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FDA CLEARS ACCU-CHEK COMPACT SYSTEM FOR ALTERNATIVE SITE
TESTING
Blood glucose system integrates no strip handling offering
more convenience and greater flexibility for people with diabetes
Indianapolis, Indiana - August 27, 2002 - Roche Diagnostics, based
in Indianapolis, Ind., announced today that the FDA has cleared
its Accu-Chek Compact Blood Glucose Monitoring System for alternative
site testing (AST), which means users can now draw blood samples
from their fingertips, palms, forearms, upper arms, thighs or calves.
The Accu-Chek Compact System already is recognized for its integrated
features, such as a drum of 17 test strips that eliminates the need
to handle individual strips.
"The addition of five new alternative site testing options
for the Accu-Chek Compact System as well as for the Accu-Chek Active
System shows how our organization is meeting the evolving needs
of our customers," said Eric Pridemore of Roche Diagnostics,
Accu-Chek Compact and Accu-Chek Active product manager." In
addition to being known as 'The One with the Drum, the Accu-Chek
Compact System will now be known as one of the most convenient and
flexible meters on the market."
Blood glucose readings taken from the palm, upper arm, forearm,
thigh or calf are similar to readings taken from the fingertip during
periods when blood glucose levels in the body are steady, according
to a study conducted by Roche Diagnostics, the makers of Accu-Chek®
products and services.
"Because some people find alternative site testing more comfortable,
the Accu-Chek Compact System may encourage people to test more frequently.
Frequent monitoring of blood glucose levels is important because
more testing can lead to better disease management, which can prevent
or delay the onset of complications," said Kurt Alexander,
MD, who practices in Noblesville, Ind. "However, patients have
to understand when forearm testing is and is not appropriate."
The study also showed that fingertip and forearm readings were
not the same during periods when blood glucose levels were rapidly
changing, especially during the two hours following meals. "I
do not recommend alternative site testing during the two hour period
after meals," Dr. Alexander advised. "I also recommend
that patients whose forearm test results do not match the way they
feel confirm those results by testing again using fingertip blood."
Because alternative sites have fewer capillaries than fingertips,
blood from these sites can be more difficult to draw to the surface.
The Accu-Chek® Softclix® Lancet Device comes with a new
clear cap attachment enabling the device to draw blood from alternative
sites.
Additional Benefits
The Accu-Chek Compact System features Automated Drum Technology,
eliminating the need to handle strips because they are self-contained
in 17-strip drums and dispensed automatically with the push of a
button. The Accu-Chek Compact System is the only system available
that offers Automated Drum Technology.
In addition, the Accu-Chek Compact System delivers results within
15 seconds and only requires a small sample of capillary blood.
The Accu-Chek Compact System also provides precision dosing. The
meter does not perform a test until the strip is properly dosed.
This ensures that the patient does not receive an erroneous result
due to an improperly dosed test strip. Other features, such as under-dosing
detection and built-in strip quality control, help assure maximum
safety and efficacy.
The Accu-Chek Compact System also features infrared data transfer
capability, allowing patients to download data into Accu-Chek
data management software, either on their personal computer or a
handheld device such as a PDA. Data can then be transferred via
modem to the patient's healthcare providers.
For more information about the Accu-Chek Compact System and alternative
site testing, visit www.accu-chek.com or call Accu-ChekSM
Customer Care at 1-800-858-8072. The Accu-Chek Compact System with
AST will be available in pharmacies and drug stores nationwide at
the end of August.
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-oriented healthcare groups in the fields of pharmaceuticals,
diagnostics and vitamins. Roche's products and services address
prevention, diagnosis and treatment of diseases, thus enhancing
well being and quality of life. Roche's Diagnostics Division, the
world leader in in-vitro diagnostics with a uniquely broad product
portfolio, supplies a wide array of innovative testing products
and services to researchers, physicians, patients, hospitals and
laboratories worldwide. Roche Diagnostics Corporation, based in
Indianapolis, is the North American headquarters for the diagnostics
business of the company. Roche Diagnostics' website is located at
www.roche-diagnostics.com.
Media note: For a copy of the white paper discussing the performance
of the Accu-Chek Compact System with alternative site testing, please
contact Catherine Narbone at Edelman Health at 312-233-1246 or at
catherine.narbone@edelman.com.
ACCU-CHEK, ACCU-CHEK COMPACT, ACCU-CHEK ACTIVE, and SOFTCLIX are
trademarks of a Member of the Roche Group. © 2002 Roche Diagnostics.
All rights reserved.
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