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/NCT05989256</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00079298</org_study_id>
      <nct_id>NCT05989256</nct_id>
    </id_info>
    <brief_title>Developing a Model to Predict Inpatient Hypoglycemic Episodes</brief_title>
    <official_title>Developing a Model to Predict Inpatient Hypoglycemic Episodes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wake Forest University Health Sciences</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will create a new model to predict hypoglycemic events in diabetic inpatients on&#xD;
        anti-hyperglycemic therapy using retrospective data with the goal of developing a model that&#xD;
        will accurately predict hypoglycemic episodes in our patient population - piloting the risk&#xD;
        score that was developed in the context of EndoTool being rolled out at the institution, to&#xD;
        determine the feasibility and acceptability of viewing the risk score in the Electronic&#xD;
        Health Record&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Design a model to predict hypoglycemic episodes in real time, rather than retrospectively&#xD;
        identifying high risk patients who experienced a hypoglycemic event at some point during&#xD;
        their hospitalization, as has been done prior. Potential predictors of hypoglycemia&#xD;
        identified in prior work and additional predictors identified by the clinical team to develop&#xD;
        a discrete-time multinomial logistic regression model to predict hypoglycemic events in real&#xD;
        time. The risk score then will be piloted in the context of our institution's EndoTool&#xD;
        Subcutaneous implementation determine the feasibility and acceptability of viewing the risk&#xD;
        score in the Electronic Health Record&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>EndoTool Utilization Rates</measure>
      <time_frame>day 90</time_frame>
      <description>rate of EndoTool utilization</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glucose Monitoring Team (GMT) Consult Utilization Rates</measure>
      <time_frame>day 90</time_frame>
      <description>rate of GMT utilization</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provider satisfaction scores</measure>
      <time_frame>day 90</time_frame>
      <description>provider satisfaction with the alert system via survey data - 10 question survey asking Providers about their thoughts about the hypoglycemia risk score - range will be reported as their a-e answers</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Inpatient hypoglycemia event rates</measure>
      <time_frame>day 90</time_frame>
      <description>Total number of hypoglycemic events (&lt;70 mg/dL) that were preceded by administration of rapid/short-acting insulin within 12 hours or an anti-diabetic agent other than short-acting insulin within 24 hours, were not followed by another glucose value greater than 80 mg/dL within five minutes, and were at least 20 hours apart divided by the total number of hospital days with at least one anti-diabetic agent administered)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Centers for Medicare and Medicaid Services (CMS) Hyperglycemia Scores</measure>
      <time_frame>day 90</time_frame>
      <description>Inpatient hospitalizations with a hyperglycemic event within the first 10 days of the encounter minus the first 24 hours, and minus the last period before discharge if less than 24 hours. Defined as: A day with at least one blood glucose value &gt;300 mg/dL; or A day where a blood glucose was not measured, and it was preceded by two consecutive days where at least one glucose value during each of the two days was &gt;=200 mg/dL divided by the number of qualifying hospitalizations where the patient is 18 years or older at the start of the admission, as well as either: a diagnosis of diabetes that starts before or during the encounter; or administration of at least one dose of insulin or any hypoglycemic medication during the encounter; or presence of at least one blood glucose value &gt;=200 mg/dL at any time during the encounter. The measure includes inpatient hospitalizations that began in the emergency department or in observational status</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hypoglycemic Events</condition>
    <condition>Hyperglycemic Therapy</condition>
    <arm_group>
      <arm_group_label>experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Service where the experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Service where EndoTool is applied without the experimental hypoglycemia risk score</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Service where EndoTool is applied without our experimental hypoglycemia risk score</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of care glucose management</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Service which has not yet implemented EndoTool - providers adjusting insulin and consulting the Glucose Management Team at their discretion</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>EndoTool</intervention_name>
      <description>EndoTool is a vendor based glucose management software</description>
      <arm_group_label>experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>glucose management team</intervention_name>
      <description>comparison group will be services that have not yet implemented EndoTool</description>
      <arm_group_label>Service where EndoTool is applied without the experimental hypoglycemia risk score</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>standard of care glucose management</intervention_name>
      <description>providers adjusting insulin and consulting the Glucose Management Team at their discretion</description>
      <arm_group_label>Standard of care glucose management</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Providers taking care of adult patients (18 years and older) on the selected medical&#xD;
               floors who are receiving anti-hyperglycemic medications on the chosen services&#xD;
               (EndoTool and risk score implementation) and comparison groups (one group with&#xD;
               EndoTool implementation and the other group without EndoTool implementation)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Providers not on the chosen services&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matthew Gorris, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah Stern</last_name>
      <phone>407.913.7232</phone>
      <email>srstern@wakehealth.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wake Forest University Health Sciences</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sarah Stern</last_name>
        <phone>407-913-7232</phone>
        <email>srstern@wakehealth.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>diabetes</keyword>
    <keyword>hypoglycemia</keyword>
    <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/NCT05989256
  org study id: IRB00079298
  nct id: NCT05989256
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This study will create a new model to predict hypoglycemic events in diabetic inpatients on
        anti-hyperglycemic therapy using retrospective data with the goal of developing a model that
        will accurately predict hypoglycemic episodes in our patient population - piloting the risk
        score that was developed in the context of EndoTool being rolled out at the institution, to
        determine the feasibility and acceptability of viewing the risk score in the Electronic
        Health Record
  Design a model to predict hypoglycemic episodes in real time, rather than retrospectively
        identifying high risk patients who experienced a hypoglycemic event at some point during
        their hospitalization, as has been done prior. Potential predictors of hypoglycemia
        identified in prior work and additional predictors identified by the clinical team to develop
        a discrete-time multinomial logistic regression model to predict hypoglycemic events in real
        time. The risk score then will be piloted in the context of our institution's EndoTool
        Subcutaneous implementation determine the feasibility and acceptability of viewing the risk
        score in the Electronic Health Record
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: EndoTool Utilization Rates
  time frame: day 90
  description: rate of EndoTool utilization
  measure: Glucose Monitoring Team (GMT) Consult Utilization Rates
  time frame: day 90
  description: rate of GMT utilization
  measure: Provider satisfaction scores
  time frame: day 90
  description: provider satisfaction with the alert system via survey data - 10 question survey asking Providers about their thoughts about the hypoglycemia risk score - range will be reported as their a-e answers
  measure: Inpatient hypoglycemia event rates
  time frame: day 90
  description: Total number of hypoglycemic events (<70 mg/dL) that were preceded by administration of rapid/short-acting insulin within 12 hours or an anti-diabetic agent other than short-acting insulin within 24 hours, were not followed by another glucose value greater than 80 mg/dL within five minutes, and were at least 20 hours apart divided by the total number of hospital days with at least one anti-diabetic agent administered)
  measure: Centers for Medicare and Medicaid Services (CMS) Hyperglycemia Scores
  time frame: day 90
  description: Inpatient hospitalizations with a hyperglycemic event within the first 10 days of the encounter minus the first 24 hours, and minus the last period before discharge if less than 24 hours. Defined as: A day with at least one blood glucose value >300 mg/dL; or A day where a blood glucose was not measured, and it was preceded by two consecutive days where at least one glucose value during each of the two days was >=200 mg/dL divided by the number of qualifying hospitalizations where the patient is 18 years or older at the start of the admission, as well as either: a diagnosis of diabetes that starts before or during the encounter; or administration of at least one dose of insulin or any hypoglycemic medication during the encounter; or presence of at least one blood glucose value >=200 mg/dL at any time during the encounter. The measure includes inpatient hospitalizations that began in the emergency department or in observational status
  arm group label: experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool
  arm group type: Experimental
  description: Service where the experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool
  arm group label: Service where EndoTool is applied without the experimental hypoglycemia risk score
  arm group type: Active Comparator
  description: Service where EndoTool is applied without our experimental hypoglycemia risk score
  arm group label: Standard of care glucose management
  arm group type: Active Comparator
  description: Service which has not yet implemented EndoTool - providers adjusting insulin and consulting the Glucose Management Team at their discretion
  intervention type: Diagnostic Test
  intervention name: EndoTool
  description: EndoTool is a vendor based glucose management software
  arm group label: experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool
  intervention type: Other
  intervention name: glucose management team
  description: comparison group will be services that have not yet implemented EndoTool
  arm group label: Service where EndoTool is applied without the experimental hypoglycemia risk score
  intervention type: Other
  intervention name: standard of care glucose management
  description: providers adjusting insulin and consulting the Glucose Management Team at their discretion
  arm group label: Standard of care glucose management
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Matthew Gorris, MD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Sarah Stern
  phone: 407.913.7232
  email: srstern@wakehealth.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No