Management of Hyperglycemia in the ER: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
Management of Hyperglycemia in the ER: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis
 and many patients with uncontrolled diabetes are admitted to the hospital after initial
 evaluation in the ED. Currently there are no guidelines in the US for the management of
 hyperglycemia in patients with diabetes during the duration of evaluation and treatment in
 the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are
 associated with increased risk of medical complications. In this study, we hypothesize that a
 defined two-step approach to the management of high blood sugars with insulin injections
 initiated in the ED may decrease length of stay in the ED or hospital, improve clinical
 outcome and prevent some hospital complications. In the first phase, patients with diabetes
 admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive
 scheduled aspart or the usual care as dictated by the ED physicians. In the second phase,
 patients enrolled in the first phase that are subsequently admitted to the hospital will
 receive a combination of detemir and aspart insulin or usual care as dictated by the
 Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously
 (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously
 several times a day and frequently before meals. Detemir and aspart insulins are approved for
 use in the treatment of patients with diabetes by the FDA. Usual care can be oral
 anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous
 insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin
 or insulin glargine.

 This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta
 and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal
 investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120
 patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo
 Nordisk.
Inclusion Criteria:

 -  Subjects meeting all of the following criteria will be considered for enrollment into
 the study:

 -  Males or females between the ages of 18 and 80 years admitted to a general medical
 service.

 -  A known history of type 2 diabetes mellitus > 3 months, receiving diet management, any
 combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones)
 and/or insulin therapy.

 -  Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence
 of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive
 serum or urinary ketones).

 Exclusion Criteria:

 -  Subjects with increased blood glucose concentration, but without a known history of
 diabetes.

 -  Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after
 initial evaluation.

 -  Patients with acute critical or surgical illness and/or expected to require admission
 to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization
 course.

 -  History of current drug or alcohol abuse.

 -  Mental condition rendering the subject unable to understand the nature, scope, and
 possible consequences of the study

 -  Inability to give informed consent

 -  Female patients who are pregnant or are breast feeding

 -  Patients who have clinically significant liver disease with ALT/AST > 3 X the upper
 range of normal

 -  Patients with serum creatinine ≥3.5 mg/dL for males or ≥ 3.0 mg/dL for females or
 currently treated with dialysis