NEWS
FDA Clears GlucoStabilizer®
Intravenous Insulin Dosing
Software
(click here for a pdf of this announcement)
CHARLOTTESVILLE, VA, October 17, 2007 – Medical Decisions
Network (MDN) announces Food and Drug Administration 510(k)
clearance for the company’s
GlucoStabilizer IV Insulin Dosing
Software.
The GlucoStabilizer software is used by hospital nurses to quickly
and accurately calculate the dosage of intravenous insulin
administered to patients with elevated levels of blood
glucose, the simple form of sugar the body converts to
energy for survival.
More
and more hospitals are adopting measures to control elevated
glucose levels (commonly referred to as diabetes or
hyperglycemia) in critical care units because studies have
shown a resulting marked improvement in patient outcomes.
These improvements include reduced
mortality
(death), length of stay, rate of infection, and a variety of
other risks.
According to
Gary Stouder, MD, at
Indiana’s Hancock Regional Hospital, "Based on what we’ve
seen so far, by automating our insulin dosing protocol with
the GlucoStabilizer software, we expect to see a decrease in length
of stay of 1 day and up to a 50% decrease in mortality in
our hyperglycemic ICU patients."
Currently, hospitals rely on printed procedures to calculate
IV insulin dosage based on hyperglycemic patients’ varying
glucose levels. More frequent glucose tests – as many as one
or more per hour for tightly controlled ICU patients –
burden the already overextended nurses. And referring to
complicated paper protocols stresses clinical staff even
more. Computerizing these calculations and providing
automated patient reports may not only improve glucose
control and save critical time and resources, but may reduce
potentially dangerous dosing calculation errors as well.
The
health benefits of this technology are hard to resist:
GlucoStabilizer users have seen a stark reduction in the incidence
of hypoglycemia, a potentially life-threatening severe drop
in blood glucose. And it takes significantly less time to
get a patient out of the danger zone and into the target
glucose range1.
According to
Greg Menke, Medical Decisions Network’s CEO, “We’ve seen
technology make sweeping improvements in the quality and
cost of healthcare. Our GlucoStabilizer Computerized Insulin Dosing
Software is another major contributor to these improvements
because it gives hospital clinicians the power to control
hyperglycemia, a huge and growing health and cost burden in
this country.”
The GlucoStabilizer is a networked application, accessible from any
computer on a hospital’s network. This means that clinicians
can continue a patient’s infusion progress even when the
patient is moved to a new unit.
“This FDA
510(k) clearance will be important for clinical
administrators who are considering the move to this
beneficial technology and feel more comfortable with FDA’s
nod,” says Menke. “It’s an important step for all of us.”
# # #
About Medical Decisions Network
Medical
Decisions Network (www.mdnoutcomes.net)
is an affiliate of Medical Automation Systems, the leader in
connectivity solutions for clinical laboratory point-of-care
data management, and TEG, Virginia, LLC, an international
healthcare research and consulting firm. GlucoStabilizer is a
trademark of Medical Decisions Network.
1. Juneja,
Rattan, et al, Utilization of a Computerized Intravenous
Insulin Infusion Program to Control Blood Glucose in the
Intensive Care Unit. Diabetes Technology & Therapeutics. Jun
2007, Vol. 9, No. 3: 232-240.
