TRUEresult store brand blood glucose monitoring system more accurate than name brand products: Study

www.homediagnostics.comSep 24 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 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.