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U.S. FDA Approves the Dexcom G4? PLATINUM Continuous Glucose Monitor (CGM)

Discussion in 'Continuous Glucose Sensing' started by Ellen, Oct 8, 2012.

  1. hawkeyegirl

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    I found a study that said Enlite's MARD with the Veo algorithm was 13.8%. There are other studies that put the MARD at 15%, but I can't tell what algorithm was used in those studies. I can't find anything that says 11%. (I think the current MM sensors' MARD is in the neighborhood of 18%.) The 98% number is in some of Medtronic's press releases, but I am suspicious about the wording that they use.

    Personally, I don't care much if a system's MARD is 14% or 16% or 12%. Until we hit fingerpoke replacement, anything as accurate as the current MM system or better is good enough for me. At this point, it's about the CGM features, and of course, neither of them seems willing or able to "steal" the best features of the other one in order to give me a clear choice in the matter.

    ETA: Some of the discrepency in the MARD stats could be attributed to the fact that there is apparently Mean MARD and Median MARD, and sometimes you can't tell which statistic you are reading.
     
    Last edited: Oct 22, 2012
  2. katerinas

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  3. katerinas

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  4. hawkeyegirl

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    This is the language that is confusing to me:

    Okay, it caught 97.5% of lows within 30 minutes of "the event." I don't know if that is good or not, and I don't know how to compare that to Dex (which does not have predictive alarms). It's also hard for me to mentally compare to what we have now, as we have the low threshold set to 80 and Low Predicted set to 20 minutes. The false alert rate seems high to me too, but I can't figure out if that's because they have the Low Predicted alert set for so far out?

    Personally, I don't give much of a crap how accurate the thing is when it comes to highs. Sure, I want to know when he's high, but most of the time, whether the CGM is reading 200 or 300, I'm going to do a finger poke anyway, so all I'm looking for is the general knowledge that he's high-ish. I have a much, much, much greater tolerance for inaccuracy in the high range.

    Which is more accurate? My overall impression is that the Dex Gen4 is slightly more accurate than the Enlite. If I could choose a Medtronic pump with an integrated Dexcom CGM, that is probably how I would roll. But, obviously that is not an option. For me, I like the MM pump SO much better than the Animas pump, and the Dexcom CGM only slightly better than MM, so we will probably go with the Veo, as opposed to the Vibe.

    Of course, I've never used the Dex Gen4 or the Enlite, so this is all based on what I've read, which of course, may be completely different from reality!
     
  5. katerinas

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    Well as you said we will have to wait and see! I would love a study compairing dex4 and the enlite sensor with the upgraded algorythm!
     
  6. karri

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    There is one more thing to this enlite vs gen4; durability. Gen4 is pushes easily for atleast 2 weeks, not so sure about enlite (well havent read that many success stories about using it for over 10days)
     
  7. karri

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    Indeed + hopefully something thats done by independent researchers (not sponsored by medtronic/dexcom ...)
     
  8. karri

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    From latest diatribe G4 review;
    So "the price" for that extended range;
    - Larger transmitter
    - Decreased battery lifespan
    - Increased price

    Eventhough I do believe gen4 is an superb/lifesaver product, why would you go "backwards" in product design(=transmitter that is).
     
  9. Nancy in VA

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    Because right now, technology doesn't exist to INCREASE range in a smaller size. The entire reason the Navigator transmitter was so much larger than all the others is the published increased range. I think 1/10th of a inch is insignificant to ge tthe increased range. Right now, we can't leave the receiver in our room at night with my daughter because it won't stay connected - the increased range will hopefully give us that so we can stop setting a clock alarm to get up and go in her room and read a receiver that we shoudl be ale to keep in our room. That's the thing I miss the most about the Nav.

    And "hawkeye" - why do you say the Dex doesn't have predictive alarms? We can set a threshhold to get alarms if she's dropping 1mg or 3mg each 5 minutes - I consider those predictive alarms

    The two things I miss the most about the Nav are:
    - readings every 1 minute instead of 5 - especially when she's dropping
    - ability to FORCE a reconnect. On the Nav, if it was disconnected, we could just say "Reconnect" and it would force one. Of course, because it pinged for a reading every minute, forcing a reconnect wasn't as hard - with the Dex taking readings every 5, we just basically have to wait until the next Ping at 5 minutes and hope she stays in range long enough for that. She hasn't been wearing it for softball and that's been the biggest challenge - trying to make sure she's in range when the 5 minute mark comes to do another ping.
     
  10. emm142

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    On the MM CGMS, 'fall rate' and 'predictive' alarms are different things. The predictive alarm alerts you a certain period of time before your BG is predicted to be low, whereas the fall rate alerts you if you are falling at a certain rate regardless of BG level. I find this helpful, because even if my fall rate isn't that high, if my BG is 90 and I'm falling I want to be alerted because I'm going to hit 70 very shortly. On the other hand if I'm 400 and falling fast I don't really want to be alerted, because I want to be falling at that point. IMO predictive alarms are more helpful than fall rate alarms, although of course they do sometimes coincide.
     
  11. Don

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    Re cost, I've always wanted to be able to compare Dexcom and MM sensor on cost per day but I'd have to use both and see how long each sensor typically lasts in my body chemistry. I wonder if using MM's rechargeable transmitter could make using CGM on part-time basis more cost-effective. It is good to see the non-invasive C8 system achieve CE Mark approval and I hope that we will someday have a more affordable option that could cost @40% cheaper than current Dex/MM systems.
     
  12. selketine

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    We use the Dex and I don't consider those "dropping" alarms to be predictive. I have them turned off actually - especially at night. If he is high I really don't want it to wake me up (we have the receiver sitting on a baby monitor so we do hear it in our room) to tell me that the bolus I gave is working and he is 250 straight down. Well - that doesn't mean he is going low - just going down fast - which I want - yippee! But don't wake me up!:p

    I set the low alarm fairly high at night sometimes (depends on the sensor - sometimes we get one that is affected by pressure so this won't work as well). I liked the predictive alarms - I'd be happier if it beeped when he was below a certain number and dropping fast rather than just telling me he is dropping fast.
     
  13. Nancy in VA

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    Ah, got it - understand the difference. I definitely don't care about the drop rate when she's high but honestly, she doesn't tend to drop fast when she's coming down from a high, just from normal into low, so maybe its just her body that drops differently.

    One thing I like about the Dex is the HARD LOW alarm at 55. We have treated on the low alarm and working on the 30 minute snooze and we'll get the hard alarm at 55 and check and she's lower. I'm just now also hearing the different beeps - the hard low is 4 LONG beeps and the low alarm after vibrate is 3 normal.
     
  14. Deal

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    What does CE Mark mean to you? http://www.guardian.co.uk/world/2012/jan/06/medical-devices-toys-safety-checks
     
  15. karri

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    In Europe, CGMs are classified as Class III Medical devices. You need to meet quality and risk guidelines, starting from your product development (iso13485,iso14971..) Also there are notified bodies(=external parties) who have to verify and certify your product before you can go to market.

    So certainly, CE marking has a meaning. (Oh yes, and if you are a toy manufacturer, you still need to CE mark your products, but the process will be different than with medical devices)
     
  16. Deal

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    Until they publish evidence from clinical trials and have it peer reviewed then they are charlatan's. CE marking can be as simple as the company stating that their device does no harm. Nothing to do with it's medical claim. The technology they are touting has been dismissed time and time again.

    Read this when you have time: http://www.mendosa.com/noninvasive_glucose.pdf

    and another specifically on Raman Spectroscopy http://journalofdst.org/March2009/Articles/VOL-3-2-SYM2-LIPSON.pdf
     
    Last edited: Nov 1, 2012
  17. Dan

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    I just got my G4 today and thought I would share some photos comparing the size of the 7+ with the G4. From my perspective the size difference is negligible. My son says he does not even notice the difference.
     
  18. Melissata

    Melissata Approved members

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    Exactly. The increased range and no disconnects at night are well worth it the tiny increase in thickness. This thing rocks. She has had it for almost a week now and it is a huge improvement in size of the receiver. Slips easily into a pocket, but we did buy an MP3 case that is made of neoprene with a clear cover to protect it more. The case that comes with it is stupid imo. Some people may like it because there is a flap over the clear front. But that is exactly why I don't like it. I want her to look at it once in a while, not just when it is alarming.
     
  19. karri

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    For low risk devices (Class I) manufacturer can self declare CE conformity. CGMs/Insulin pumps are not low risk devices (CGM is Class III, Insulin Pump is IIb). This means that in order to get CE mark, you must use third party to assess conformity.

    Then about clinical trials/data. You need to do this for medical devices in order to declare conformity. There are different routes to do this.

    Generally, if we are talking about low/medium risk devices(class I,IIa,IIb) + there is existing clinical data about device/similar system, manufacturer can go thru "literature route".

    For Class III(and/or new devices that dont have existing clinical data) then you need to do clinical investigation.


    And now that we are on the topic of clinical trials;) Recommended read for everyone whos interested about pharma and their ways. Bad pharma
     
  20. karri

    karri Approved members

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    Oh, been looking for one, what was this case that you bought?
     

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