Diabetes Mellitus, Type 2 Clinical Trial
Official title:
ED Management of Severe Hyperglycemia: An Open-Label Randomized Clinical Trial
Emergency Department (ED) patients with severe hyperglycemia will be randomized to two
treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL.
Randomization is stratified by whether the chief complaint is "High Blood Sugar" in the
electronic medical record or other.
It is common practice to provide insulin and/or intravenous (IV) fluids to lower glucose
levels prior to discharge in patients that present with hyperglycemia. There is, however, no
data supporting this practice.
A recent retrospective observational cohort study (HSR# 12-3497) of 567 ED patients with
severe hyperglycemia demonstrated no association between discharge glucose levels and
short-term adverse outcomes at 7 days (return ED visits, diabetic ketoacidosis (DKA),
hospitalization, and death).
There were no other short-term adverse outcomes associated with the degree of glycemic
control. Less than 1% of patients developed DKA at 7 days. No patients died.
As this was a retrospective study, the conclusions that can be drawn are limited by the lack
of randomization and control; it is necessary to conduct a randomized controlled trial to
quantify how much time is expended caring for these patients, and gather safety data.
This is important because much time and money is focused on glucose reduction, which may not
change short-term outcomes. Furthermore, in retrospective analysis approximately 1.5% of
patients receiving therapy for hyperglycemia developed iatrogenic hypoglycemia during the ED
stay.
To detect a difference in length of stay by 60 minutes (Standard deviation is 100 minutes)
with an p=0.05 and b=0.8, enrollment of 45 patients per group will be required, with a total
enrollment of 90 patients. Enrollment will stop when 45 patients in each group have been
contacted in follow-up.
This study will only include patients who are discharged from the ED. Patients who are
enrolled and then eventually admitted to the hospital will be tabulated but excluded from the
length of stay analysis.
Statistical analysis will be completed for the primary outcome with a Mann-Whitney U test,
assuming the data will not be normally distributed. Secondary outcomes will be compared with
chi-squared testing. A secondary regression model will be formed, based on covariates that
could influence ED length of stay, such as amount of diagnostic testing completed.
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