Overview

This trial is active, not recruiting.

Conditions diabetes, hypoglycemia
Sponsor University of Pittsburgh
Start date August 2014
End date September 2017
Trial size 100 participants
Trial identifier NCT02228642, PRO14030372

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Measures of cognitive function following a hypoglycemic event
time frame: Within 24 to 36 hours of a hypoglycemia event.

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization
Principal investigator Mary T Korytkowski, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.