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.

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