Hypoglycemia in Hospitalized Patients

NCT ID: NCT02228642

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-03-31

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.

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.

Conditions

Diabetes; Hypoglycemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Mary Korytkowski

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary T Korytkowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh School of Medicine, Department of Medicine

Locations

University of Pittsburgh Medical Center PUH SSY

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO14030372

Identifier Type: OTHER

Identifier Source: secondary_id

PRO14030372

Identifier Type: -

Identifier Source: org_study_id