Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU

Increasing evidence from observational studies in hospitalized patients with and without
diabetes indicates that hyperglycemia is a predictor of poor outcome. Blood glucose control
with intensive insulin therapy in patients with acute critical illness reduces the risk of
multiorgan failure and systemic infection, and decreases short- and long-term mortality.

The use of intravenous insulin infusion is the preferred route of insulin administration for
the management of diabetic subjects with diabetic ketoacidosis and nonketotic hyperosmolar
state, intraoperative and postoperative care, the postoperative period following heart
surgery and organ transplantation, acute myocardial infarction, stroke, and critical care
illness. Some of these settings may be characterized by, or associated with, severe or
rapidly changing insulin requirements, generalized patient edema, impaired perfusion of
subcutaneous sites, requirement for pressor support, and/or use of total parenteral
nutrition. In these settings, the intravenous route for insulin administration has been
considered superior than the subcutaneous injection of split-mixed regimen of intermediate
and regular insulin with respect to rapidity of effect in controlling hyperglycemia, overall
ability to achieve glycemic control, and most importantly, preventing hypoglycemic episodes.
Recently, several insulin infusion protocols have been reported in the literature; these
algorithms and formulas, however, may be confusing and difficult to follow and may increase
the risk of dosing errors. To facilitate patients care, insulin algorithms could be placed on
a computer and used at the patient bedside to direct the nursing staff administering the
intravenous insulin. The Glucommander is one of such computer-derived insulin infusion
protocol which has been used successfully in over 5,802 patients with diabetes between 1984
and 1998. The study hypothesizes that management of inpatient hyperglycemia with a
computer-guided intravenous infusion protocol will facilitate smoother glycemic control with
a lower rate of hypoglycemic events than treatment following a standard insulin infusion
algorithm in critically ill patients in medical the ICU. The study also aims to determine
differences in glycemic control between treatment with a computer-guided intravenous infusion
protocol (Glucommander) and a standard insulin infusion algorithm in critically ill patients
in the ICU.

Inclusion Criteria:

1. Males or females between the ages of 18 and 70 years admitted to a medical ICU

2. A known history of diabetes mellitus or with new hyperglycemia untreated or treated by
diet, insulin therapy or with any combination of antidiabetic agents (sulfonylureas,
metformin, thiazolidinediones).

- Blood glucose greater than 120 mg/dl on ≥ 2 occasions for known, treated
diabetics or greater than 140 mg/dl on ≥ 2 occasions for those with new
hyperglycemia.

3. Subjects must have an admission blood glucose < 400 mg/dL, without laboratory evidence
of diabetic ketoacidosis (serum bicarbonate < 18 milliequivalents/L or positive serum
or urinary ketones).

Exclusion Criteria:

1. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and
hyperosmolar hyperglycemic state [38].

2. Patients with known HIV, severely impaired renal function (serum creatinine ≥3.0
mg/dl).

3. Patients with mental condition rendering the subject unable to understand the nature,
scope, and possible consequences of the study.

4. Female subjects who are pregnant or breast feeding at time of enrollment into the
study.