Dexcom G5 Approval by FDA


awesome news. Thanks for sharing.

Just ordered mine. Being able to eliminate the receiver and have the G5 transmitter talk directly to my iPhone/Apple Watch is going to be awesome. Cannot wait for this.

You can order it already?

yes, either through Dexcom directly or through your distributor that you get your Dexcom supplies from.

I was surprised that the G5 announcement came today, but earlier is usually better. I was expecting it more in the end of the year timeframe.

So, I read the website, watched the videos, and talked with customer service with my list of initial questions. I’m happy to see that the G5 trnasmitter will be able to talk directly to both my phone and the G5 receiver. I also like that the receiver is still part of the package since I like the redundancy of two receivers (receiver + phone) overnight, both capable of voicing audible alarms. The high alarm is a higher pitched sound than the low alarm, something I would have reversed. These kind of things should be user selectable. It wil be nice to be able to leave the receiver behind during the day since most of us keep our phones dependably nearby.

The screen background color on the phone app as well as the receiver is white. Let’s hope that solves the readability in the sunlight issue.

One thing the website left out, unless I missed it, is that the transmitters will only be good for 3 months. I learned during the customer service call that that will be a hard-wired deadline and will not work after 3 months. I don’t like that from a user point of view; perhaps there’s a good reason for this but the website is quiet on this. New systems will deliver with 2 transmitters. I’m curious if the insurers will go along with this second doubling of transmitter need in the last few years. I guess the blue-tooth communication needs the extra juice.

The initial roll out of the G5 will only be Apple compatible in the share mode but the company expects Android share compatibility next year. It already is Android compatible in the follow mode.

The Apple Watch issue is not clearly addressed either. The only place the Apple Watch is mentioned is in the FAQ section. It is missing from the table of compatible components.

Can I view my Dexcom G5 Mobile CGM data on an Apple Watch?

No, Dexcom G5 Mobile users will not be able to see their data on the Apple Watch. Followers, using the Dexcom Follow app, will able to use the Apple Watch to view the Sharer’s CGM data.

This leads me to believe that the users can use the watch in follow mode but not in share mode. The customer service rep was shaky in her understanding of this so I’m still not certain about the Apple Watch change from the G4 to the G5. The big thing for me is glanceability. As long as I can see my BG on my wrist, I’ll be happy. I’d love to be able to use the great Apple Watch wrist tap alarms but it appears that Dexcom and/or the FDA doesn’t like that idea. These should be user selectable even if they have to put out all kinds of legalese disclaimers.

At this point I’m not sure if the tradeoff in battery life is worth the improvements of the G5. As long as my insurance goes along with the program, I’ll likely do the upgrade. I’ll also monitor things to see what else pops up that I don’t understand yet.

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Hope I can get mine in Oct. when I am eligible for a new receiver.

As much as I love Dexcom, I hate this. As someone who pays out of pocket, I already spend thousands of dollars and there is no way I can afford these types of devices if they start building in self-destruct dates just so the company can make extra money.

Unfortunately, it’s hard to protest something like this because these devices are so life-changing and few people will give them up. I will say, though, that as soon as the FreeStyle Libre hits Canada (I’ve heard early 2016), I’ll probably be taking my business to Abbott.

Jen, I share your antipathy. Private enterprise hides the internal discussion that shaped this policy. Was it more bottom line oriented or engineering influenced? As much as I’ve been impressed with Dexcom’s technological trajectory, it’s not unreasonable for us to imagine that business and marketing concerns dominated this internal discussion and ultimate policy.

One question I didn’t ask and wish I had: Will the current G4 system remain in place? If so, for how long? I don’t think the improvements made with the G5 are persuasive to me. I know others love the idea of reducing their tech-load by one receiver. I think losing 3 months on the transmitter battery life is a steep cost. I have a feeling that, absent the FDA regulators, Dexcom would’ve deleted the receiver altogether.

The 3-month hard-wired embedded deadline was only communicated to me by one customer service rep. I’ve yet to see that assertion confirmed anywhere else. I’m hoping this is not true but I have no reason to doubt this source, at least for the time being.

I’m not enamored with technology advances for the sake of technology alone. I don’t see the integration of CGMs with pumps as desirable. An insulin pump with a small voice buried under layers on blankets is not a good plan. I sense that I’m in the minority on that, however. Maybe if enough of us current G4 users hold back and don’t upgrade then the company might examine some of the decisions they’ve made.

I also an very interested in Abbott’s Libre flash glucose monitor that needs no calibration. If this system is indeed accurate and precise enough to base treatment decisions on, then I think it could provide some competition to Dexcom. They need to take the next step and push that data to a receiver instead of only allowing deliberate inquiries to display data. We shall see.

I’m guessing it will be in place at least for the next few years, since pumps like the Vibe and (I think) next generation of the Omnipod and t:slim will be using G4. My understanding is that the sensors also haven’t changed, so as long as transmitters and receivers are available, you could continue to use it.

This is something else I have a concern over, as someone who pays out of pocket, although it may be that Health Canada doesn’t have such a requirement. The receiver costs $700, so that’s an additional $700 that anyone paying for this themselves who has an iPhone was hoping to save. The more I hear about the G5, the more expensive it seems to get for anyone who doesn’t have CGM coverage.

I know someone else who contacted customer service and was told the same thing. It’s also been reported on Diabetes Mine.

[quote]They need to take the next step and push that data to a receiver instead
of only allowing deliberate inquiries to display data. We shall see.[/quote]

I would miss the loss of alarm functionality. But I don’t think alarm functionality is worth spending thousands of dollars extra each year in transmitter and receiver costs. And the advantage would be zero dropouts in data, including while swimming, and a much smaller sensor site (it looks about the profile of a Contact-Detach set to me).

Maybe the 3 month transmitter is an innocent development and due to what Terry theorizes that the bluetooth signal uses up more juice. And hopefully the cost will be reduced appropriately to match the cost of G4’s transmitter. Beyond that, the G5 is what CGM should be with as little hardware as possible. It isn’t perfect. The company favors simplicity over customization but this is a small nit compared to their constant success in improving accuracy and convenience.

You make a good point about the possibility that Dexcom may choose to price the 3-month transmitter at half the cost of the current 6-month transmitter. The part that rubs me the wrong way is a hard and fast 3-month demise of the transmitter programmed into it. Was this an engineering or user safety concern? Or is it more driven by business? When will this 3-month clock start? When the transmitter is shipped or when it goes into service?

It makes sense that asking the transmitter to broadcast bluetooth would shorten its life. But why take away from the user the “bonus time” we now get out of the 6-month warranteed transmitter when it often exceeds that minimum service life. It’s kind of like programming a car to self destruct when the warranty expires. Consumers don’t like planned obsolescence. The current technology can sense when the transmitter battery is nearing the end of its life and it gives a warning. I’d like to know more about this issue but it’s not available. This development can make it harder for people who pay out of pocket for CGMs.

Don’t get me wrong. I think that Dexcom has produced a great product that has helped me, a lot. I just think that the customer needs sometimes take a back seat to other more powerful interests.

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The transmitter has a grace period of 18 days, so 90+18 (tweet by diabetesmine)

@mikep - Did you order as an upgrade, or a new order? We called yesterday, were told to order online, but the only options online were for upgrading. Sometimes the CS reps don’t all catch up quickly on new devices, so hoping with another call we’ll get another answer.

I only got my first Dexcom earlier this year–thought I wasn’t going to be able to get one of these until my 4 years were up. But then the word “upgrade” appeared in this thread. It turns out I’m eligible for the $200 one. Holy crap! I could manage that OOP if I have to. Suddenly this discussion is not so academic any more. Particularly that 3-month built-in expiration, which does give me pause. Still, I really get a lot of use out of being able to with Share on my iPhone. Being able to upgrade that to full Bluetooth integration is really attractive. Decisions…

Seriously, what was someone [not] thinking when they designed the G5 to be Apple watch compatible for Followers but not for Sharers? Come on, who checks their Dex numbers more often, the PWD or their Followers?!?!? (With the exception of the PWD’s Mom, of course {me!})

Aside: Did you ever stop and think about the whole “Sharers” and “Followers” Dexcom terminology? Makes you PWDs sound more like the heros/stars/G_ds that you actually are!

Hey Lorraine. My G4 transmitter is OOW so I just placed order for the G5 with my medical supply company.

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One of the upgrade offers includes 2 transmitters, I presume shipped together. In that case, it makes no sense that the shipment date, +18 days, starts the clock. What about the second transmitter set aside for the second 90-day period?

Thanks for the info!

It’s not the shipment date but the start of the first sensor that starts the countdown. This transmitter has “memory” and a
brain :slight_smile:

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