Did Dexcom make the right G6 choice?


#23

I’m not so sure about that. This is the device that is implanted with a doctor’s office procedure, isn’t it? I’ve read two accounts recently of people who participated in the pre-market trial and are not happy with residual scars and pain.

Senseonics does not post the size of this device but it looks like a small round tube, about the size of a small circuit board fuse. It looks like it’ll only last 90 days. Here’s a picture from the Senseonics website.

53%20PM

You still need to wear a transmitter externally to send info to a smartphone app/display.

11%20PM

I’ve found it very easy to insert the small sensor wires of Dexcom’s CGMs and I like the almost instant healing when I remove them, even after 2-3 weeks. You could be right but I think people will be reluctant to have the Senseonics device implanted. We’ll see.


#25

I just had my endo appointment last week and my cde and endo both mentioned this. I said I will still have to do finger sticks because dexcom is often very off for me, 50-100 points and even 20 points can make a difference for me. I’m not sure how any of this got approved and I hope it isn’t going to affect my coverage for test strips.

How is it supposed to be accurate with no calibrations, have they explained any of this? Just last week dex gave me a reading of 100 so I ignored it. Then I was going to eat dinner and my fs were 170! Had to change my meal, prebolus etc. I will never treat based on dexcom only. I will continue to use it since it’s life saving for me even with the inaccuracy.

I agree that 2 calibrations is a joke and not worth eliminating. I want to know how it was approved because I guarantee there will be times when it’s very off, and then how do you even correct it back. This is a bad move.

Are they going to get rid of the 2 hour wait for data when inserting a new sensor which isn’t even needed? That would be a help, along with a smaller insertion needle to cause less trauma, and a sensor in the future which lasts a few months and which is under the skin.

A cheaper device overall which performs better is what’s needed. Instead they seem to be going in the direction of more control and keeping it as expensive as possible. I change my sensors every week now due to a bunch of expired sensors and due to severe allergic reactions.

I was reading about this last year and it seems it’s under consideration here now so I hope I get to try this one. We need more choices.


#26

@Terry4 the Senseonics implant that I saw last month was closer to the size of long grain rice. Until it’s launched it’s a guess, but I would put up with the marginal scarring to not have to change grifgrips every ~6 days or so for a month. For me it’s about accuracy vs cost. I have enough scars already that a few more won’t make much of a difference.


#27

The advisory panel voted on the 90 day version. It is inconceivable that the FDA will not go along with the advisory panel. The FDA should rubber stamp the approval in less than 60 days.
Senseonics has already launched the XL version in Europe which is approved for 180 days. I would expect they would soon submit to the FDA a request to market for the XL (180 day) version here in the US as well.

The sensor is 18.3mm long and 3.5mm in diameter.

image

Every five minutes, the Transmitter sends power via NFC magnetic link to activate the Sensor, and then uses this same magnetic link to capture the readings.

EDIT: Some of Senseonics plans:

Senseonics CEO
March 13, 2018

As previously announced, we are working on an integrated automated insulin delivery system combining Eversense with a TypeZero artificial pancreas algorithm and the Roche Accu-Chek insight pump. The NIH funded study to test this integrated system is expected to start in the second half of the year and we are actively seeking opportunities to advance our dense data capability by partnering with digital health companies.

Finally, we are very excited to have now seen the early data on our Gen2 sensor that is aimed at longer duration and optimal performance and usability. Specifically, we look forward to the not-too-distant future where we expect to be the first company to offer a sensor that lasts for a full year of continuous sensing.


#28

So, it’s a little bit fatter than 1/8" around and just under 3/4 " long. Interesting concept. The external transmitter is off-putting to me. My big ol’ G4 transmitter is not nearly that volume. That transmitter reminds me of an Omnipod package.


#29

The transmitter is bigger than an Omnipod I think. I didn’t hold them side by side, but appearance-wise it just seems bigger.


#30

The Transmitter contains a rechargeable battery that powers, communicates, and captures information from the Sensor, calculates glucose values and trends using a proprietary algorithm (see System Algorithm, below), and transmits information to the MMA. It is approximately 1.5 by 1.9 inches across and 0.3 inches thick and worn externally over the inserted Sensor using a replaceable, silicone-backed adhesive patch.

As I understand it, the Gen 1 transmitter was used in the studies and trials but Senseonics is asking for the FDA to approve the Gen 2 transmitter.


#31

That Gen 2 design does have a lower profile, an improvement over the first generation. We’ll see how many in the diabetes community volunteer for this system when the FDA approves it. I will hold back with my reliable G4 and read the comments from early adopters.


#32

I personally have stuck with the G4 and never “upgraded” to the G5. I use xDrip+ and have all the information I need. I have a transmitter with a battery that was replaced by a friend on Facebook and have enjoyed outstanding service from the system since I started using it in November 2012.
The G6 sensors come “pre-calibrated” just like the Libre sensors. Each sensor comes with a unique bar code. This code can be scanned into the receiver and you will not need to calibrate for the entire 10 days of use. The sensor shuts down after 10 days and cannot be restarted. This was required by the FDA because eventually these sensors will integrate with pumps and become part of a closed loop system that will dose insulin. These systems are in development but are not available yet.

If however, you decide to enter the unique bar code into the transmitter manually, you will be required to enter a calibration once a day. The sensor will “shut down” after 10 days, but will be able to be restarted without a code thereby requiring calibration once a day.

I have more than a dozen G4/5 sensors. I have 2 dead transmitters that will be fine with a new battery. I have 3 G4 Receivers with Share. But I can see the writing on the wall. Dexcom will phase out the G4/5 system for anyone who isn’t using the Animas Vibe in warranty. Eventually we’ll all have to move to the G6. I’m hoping to hold out until the Omnipod Horizon in 2019/2020. I only used 15 sensors last year and I get 12 sensors every 90 days so I’ll be safe for a while.


#33

Are you sure? Every other source I’ve read states that the sensor will not be able to be used beyond 10 days. It would be nice if your understanding is correct but I fear it’s not.


#34

Here is a nice video covering Eversence XL (the one for 180 days). He has also price comparison in the description between Eversence, Libre and Dexcom for UK. It is interesting when I asked about limited number of sites the guy in the comments said that the sensor is reinserted in the same place as the previous one.


#35

I pay for mine up front and hope that insurance will reimburse. This is good to know, because I don’t always get reimbursed. On lucky, odd, occasions I can get a sensor to last 40 days with pretty good accuracy. Noone asks for diabetes. Why are they making more changes to restrict access to the tech that can improve quality of life for us poor sods stuck with the dreaded diagnosis? :frowning: Makes me sad.


#36

I don’t want to be tied down to more doctor office visits for more procedures. The fact that I can insert a G4 or G5 system at home, or work, or wherever I am, and NOT in an office is nice. What else can it do that they are not telling the general public?


#37

Terry this is information from a friend who spoke with a tech at Dexcom.
I have more faith in the DOC to figure out some kind of work around. With the G4 Dexcom said the transmitters were warranted for 6 months, mine lasted at least 12 months each. Dexcom said change your sensor every 7 days and wear it on your abdomen only. I have worn a sensor for 53 days with great accuracy on my ankle. My current sensor is 28 days old on the back of my arm and it expired in September 2017. Dexcom said you could not replace the battery on a transmitter and you had to purchase a new one. I am using a transmitter with a replaced battery. It is accurate and is warranted for 9 months instead of 6. The G5 transmitters batteries can also be replaced. They cannot be used with the Clarity app, but they can still be used with a couple of alternate programs either xDrip+ or Spike with the same efficacy. These programs can also be used when the G5 transmitter hits the 112 day “hard shut off”. The transmitters still continue to work. I’m not sure how long because I have not followed that system at all anyway.
The CGM in the Cloud folks wanted to be able to follow their kids and invented the G4 with Share before the Dexcom folks did.
I have no doubt at all if there is a “hard shut off” of the G6 someone in the DOC will find a way around it. We’re an extremely resourceful group.


#38

I, too, hope that the resourceful members of the “We Are Not Waiting” movement will be able to uncover some kind of workaround to extend the life of the G6 beyond 10 days, if it’s possible.

I’ve read that the G6 will be available on June 4. We will soon find out the answers to our questions.


#39

I’m not overly concerned. I have enough sensors and supplies for the rest of this year and into next year so by then I imagine either there will be a work around, or they’ll be close enough to introducing the Horizon, I’ll have to upgrade anyway.


#40

You have a choice with the G6: either register the sensor serial number when you start it and have calibration-free 10 days of use, or don’t enter the serial number, and have to calibrate twice a day, and have 10+ days of use. The automatic shutdown is a function of the serial number based pairing.


#41

Dexcom G6 Unboxing


#44

If being able to restart the sensor and run it past 10 days with callibrations is true, that would make me VERY happy! :smiley:


#45

My CDE pointed me to this page when I asked if I would be forced to upgrade to the G6: https://www.dexcom.com/faq/dexcom-g6-upgrade-program

Looks like as soon as I go out of warranty, I will be automatically upgraded to the G6. Those already out of warranty will be getting the G6 upgrade after 90 days.