OmniPod & Navigator: When’s the Wedding?

How sweet would it be to have a tubeless insulin pump that also “talks” to a state-of-the-art CGM (continuous glucose monitor)? It may be coming sooner than we think…

Tech_wedding Obviously, Insulet Corp. and Abbott Diabetes Care are in bed together: the integration of Abbott’s FreeStyle glucose meter into the OmniPod wireless insulin pump was a stroke of genius, as far as I’m concerned. Many of you also noticed that Insulet made mention of Abbott’s new Navigator continuous glucose monitor in a recent SEC filing:

“We have partnered with Abbott Diabetes Care Inc., a global healthcare company that develops continuous glucose monitoring technology, to develop a product that will integrate the receiver portion of Abbott’s continuous glucose monitor, the FreeStyle Navigator, with the OmniPod System PDM.”

Oh, how I tried to get details on this, but both companies are mandatorily tight-lipped.

Here’s what I do know:
The companies have “an active R&D cooperation” to integrate continuous glucose monitoring into the OmniPod.

Once complete, the new product will consist of a single handheld device with all the same functionality of the current OmniPod PDM — including integrated FreeStyle fingerstick monitor — plus the capability to pick up and display data from the Navigator CGM.

The patient will wear two separate insertions, i.e. the Pod and the Navigator sensor will NOT be combined. But the built-in FreeStyle will serve to calibrate the CGM, so the controller unit at least is a real all-in-one deal.

Looks like Abbott’s strategy with the Navigator is to become the ‘Intel Inside’ of insulin delivery products.

The company couldn’t share any details on timing, in large part because the Navigator is still awaiting FDA approval. Part of the hold-up is its PMA (pre-market approval) status, he says. This is reserved for new technologies/therapies hitting the market for the first time, and thus requires a higher level of scrutiny than for “predicate devices” that are already mass-marketed, such as insulin pumps. Still makes me wonder how the DexCom managed its lightening-fast FDA approval?

Anyway, it’s pretty clear that the OmniPod/Navigator wedding won’t be this year. But the participants are optimistic that the engagement won’t drag on too long. I, for one, am excited to dance at that wedding.

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16 Responses

  1. Scott
    Scott June 14, 2007 at 7:45 am | | Reply

    I think this is a question that many people are wondering … lets hope we get answers sooner rather than later!!

  2. Jules
    Jules June 14, 2007 at 10:16 am | | Reply

    AMY: once again thank you for your valuable info. As a current OmniPod user, I’d give up my car to have this duo.

  3. Melissa
    Melissa June 14, 2007 at 10:36 am | | Reply

    Thanks for the information! I have approval to start using the Omnipod, but I haven’t set up an appointment yet to actually get the Omnipod, now I’m wondering if I should wait for the CGM. Although, I’m not to keen on having 2 things inserted into my skin like that simply because I am already experiencing problems with absorption due to 4 years of using an insulin pump. I guess I’ll have to think about this a little longer before I actually do anything. :)

  4. Clemma
    Clemma June 14, 2007 at 10:51 am | | Reply

    That’s funny, I talked with an OmniPod rep just the other day. He told me the Navigator WILL be built into the pods, and the only upgrade necessary for existing customers will be to buy a new remote unit for about $300. I’ll try to clarify that with him.

  5. Kevin D.
    Kevin D. June 14, 2007 at 1:09 pm | | Reply

    Clemma, while I don’t deny that claim by the MM rep I’ve heard everything of it not being possible.

    The only way it would be possible is if it had another inserter at the opposite end of the pod to insert the CGM the opposite way. And then you’d have to worry about CGM insertions getting into the same path as former pump canulas.

    The problem is CGM sensors go wacky with any sort of liquid interfering. So insulin would definitely interfere with the results of the CGM unit. So I don’t see how they could possibly make a one unit device.

  6. Greg C.
    Greg C. June 14, 2007 at 7:57 pm | | Reply

    When they toured the investment community I asked them when the OmniPod would have an Abbott sticker on it, and they said they could not talk about it. It is coming, but you will have to wait until the FDA gets their butt in gear.

    This is from the website/mgmt section

    Jeff Smith has served as Insulet’s Vice President of Marketing and Business Development since October 2004. He previously served as the Company’s Vice President of Sales and Marketing. Prior to joining Insulet, Mr. Smith was Vice President of Sales and Marketing at MediSense Products/Abbott Laboratories. Mr. Smith earned a Bachelor of Science from Mount Allison University, Canada.

  7. Jay
    Jay June 14, 2007 at 8:12 pm | | Reply

    So why would I need a Abbott stick based monitor in my PDM if I have a CGM? I may be missing something but if I have a CGM always talking to my Pod, I should maintain great glucose control, without so much manual intervention, correct? I want a piece of cake? No prob, eat away and the 2 devices talk to each other and adjust according to the CGM

    So a pod that has lets say 200u with a built in CGM could be all I need and maybe I check with strips for sanity purposes only to be sure all is working?

    That would be sweet, tell me more, do I have this right?

    thanks

    Jay

  8. Lori
    Lori June 14, 2007 at 9:10 pm | | Reply

    Doesn’t MiniMed already have an insulin pump and CGM all in one?

  9. mcityrk
    mcityrk June 15, 2007 at 12:01 am | | Reply

    Hi All-

    As long as the CGM requires calibration rechecks over their lifetime [and nothing indicates that this limitation will be eliminated anytime soon for the current or expected to be approved devices] you still need a fingerstick meter to verify CGM performance.

    Additionally, since its been three years since the Navigator went before the FDA for approval you have to wonder if it is more than FDA footdragging that is the problem here-

    mcityrk

  10. Greg C
    Greg C June 15, 2007 at 5:33 am | | Reply

    MiniMed does have a combo device. Speaking of MiniMed, Medtronic had a chance to purchase Insulet, but passed because they thought that the OmniPod would cannibalize their $4000+/pump sales.

  11. Arthur Ganger
    Arthur Ganger June 15, 2007 at 5:41 am | | Reply

    WIll the navigator be water proof unlike the Dexcom?

  12. Steve
    Steve June 15, 2007 at 9:14 am | | Reply

    So far the Omni-Pod is only available in limited markets. This sounds like another “coming soon” innovation that may never happen. Even if it does, only East Coasters and people like Amy T. who do work for Insulet, get paid, but “aren’t employees”?! can get the Omni-Pod. I am hopeful, but experience has taught me not to dance until the party actually starts…

  13. Melissa
    Melissa June 15, 2007 at 9:59 am | | Reply

    Steve, I don’t know what area you are in, but the Omnipod is now available as far out as Minnesota. I wasn’t sure if it actually became available here or if they were appeasing me because I was constantly checking on the progress, but then I found out through my insurance company that there was another person here who just went through the approval process for the Omnipod. Granted, it’s been slow going, especially since I’d heard of the Omnipod 2 years before it was released to anyone, but it’s coming. Sometimes I had being *so* informed, it makes the waiting harder.

    I’m still sitting on the fence about CGM. Are any of them accurrate enough to replace fingersticks yet? That would be a plus, but the double insertion sites is a negative. And whatever happened to the dozen or so “noninvasive meters” that we’ve been hearing about for the last 10 years?!?

  14. Mary
    Mary June 15, 2007 at 4:57 pm | | Reply

    Amy,
    I live in the Bay Area and according to the Omnipod site, I can’t get an Omnipod. When will the company make the product available in Northern California? Do you have any inside information?

  15. Florian
    Florian June 16, 2007 at 6:56 am | | Reply

    I went to a patient information session at Insulet to learn about the OmniPod. After the presentation there were a lot of questions about CGM and I believe the comment was made that many people who start out with CGM give up on it after a while. I think it’s because it takes a lot of effort to make it work and be useful. I hope Abbott and Insulet Engineers and Designers can come up with an easy to use functional unit with an EASY button.

  16. June S.
    June S. June 28, 2007 at 2:17 pm | | Reply

    I just bought 15 shares of stock with Insulet. It’s not doing remarkably well, but in an article I read on the WWW, Insulet expects to use the profits from its IPO (Initial Public (stock) Offering) to boost manufacturing. The problem is that they can’t supply all the folks who want the OmniPod. I got mine in January 2007, and have never been happier. I began taking injections when I was a teen in 1972. The best thing for me is being able to sit down at a table with my friends and just click a few buttons to take insulin, rather than excusing myself to use the rest room and then trying to inject in a dark bathroom stall! The other great thing is being able to swim, shower and bathe with it. The OmniPod has really changed my life for the better, and I am NOT an Insulet employee. I’m just now a very happy Type I diabetic!

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