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VA RESEARCH ON MISCODED BLOOD GLUCOSE METERS --

There can be significant insulin dose errors

when the meters are miscoded.

 

 

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Study Confirms That Significant Insulin Dose Errors Can Result When Blood Glucose Meters are Miscoded

Findings Published in Journal of Diabetes Science and Technology
Accurate Coding is Key to Preventing Potentially Serious Health
Complications Associated with Errors in Insulin Dosing

TARRYTOWN, N.Y., /PRNewswire/ -- When persons with diabetes use
miscoded blood glucose meters to determine how much insulin to take,
significant errors in insulin dose can result that may potentially lead to
short- and long-term health complications, according to findings of a new
study just published in the Journal of Diabetes Science and Technology
( http://www.journalofdst.org ).

The study findings also showed that meters with No Coding(TM)
technology (meters that automatically set the correct code anytime a test
strip is inserted) gave superior performance over meters used in this study
that had been correctly coded manually. This also translated into a lower
probability of insulin dose error.

The American Diabetes Association estimates that there are 14.6 million
children and adults diagnosed with diabetes in the United States(1), of
which an estimated 4.4 million, or 30%, require insulin to manage their
disease(2). Those who require insulin must closely monitor their blood
sugar with a blood glucose meter to plan their meals, exercise regimens and
insulin dosage.

In this study, using the low dose insulin algorithm, for certain
miscoded blood glucose meters, the probability of insulin error of plus or
minus 2 units of insulin could be as high as 50% as compared to 7.1% for
correctly, manually coded meters. The probability of insulin dose error of
plus or minus 3 units of insulin could be as high as 22.3% for the miscoded
meters but only 0.49% for the correctly, manually coded meters.

For the meters that do not require manual coding, the probability of
plus or minus 1 unit and plus or minus 2 units of insulin could be as high
as 35.4% and 1.4% respectively. There were no calculated insulin dose
errors above plus or minus 2 units with the meters that do not require
manual coding.

Coding is the process by which a blood glucose meter is matched to each
new box of test strips being used. This is done either by inserting a code
strip or code chip into the meter, or by entering a code number into the
meter. If this step is not performed, the meter may give inaccurate
results, which may lead to wrong therapy. For example, relying on a
miscoded blood glucose meter to determine how much insulin to take can
result in a potentially harmful overdose. Insulin overdose may cause
dangerously low blood sugar (hypoglycemia) leading to behavioral changes,
confusion, loss of consciousness and, if untreated, seizure, coma and even
death. Chronic underdosing of insulin may contribute to the long-term
health problems associated with high blood sugar including kidney disease,
nerve disease, eye problems, and heart disease.

"When dealing with patients with diabetes we've observed that many
either do not understand what proper coding is, or do not realize its
importance. Patients sometimes use expired test strips and/or do not
properly code their blood glucose meters to the lot of test strips they are
using," said Dr. Steven Edelman, an author on the study, and Professor of
Medicine, division of Endocrinology and Metabolism, University of
California, San Diego, and the Veterans Affairs Medical Center and founder
of TAKING CONTROL OF YOUR DIABETES ( http://www.tcoyd.org ).
"This is significant because a previous study I conducted found that
approximately 16% -- or one out of six -- persons failed to properly
manually code their blood glucose meters to the lot of test strips being
used(3)," said Dr. Charles H. Raine, III, also an author on the newly
published study and Director, Diabetes Control and Endocrinology Center,
Orangeburg, South Carolina. "Understanding the potentially serious
consequences of relying on a meter that is not properly coded -- is
essential for every person with diabetes, especially those who need to take
insulin," he added.

The study authors concluded that to avoid insulin dosing errors, people
should be carefully instructed how to correctly code their meters or be
advised to use a blood glucose meter that does not require manual coding.
Study Design

The study involved 116 patients at three clinical centers. The blood
glucose values for patients in this study ranged from 52 - 498 mg/dL. After
fasting, the patients were given a two-hour meal tolerance test. At zero,
60 and 120 minutes the study subjects' fingerstick blood was tested on five
different popular blood glucose meters (two were meters with No Coding(TM)
technology).

Some of the meters that do require coding were purposely miscoded to
the lot of test strips. The meters with No Coding(TM) technology were
always properly coded due to their inherent design. The values from all the
meters were compared with blood glucose values measured on a laboratory
glucose analyzer to determine how accurate (inaccurate) the meters were.
Glucose values obtained from some of the miscoded meters used for this
study showed an average error ranging between plus 29% and minus 37%.

Using the blood glucose values from these meters along with three insulin dose algorithms, Monte Carlo simulations, (a statistical method that uses
existing data sets to forecast performance in the field) were conducted on
the data from the clinical trial to generate 'ideal' and 'simulated-meter'
glucose values, and subsequent probability of insulin dose errors based on
normal and empirical distribution assumptions. This simulation was based on
various assumptions such as, one unit (1U) of insulin covers 50mg/dL blood
glucose* (low dose algorithm). From these calculations, the probability of
insulin dose errors for the three types of blood glucose meters (miscoded,
manually correctly coded and those that do not require coding) were
determined.

The probability for an error of plus or minus one unit of insulin using
the low dose algorithm was as high as 44.6% for correctly, manually coded
meters compared to 49.6% for incorrectly coded meters. The probability for
an error with a miscoded meter of plus or minus four units of insulin was
as high as 1.4% and for plus or minus five units of insulin was as high as
0.04%. There was no instance of a plus or minus four or five unit error
with correctly, manually coded meters using the low dose algorithm. For
meters that do not require coding there were no calculated insulin dose
errors above plus or minus two units. Results using empirical distributions
showed similar trends of insulin dose errors.

Bayer HealthCare, Diabetes Care

Bayer HealthCare, Diabetes Care is a worldwide leader in diabetes,
supporting customers in 100 countries. Since the introduction of
CLINITEST(R) reagent tablets in 1941, Bayer has led the way in diabetes
care product innovation. The company changed the face of diabetes care in
1969 when it introduced the first portable blood glucose meter and test
strips. Bayer HealthCare further innovated diabetes management by being the first company to introduce a suite of blood glucose monitors with No
Coding(TM) technology. The BREEZE(R) and CONTOUR(R) blood glucose
monitoring systems offer people with diabetes an unparalleled choice in
diabetes management systems. The Arthritis Foundation in the United States
and the Arthritis Society of Canada each granted Ease-of Use Commendation
to the BREEZE meter, representing the first time a blood glucose meter has
been recognized as easy to use for arthritis sufferers.

In July 2006, Bayer Diabetes Care acquired Metrika Inc., maker and
manufacturer of A1CNow+(R), a meter-based diabetes monitoring system for
measurement of HbA1c (glycated hemoglobin) an important indicator of long
term blood sugar control.

Bayer HealthCare, Diabetes Care global headquarters is located in
Tarrytown, New York, in the United States and operates as part of Bayer
HealthCare LLC, a member of the worldwide Bayer HealthCare group.

Bayer HealthCare

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's
leading, innovative companies in the healthcare and medical products
industry and is based in Leverkusen, Germany. The company combines the
global activities of the Animal Health, Consumer Care, Diabetes Care and
Pharmaceuticals divisions. The pharmaceuticals business operates under the
name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and
manufacture products that will improve human and animal health worldwide.

* Small variations may occur due to the nature of Monte Carlo simulation.

1 American Diabetes Association:
http://www.diabetes.org/diabetes-statistics.jsp

2 Roper 2005 U.S. Diabetes Patient Marker Study, April 19, 2006

3 Raine, C.H. Endo Prac 9: pg 137, 2003
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation,
development or performance of the company and the estimates given here.
These factors include those discussed in our public reports filed with the
Frankfurt Stock Exchange and with the U.S. Securities and Exchange
Commission (including our Form 20-F). The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to future events or developments.

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Larry Scott  --