Hypoglycemia in Hospitalized Patients

NCT02228642 | Completed

• 1 other identifier: PRO14030372
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypoglycemia

Keywords

Type 1 diabetes; Type 2 diabetes; Hypoglycemia; Cognition disorders; Inpatient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measures of cognitive function following a hypoglycemic event

  Within 24 to 36 hours of a hypoglycemia event.

Other Outcomes (2)

• Adverse events following a hypoglycemic event.

  Up to one year following the hypoglycemia event

• Measure of cognitive function

  Within 24 to 36 hours of the index hypoglycemic event

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. .

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center PUH SSY

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Cognition Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mary T Korytkowski, MD

  University of Pittsburgh School of Medicine, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 29, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (1)