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Non invasive monitor cleared for sale in Europe!

Discussion in 'Research' started by carbz, Nov 6, 2012.

  1. Deal

    Deal Approved members

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    That is one sign that the technology/implementation is not as good as we dream it should be. Another sign is that in the one demonstration they did do they had a non-diabetic person wear it. Guess what, the numbers where good.

    If this thing really worked they would have youtube videos of T1 people wearing it and eating candy. They would be showing it off to endo's and at diabetes related conferences and allowing people to try it and blog about it. If not in the USA due to legal restrictions at least somewhere. So far, after over a year of having what they called a working prototype there is still not a stitch of independent evidence that it even works? Why?
     
  2. Brenda

    Brenda Junior Member

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    I would like to address this comment: "Still I find it downright ludicrous that a meter needs FDA approval."

    Like most people on in the type 1 world, I get frustrated with the annoyingly slow pace of the FDA approving devices. However, in the end, I think the work they do is worthwhile.

    With respect to meters, the manufacturers need to show that they work properly because people dose insulin based on the readings they provide. Yes, I know there is some degree of error, but blood glucose meters are much better than urine testing. Perhaps it is just a matter of time, years probably, before there is a true CGM/noninvasive BG testing method that will not also require a finger prick as well.

    For now, I am grateful for the current technology because it's a far cry better than what we had when our daughter was diagnosed 25 years ago. In the coming years, there will probably be better technology and maybe even a cure. In the meantime, our daughter does whatever she can to remain healthy.
     
  3. carbz

    carbz Banned

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    I may a rare case but because of my sensitivity to the glucose levels I've been able to achieve A1'c levels in the low to mid 6's over the last decade with infrequent testing. I make mistakes and still experience lows often but overall my control is as probably as good as the average diabetic that tests all day long. I knew this morning my sugar was high and was figuring anywhere from 150 to 200 and was 185. The sugar swings are hellish for me and personally I'd rather test all day because I can't feel anything. FWIW Grove Instruments is close to getting their Non Invasive meter that will replace finger pricks to the market.... http://medcitynews.com/2012/06/bloodless-glucometer-uses-light-to-check-blood-sugar-in-20-seconds-or-less/
     
    Last edited: Nov 9, 2012
  4. andynew

    andynew Approved members

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    The way I read this is that this device will replace 'finger prick's' day to day and it is accurate but, you can't wear it while swimming, while travelling on a plane so there will be times when you can't use this device and have to revert to finger pricking.
     
  5. DadCares

    DadCares Approved members

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    I have question. If I have a friend in the UK (who doesn't have diabetes) order the device, can he then send me the device personally once he's received it? I pay him and he pays the company.
     
    Last edited: Nov 15, 2012
  6. karri

    karri Approved members

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    Well yes, but obviously there are few issues;
    1) "All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry."

    So if your shipment gets stuck/inspected in customs then you can most likely say byebye to your device. Of course you could try in this situation say that its not for medical use and see what happens

    2) Warranty becomes bit complicated. (Well obviously it will be valid, but if something gets broken, then you need to reuse your UK friend)
     
  7. selketine

    selketine Approved members

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    I wonder if it is different if you are wearing the device as opposed to just mailing it. I don't know that the airport screeners would know if it is approved or not approved for sale in the USA - maybe they just look at whether it is a threat or not (and it isn't plant or animal so doesn't go into that issue). I can't imagine them pulling it off you and taking it - but it would be a bigger expense to actually go there and pick it up.

    Since it doesn't require a prescription - is it just like mailing OTC items?

    I mean if I lived in Europe and sold you a tin can with a flashlight inside it and you strapped it onto your belly and told people it was to help you monitor your blood sugar - well ... it was sold for medical purposes I guess but it isn't approved anywhere and isn't dangerous.:p

    I'd hate to pay $1000's of dollars to find out though!
     
  8. millyyates

    millyyates Approved members

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    Are they shipping them out yet? Does anyone have one?

    Someone with one will pop up on a web board somewhere the day they get one.
     
  9. karri

    karri Approved members

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    I'd guess there might be other problems, as seen here Oakland traveler arrested for watch
     
  10. karri

    karri Approved members

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    Hasnt been launched yet. Coming up in few months they say.
     

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