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
posted by Bernard @ 9:16 AM
13 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.
I can give you 1st hand knowledge as someone who as been using the Navigator for several months now.
I absolutely love it.
There is a bit of a "learning curve" when looking at interstital fluid glucoses vs finger sticks. However, once you take into account the approximate 14min lag time of interstitial fluid vs BG, its quite enlightening.
To address some of the questions posted earlier.
1. Comes with integrated FreeStyle meter. Used to calibrate the sensors and to perform normal fingersticks. There is no option to manually enter glucose values.
2. Sensor/transmitter is waterproof, so you can swim/bathe, etc. The Reciever is not however.
3. Wireless range on between transmittor/sensor and reciever unit. They publish 10 feet,however I have found that to be VERY conservative. I frequently leave my reciever on the kitchen counter and do whatever around the house (distances up to 30-40 feet). If the reciever looses communication from the transmittor/sensor for 10min, there is an option for alarms. I generally on concern myself with ensuring it is in the same room, or use it with the belt clip accessory, which makes it loo like you are wearing a pager type device.
4. Insurance--varies alot, my insurance covered it completely, but I've heard others balk completely. But its new technology, time will bring insurance companies around.
From a performance standpoint, I have nothing but praise for the system. I've been thoroughly pleased with the accuracy and performance. Typically I do 4 fingerstick calibrations over the 5 day sensor life, 3 of those are in the 1st 24 hours, and the 4 about 72 hours after insertion.
I initially had some issues with sensors mounted on my abdomen, but after only using them on my arms, I've not had a single problem with them. In fact, on my arms, I totally forget that I'm wearing it.
I have also had no issues with the adhesive not lasting the 5 days. The adhesive also breaks down easily with just alcohol pads, so removing is pretty easy.
I also love the alarms you can set when you cross certain glucose thresholds, low or high, and the predictive alarms so you can act, rather than react.
I'm not on a insulin pump (yet) and I've already been able to identify and adjust some of my insulin doses for my basal's, was taking too much, and I can currently see when my basal injections begin to fade around 18hrs post injection. Hopefully this will resolve when I get a pump.
Anyway, like I said earlier, I've been very happy with this device overall. I'm hoping there will be some future developements, perhaps integration with some insulin pumps.
im trying to get the freestyle navigator but Im still waiting on insurance coverage verification - its been over a week - i have bluecross and united health care .. does it normaly take this long of a wait ?
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