- advertisement -

Dexcom FDA Approval

Discussion in 'Parents of Children with Type 1' started by Jordansmom, Jan 23, 2015.

  1. Jordansmom

    Jordansmom Approved members

    Joined:
    Aug 23, 2008
    Messages:
    2,172
  2. hawkeyegirl

    hawkeyegirl Approved members

    Joined:
    Nov 15, 2007
    Messages:
    13,157
    I can't figure out what the sam-hill this is. At first, I thought it was just Share, but this paragraph makes me think it's something more:

    But then I think that whoever wrote this might just not have a clue what they're talking about. The G5 was supposed to transmit directly from the TRANSMITTER, not the RECEIVER. I don't think the receiver was ever intended to transmit anything.

    So yeah. No clue what this is.
     
  3. Megnyc

    Megnyc Approved members

    Joined:
    Nov 8, 2012
    Messages:
    1,373
    There is a new reciever coming out that is supposed to skip the share dock and directly upload to the app. If you are on the dex fb group you can search and pictures will show up. It looks like the current reciever but says share on it. I think that is what this might be but I would be really surprised it was approved so quickly since it was just submitted. I thought I heard dex was expecting approval in June.
     
  4. Melissata

    Melissata Approved members

    Joined:
    Feb 19, 2009
    Messages:
    1,650
    From Facebook: DiabetesMine.com An FDA spokesperson says this: "Wired vs. wireless. The device approved in October was a Dexcom accessory cradle for the monitoring device. The Share requires the Dexcom receiver to be docked, so it typically is used only at night. The system FDA just cleared can communicate all the time wirelessly, and does not have to be in close proximity to the patient."
     
  5. MHoskins2179

    MHoskins2179 Approved members

    Joined:
    Mar 14, 2010
    Messages:
    494
    This is what Dexcom's calling Share Direct, and it's what Megnyc describes above in #3. Basically, a way to bypass the Share docking cradle by using a new G4 With Share Receiver. It doesn't go as far as the G5 eventually will, in talking directly to a smartphone without needing a receiver.

    I had a post at the start of the year on DiabetesMine about D-Tech 'Spectations, and this was one of them. Melissa Lee had a great post on A Sweet Life that mentioned this, too.

    Dexcom says as of 6:40p EST that they'll be issuing a press release on Monday at 8a EST, and won't be commenting before then.
     
  6. Jordansmom

    Jordansmom Approved members

    Joined:
    Aug 23, 2008
    Messages:
    2,172
  7. Jordansmom

    Jordansmom Approved members

    Joined:
    Aug 23, 2008
    Messages:
    2,172
    I believe its entirely possible that it wasn't ever meant to transmit anything and that Nightscout changed a lot of plans at Dexcom.
     
  8. hawkeyegirl

    hawkeyegirl Approved members

    Joined:
    Nov 15, 2007
    Messages:
    13,157
    I think that's probably true, but I do have to give them props for the sheer speed at which this has all come about. Medtronic had me conditioned to expect progress in increments measured in centuries.

    Well. Anyway. I am flabbergasted that this has happened so fast, and interested to see exactly how this all works. And slightly annoyed that I may have to give up my Droid phone for an iPhone.
     
  9. Jordansmom

    Jordansmom Approved members

    Joined:
    Aug 23, 2008
    Messages:
    2,172
    I agree and I also have to give them a ton of credit for not gouging desperate people. For all the complaining I am doing over the $300 I spent on the Share cradle a few months ago, I am so thankful they don't have the ethics of Medtronic with their outrageously priced Mysentry. They also don't seem to hold back new technology to sell old stock or charge outrageous upgrade fees. I should probably not say that so quickly since I don't know yet what they're going to do for me with a brand new Share cradle and receiver still in the box.:frown:

    ETA: Its frustrating to have just purchased the Share but its doubtful Dexcom knew when this upgrade would be approved. At least they seem to be super quick to ship products that get FDA approval. We're still waiting for our Animas Vibe to ship and it was ordered the morning it was approved back in Dec.
     
    Last edited: Jan 23, 2015
  10. sszyszkiewicz

    sszyszkiewicz Approved members

    Joined:
    Dec 24, 2013
    Messages:
    842
    Not for nothing guys, but Dex receivers were pretty touchy before this enhancement. :) The Share cradle seems way sturdier. I know the mobile piece is *really* attractive, but the craftmanship of their receivers was questionable before this enhancement.

    Dont get me wrong, the mobile tech is great, but the reason I love Dex is the accuracy of the sensor. I am looking forward to the day when I have a sensor for DS that takes away fingersticks. That is where I hope they are spending the majority of time and energy.
     
  11. Jordansmom

    Jordansmom Approved members

    Joined:
    Aug 23, 2008
    Messages:
    2,172
    I don't find the Dexcom receiver touchy. But the one weak spot I've experienced (the charging port) is much more at risk pushing it into the fixed point charging cradle. You can't stabilize the connection and carefully line them up. It just gets shoved into the cradle every night. If it doesn't go in the cradle it can stay unplugged for a week before recharging. Much less risk to the weak point of the design.
     
  12. sszyszkiewicz

    sszyszkiewicz Approved members

    Joined:
    Dec 24, 2013
    Messages:
    842
    Yes that is certainly true. That port is the worst part.

    Personally we are on our 4th receiver here in less than a year. They previous 3 each failed for separate reasons. One flashed white when we turned it on, it then rattled, and that was it. One the sound failed. One couldn't hold a charge. I don't think they engineered this device for the rigors a 12 year old puts it through.

    We use the Share, and yes each night I place the receiver oooh so gently into that cradle and I think to myself "can't wait for the dex to start talking to the iPhone directly."
     
  13. Beach bum

    Beach bum Approved members

    Joined:
    Nov 17, 2005
    Messages:
    11,315
    Same here.
    My question is if it will cover all users, not just adult? Like the newest upgrade. It only applies to the adult version, not the pediatric.
     
  14. virgo39

    virgo39 Approved members

    Joined:
    Jan 8, 2010
    Messages:
    1,691
    This is exciting news. We purchased the Dexcom share, but don't use it as much as I thought due to lack of portability.

    Does anyone know how much data a set-up like this uses on a monthly basis? I am wondering because we have DD on a pay-as-you-go plan for her iPhone 5c, for calls, texts, and data. She seldom uses data (phone use is limited to calls and texts to caregivers, use of data for carb look-ups, and some texting to cousins using iMessage). In a year, I think we've paid less than $10/month (probably closer to $5).

    Adding her to our AT&T plan (which we are committed to as DH gets an employer rate), would result in some additional monthly fees. Depending on how much data it uses, we might be able to keep her on the current plan.
     
  15. Nancy in VA

    Nancy in VA Approved members

    Joined:
    Jul 16, 2007
    Messages:
    7,308
    I don't think the Dexcom receiver is fragile at all. Except for the fact that the "door" for the USB port has fallen off ours both times almost immediately, our first one last 18 months - 6 months past warranty. We're coming up on a year for our second one and have never had a problem. We only charge when it gets low, because honestly we don't notice before.

    Can anyone break down in "3rd grader" simplicity what has been approved here and what we, as parents, would need to buy in order to put this in place. Right now we have a Dexcom receiver and a transmitter. My husband and I each have an iPhone. My daughter has no phone.
     
  16. virgo39

    virgo39 Approved members

    Joined:
    Jan 8, 2010
    Messages:
    1,691
    As I am reading it, you would need an iPhone for your daughter and a data plan, her phone would need a Dexcom app for sharing the data (seems like it would be the same app used for the current Dexcom Share set up with the charging block) and your phones would need a Dexcom app to follow the data (again, seems like it would be same as current Dexcom Follow app).

    The new receiver sends the CGM readings to your DD's iPhone app (so she'd need to carry both).
    DD's iPhone app send readings to the cloud.
    You and your DH could access data in the cloud in real-time using your iPhone app.

    We found setting up the first Dexcom Share (with charging block) to be very straightforward, this seems even more so.
     
  17. sszyszkiewicz

    sszyszkiewicz Approved members

    Joined:
    Dec 24, 2013
    Messages:
    842
    It is a new receiver that cAn talk to an iPhone directly without the need for a special cradle. So basically it is the Share system without the cradle. Very portable. Even more so than Nightscout because no wires.
     
  18. hawkeyegirl

    hawkeyegirl Approved members

    Joined:
    Nov 15, 2007
    Messages:
    13,157
    We used the Medtronic sensor for years before Dex, and that receiver (the Guardian) was built like a tank, so I was wary of switching over to Dex. I've been pleasantly surprised that we've had no issues with receiver durability, other than the charging port getting a bit fussy on our first receiver. I wish it was waterproof, or even just water resistant, but other than that, I have no complaints.

    I am interested to see whether they'll offer an upgrade program for this new receiver. Even if it's not approved for pediatric use, I assume our endo could prescribe it off-label. I don't think we're due for a new receiver until this summer, though.

    I would not think this setup uses a lot of data. It sounds similar in concept to Nightscout, and it definitely doesn't use much data.
     
  19. Jordansmom

    Jordansmom Approved members

    Joined:
    Aug 23, 2008
    Messages:
    2,172
    I would not expect any difference with the pediatric version because 1) The Share works for both versions but 2) The FDA has decided Class II devices like this don't even need FDA approval. They just need to register themselves with the FDA. In my mind that is huge news hidden in this approval for Dexcom.

    http://medcitynews.com/2015/01/fda-oks-dexcoms-mobile-apps-support-continuous-glucose-monitoring/
     
  20. Mish

    Mish Approved members

    Joined:
    Aug 20, 2009
    Messages:
    1,393
    well, we are due for a new receiver and I think I'll just wait until we can get this. Why would I want to do otherwise? This is kind of huge, IMO.
     

Share This Page

- advertisement -

  1. This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
    By continuing to use this site, you are consenting to our use of cookies.
    Dismiss Notice