38 Responses

  1. Casabby
    Casabby April 4, 2011 at 7:17 am | | Reply

    Did you get any clues when the new sensors from Medtronic are expected to be released? I assume that entered the “all I can say” venue…. After goose-egg bruising and swelling from several of my latest sensors (and 2-1/2 years of unreliable results), I’m not sure that I can ever force myself to use one of the old sensors again. I keep using the system because insurance won’t approve me for a new system. I hope to hang on long enough for the new sensors from Medtronic, but I’m losing hope.

  2. Annie
    Annie April 4, 2011 at 7:29 am | | Reply

    In regard to your information on the FDA hold up of the Veo system—my husband has presented to the FDA several times. He is consistently disappointed/astounded to find the review panels are either uninformed or uneducated as to the technology they are considering for approval.

  3. David Edelman
    David Edelman April 4, 2011 at 7:59 am | | Reply

    Casabby, the new sensors will probably not be available for at least 2 years.

    The new sensors only work with the new pumps because the current pump only supports 3-day sensors (and the new ones are 6-day). Based on their feedback from the FDA, it is unlikely that the new pump will be released for at least two years. They need to complete a current study and conduct another 6-month study (which actually takes 12-months). Then the FDA needs to give approval which can take a year.

  4. Bernard Farrell
    Bernard Farrell April 4, 2011 at 8:19 am | | Reply

    As I learn more about FDA reviews for our technology, it’s clear to me that there may be a role for the DOC in those reviews. We are experts in diabetes care for ourselves as individuals and many of us has used a large number of devices so we’re familiar with their benefits and shortcomings.

    Maybe it’s time to start brainstorming about a way to establish some type of relationship with the FDA and ultimately reduce some of the roadblocks we’re encountering.

  5. BadShoe
    BadShoe April 4, 2011 at 8:41 am | | Reply

    I think I heard them say that data mining is conducted on data after consent but that maybe a good point to check.

  6. Mike Hoskins
    Mike Hoskins April 4, 2011 at 8:54 am | | Reply

    Amy – thank you for this rundown! Very awesome and informative. On the whole MyMedtronicConnect – are they at least considering or working toward having it include those management aspects? Is this a “first step” type of thing, or is this what the end-vision was? To me, that seems like MM just wanted to jump on the App Bandwagon and not actually provide anything truly useful to the consumers being served. This is a great idea, but I too only think it really serves a need if offering something practically useful on the day to day, what you might actually want and really need from a smart phone app in the first place? Hope they are moving in that direction…

  7. Annie
    Annie April 4, 2011 at 9:40 am | | Reply

    Bernard—EXACTLY what I was thinking. At the very least, when reviewing diabetic technology, there should be an endocrinologist and/or a PWD involved in the process. Isn’t this just common sense???

  8. Kassie
    Kassie April 4, 2011 at 9:48 am | | Reply

    I’ll admit that I’m one of those people who will need a lot of convincing before I let an insulin pump decide on dosing. Did they really say that they consider night time as a good first step for closed loop approval? That terrifies me. I definitely want to be awake/aware when that machine is in control!

  9. Anne Findlay
    Anne Findlay April 4, 2011 at 2:58 pm | | Reply

    how about a semi-closed loop where actions by the pump that are derived by CGM have to be confirmed by the user?

    Anonymized “data mining” seems completely reasonable to me. This is common in medical research and will presumably lead to improvements in care. If someone thinks my data can be helpful, they can have it (if it is anonymized). I am sure there is a disclosure of some sort in the software license agreement when you install it. This is more commonly called “chart review” and does not always even require the consent of the patient; these studies are carefully regulated by institutional review boards (a panel of lay people and professionals who examine research involving human subjects). Thank all those patients before you for the good medical care you get now.

  10. Heidi
    Heidi April 4, 2011 at 5:07 pm | | Reply

    I appreciate that Medtronic has enlisted the help of the DOC. It’s great to get a glimpse into the future of our technology and also to know that Medtronic is not just focused on technology, but also on the emotional and social aspects of living with diabetes.

    “Low glucose suspend” sounds much better to me than “closed loop at night only.”

  11. Casabby
    Casabby April 4, 2011 at 5:55 pm | | Reply

    David–Thanks for the update, although it is disappointing information. I had wondered whether the new sensors would work with the old transmitters and it’s not surprising that they won’t. I just want smaller sensors and shorter insertion needles. Oh yes, and more accurate sensors.

  12. Megan
    Megan April 5, 2011 at 8:11 am | | Reply

    Not to contradict David, but all the information I’ve received (some from Medtronic employees) is that the new sensors WILL work with the old pumps. The old pumps will still require a restart on days 3 and 6, and will not have the upgraded algorithm that the next gen pump will have, but the new sensors will come out before the new pump.

    1. AllisonB
      AllisonB April 5, 2011 at 8:16 am | | Reply

      @Megan: I was in the same tour team with David, and I can only confirm what we were told by Jonathan Riley of Medtronic, and that is that the new Enlite sensors will not work with the old pumps. The reason is the FDA will not approve anything that requires circumventing pre-existing FDA approved products. If the old pumps “require” sensors to be changed every 3 days, and the new sensors are being marketed to last 6 days, then the FDA will not allow Medtronic to market something that would require ignoring an already existing FDA approval. Does that make sense? They are not allowed to tell people to just “restart the insulin pump” on the 4th day, even if reps may say that you can do that. Technically they are not allowed to.

      The Enlite sensors will be approved in Europe, but they will not be approved for the US.

  13. Megan
    Megan April 5, 2011 at 8:20 am | | Reply

    Well, it would not be the first time Medtonic has lied to me. We are happy with their product, but just so OVER the way they make promises that they can’t/don’t deliver. When my son was diagnosed 3 years ago, the new sensor was going to be out “next year.” And MySentry? That was just around the corner.

    I’ve also heard from a fairly reliable source that the patch pump may be scrapped altogether because market studies are showing that it’s not a big revenue-earner.

    A year from now when his pump goes out of warranty, I think we’ll be seeing what else is out there.

    1. AllisonB
      AllisonB April 5, 2011 at 8:47 am | | Reply

      @Megan: I think it was mentioned in the post, but a huge factor is the FDA. The FDA has become even more strict in recent years, requiring more and more clinical trials and studies to answer even the most mundane (to us) concerns. That causes quite a bit of unpredictability in the market. However, I agree that we should not sacrifice our health while we wait for the “next big thing” and I fully support people utilizing multiple companies to get what they need.

  14. Megan
    Megan April 5, 2011 at 10:11 am | | Reply

    Oh, I know some of it is the FDA, no doubt. I also think some of it is Medtronic promising more than it can reasonably deliver in an attempt to keep customers waiting around hoping that the next big thing is indeed right around the corner. I mean, it’s pretty obvious to me that last year when they promised the new sensor late FY 2011 and the new pump early 2012 they must have known that neither of those things was likely to happen. (And the year before, they promised both of those things earlier than that.)

    It is just very disheartening to me that JDRF is focusing less on a cure, but hey! Let’s all get excited about the AP! Well, okay. The AP would be pretty great. Except device companies can’t get the most basic changes through the FDA, so hmmmmm, that AP isn’t looking like it’s coming so soon either. I’ve never had a lot of hope for a cure, but I was really hoping that technology would make my son’s life substantially easier before he left for college. And now…I don’t know that we’ll have much that’s all that different before that happens. :(

  15. Megan
    Megan April 5, 2011 at 10:21 am | | Reply

    Yeah, this all leaves me feeling bitter and sad. JDRF is turning away from its focus on a cure, and looking at AP technology that will make PWDs lives better. Well, okay. I’ve never held out that much hope for a cure anyway. But when companies struggle for years to get the most basic upgrades to products through the FDA (it took 19 months for approval for the Revel, and it had minor, minor upgrades!), how long will it take for anything actually revolutionary to get through?

    So less money going toward a search for the cure, and technology moving at a snail’s pace. Guess I should just get used to our high-maintenance sensors that leave my son’s skin looking terrible, and a pump that looks like a 1980s beeper. Because if MM is saying now that it will take two years for the new sensor and pump, it will be at least four. :(

    1. AllisonB
      AllisonB April 5, 2011 at 12:49 pm | | Reply

      @Megan: I actually learned this afternoon that we were both partially correct. The new sensors do work just fine with the old pump, however, the FDA won’t allow Medtronic to market a system that requires a restart of the sensor. FDA requires that Medtronic also have a pump that will run a sensor for 6 days straight, which is why the sensor isn’t being delayed in the U.S.

      Apologies for any confusion!

  16. Megan
    Megan April 5, 2011 at 2:17 pm | | Reply

    @Allison: Did you mean to say in your last sentence “which is why the sensor IS being delayed in the U.S.?”

    Thanks for the clarification. Much appreciated.

    1. AllisonB
      AllisonB April 5, 2011 at 2:25 pm | | Reply

      @Megan: Yes! I did. The whole sentence should read:

      FDA requires that Medtronic also have a pump that will run a sensor for 6 days straight, which is why the sensor is being delayed in the U.S.

  17. julie
    julie April 5, 2011 at 5:48 pm | | Reply

    thankyou, good post. this has changed my perspective on medtronic, where their pump was probably being inched out of the running for my young son, im now re-considering with the work going into cgms. we are waaaay behind with technology in australia, both availability and affordability. if the you are talking 2 years in the US, then its prob 5 or more here :(

  18. Tracy
    Tracy April 5, 2011 at 7:45 pm | | Reply

    Where are all the blog posts about the 2 year delay of the Medtronic Enlite sensors? 25 bloggers and no one is blogging about it. Hmmm….

    1. AllisonB
      AllisonB April 5, 2011 at 7:58 pm | | Reply

      Tracy, I can’t speak for other bloggers, but we did address it in the comments here (apologies for leaving it out of the text!). But there’s really nothing left to blog about. The 2 year delay is primarily the responsibility of the FDA, because the sensors are done. It’s not that Medtronic has delayed the technology of the sensors, but the FDA is basically requiring them to create a new system – a new insulin pump – which takes time to develop and run through clinical trials (which David described earlier). If anything, we may explore the issues with the FDA in upcoming posts.

  19. Tracy
    Tracy April 5, 2011 at 8:31 pm | | Reply

    Telling me the Enlite sensor is compatible with current Minimed pumps is like rubbing salt in my wounds. Seriously. Why even go there when the FDA has blocked it from ever being used in the current pumps? Please don’t send mixed messages that give people false hope. Some of us are at the end of our rope with MM promising products they cannot deliver.

    When did the FDA tell Medtronic there would be a 2 year delay on the sensor and when are they planning to announce that? Something smells kinda funny.

  20. Tracy
    Tracy April 5, 2011 at 9:22 pm | | Reply

    Oh Allison, I think there is plenty to blog about. You were the only 25 people in the country to find out about this bombshell and yet you
    don’t find that blog worthy? I find that really hard to swallow.

    I guess we can blog about Carelink and the Veo (safe topics), but we choose not to bring up the disturbing news that the long awaited MM sensor will not get FDA approval for at least two years. Thank you Dave for at least having the courage to state this in the comments section.

    99% of the Diabetic community is blissfully unaware of Medtronic’s 2 year delay. Many of us have been following the Enlite for a long time, hoping for anything that makes our lives easier. I think you should ask yourself why you chose NOT to blog about this.

    My opinion only.

  21. Megan
    Megan April 6, 2011 at 7:47 am | | Reply

    I wanted to add that my understanding from contacts at MM is that it is not a surprise that the FDA will not allow them to release the new sensors for use with the existing pumps. MM has known this for quite a while. They originally intended to do a software upgrade of the Revel pumps, allowing for 6-day sensor wear. That would have made it through FDA review much more quickly than an entirely new pump. Instead, they’ve decided to wait to release the Enlite with the next generation pump.

    I suspect that if Animas and/or Insulet had brand-spanking new integrated pumps on the near horizon, MM would have done the software upgrade so that they would also have something new out. But when you’re the market leader, holding market share, and your competition can’t find its collective rear ends with both hands and a flashlight, what incentive do you have to get anything new out quickly?

  22. Kristin
    Kristin April 6, 2011 at 2:14 pm | | Reply

    Thanks for the update! I would be curious about two more points:

    - Why do you think that Medtronic invited members of the DoC? I think there are plenty of good reasons, but I wonder what your impression was of their purpose in organizing such an event.

    - How many of the people that attends USE Medtronic products? Although Medtronic has the market share, I notice on TuDiabetes that many experienced pumpers run away from Medtronic when they can, especially for the CGMS! Do they seem aware how poor the reviews are of the MM CGMS compared to Dexcom? I guess they are (and the new sensor should be the complete answer), but I would be curious if they brought this up directly.

    I use the MM722 (without CGMS) and also use Carelink. I figured that they were data mining (and I’m actually fine with it). Whenever I want to get a report for even one day of pump data, I need to upload all the data on the pump. I wonder how useful the data is given that so much information is still missing (in my case, my blood sugars readings).

  23. Karrie
    Karrie April 6, 2011 at 6:59 pm | | Reply

    Hi Guys,

    This is Karrie Hawbaker, PR Manager at Medtronic. I’m glad you’re all so anxious for a new sensor here in the U.S. Those who were with us on Friday can attest – so are we! We invest heavily in research and development, are excited by our product pipeline and want to get new products to market as quickly as possible.

    I know there are a lot of rumors floating around about Enlite. The thing is, Enlite is approved in Europe and we are working with our regulatory partners to bring it to the U.S. However, this is taking longer than we anticipated which, as you may have already heard from others in the industry, is not uncommon for medical devices in this regulatory environment. So, we really cannot predict the timeline. And because you are consumers, FDA doesn’t allow us to talk to you about products that are not yet approved in the U.S.

    I can tell you that we are committed to designing sensors that work with our existing integrated system. And I can tell you that getting a medical device approved in the U.S. involves an ongoing dialogue between the FDA and the manufacturer to ensure that the clinical evidence meets safety and efficacy standards.

    So, please, I encourage you all not to jump to conclusions about what the timing is before even we know what that will be or about the product offering before it is approved by the FDA.

    And please know that we’re really not holding out on you. We’re working as hard as we possibly can to get a new sensor (and other future products) to you as soon as possible.

  24. Tracy
    Tracy April 6, 2011 at 7:35 pm | | Reply

    I agree with Megan, my gut feeling is that MM has known they couldn’t get approval on Enlite for a LONG time, and kept it under wraps (still is). There are standard, preset conferences set up throughout the FDA filing process, even though MM wants us to think they just sit back helplessly and wait. I’m sure this came up early on.

    Remember when MM announced they were extending the current sensor to 6 days (same sensor, longer wear) then that plan was abandoned and the new Enlite was announced? Same deal, same issue. The original plan was probably scrapped because the FDA told them they wouldn’t allow it until the pump was upgraded. MM knew that would be the case for Enlite too. Why wouldn’t it be?

    My Opinion Only.

  25. Michelle
    Michelle April 7, 2011 at 5:27 am | | Reply

    with all due respect Karrie (and in fairness of disclosure my son is a Revel/Cgm users) it sounds an awful lot like the phantom CGM parent monitor that was “being held up by the FDA” back in 2006 and which still has not made it to market. Not everything is the FDA’s fault. MM has a track record of enticing customers with promises of things with no way to deliver them, and then they blame the FDA. If there was competition RIGHT NOW for another integrated pump with better sensors I have no doubt MM would find some way to get their to market first. As it stands though, it makes little business sense for you when you already own the market, to introduce a new product just to appease a few small CGM users.

    I’m tired of the FDA being blamed for every holdup. I’d think by now you all know how the FDA works, so instead of pulling the old “Oh, surprise, FDA wants something ELSE..who knew??” you could maybe be honest and say you have no intention of getting that “something else” to market until it’s absolutely necessary.

    And while we’re talking – could you PLEASE for all that’s good, get a version of Carkelink PRO with the EXACT same data (minus the dosing ‘suggestions’) to consumers? The dumbed down carelink version you have for us is insulting.

  26. Sarah
    Sarah April 7, 2011 at 5:40 am | | Reply

    I couldn’t agree more with both Tracy and Megan.

    And Karrie … perhaps you can’t fully appreciate how condescending it feels to be told, on the one hand, that you can’t talk to us because the FDA has muzzled you, and yet, we must not, “jump to conclusions”. No, we must sit quietly on our hands and wait …and wait and wait and wait.

  27. Megan
    Megan April 7, 2011 at 1:13 pm | | Reply

    Karrie, thank you for posting.

    I do have a couple of bones to pick with what you posted. First off, it’s obvious to me that it’s not quite as simple as MM not being able to talk about products that are not yet approved in the U.S. I remember seeing a video a year or two ago that was posted several places on the net where one of the Medtronic mucky-mucks was holding a prototype patch pump and talking at length about it. I’ve also seen multiple timelines given for the product pipeline in quarterly and annual investor presentations and stockholder reports. There was a focus group for (the mythical) MySentry at Friends for Life 2009. I’m sure there are some restrictions on what you can say about non-FDA approved products, but I don’t think they’re as draconian as you represent.

    The fact of the matter is, in the past four years, Medtronic has not hit one projected release date. It is downright infuriating to be told time and time again, “Oh, next year. Next year. Next year.” You’re pissing us off. I mean, the year the Revel came out, you were projecting release of the next gen pump approximately a year later. Come on. No one believes you would release two pump updates so close to each other. It was laughable. Why do you DO this?

    We are Revel/CGM users, but my patience is wearing thin. There have not been any significant changes to Medtronic’s pump or CGM in years and years. You can blame the FDA, but I sincerely doubt the FDA is responsible for MySentry being promised and not delivered for FIVE years now. Even Abbott was able to beat that sort of timeline with their ill-fated Navigator.

    So my advice to you is to give yourself plenty of “wiggle room” in your product pipeline predictions and surprise us when they’re released early. You’re going to make people a lot happier than this “Next year, oh NEXT year” crap that we see time and time again.

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