Abbott Navigator Approved in Europe!

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. Navigator_wear

(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.”

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18 Responses

  1. Becky
    Becky June 6, 2007 at 1:40 pm | | Reply

    Did you not hear that Dexcom 7 day system was approved by FDA last week? No more shower patches, better accuracy and an upgraded receiver/software :) http://biz.yahoo.com/ap/070531/dexcom_fda.html?.v=1

    Dexcom is holding a conference call June 11 to discuss rollout of the new system.

    I used to be a Navigator hold-out but if they haven’t reduced the 10 hour warm up period , I won’t even consider switching. I wonder if that is something they can fix without reapplying to the FDA. Probably not.

  2. AmyT
    AmyT June 6, 2007 at 1:57 pm | | Reply

    Thanks, Becky. Glad to hear they are all getting better. Now we just need to fix the cost/reimbursement issues.

  3. Felix Kasza
    Felix Kasza June 6, 2007 at 2:22 pm | | Reply

    Endocrinologist: “Facharzt für Endocrinologie”.

    Cheers,
    Felix.

  4. AmyT
    AmyT June 6, 2007 at 2:32 pm | | Reply

    Danke, Felix. Eigentlich war das ein Witz :)

  5. JasonJayhawk
    JasonJayhawk June 6, 2007 at 6:54 pm | | Reply

    I remember some mention of the 7-day FDA hold-up for the Navigator release. I wish they’d spend their time pondering over potential life-threatening medications (oral medications) rather than spend 3 months trying to decide if the sensor is going to leave a scar! *sigh*

  6. AmyT
    AmyT June 6, 2007 at 7:01 pm | | Reply

    Yeah, Jason, I don’t really get the big deal on the 7-day DexCom approval, since everybody wore it longer than 3 days already.

  7. Brian
    Brian June 6, 2007 at 11:19 pm | | Reply

    Amy, love the blog, but I was somewhat taken aback by the tone of your comments about CGMSs. I have found that their accuracy is actually very good. I have sensed bitterness from many concering CGMS. I think it could stem from (a) reluctance to embrace new things, (b) cost, (c) lack of proper teaching in how to optimally use the technology, or (d) some combination of these and other factors… I have found if you follow certain guidelines (calibration, site care, etc.), the CGMS can be the greatest thing in the world. And it is for me. I wish blogs were as popular when pumps first came out so we could have something to compare all of the negative feedback to. Please don’t be so harsh for a thing that has been, at least for me, so darn great!

  8. christmasx2
    christmasx2 June 7, 2007 at 5:38 am | | Reply

    Regarding the 10-hour warm up on the Navigator, it appears that the reason for the warm up is that the accuracy within the first 10 hours is not very good, so they block that data. See a link to a May 7th study about the Navigator at http://www.childrenwithdiabetes.org, which references this issue. I am looking forward to the approval of the Navigator and to hearing what bloggers report.

  9. Felix Kasza
    Felix Kasza June 7, 2007 at 6:39 pm | | Reply

    Does the Navigator have approval for medical use, or just CE approval? CE is something required of even a toaster; it does not (or did not, when I left Europe in 2004) equate to what would be FDA approval over here.

    Cheers,
    Felix.

  10. AmyT
    AmyT June 8, 2007 at 9:16 am | | Reply

    Yes, Felix, it’s approved for medical use in Europe.

    In fact, Abbott tells me the European authorities have approved Navigator requiring fingerstick tests only when glucose is changing rapidly (ie. trend arrow straight up or down), and to confirm hypoglycemia. This is NOT just an “adjunctive therapy” approval as all the other systems have worldwide.

  11. mcityrk
    mcityrk June 8, 2007 at 9:00 pm | | Reply

    Hi Amy-

    Sorry, but if you still have to confirm readings with fingersticks under the most critical circumstances, that still is adjunctive!!!!!

    mcityrk

  12. Angela
    Angela June 9, 2007 at 8:13 pm | | Reply

    Hi,

    Amy I was wondering if there is a way to get on the freestyle Navigator out here. I was on study for it out here and now I’m not if you could let me know if the have any other studies or how to get on one out here.

    Angela

  13. marian
    marian June 17, 2007 at 11:23 am | | Reply

    Hi,

    Does anybody know where can I buy this device from?

    Thanks

  14. Timmy
    Timmy June 28, 2007 at 10:50 pm | | Reply

    I looked on amazon.co.uk and they didn’t have the Navigator. Neither did the website for the British Pharmacy chain Boots. Even if I find it for sale online, I wonder if a European seller would be prevented from shipping it to me here in the U.S. before the FDA approves it. Hopefully not. European certification is fine for me.

  15. Jim
    Jim August 13, 2007 at 4:17 pm | | Reply

    I travel to England regularly and I even have an NHS card and GP from when I used to live there.

    Does anyone know how I can get one?

  16. Kevin
    Kevin August 22, 2007 at 4:48 am | | Reply

    I live in the UK and, as far as I know, the Freestyle Navigator is not yet available. It does have CE approval, which means it can enter the market, but Abbott don’t seem to have started selling yet. I’m sure it won’t be long though. I’d recommend contacting Abbott directly to enquire, which is what I’ve done, although I’m still waiting for a reply.

  17. jon
    jon August 29, 2007 at 9:11 am | | Reply

    My 6r olddaughter was in a clinical trial for the navigator over the past year. we loved the sstem and were impressed with how accurate it was. it was taken away and we were forced to purchase a minimed Guardian out of pocket. We are not happ with this system, it is inaccurate a majority of the times-up to 100 points off. I would gladly purchse a Navigator out of the country. If any one has any information how I would appreciate it.

  18. Bobby
    Bobby January 15, 2008 at 6:39 am | | Reply

    The system is being sold in Germany and the Netherlands. One needs a prescription and a mailing address to have the product shipped to within the country it is ordered from. There is also a training session that has to be scheduled with the prescribing doctor….

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