Abbott FreeStyle Navigator is approved
Today Abbott reported that the FDA has (finally) approved the FreeStyle Navigator continuous glucose monitor(CGM) for sale in the US.This is one of the most anticipated CGM devices. Many people I've spoken with have expected that this CGM will solve all the shortcomings of the Dexcom and Minimed devices. I've also talked with several people who have been using the Navigator. My take is that this is no more perfect that the existing CGM alternatives.

Abbott, who even has a special site for the Navigator, says that it will be available in the second quarter of 2008. Like all CGMs you will need a prescription to get hold of one.
A few interesting aspects of the Navigator:
- Five-day sensor.
- Five direction arrows to indicate rising or falling blood sugar
- The receiver has a built-in FreeStyle meter.
- Designed to 'accomodate' swimming. Does that mean the receiver is waterproof?
- The receiver can be up to 10 feet from the transmitter
One part of this animation shows the sensor being worn on the back of the arm. That's a very different location that is currently recommended for CGM sensors.I'll post more news about the FreeStyle Navigator as I learn about it.
Update: My understanding is that the built-in FreeStyle meter is used to calibrate the Navigator. I do not think they support manual input of the values. I'll try to confirm this and update the page when I learn more.
Labels: Abbott, CGM, FreeStyle Navigator




11 Comments:
This is so great. Thanks for the heads up!!
do you know whether you can use any meter with it or is it specific to one?
AWESOME!!! More and better options for us!
A quick glance at the website reveals the following:
1. The sensor needle goes in vertically. Could this pose problems for those that don't have a lot of fat in the insertion area?
2. Looks like Abbot recommends the use of the Navigator in patients 18 years or older. That doesn't make a lot of sense.
3. It may be worthwhile to request a review unit and write up a review. Would Abbot be up to it?
4. Only time will tell if the sensor will last beyond the approved 5 days.
5. More competition is good. I hope this forces Dexcom and Minimed to rethink pricing on their products.
Keeping my fingers crossed for this one...
This would be most excellent. Are they also working on insurance issues? This might hinder larger use if the unit/sensors are as expensive as other CGMS...
Oh, the day when these things are as common as iPods...:-)
I'm running through the Flash Virtual Navigator and it says "Test Strip port Where Freestyle test strips are inserted to calibrate the Receiver or manually check blood glucose levels."
So it's like having a built in meter. Nice.
now, when will it integrate with cozmo.....
Hey Bernard!
The folks I have talked with that have used it and other CGMs are positive about the Navigator. That said there are not a lot of them so YDMV.
From my perspective both this and Dex need pediatric FDA approval and they all need some insurance support.
I look forward to user comments particularly some head to head comparisons of systems but I don't know anyone with that kind of cash to throw around.
I don't personally think this will solve the shortcomings of the other devices, since most shortcomings are related to wearing a second site/device and to the use of interstitial fluid glucose rather than blood glucose. Both things still apply to Navigator. And it isn't integrated into a pump...
BUT... choice is good. The current devices don't suit everyone. For some people one works better than another and the Navigator may be some people's "best". Equally it may be some people's "worst", and it will be a shame if this applies to some people who've held out for Navigator and then write off CGM without ever trying the other devices, just because Navigator does not suit them.
Competition is also always good, and will hopefully lead to lower prices and further research and development.
This is so cool! Seems they took forever.
Any idea if there are plans to integrate it with the Cozmo? I hope so.
Now I just have to wait till anything other than the MiniMed CGMS comes to Canada ...
Hi folks,
I spent a lot of time documenting my experiences while I wore the Navigator in a three month trail. I really loved the thing and now that I've had the Minimed CGM for a year, I would say the Navigator still rocks, especially from a user-friendliness perspective. The cost of the sensors, however, is pretty steep.
My latest blog entry provides links to Navigator specific posts that might be of interest.
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