to use CGM devices and Clarity software as a telemedicine platform in
      order to improve glycemic control and improve health outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Hemoglobin A1c (HbA1c) among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
time frame: Through study completion, 6 months after randomization
measure: Change in the number of hypoglycemic episodes among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
time frame: Through study completion, 6 months after randomization
measure: Change in the number of hospitalizations among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
time frame: Through study completion, 6 months after randomization
measure: Change in the number of ED visits among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
time frame: Through study completion, 6 months after randomization
measure: Change in mortality among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
time frame: Through study completion, 6 months after randomization
arm group label: Continuous glucose Monitoring and Clarity
arm group type: Active Comparator
description: Patients with DM2 and abnormal glycemic control followed by Continuous glucose Monitoring, using Clarity software
arm group label: Point of Care Fingerstick Glucose values
arm group type: Placebo Comparator
description: Patients with DM2 and abnormal glycemic control followed by Point of Care Fingerstick Glucose values
intervention type: Device
intervention name: Continuous glucose Monitoring Devices and Clarity Software
description: Patients with DM2 at the intervention group will be managed by Continuous glucose Monitoring and Clarity software
arm group label: Continuous glucose Monitoring and Clarity
intervention type: Other
intervention name: Point of Care (POC) blood glucose
description: Testing Blood Glucose levels with Point of Care (POC) blood glucose
arm group label: Point of Care Fingerstick Glucose values
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Ilias Spanakis
investigator title: Assistant Professor of Medicine, VA Staff Physician
mesh term: Hypoglycemia
mesh term: Hyperglycemia
sharing ipd: No
ipd description: No, only de-identified data are going to be shared.