Evaluation of the FreeStyle Lite Blood Glucose Monitoring System

Method: Clinical accuracy for fingertip capillary blood testing was assessed at three diabetes clinics with three lots of FreeStyle Lite test strips. At the same clinics, lay user performance and alternative site testing (on forearm, upper arm, palm thenar, palm hypothenar, back of the hand, calf and thigh) were also evaluated. FreeStyle Lite system results in these studies were compared to the plasma equivalent glucose values of the fingertip blood samples measured by the YSI Glucose Analyzer. Subjects participating in the user performance study rated the ease of use of the FreeStyle Lite system. Laboratory studies were performed at Abbott Diabetes Care to validate analytical performance of the FreeStyle Lite system under various testing conditions.