Clinical performance study reveals the accuracy and precision of TRUE2go system

Home Diagnostics, Inc. (NASDAQ:HDIX), a leading developer, manufacturer, and marketer of blood glucose monitoring systems, today announced the results of a TRUE2go™ 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.