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News

Abbott’s Continuous Glucose Monitoring System receives FDA approval

Abbott Diabetes Care : 13 March, 2008  (New Product)
The US Food and Drug Administration (FDA) has approved the FreeStyle Navigator Continuous Glucose Monitoring System in the USA for people with diabetes.
Designed to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen, Abbott's FreeStyle Navigator system provides minute-by-minute information about which way and how quickly blood sugar levels are changing.

The 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. The system received the CE Mark in June 2007 and has been available outside the USA 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, MD. 'We are always looking for new tools like these to enable people with diabetes to continuously monitor their glucose levels, putting them on the offence, not defence, so they can take action before a high or low glucose level occurs.'

For people with diabetes, less time spent with low (hypoglycaemia) or high (hyperglycaemia) blood sugar has been correlated with less risk for a number of serious short- and long-term diabetes-related complications. 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.

The system 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.

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.
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