Hypoglycemia in Hospitalized Patients
This trial is active, not recruiting.
|Sponsor||University of Pittsburgh|
|Start date||August 2014|
|End date||September 2017|
|Trial size||100 participants|
|Trial identifier||NCT02228642, PRO14030372|
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.
|Observational model||case control|
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.
Measures of cognitive function following a hypoglycemic event
time frame: Within 24 to 36 hours of a hypoglycemia event.
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
|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.|
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