Thursday, June 7, 2007

Navigator® Continuous Glucose Monitoring System Approved in Europe

Filed under: Medicine , Pediatrics

Amy Tenderich of Diabetes Mine is reporting that Abbott has received the European CE Mark of approval to market its FreeStyle Navigator® Continuous Glucose Monitoring System for people with diabetes.

The company explains its system:

The FreeStyle Navigator System is designed to discreetly measure glucose levels once per minute without the recurring pain and hassle that can accompany conventional blood glucose testing. With early warning alarms that alert the patient to potential highs and lows, and by providing glucose information once per minute (equivalent to 1440 times per day), the FreeStyle Navigator system provides a more complete picture of where the person's glucose level is, and where it is going -- up or down. For people with diabetes, less time spent in either a hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) state has been correlated with better diabetes management and reduced risk for a number of serious short- and long-term diabetes-related complications.

Abbott's FreeStyle Navigator System offers a number of key advances for people with diabetes. 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 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. The FreeStyle Navigator System features a disposable sensor that is worn for up to five days, then replaced; a transmitter with a 10 foot (3 meter) range; and a wireless receiver with a built-in FreeStyle(R) blood glucose meter.

Amy, who always has a great pulse on the diabetes industry (as well as a very personal knowledge of these devices), is quite optimistic:

This is quite exciting, in light of the fact that continuous glucose monitoring (CGM) products to date have not lived up to their potential, so to speak. Their accuracy is mediocre at best, and they have a lot of drawbacks for users: the need for multiple daily calibrations with a separate fingerstick meter, awkward plastic patches for swimming and showering, annoying alarms that cannot be adjusted, and short three-day sensor life, to name a few.

From the literature, the Navigator does sound like a great leap forward, and patients in early studies seem to concur. Abbott's system uses a novel "wired enzyme" technology that promises much improved accuracy, and it sports a built-in FreeStyle fingerstick meter for easy calibration. It's waterproof, uses a replaceable battery, and has a five-day sensor life instead of only three! (perhaps part of the reason for the FDA hold up?)

Imagine: accurate, consistent, automated BG monitoring in a form offering comfortable long-term wear. Wow. Now that's what I'd call "disruptive technology."

Diabetes Mine: Abbott Navigator Approved in Europe!

Press release: Abbott Receives European CE Mark Approval for FreeStyle Navigator(R) Continuous Glucose Monitoring System ...

Product page: FreeStyle Navigator® Continuous Glucose Monitoring System ...

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