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FreeStyle Navigator, a Continuous Glucose Monitoring System, Gains FDA Approval

ABBOTT PARK, Ill., March 13 /PRNewswire-FirstCall/ -- The Food and Drug Administration (FDA) has approved the FreeStyle Navigator(R) Continuous Glucose Monitoring System (http://www.continuousmonitor.com/) in the United States for people with diabetes. Designed to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen (http://www.abbott.com), Abbott's FreeStyle Navigator system provides minute-by-minute information about which way and how quickly blood sugar levels are changing. This information can lead to proactive adjustments that can result in tighter glucose ranges. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.

The FreeStyle Navigator system will be available in the second quarter of 2008 by prescription only. It received CE Mark (http://www.abbott.com) in June 2007 and has been available outside the United States since September 2007.

"Understanding glucose trends, with the goal of minimizing fluctuations, is an important part of improving the management of diabetes," said endocrinologist and Director of the International Diabetes Center Richard Bergenstal, M.D. "We are always looking for new tools like these to enable people with diabetes to continuously monitor their glucose levels, putting them on the offense, not defense, so they can take action before a high 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 accurate zones, A (81.7 percent) and B (16.7 percent), which means that measurements allowed patients to make either correct and safe treatment decisions, benign treatment decisions, or no treatment decision at all.

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 system also stores up to 60 days worth of glucose information that can be analyzed by the user or a health care professional.

Indicated for people ages 18 and older, the FreeStyle Navigator system is designed to continually record interstitial fluid glucose levels for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator system are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.

Additional information about the FreeStyle Navigator system is available at http://www.continuousmonitor.com/.

Source: Abbott

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