Hypoglycemia in Hospitalized Patients

Diabetes Clinical Trial

Official title:

A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228642
• Other study ID #: PRO14030372
• Secondary ID: PRO14030372
• Status: Completed
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hypoglycemia

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center PUH SSY	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events following a hypoglycemic event.	Information regarding falls, myocardial infarction, arrhythmia, seizures or other adverse events that occur following the hypoglycemia event will be collected.	Up to one year following the hypoglycemia event
Other	Measure of cognitive function	STROOP color word interference test	Within 24 to 36 hours of the index hypoglycemic event
Primary	Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores	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.	Within 24-36 hours following a hypoglycemia event.
Secondary	Measures of cognitive function following a hypoglycemic event	Cognitive function testing will be performed using the St Louis University Mental Status Exam Survey (SLUMS)	Within 24 to 36 hours of a hypoglycemia event.