Thirty-one years ago, I was checking my blood sugar with this giant lancing device, using a heavy brick of a glucose meter, and chasing my blood sugars with Regular and NPH insulin. If you told me that the future of diabetes would include streaming video of where my blood sugars have been and where they might be headed, I’d have bonked you on the nose with a newspaper. “No. NO! Bad dog. Don’t make false promises – they’ve already told me a cure would be here in five years and I know that’s bullshit.”
But oh hey, Dexcom G6. Just approved by the FDA and slated to hit the market (and my body) sometime in the second half of the year (but potentially at the close of Q2), continuously monitoring my blood sugar just got easier.
I know a lot of sites have already covered the Dexcom G6 approval (this write up at DiabetesMine is very thorough), but I wanted to give a few quick details and a look at the demo kit I received yesterday.
Here are the new Dexcom bits and pieces that were sent over to me. No, none of these pieces actually work as they are part of a marketing outreach plan, and yes I was disappointed as hell that I couldn’t stick on the new G6 sensor as I am very excited to try it.
This is the new insertion device – looks straight outta Wall-E – and the new transmitter and sensor. The G6 transmitter is much thinner than the G5, by about a third.
Here is a visual only useful for Americans. But this is the transmitter and sensor pitted against a quarter, for reference.
And here is the transmitter and sensor all on their own. It’s very thin and it would have been great if I had a G5 transmitter to compare it to, but my current sensor is only on day 4 and there’s no way I’m ripping that thing of yet.
Here’s a quick look at the demo receiver (with an off-center thumbs up at the end):
First impressions on this new iteration of my CGM standard?
- YES the Tylenol indication is gone. Now a headache can be treated without screwing up my Dexcom’s sensor integrity.
- It’s so much smaller than the G5. I can’t wait to wear this lower profile device.
- The insertion device looks way friendlier than the current G5 (and all the previous versions, way back to my first STS insertion device). From what I’ve heard, this insertion device comes with every single sensor. Which I think is a huge waste of plastic, so I’m hoping that a recycling program for this thing comes about.
- There’s a hard stop at the 10 day mark for this sensor. I currently restart my sensors, but haven’t ever made it a full two rounds with one sensor as my skin hates most adhesives and only recently stopped having a blistering reaction to the Dexcom adhesive. The inability to restart a sensor is a big deal for people paying out of pocket, among other reasons — more on that in a minute.
I talked with Dexcom’s CEO, Kevin Sayer, about the new G6, and he was kind and patient as I took the call from a busy coffee shop. (And if you have other questions, there’s a very good FAQ section on Dexcom’s site that might have an answer or two for you.)
I asked him about factory calibration for the G6, and he said that the goal was to have the algorithm perform consistently on all days and all ranges, and that performance is very strong. The accuracy is a experience similar to the 505 and across all ranges, it performs better on the first day than G5 did. (A nice note, as many Dexcom users have complained about poor response from their sensor on the first day.)
And even though the G6 comes out of the box calibrated, patients can still calibrate their sensor if they think it’s necessary. “If a patient truly thinks the system needs to be calibrated, they can calibrate it. Also, our pump partners may want the system calibrated. If a patient feels there is variation and they want to calibrate the system, they can,” said Sayer.
There’s also a new alert in play for the G6 system, one that alarms when a low is expected. “The “Urgent Low Soon” alert is a new alert that can warn users in advance (within 20 minutes) of a severe hypoglycemic event (55 mg/dL) — allowing them time to take appropriate action before an event happens.”
On the 10 day use period for the G6, it’s confirmed that the sensor times out and can’t be restarted. “As we got our system approved under the special controls required by the FDA, the system cannot be used longer than it’s approved duration,” said Kevin Sayer. Personally, this is a rough change, as many people with diabetes pay for their CGM supplies out of pocket, and a hard stop at 10 days would cut into a lot of budgets. But he mentioned that a company goal is to extend the life of the sensor, and that they are working for approval for 14 day use, after they can meet the requirements set forth by the FDA. There isn’t a set timeline for a 14 day sensor, but Sayer was hopeful for 2019. He also mentioned that Dexcom will be providing their own overtape to help keep the sensors in place for approved duration.
The sensor size is much smaller, and Kevin says that another company goal is to continue to reduce the sensor size. “When I see kids running around with the sensor on, I look at them and say, ‘This has got to be smaller.'” Agreed. And the new G6 is smaller in hopes of reducing tugging and snagging on clothes, which will be useful in my house (see also: my son uses my sensor as a rung with which to climb me)
One of the big things about this approval is that Dexcom is moving to the FDA 510K class. The FDA has established standards as to how sensors have to perform to be approved. The FDA website defines a 510K class device as “A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.” Basically, approvals should be able to roll out in a more expedited fashion as a result. Which is exciting. Full docs from the FDA on that process can be found here.
Technology keeps getting better. It’s an exciting time to be a CGM user. But as I write this, I’m reminded that this technology is only great for people who can access it, and that folks in our community still struggle to access insulin every day. Which is why I’m closing with a request for you to consider donating to the International Diabetes Federation’s Life for a Child program, and/or to explore participating in the T1International #insulin4life efforts. Access matters, and even the best devices are useless if we are without insulin.
Let’s all move forward, making sure we take care of our community as a whole along the way.
Hmmm not digging the hard stop! I can go about 20-30 days on one now! But hmm the rest is amazing!!
You’re right—there are a lot of exciting developments in the world of diabetes management. I was initially excited about the Dexcom G6, but I’m afraid the forced 10-day lifespan of the sensor will be a deal-breaker for me. I need to be able to get as many weeks as possible out of every sensor.
I admit, I’m frustrated right now with our broken, convoluted healthcare system. Other than diabetes, I am a very healthy person—and even with diabetes, I have minimal impact on the system. With tools like CGMs and insulin pumps, I could manage my diabetes on my own with perhaps an annual meeting to touch base with my doctor. But changes in my job have put me in the low-income category, and even with Obamacare, I can barely afford my monthly insurance premium plus the out-of-pocket costs each time I have to place an order for some piece of equipment. Moreover, I can barely afford the time it takes to explain things to insurance representatives, and ask my physician’s assistant to re-send forms, and keep up with the changes in pharmacies and durable medical equipment suppliers. For all the talk about FDA approvals and patient safety, I can’t help thinking that the 10-day limit is really Dexcom’s way of getting as much income as possible from patients who have no other choice.
Sorry for my cynicism.
I couldn’t agree more with you.
FYI–You can trick the sensor to restarting. Save the serial number of the sensor when you insert it.
Thanks for the overview Kerri!! I’m not happy about the hard stop at 10 days as I usually wear my sensor for 2-3 weeks and share my extras w a friend who pays out of pocket, so I’m gonna try to keep my G5 as long as I’m able. But the improvements are remarkable!! Happy Easter!!
Great closing message here, Kerri.
Grateful for the stripey-armed demo that helped me chill out a little in regard to the consumable nature of the inserter, because it’s smaller than imagined. I liked that suspenseful music, too. I’m excited. Perfect timing for our college-bound person who really misses acetaminophen. I hope it’s attainable for everyone.
As always Kerri is spot on. I’ve been following her since diagnosis in 2008.
While I’m currently a pay out of pocket, I will not be looking to change as I get at least 22 days with one G5. Not to mention I also swap out old batteries so I can reuse dead transmitters. Keep going Dexcom!!
I don’t pay out of pocket, but my copay isn’t all that cheap. However, I have heard something about manual activation and calibration of the sensor does allow it to be restarted. Of course, then it would require daily calibration. If true though, I think that is an acceptable trade-off to extend the wear.
PS: I am still on the G4 Share (though I don’t use the share) and just got a new receiver in January! Guess I’ll have to upgrade if I want to upgrade to this eventually!
Thanks for sharing! I definitely know that lancing device and I’m glad it has gone by the wayside (but still it lives on in my nightmares – I still recoil in horror at the sight of it 30-some years later). And I definitely would have thought someone was crazy and told them to get out if they told me in the future I could look at my watch and know my blood sugar. That’s the blessing of technology.
Of course, there can be tradeoffs with that blessing, and this 10 day hard stop is not ideal to say the least. Now, I’d be willing to bet some workarounds will be made, so time will tell. But it’s just unfortunate that’s the case out of the gate with this. At minimum, it’s frustrating.
Ultimately though, I am excited to get my hands on this and slap it on (which will be much easier now, looking at the insertion device). The ability to not calibrate and give my well-worn fingertips a full rest is hard for me to overlook. And to have this in combination with continuous information and alarms is a huge benefit that the younger me freshly terrified by that giant lancing device could have never imaged.
But I do agree that while all this is wonderful, it’s not useful if you can’t afford it or insulin. So thanks for the ways we can help with that in the short term while pushing insurance companies and policy makers to help even more in the long term.
Great overview, Kerri. Always excited to see the continuing advancements from Dexcom … one GREAT company.
I’ve been using CGM for 8+ years and have had all the Dexcom variations and now using G5.
I’m ‘mature’ and my G5 is covered with Medicare. It will be interesting to see how long it will take CMS / Medicare to let the G6 into their coverage system.
An article I read said the G6 will actually be cheaper but that might have been compared to using a G5 system for only 7 days. I’m not sure how it’ll turn out but the small-ness and no Tylenol interference makes the G6 sound very very promising!
It looks good but id stick with the g5 until it died! I use sensors for 14 – 21 days can’t afford it. If one dies I’m without one for the rest of the session! I’d like them to either be extendable or lower the price. Won’t be buying one soon!
Thanks so much, Keri. My thee year old son was diagnosed in January. In the beginning, as I was dealing with grief, my main go-to method was to go online and research all the available technology as well as both the technology and new therapies just over the horizon. I’m so grateful for all those who came before my son and helped make his way easier.
My son is very sensitive and so we weren’t sure when he’d be able to take advantage of CGM technology. He’s gotten used to the finger pricks and the injections but my wife is up every few hours checking his blood sugar, so it’s been clear we needed to find a way to avail ourselves. Then the Freestyle Libre was approved for use in the U.S. but not for children. Still, it was an exciting breakthrough because it looked like the injection was essentially painless. I knew Dexcom was working on an upgrade but thought it was around a year off.
When my wife told me, two days ago, that it had hit the market and was approved for use without even a single finger prick, I immediately began researching. Looks like this is the device we were hoping for. I’ve already placed our application. Had to then follow up with a phone call to let Dexcom know to hold off on the G5; that we’d prefer to wait for the G6. Until it’s available we’ll do what we’re doing now.
Cost is of course a concern. This stuff ain’t cheap. But when it’s one’s three year old child, one just thanks God that one can afford it (if one can afford it). My heart goes out to those children and parents who can’t afford the technology, particularly single moms and dads, struggling to make ends meet on minimum wage incomes. And parents who don’t have the wherewithal to manage the carb counting and computations. It’s heartbreaking to realize that children are still going blind and facing other health challenges and dying young because of type one.
I recently upgraded to a new pump and the G5, almost 28 years to the day after being diagnosed with T1D. It was hard to wrap my brain around how much the technology has improved since that time, when my glucose meter that took 45 seconds to give a reading was “state of the art.” It’s exciting to see the G6, but the sensor time-out seems like a major drawback (and one, as a previous poster noted, that’s designed to maximize profits for Dexcom). Clearly this makes things even tougher for people with no insurance, but insurance or not, it drives up costs for everyone.
I, too, am very disappointed that the G6 times out. Sayer said, and I’m paraphrasing, that the FDA requires a hard stop so that it can be factory calibrated. Personally, I’d rather stick my finger once or twice and be able to restart the sensor, but it seems like the G6 is following in the Libre hard-stop footsteps, per FDA regulations.
Great information, thanks! After reading all these other comments saying people get several weeks of wear from their sensors, I’m sitting here frustrated. I rarely get past 10 days with accurate numbers …I have no issues at all with them sticking to my skin, but usually by about day 10 I’m getting all ??? and very inaccurate numbers (like 100+ points off). Even if I pop the transmitter out and try cleaning it to see if I can get the ??? to go away, it rarely makes a difference. I wonder why my body chemistry makes my sensors fail so early when most people don’t have this problem. Where do people wear their sensors to get 3 accurate weeks out of them? I’m usually not a belly wearer, because I get much better absorption from my insulin pump there so I reserve that space for omnipods. I like thigh, upper buttock, and arms for Dexcom, but again, rarely get more than 10-14 days out of my sensors.
Anyway, it seems like I’m in the minority when I say a 10 day sensor doesn’t bother me, since I rarely make it past 10 days with the current ones!
I use my stomach area either side actually. Will get 14+ days. Use the dreaded ??? Last weekend. I just rebooted it and it went back to normal. They get less accurate the longer they are in, don’t believe this bullshit people getting 21+ days and they are all very accurate. It don’t happen!
Kerri,
As a T-Slim pump user, have you heard any more about the integration with the X2 pump. My understanding is the low-glucose suspend will work with the G5 out in June and the semi-bionic pancreas will work with the G6 out in January. Is that correct?
Hi Kerri,
What is the best way to receive dexcom G6 demo kit? I am a health professions graduate student working on a master’s project on CGM systems. I will be presenting my research soon and would love to demonstrate Dexcom components to my audience. I have contacted Dexcom customer service but have not heard back. Do you have any advise how to receive the demo kit?
Thanks in advance!