FDA Approves Abbott's FreeStyle Navigator(R) Continuous Glucose Monitor...(uratezones A (81.7 percent) and B (16.7 ...),Health

Home Use Study(3): In a study on the safety and efficacy of the FreeStyle Navigator system, 123 people with type 1 and type 2 diabetes used it in their homes for 40 days, wearing the sensor on the back of their upper arm or abdomen. Continuous glucose values were not visible to the user during the first half of the study, but were visible to the user during the second half of the study. A Clarke Error Grid (CEG) analysis demonstrated that 96.8 percent of the values were in the most accurate zones (zones A and B). Using a FreeStyle Navigator system, study participants with type 1 diabetes spent significantly less time in a hypoglycemic state (i.e., low blood sugar) -- a serious condition for this population -- during the phase of the trial when values were visible to the user. In addition, participants using a FreeStyle Navigator system who had type 2 diabetes spent significantly less time in a hyperglycemic state. Hyperglycemia (i.e., high blood sugar) is a serious problem, particularly for people with type 2 diabetes.

About the FreeStyle Navigator System

The FreeStyle Navigator system is composed of three parts: a sensor, a transmitter and a receiver. The sensor, worn for up to five days and then replaced, is placed just under the skin and is attached to a plastic sensor mount with adhesive to adhere to the skin, like a patch. The transmitter snaps into the sensor mount and sends glucose information wirelessly to the pager- sized receiver. The system discreetly measures glucose levels once per minute; provides high/low glucose alarms based on customizable, physician- and patient-determined levels; and delivers early-warning alarms that indicate if glucose levels are likely to be too high or too low 10, 20 or 30 minutes in advance. The
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