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Published Study Demonstrates Clinical Accuracy and Ease of Use of TRUE2go Blood Glucose Monitoring System from Home Diagnostics

Wed. October 21, 2009; Posted: 08:30 AM
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FORT LAUDERDALE, Fla., Oct 21, 2009 (BUSINESS WIRE) -- HDIX | Quote | Chart | News | PowerRating -- Home Diagnostics, Inc. (NASDAQ:HDIX), a leading developer, manufacturer, and marketer of blood glucose monitoring systems, today announced the results of a TRUE2go(TM) clinical performance study published in the October 2009 issue of the journal Diabetes Technology & Therapeutics. The study, "Clinical Performance of the TRUE2go Blood Glucose System -- A Novel Integrated System for Meter and Strips," demonstrated the accuracy and precision of the TRUE2go system and found that it was both easy and convenient to use by patients. Diabetes Technology & Therapeutics is a peer-reviewed journal written for clinicians with the goal of promoting communication between developers and users of new diabetes treatment, monitoring, diagnosis and prevention technologies.

"This study is significant in that it clearly proves that TRUE2go is a system designed with user convenience in mind and instructions and features that make it easy for people living with diabetes to consistently and accurately self-monitor their blood glucose levels," said Joe Capper, president and chief executive officer of Home Diagnostics. "As one of the best predictors of good glycemic control and overall management of diabetes, self monitoring is a critical element of living well with diabetes."

As the number of people with diabetes continues to grow around the world, it is increasingly important to minimize the complications of diabetes by encouraging the achievement and maintenance of glycemic control. To help people with diabetes control their blood glucose levels, manufacturers need to develop products that are simple, easy to use and accurate. As a result, the TRUE2go is a no-coding meter about the size of a quarter that easily attaches to the top of a vial of test strips. The TRUE2go system requires a small 0.5 microliter of blood and produces accurate results in as fast as four seconds. TRUE2go offers people with diabetes convenience and ease of use that, in turn, encourages more frequent blood glucose monitoring and improved glycemic control. In addition, TRUE2go offers unparalleled value and performance -- the system retails, on average, for $9.99 for the meter with 10 test strips included -- eliminating another key barrier to consistent monitoring.

The purpose of the TRUE2go study was to test the accuracy and precision of the TRUE2go system and to evaluate whether lay people could use the system as easily as healthcare professionals. The study was also designed to assess lay users' understanding of and compliance with the TRUE2go system's instructions for use and to evaluate users' satisfaction with the test system.

Key study findings include:

-- TRUE2go is accurate and convenient to use and its instructions are easy for lay users to understand;

-- TRUE2go features offer convenience for the user and could improve compliance of testing for people with diabetes;

-- 100 percent of glucose test results fell within ISO-recommended limits for glucose concentrations ranging from 24 mg/dL to 549 mg/dL;

-- Lay users' understanding of and compliance with TRUE2go system instructions were excellent, as was their satisfaction with the system.

Study subjects were male and female adult patients with type 1 or type 2 diabetes from varied educational levels. The study was performed at four clinics in the United States and designed to comply with International Organization for Standardization (ISO) 15197:2003, a performance standard for self-testing blood glucose monitoring devices that includes evaluations for accuracy and is an FDA-recognized consensus standard.

The "Clinical Performance of the TRUE2go Blood Glucose System ---- A Novel Integrated System for Meter and Strips" study was authored by Mark S. Kipnes, M.D., Hal Joseph, R.P.A.-C., C.D.E., Harry Morris, D.O., M.P.H., Jason Manko, B.S., and Douglas E. Bell, Ph.D.

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(TM), TRUEresult(R), TRUEbalance(TM), TRUEtrack(R), Sidekick(R), TRUEread(R) and Prestige IQ(R) 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.

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 IQ(R) are trademarks of Home Diagnostics, Inc. All other trademarks are property of their respective owners.

[HDIX-F]

SOURCE: Home Diagnostics, Inc.

Home Diagnostics, Fort Lauderdale 
Sabrina Rios, Corporate Communications Manager, 954-332-2141 
srios@hdidiabetes.com 
or 
Schwartz Communications 
Marisa Borgasano or Jennifer Barlow, Media Relations, 781-684-0770 
homediagnostics@schwartz-pr.com
For full details for HDIX click here.

    


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