Hypoglycemia in Hospitalized Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia; Diabetes

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.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center PUH SSY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

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Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measure of cognitive function	STROOP color word interference test	Within 24 to 36 hours of the index hypoglycemic event

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Mary T Korytkowski, MD, University of Pittsburgh School of Medicine, Department of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Hypoglycemia; Type 2 diabetes; Type 1 diabetes; Inpatient; Cognition disorders
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: PRO14030372 (Other Identifier: PRO14030372)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided