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This article originally posted and appeared in  Issue 489

Clinical Study Supports Accuracy of Store Brand TRUEresult Blood Glucose Monitoring System in Comparison to Name Brand Systems

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FORT LAUDERDALE, Fla., September 23, 2009, 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 GoldSensorT laser accuracy and TRUEfillT 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 TRUE2goT, TRUEresult®, TRUEbalanceT, 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 GoldAward 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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This article originally posted 06 October, 2009 and appeared in  Issue 489

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