Hypoglycemia in Hospitalized Patients



Status:Completed
Conditions:Hospital, Endocrine, Diabetes
Therapuetic Areas:Endocrinology, Other
Healthy:No
Age Range:18 - 90
Updated:9/9/2018
Start Date:August 2014
End Date:March 2016

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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.

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.

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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
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from
Pittsburgh, PA
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