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37 Responses

  1. Becky Thomson
    Becky Thomson April 12, 2011 at 4:42 am | | Reply

    “That’s all we know about that for now. Except of course that Europe will get the Vibe first.

    Invented here; Enjoyed there. Grrrr.”

    OK, I’m actually slightly put out by this, if I’m honest. The UK is so rarely ahead of the curve in any tech – CGMS are virtually impossible to get over here, and so few people have access to pumps full stop. We’ve only just had the Omnipod released. I can understand frustration that you’ll have to wait for the Vibe – I have the 2020, and would love to have the option of CGM function that the Vibe will offer, but I’ve got another three and half years left on my 2020. So whilst I understand the frustration, I resent the implication that we in Europe shouldn’t be allowed access to new developments, and that it should always be released in North America first.

    I’m sure I’m taking this a bit too much to heart, and of course it’s hard to read tone over the internet. I usually love the content here, and when something like this bothers me, I just feel I have to say something about it.

    - Becky

    1. David Van Duzen
      David Van Duzen July 12, 2012 at 1:10 pm | | Reply

      Just to clarify, we live in BC Canada and we just got our son on the Minimed Veo, it is available in Canada and we have been to the Enlte will be here very soon as well :)

    2. Alex
      Alex November 28, 2013 at 1:23 pm | | Reply

      Hello, I live in Milan. And I tried the Medtronic system with the glucose control, that you think is much better because it s smaller,,,,sorry to disappoint you, but it’s really crappy, the sensor, doesn’t work well at all, my glucose level was never the same as with finger blood…the first 2 days because its calibrating…then the last day it also goes different, so in5 days it work 2 days….now I’ve got Animas vibe….its the best one i think…if any one wants to ask me something about it…

  2. Greg C
    Greg C April 12, 2011 at 5:26 am | | Reply

    Due to some issues regarding the 510(k) process at the FDA, the FDA has become much more conservative in the last few years. Many Medical device companies are now looking to receive CE Mark (European approval) prior to FDA PMA or 510(k) approval. The combo OmniPod/Seven Plus and Animas/DexCom products have both been delayed due to tighter FDA standards. Unless things change at the FDA, Europe will proabably see more of these products before the US does.

  3. Bernard Farrell
    Bernard Farrell April 12, 2011 at 5:55 am | | Reply

    I know that we can (within limits) import drugs for personal use. What about devices?

    I think the FDA has been very reactive to criticism of mistakes made in approvals. I’m sure the EU process has similar mistakes though they’ve probably not made news over here. I am concerned that our process seems to be getting slower and more obtuse while the EU one appears to be better defined and more predictable. I do hope the FDA woes are resolved, and I really how that the DOC can engage with the FDA in a useful way that perhaps helps this process when it comes to devices for diabetes.

  4. Katie
    Katie April 12, 2011 at 6:09 am | | Reply

    Am I the only one thinking “what does it matter if the Medtronic sensor is smaller and less painful if the accuracy/reliability doesn’t improve.” Now, I understand that it is not in Medtronic’s best interest to flaunt any improved accuracy until the new product is available, because it essentially acknowledges that their current sensors leave something (read: A LOT) to be desired.

  5. Brent
    Brent April 12, 2011 at 7:56 am | | Reply

    Thanks Amy!

    Is there any information on how the calibration process might change (read: be improved) with the Enlite?

    Thanks,

    Brent

  6. AmyT
    AmyT April 12, 2011 at 8:22 am | | Reply

    @Becky – Wow, we would never intentionally imply that people in Europe should NOT BE allowed access to new developments – what the heck?! All we’re saying here is how frustrating it is for us stateside PWDs to have to watch from the sidelines and not have direct access to these newest tools ourselves. In other words, booh on the FDA.

  7. Greg C
    Greg C April 12, 2011 at 9:03 am | | Reply

    Here is a link to a study (came out last October) comparing the FDA and Europe in terms of costs and approval process.

    http://www.massdevice.com/news/study-fda-related-activities-cost-24-million-510k

  8. Becky Thomson
    Becky Thomson April 12, 2011 at 11:21 am | | Reply

    @Amy

    Oh, booh to the FDA I can totally get on board with :) Like I say, I was sure it was just me being overly sensitive and reading into the tone something I wasn’t there. I don’t see any reason there can’t be a universal release either.

  9. Anne
    Anne April 12, 2011 at 12:40 pm | | Reply

    come on FDA!!!!!!! very cool news about the Vibe.

  10. Sarah
    Sarah April 12, 2011 at 1:38 pm | | Reply

    Thanks for this update. It’s so frustrating waiting and waiting for the next best d-tech to come along…and I feel incredibly privileged to be able to even make that statement, given that I’m lucky and in the small % able to have both pump and CGM. I’ve been waiting for that integrated animas/dex for nearly 2 years, though, and eagerly anticipating the day it will be available in the U.S.

    1. Pauline Clark
      Pauline Clark April 23, 2012 at 7:17 am | | Reply

      I am interested in hearing you are on a pump with CGM. Did you get funding for the CGM from your PCT or Hospital, or are you funding it yourself, if so can you tell me approx how much a month it cost.s. i am on an Animas 2020 and have been trying to get a CGM for 3 years now.

  11. Anon
    Anon April 12, 2011 at 3:33 pm | | Reply

    Seriously….they put a man on the moon with less technology than I carry in my purse. So where’s the Vibe remote? I’m not buying this “radio frequency” stuff. Don’t make Animas users choose between a CGM and a remote. Figure it out. Now.

  12. Lili
    Lili April 12, 2011 at 6:40 pm | | Reply

    I’m not very enthused about the name of the Animas Vibe – imagine the TSA conversations alone.

  13. T1 in Boston
    T1 in Boston April 12, 2011 at 8:19 pm | | Reply

    Time to slow down that automatic every-three-month sensor order w Minimed. Hate it when they phase something out and I still have three months left!

    Great news. Heard it here first! (Agreed they HAVE to be aware of all of our sensor problems – this HAS to be an improvement!)

    (PS Am I the only one who thinks it’s funny that the Paradigm 523 has a Link Sensor option for “Reconnect old sensor” that is disabled? I mean, c’mon!)

    1. PhotoDave
      PhotoDave February 2, 2012 at 11:20 am | | Reply

      Funny. The “reconnect old sensor” on my 523 works just fine. Better get yours checked.

  14. Natalie Sera
    Natalie Sera April 12, 2011 at 8:41 pm | | Reply

    Well, both my Medtronic 722 pump and my CGM will both be out of warranty in 2012. Maybe a good time to take a close look at the Animas/Dex. Medtronic sensors do leave something to be desired — some have been spot-on for days, and others wacky right from the start-up. Maybe the Enlite will be better, but who knows?

  15. Heidi
    Heidi April 13, 2011 at 6:22 am | | Reply

    Nice update :-)

    @Amy, I totally get what you say about the frustration of being on the sideline of new releases – that’s exactly how it feel here in Denmark (and probably also most of the time in the UK, @Becky), regarding most pumps, insulin, CGM systems, you name it. And even though the Paradigm Veo apparently is available in the UK, I haven’t heard it should be in DK, European Union regardless.

    And another thing, it’s actually funny (not in the good way) that something like disregarding guidelines might be the FDA argument for halting the Enlite release – I bet most of us PWDs at some point, if not on a regular basis, have disregarded guidelines, whether it be for replacement of needles and lancets, or CGM sensors. I for one have been using the Metronic CGM for 4 years now, on and off, and have never discarded a sensor after just 3 days; I always restart it for at least a total of 6 days :-)

  16. Megan
    Megan April 13, 2011 at 7:32 am | | Reply

    Honestly, this could have been easily solved by Medtronic seeking 6 day wear approval for their sensors years ago. As a couple of posters have noted, absolutely no one I know wears them for only 3 days.

  17. karend1
    karend1 April 18, 2011 at 7:44 pm | | Reply

    My MM 722 is out of warranty right now and I so was not a fan of the MM CGM. I fought the denial and won, but then hated the thing.

    Someone please help me decide if now after 8 years should I swith pump makers and go with the Animas because of the Dexcom/Vibe? Plus I need all this decided before 2012 as my medical insurance is gonna go through the roof because I have a chronic illness.

  18. Jamila
    Jamila April 30, 2011 at 3:06 pm | | Reply

    Will the animas vibe still have the one touch meter remote? Please say yes!!!

  19. Jamila
    Jamila April 30, 2011 at 3:16 pm | | Reply

    I would love it even if the remote didn’t show the cgm info. As a pump, the remote is a MUST.

  20. nel
    nel May 26, 2011 at 9:16 am | | Reply

    please note Medtronic Paradigm Veo is available in Canada since 2010 . I got mine , Feb. 2011.

  21. Kya
    Kya June 23, 2011 at 2:31 pm | | Reply

    Just came across this video for Animas Vibe..

    http://www.youtube.com/watch?v=hgtuoFVKFds

  22. Dick Engel
    Dick Engel July 24, 2011 at 4:35 am | | Reply

    Becky – No one wants to deny Europe access to the innovations – we just want them too – our complaint is not against Europe it is against our own overly restrictive FDA . They have taken a zero risk policy which is stupid. One can’t walk across the street with zero risk so would they have us stop walking across the street?? (I think they would if they could the current administration is regulation happy – They think the government should control every aspect of our life). As an american manufacturing engineer – I think its great that we can export American designed goods anywhere in the world. Its good for the exporting country and also good for the importer. One has access to jobs and the otgher access to technology. I just we could use what we invent and make!!

  23. Lee
    Lee September 7, 2011 at 4:29 am | | Reply

    I’m new to the CGM and have learned more from this blog than from all the user guides I’ve read. Can someone help me with this? There have been on a couple of occasions a 100 point discrepancy between my sensor readout and my glucometer. I calibrate at least four times an day. A 50 point difference is not unusual. Is this a problem with other CGM users or am I doing something wrong. I’ve asked my trainer and she says a 50 point difference is not unusual. But how do you calculate the correct bolus if you’re going by the sensor if you’re 50 points off? I find I’m testing now more than before I got the CGM. Thanks for any pointers for this newbie.

  24. Megan
    Megan September 20, 2011 at 9:49 am | | Reply

    Is there any way to find out where the Enlite sensor is with FDA approval status? I tried calling the FDA got a freaking answering machine after I pushed 3,000 buttons to get the right office. I have also asked MM but they won’t say a dang thing. I am currently fighting my insurance to get CGM but if the Enlite is near approval I will wait. Does anyone know anything?

  25. Doug
    Doug September 29, 2011 at 8:29 am | | Reply

    Megan, I just stumbled across a link to Medtronic’s Australia website that has a lot of infomation on the Enlite sensor:

    http://www.medtronic-diabetes.com.au/Enlite-sensor.html

    As far as getting it here in the US, if I were you I’d go ahead and get the approvals needed for the current system. From the info on the Australian site, it appears to be compatible with the existing US pumps and transmitters already, so it probably means you just have to alter your standing prescription for the sensors to get them when they’re finally available.

    As far as the FDA approval, if there’s a snafu in getting the US pumps to let these run 6 days instead of 3, I think there will be unspoken knowledge that the sensors will safely go 6 days and you have to manually restart the sensor on day 3 to go another 3, just as we all do now with the current sensors (with my doctor’s full approval, I might add). If/when the FDA approves the 6 day use, you’ll probably have to trade up to a new pump since it’s in the pump’s firmware, but Medtronic has beeen very generous in the past in providing hardware upgrades at a reasonable cost to existing customers so I’m not concerned about that.

    Myself, for a variety of reasons I stopped using my Medtronic CGMS system about six months ago, mostly due to the sensors being buggy and a pain to use (literally and figuratively). These new sensors would definitely put me back in the active user category again, from what I’ve been reading about them. Hope this helps.

  26. John T
    John T November 8, 2011 at 8:47 am | | Reply

    I would like to know the steps or (procedures) used to extend the use of a Glucose Sensor beyond three days using a MiniLink Transmitter and Real-Time REVEL MM pump

  27. Mariya B
    Mariya B November 30, 2011 at 6:09 am | | Reply

    I moved from US to UK for school and although I got the Veo (switched from the Revel) the CGMS wasn’t approved (apparently usual practice). Then, mind you, I found out that the radio frequency is different so I can’t use my old transmitted with the Veo. The support team said that I was going from a US pump to a worldwide one. What a stupid issue! And I have to spend money on a new carelink for an issue of radio frequencies?

  28. Ian J
    Ian J March 23, 2012 at 10:57 am | | Reply

    It’s nearly a year after this article was published and there’s still….. nothing. I wish there was more transparency to the process. What stage of approval is the animus vibe and enlite sensor in at the moment? What’s holding it back? Do they even have a time table for approval?!?

    1. Mark
      Mark May 1, 2012 at 2:12 pm | | Reply

      Damn. I was reading this page thinking it was written a few weeks ago when it was actually a year ago… Any more news on the Enlite sensors? I’m just too skinny for the other sensors.

  29. Brent Allsop
    Brent Allsop June 8, 2012 at 1:38 pm | | Reply

    Does anyone have any news when anyone will finally have a system with blue tooth and running on and controlled by a smart phone app, instead of their primitive display/interfaces?

    Also, has anyone ever looked into jail braking any of these hellish / restrictive devices. I’m an engineer, and if I could reprogram some of these insanely annoying, ruin my life, and almost kill me, ways things work, my blood pleasure would probably drop significantly, not to mention have better control.

    I mean, can anyone even figure out the algorithm the mini med uses to map isigs to what it logs/displays? Whatever it is, it is insane, and blinds us from the most important trending data contained there in – again, ruining my life, like so many other terrible things.

    1. Mark
      Mark June 18, 2012 at 8:48 pm | | Reply

      Brent,
      I’m also a bit technically minded – not as much as you, though. But i do have statistical skills (multiple regression using Stata). Maybe we could join forces if you can figure out a way to jailbreak the minimed.

    2. Paul
      Paul September 7, 2012 at 3:18 pm | | Reply

      Accu -Chek has a new pump with a BLUE TOOTH meter remote. It is called the Combo and has been out in Europe and Canada for a bit. It looks nice.

  30. Maria
    Maria August 4, 2012 at 3:00 pm | | Reply

    The use of a smartphone to control the cgms and pump features would be fantastic! This should have been part of the next step, when planning to advance care and improve BG management, using cgms/pump systems!

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