Home Diagnostics, Inc. (NASDAQ:HDIX), a leading manufacturer and
marketer of diabetes testing supplies, today announced that a new
study has shown that its TRUEresult® store brand blood glucose
monitoring system is comparable to the performance of more
expensive name brand systems. The comparative study, titled
“Accuracy Study of Blood Glucose Monitoring Systems,” evaluated the
performance of four commercially available blood glucose monitors,
including LifeScan’s OneTouch Ultra 2, Bayer’s Ascensia Contour and
Abbott’s FreeStyle Freedom Lite, and found that TRUEresult, Home
Diagnostics’ store-branded meter, yielded accurate results
comparable to those obtained by the more expensive name brand
products.
“After reviewing the results of this study, you have to ask
yourself, ‘Why would I ever again pay so much for a name brand
system when store branded systems provide this level of
performance? What’s all of the extra money for?” said Joe Capper,
president and chief executive officer of Home Diagnostics. “The
results of this study reinforce the fact that Home Diagnostics is
delivering on its commitment to provide affordable diabetes care
products while maintaining the highest quality products for our
customers. As the store-branded glucose monitoring system of choice
for retailers such as CVS, Rite Aid and Walgreens, TRUEresult can
save people with diabetes over $400* a year in diabetes testing
supplies in comparison to the name brands. For diabetes patients,
many of whom struggle with the recurring cost of testing supplies,
the study demonstrates that it often pays to buy store brands.”
The study of 100 subjects with Type 1 and Type 2 diabetes
leveraged stringent quality standards in evaluating meter
performance. System accuracy was compared to the Yellow Springs
Instrument (YSI) reference laboratory method for glucose readings.
In addition, all systems were evaluated using the International
Standard Organization in ISO 15197: 2003 criteria for evaluating
the performance of blood glucose monitoring devices, the most
rigorous performance standard in the blood glucose monitoring
industry. Study results found that the TRUEresult system
performance exceeded the minimum performance criteria outlined in
the ISO protocol with 199 out of 200 (99.5 percent) results within
the ISO stated accuracy limits. In addition, the study found
that:
- TRUEresult showed excellent
accuracy with 98.5 percent of glucose results within Zone A of the
Parkes Error grid. The Parkes Error grids are divided into five
Zones representing the degree of risk posed by the meter
measurement. Zone A represents no effect on clinical action.
- TRUEresult showed good
reproducibility with 100 duplicate samples compared to the measured
precision of Ascensia Contour, OneTouch Ultra 2 and FreeStyle
Freedom Lite.
- Overall, TRUEresult performance
was comparable to the OneTouch Ultra 2, the FreeStyle Freedom Lite
and the Ascensia Contour when tested on people with diabetes.
TRUEresult, part of Home Diagnostics’ TRUE family of products,
is the company’s advanced, high performance no-coding meter for
at-home testing. No-coding technology simplifies blood glucose
testing by eliminating the need for users to code the meter with
each new box of test strips. TRUEresult also delivers precise
results in as fast as four seconds using only 0.5 microliters of
blood. The combination of no-coding technology and small sample
size makes it more convenient and cost effective for people with
diabetes to test their blood glucose levels more often, allowing
for greater control of glucose levels. The meter is compatible with
Home Diagnostics’ TRUEtest platform of blood glucose test strips
featuring the company’s patent-pending, state-of-the-art
GoldSensor™ laser accuracy and TRUEfill™ beveled tip. These
innovative features ensure highly accurate test results and first
test success by allowing for greater sampling precision and
consistency.
Blood glucose monitoring products manufactured by Home
Diagnostics can typically save people with diabetes up to $400* per
year on diabetes testing supplies in comparison to competitive
products, and are covered by Medicare, Medicaid and most
third-party insurance providers.
About the Study
The clinical evaluation of the TRUEresult, OneTouch Ultra 2,
Ascensia Contour and FreeStyle Freedom Lite Systems was conducted
by the staff at the International Diabetes Center in Minneapolis,
MN under the direction of the principal investigator, Richard
Bergenstal, M.D.
About International Diabetes Center at Park Nicollet
International Diabetes Center at Park Nicollet provides
world-class diabetes care, education and clinical research to meet
the needs of people with diabetes, their families and the health
professionals who care for them. Located in suburban Minneapolis,
the center is recognized internationally for its range of clinical
and educational programs, products and services. International
Diabetes Center is part of Park Nicollet Health Services.
About Home Diagnostics, Inc.
Based in Fort Lauderdale, Florida, Home Diagnostics, Inc.
(NASDAQ:HDIX) is a leading developer, manufacturer and marketer of
diabetes management products. Home Diagnostics, Inc. offers a
portfolio of high-quality blood glucose monitoring systems that
spans the spectrum of features and benefits to help every person
with diabetes better monitor and manage their disease. The Home
Diagnostics, Inc. product line includes TRUE2go™, TRUEresult®,
TRUEbalance™, TRUEtrack®, Sidekick®, TRUEread® and Prestige Smart
System® blood glucose monitoring systems. The products are
available in more than 45,000 pharmacies throughout the U.S. Home
Diagnostics is the exclusive co-brand supplier of blood glucose
monitoring systems for leading pharmacies including CVS, Rite Aid
and Walgreens, as well as distributors such as AmerisourceBergen,
Cardinal Health, McKesson, Invacare and Liberty Medical. Home
Diagnostics, Inc. was named one of Forbes magazine’s “200 Best
Small Companies” in 2008, and in 2009 received several recognitions
for the company’s TRUE2go blood glucose meter, including a Medical
Design Excellence Award (MDEA) and a Gold Award in the Medical/Test
Equipment category as part of appliance DESIGN Magazine’s 22nd
Annual Excellence in Design (EID) Awards Competition. For more
information please visit www.homediagnostics.com.
*Data on file with Home Diagnostics, Inc.
Forward-Looking
Statements
The above statements include forward-looking statements and are
subject to risks and uncertainties. Forward-looking statements give
the Company’s current expectations and projections relating to its
financial condition, results of operations, plans, objectives,
future performance and business. The statements can be identified
by the fact that they do not relate strictly to historical or
current facts. These statements may include words such as
“anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,”
“believe” and other words and terms of similar meaning in
connection with any discussion of the timing or nature of future
operating or financial performance or other events.
All statements other than statements of historical facts
included in this release that address activities, events or
developments that we expect, believe or anticipate will or may
occur in the future are forward-looking statements.
These forward-looking statements are largely based on our
expectations and beliefs concerning future events, which reflect
estimates and assumptions made by the Company’s management. These
estimates and assumptions reflect the Company’s best judgment based
on currently known market conditions and other factors relating to
the Company’s operations and business environment, all of which are
difficult to predict and many of which are beyond its control.
Although the Company believes its estimates and assumptions to
be reasonable, they are inherently uncertain and involve a number
of risks and uncertainties that are beyond the Company’s control.
In addition, management’s assumptions about future events may prove
to be inaccurate. Management cautions all readers that the
forward-looking statements contained in this release are not
guarantees of future performance, and the Company cannot assure any
reader that those statements will be realized or the
forward-looking events and circumstances will occur. Actual results
may differ materially from those anticipated or implied in the
forward-looking statements due to the factors listed in the “Risk
factors” and “Management’s discussion and analysis of financial
condition and results of operations” sections contained in its
filings with the Securities and Exchange Commission. All
forward-looking statements speak only as of the date of this
release. The Company does not intend to publicly update or revise
any forward-looking statements as a result of new information,
future events or otherwise, except as required by law. These
cautionary statements qualify all forward-looking statements
attributable to the Company or persons acting on its behalf.
TRUE2go, TRUEresult, TRUEtrack, TRUEbalance, Sidekick, TRUEread
and Prestige Smart System are trademarks of Home Diagnostics, Inc.
All other trademarks are property of their respective owners.
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