Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2

In the current second phase of this project (Phase-2), we will introduce the refined,
validated, and safe eProtocol-insulin into a second group of naïve ICUs, none of which
participated in eProtocol-insulin development, refinement or validation. Our primary goal in
this second phase is to determine the feasibility of exporting this tool to naïve ICU
environments. In this second phase we will also compare the effects of the eProtocol-insulin
and ordinary care approaches to glucose control on the bedside nurse's experience.

This second phase will be a prospective cohort study. We will determine the feasibility of
distributing eProtocol-insulin and will further validate eProtocol-insulin in >4 adult and
>4 pediatric ICUs. If necessary we will modify eProtocol-insulin with an iterative
refinement process, with Institutional Review Board (IRB) and independent Data and Safety
Monitoring Board (DSMB) oversight. eProtocol-insulin will be considered refined if >90% of
the instructions are accepted and if the percent of glucose values between 70 and 110 mg/dl
(3.9-6.1 mMol/L) are equivalent to our Phase-1 refinement and validation experience of 46%%,
and if the rate of glucose values < 40 mg/dl (2.2 mMol/l) is less than 0.5% of glucose
measurements.

Inclusion Criteria:

1. Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for
glucose control in their ICUs would include patients who require mechanical
ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g.
dopamine >3 mg/kg/min, dobutamine, epinephrine, or vasopressin).

2. Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose
control in participating adult ICUs include critically ill patients with an
anticipated ICU length of stay of 3 or more days.

Exclusion Criteria:

1. Pregnancy (negative pregnancy test required for females of child-bearing age)

2. Age less than one month

3. Inborn errors of metabolism that the clinician suspects will affect glucose
homeostasis

4. Acute or chronic liver disease with any documented episode of blood or plasma glucose
<60 mg/dl within the 24 hours prior to study entry

5. Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in
ketoacidosis will be eligible if attending physicians intend to use intravenous
insulin as part of ordinary care)

6. Severe chronic liver disease (Child-Pugh score >10)