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FDA Approves Abbott's FreeStyle Navigator(R) Continuous Glucose Monitoring System
Date:3/13/2008

h or low glucose level occurs."

For people with diabetes, less time spent with low (hypoglycemia) or high (hyperglycemia) blood sugar has been correlated with less risk for a number of serious short- and long-term diabetes-related complications.(1) By measuring glucose levels continuously, the FreeStyle Navigator system is designed to provide more and better information than traditional fingerstick glucose measurements, which can lead to improved diabetes management.

Abbott's FreeStyle Navigator system offers a number of key advances for people with diabetes who require insulin and want to tightly manage their disease. The system monitors glucose levels by measuring and transmitting glucose information once per minute to the pager-sized receiver, which can be clipped to a belt or carried in a pocket or purse. It also provides audible or vibrating alarms before glucose levels become too high or too low, displays five directional trend arrows to help people understand if glucose is rising or falling, and stores historical data and glucose trend information for up to 60 days. Additionally, the sensor and transmitter are designed to accommodate showering, swimming and a range of normal physical activities.

Clinical Trial Results

The accuracy, safety and efficacy of the FreeStyle Navigator system have been demonstrated in two separate pivotal clinical trials, including a five-day, in-clinic study and a study of people with type 1 and type 2 diabetes at home.

Five-Day In-Clinic Study(2): Abbott conducted a study to test the accuracy of its FreeStyle Navigator system in 58 subjects ranging in age from 18 to 64. This study met its primary endpoint of demonstrating accuracy over five days of wear. Using the Clarke Error Grid (CEG), comparing readings from a lab reference to a reading from the FreeStyle Navigator Continuous Glucose Monitoring System at a specific point in time, a combined 98.4 percent of the measurements were in the most acc
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SOURCE Abbott
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