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Hypoglycemia in Hospitalized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02228642
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : September 7, 2018
Information provided by (Responsible Party):
Mary Korytkowski, University of Pittsburgh

Brief Summary:
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.

Condition or disease
Diabetes Hypoglycemia

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization
Study Start Date : August 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Primary Outcome Measures :
  1. 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. ]
    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.

Secondary Outcome Measures :
  1. Measures of cognitive function following a hypoglycemic event [ Time Frame: Within 24 to 36 hours of a hypoglycemia event. ]
    Cognitive function testing will be performed using the St Louis University Mental Status Exam Survey (SLUMS)

Other Outcome Measures:
  1. Adverse events following a hypoglycemic event. [ Time Frame: Up to one year following the hypoglycemia event ]
    Information regarding falls, myocardial infarction, arrhythmia, seizures or other adverse events that occur following the hypoglycemia event will be collected.

  2. Measure of cognitive function [ Time Frame: Within 24 to 36 hours of the index hypoglycemic event ]
    STROOP color word interference test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Non-critically ill hospitalized patients with a diagnosis of diabetes at time of admission using established ADA criteria or prior physician diagnosis who experience a documented episode of hypoglycemia, defined as a blood glucose < 70 mg/dl.



Inclusion Criteria:

  • Diagnosis of diabetes
  • Non-critically ill hospitalized surgical and medical patients
  • Anticipated length of stay (LOS) >3 days
  • Anticipated life expectancy > 1 year
  • Mentally competent individuals

Exclusion Criteria:

  • Patients who are admitted for hypoglycemia or Diabetic Ketoacidosis
  • Anticipated LOS <3 days
  • Mentally incompetent individuals defined as any patient with evidence of dementia or delirium recorded in their medical history or progress note
  • Patients receiving Total Parenteral Nutrition
  • Treatment with high dose narcotic medications
  • Patients who would not be able to follow up at 3 to 6 and 9-12 months by telephone call
  • Patients with expected life expectancy < 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02228642

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United States, Pennsylvania
University of Pittsburgh Medical Center PUH SSY
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Mary T Korytkowski, MD University of Pittsburgh School of Medicine, Department of Medicine

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Responsible Party: Mary Korytkowski, Professor of Medicine, University of Pittsburgh Identifier: NCT02228642     History of Changes
Other Study ID Numbers: PRO14030372
PRO14030372 ( Other Identifier: PRO14030372 )
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mary Korytkowski, University of Pittsburgh:
Type 1 diabetes
Type 2 diabetes
Cognition disorders
Additional relevant MeSH terms:
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Glucose Metabolism Disorders
Metabolic Diseases