It seems like we’ve been waiting a very long time for a step forward on Abbott Diabetes’ promising new CGM system, the Navigator. Well, there’s good news today for our diabetic kin in Europe: the Navigator has received “CE Mark” approval, the equivalent of FDA approval for use in adults across Europe.
(Geez, I’m going to be there next week! Maybe I can snake me one… if I only knew how to say “endocrinologist” in German)
The company is “optimistic” that FDA approval will follow shortly.
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.”