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December 1, 2009

New Blood Glucose Monitoring System

Home Diagnostics, Inc., a leading developer, manufacturer, and marketer of blood glucose monitoring systems, has announced the results of a TRUE2go™ clinical performance study published in the October 2009 issue of 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 showed that the system was both easy and convenient to use by patients. Key study findings are as follows:

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

TRUE2go features offer convenience for users and could improve compliance with testing for patients with diabetes;

100% of glucose test results fell within International Organization for Standardization (ISO)-recommended limits for glucose concentrations ranging from 24 mg/dL to 549 mg/dL; and

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

 

Study subjects were adults of either sex, with varied educational levels, who had Type 1 or Type 2 diabetes. The study was performed at 4 clinics in the U.S. and was designed to comply with 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.

As the number of persons with diabetes continues to grow, practitioners recognize the increasing importance of minimizing diabetes complications by encouraging achievement and maintenance of glycemic control. To help patients 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 0.5-mL of blood and produces accurate results in as fast as 4 seconds. TRUE2go offers patients with diabetes convenience and ease of use that, in turn, encourages more frequent blood glucose monitoring and improved glycemic control. TRUE2go also offers great 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.

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