<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/NCT02228642</url>
  </required_header>
  <id_info>
    <org_study_id>PRO14030372</org_study_id>
    <secondary_id>PRO14030372</secondary_id>
    <nct_id>NCT02228642</nct_id>
  </id_info>
  <brief_title>Hypoglycemia in Hospitalized Patients</brief_title>
  <official_title>A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at&#xD;
      risk for losing the ability to develop symptoms that warn them that they are having a low&#xD;
      blood sugar. There is almost no available information investigating how the inability to feel&#xD;
      symptoms of a low blood sugar contributes to the risk of this happening when people with&#xD;
      diabetes are hospitalized. The purpose of this study is to develop a symptom score model that&#xD;
      will help to identify patients at risk for low blood sugars in the hospital and to examine&#xD;
      what happens to patients who do experience a low blood sugar in the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who develop recurrent hypoglycemia are predisposed to developing&#xD;
      hypoglycemia-associated autonomic failure (HAAF, impaired awareness). There is almost no&#xD;
      information investigating the contribution of HAAF as a risk factor for hypoglycemia in&#xD;
      hospitalized patients. Our central aim is to develop a validated inpatient hypoglycemic&#xD;
      symptom score model to examine HAAF and its correlation with cognitive dysfunction,&#xD;
      re-hospitalization rates, inpatient morbidity and mortality.&#xD;
&#xD;
      This will be a prospective non-blinded study performed in a tertiary care center that will&#xD;
      include non-critically insulin treated patients with Type 1 and 2 Diabetes. We will identify&#xD;
      patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (&lt;&#xD;
      40 mg/dl) within the prior 24 hours by daily generated computerized reports. Participants&#xD;
      will be asked to complete a Hypoglycemia Symptom Scores Questionnaire and cognitive testing&#xD;
      within 24-36 hours post event. Participants will be contacted at 6 and 12 months following&#xD;
      the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia,&#xD;
      need for re-hospitalization, and occurrence of any new diabetes related complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores</measure>
    <time_frame>Within 24-36 hours following a hypoglycemia event.</time_frame>
    <description>Hypoglycemia Symptom Score Questionnaires will be administered to participants in time frame described. These questionnaires include a list of potential autonomic and neuroglycopenic symptoms that can occur in response to hypoglycemia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measures of cognitive function following a hypoglycemic event</measure>
    <time_frame>Within 24 to 36 hours of a hypoglycemia event.</time_frame>
    <description>Cognitive function testing will be performed using the St Louis University Mental Status Exam Survey (SLUMS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events following a hypoglycemic event.</measure>
    <time_frame>Up to one year following the hypoglycemia event</time_frame>
    <description>Information regarding falls, myocardial infarction, arrhythmia, seizures or other adverse events that occur following the hypoglycemia event will be collected.</description>
  </other_outcome>
  <other_outcome>
    <measure>Measure of cognitive function</measure>
    <time_frame>Within 24 to 36 hours of the index hypoglycemic event</time_frame>
    <description>STROOP color word interference test</description>
  </other_outcome>
  <enrollment type="Actual">58</enrollment>
  <condition>Diabetes</condition>
  <condition>Hypoglycemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Non-critically ill hospitalized patients with a diagnosis of diabetes at time of admission&#xD;
        using established ADA criteria or prior physician diagnosis who experience a documented&#xD;
        episode of hypoglycemia, defined as a blood glucose &lt; 70 mg/dl.&#xD;
&#xD;
        .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of diabetes&#xD;
&#xD;
          -  Non-critically ill hospitalized surgical and medical patients&#xD;
&#xD;
          -  Anticipated length of stay (LOS) &gt;3 days&#xD;
&#xD;
          -  Anticipated life expectancy &gt; 1 year&#xD;
&#xD;
          -  Mentally competent individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are admitted for hypoglycemia or Diabetic Ketoacidosis&#xD;
&#xD;
          -  Anticipated LOS &lt;3 days&#xD;
&#xD;
          -  Mentally incompetent individuals defined as any patient with evidence of dementia or&#xD;
             delirium recorded in their medical history or progress note&#xD;
&#xD;
          -  Patients receiving Total Parenteral Nutrition&#xD;
&#xD;
          -  Treatment with high dose narcotic medications&#xD;
&#xD;
          -  Patients who would not be able to follow up at 3 to 6 and 9-12 months by telephone&#xD;
             call&#xD;
&#xD;
          -  Patients with expected life expectancy &lt; 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary T Korytkowski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh School of Medicine, Department of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center PUH SSY</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Mary Korytkowski</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Type 1 diabetes</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Cognition disorders</keyword>
  <keyword>Inpatient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02228642
org study id: PRO14030372
secondary id: PRO14030372
nct id: NCT02228642
lead sponsor: 
has dmc: No
Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at
      risk for losing the ability to develop symptoms that warn them that they are having a low
      blood sugar. There is almost no available information investigating how the inability to feel
      symptoms of a low blood sugar contributes to the risk of this happening when people with
      diabetes are hospitalized. The purpose of this study is to develop a symptom score model that
      will help to identify patients at risk for low blood sugars in the hospital and to examine
      what happens to patients who do experience a low blood sugar in the hospital.
Patients who develop recurrent hypoglycemia are predisposed to developing
      hypoglycemia-associated autonomic failure (HAAF, impaired awareness). There is almost no
      information investigating the contribution of HAAF as a risk factor for hypoglycemia in
      hospitalized patients. Our central aim is to develop a validated inpatient hypoglycemic
      symptom score model to examine HAAF and its correlation with cognitive dysfunction,
      re-hospitalization rates, inpatient morbidity and mortality.

      This will be a prospective non-blinded study performed in a tertiary care center that will
      include non-critically insulin treated patients with Type 1 and 2 Diabetes. We will identify
      patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (<
      40 mg/dl) within the prior 24 hours by daily generated computerized reports. Participants
      will be asked to complete a Hypoglycemia Symptom Scores Questionnaire and cognitive testing
      within 24-36 hours post event. Participants will be contacted at 6 and 12 months following
      the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia,
      need for re-hospitalization, and occurrence of any new diabetes related complications.
observational model: Case-Control
time perspective: Prospective
measure: Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores
time frame: Within 24-36 hours following a hypoglycemia event.
description: Hypoglycemia Symptom Score Questionnaires will be administered to participants in time frame described. These questionnaires include a list of potential autonomic and neuroglycopenic symptoms that can occur in response to hypoglycemia.
measure: Measures of cognitive function following a hypoglycemic event
time frame: Within 24 to 36 hours of a hypoglycemia event.
description: Cognitive function testing will be performed using the St Louis University Mental Status Exam Survey (SLUMS)
measure: Adverse events following a hypoglycemic event.
time frame: Up to one year following the hypoglycemia event
description: Information regarding falls, myocardial infarction, arrhythmia, seizures or other adverse events that occur following the hypoglycemia event will be collected.
measure: Measure of cognitive function
time frame: Within 24 to 36 hours of the index hypoglycemic event
description: STROOP color word interference test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mary T Korytkowski, MD
role: Principal Investigator
affiliation: University of Pittsburgh School of Medicine, Department of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Mary Korytkowski
investigator title: Professor of Medicine
mesh term: Hypoglycemia
sharing ipd: Undecided