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.|
|ClinicalTrials.gov Identifier: NCT02228642|
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : September 7, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||58 participants|
|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|
- 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.
- 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)
- 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.
- Measure of cognitive function [ Time Frame: Within 24 to 36 hours of the index hypoglycemic event ]STROOP color word interference test
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 ClinicalTrials.gov identifier (NCT number): NCT02228642
|United States, Pennsylvania|
|University of Pittsburgh Medical Center PUH SSY|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Mary T Korytkowski, MD||University of Pittsburgh School of Medicine, Department of Medicine|