Could a 6-Month CGM Be Your Happily Ever(sense) After?

The Eversense E3 implantable CGM is a unique continuous glucose monitoring system, and it was recently approved for 6-month wear time, the longest of any CGM on the market. Drs. E+P share more about the features and highlights.

Dr. Edelman is on the Board of Directors of Senseonics and Ascensia is a corporate  sponsor of TCOYD.

 

Additional Resources:

Watch Dr. E’s Eversense E3 CGM Insertion – We Filmed It LIVE!

35 Comments
  1. Very interesting

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    Will the Eversense be available to diabetes patients at San Diego Veterans Faciliiy?

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    One of the concerns I have about all the CGM’s that I know of is that none of them are, in my opinion, really good enough (i.e., reliable enough) to be safe for a closed loop system. Don’t get me wrong! I agree that if you’re T1D then a cgm is a necessity! But that’s with YOU controlling how much insulin you’re giving yourself. But I don’t think that any of the CGM’s presently on the market are reliable enough to be part of a safe closed loop system…even though there are DIY’s and others using them that way. Let’s say you’re using a present day cgm with a pump in a closed loop system and, somehow, the cgm goes bonkers…says you’re really high when you’re actually already too low. You might get a huge dose of insulin which could put you in a comma! When you’re using the cgm open loop, then you’re adding a huge additional layer of protection because you’re monitoring things and you know when the cgm might be off and know when to modify what its telling you to do. But in closed loop where the decisions are made by a microprocessor that doesn’t have any way to modify what it’s being told, then that’s a single point failure which isn’t good enough for life critical systems. Remember the Boeing 737 MAX fiasco? they had flight control system entirely dependent on a single airspeed sensor (a single point failure). When that sensor got clogged or knocked out, there was another airplane crash with hundreds of fatalities. what we need, for the next generation of cgms, the ones that will be used in closed loop, are sensors that not only work, but also tell you when they are NOT working, so that your closed loop system will alert the user and then take itself off line so that you don’t get a huge dose of insulin when it isn’t needed.

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      Which closed system are u on?

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        I’m helping my son who is T1D. (I’m what Dr. E calls T3…I take care of my son’s diabetes). We’re using G6 and Medtronic 670G in open loop. We tried the 670G with Medtronic’s Guardian CGM, and not only did it not have Dexcom’s features like the Follow app, it was also a painful, bloody mess getting it installed…Like committing Hara Kiri. And it didn’t work in closed loop anyways! We ditched the Guardian sensors and now use the 670G with Dexcom G6 in open loop. This way we’ve been able to keep Leonard’s A1c between about 6.2 and 6.8 most of the time. Last doctor’s visit Leonard had A1c of 6.3, which is good, even if it isn’t great. Yes, I know that closed loop would probably keep it below 6.0, and not keep us awake at night. BUT MY POINT IS: There is _NO_ CGM out there, of which I’m aware, that’s been designed for, or is good enough, for a fully automated, closed loop system, in my opinion. All of the CGM’s were really designed for, and are really only good enough for, operating open loop (i.e., with the user monitoring the BG level and injecting/pumping accordingly) but none are, IMHO, good enough to operate fully automated closed loop (i.e., without at least human intervention as a backup). For a fully automated system, I’d like to see like a multi-sensor system or some other backup system, so that if the two sensors don’t give similar data, that the system alerts the user and gracefully shuts down any further automated insulin delivery until the reason for the discrepancy is resolved. In other words, no one-point failure will cause the entire system to overbolus the user. Yes, I know what I’m saying is going to piss-off a lot of people. Might even get me kicked off this website. I’m just stating my opinion. (Might even motivate the CGM engineers at Dexcom, Medtronic, Eversense, and Abbott…).

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          I admire your dedication to your part in your son’s care. I am the T1 and LOVE my T3 support. I am glad the T1 community is catching on to how important the team approach is. I am not contacting you because I am concerned about your reaction to an A1C test result. First.. 6.1 is GOOD and you should be celebrating the success of you, your son, and the rest of your team. I have had this for 42 years, so I offer a long term perspective. While your hard work is paying off now, please remember that this is for a LONG LIFETIME of hard work. Growing up with this has many challenges. Perfection is not the healthiest goal. I hope you and the rest of the team take the time to celebrate. New technologies and medical advances are changing this disease for the better. I wish your son a wonderful journey and please take a moment to stop worrying and just enjoy your time with him.

    • I hear your concern but they are incredibly safe and all systems have CGMs with alarms. The control of folks on these systems have never been better which means more TIR and less hypos and hypers. I have not heard of any serious issues on these systems. The best thing that has ever happened to myself and my patients.

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        I agree with everything you say. We’re talking about two different things. What I’m saying does not dispute what you’re saying. Rather, I’m saying that however remarkable these present CGM systems are, there is still room for further improvement in the area of redundancy and thereby better for fully automated systems. Because, right now, if just one of these CGM sensors are used on a fully automated closed loop, and if the sensor fails, the patient could get a dangerous over-bolus. That means that this is a single point of failure.

        Let me give you an example of where I think there might be a fairly easy way to improve reliability: Design a closed loop system that allows the taking of data from TWO (2) sensors and thereby validating that both are working. If their readings are not consistent within a specified range, they issue an alert and shut down the pump until the discrepancy is resolved. There are probably better ways of getting redundancy, but that would likely work.

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    Anyone who can produce a smart watch that can give accurate continuous readings I guarantee will have my full undivided attention. I do use FS Libre 1 currently & have for almost 2 yrs.

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    I’d be curious to know a ‘cash-paying’ cost on all three systems. My endo said the Eversense isn’t popular because many endocrinologists don’t want to have the job of insertion procedure. It’d be nice if Eversense offered a listing of trained professionals who can do the insertion and costs associated over a 6-month period, compared with Dexcom and Abbott (and Medtronic, if they’re still afloat with their sensor!).

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    What about Medtronic??? Medicaid (not Medicare) STILL won’t pay for the CGM because it’s not approved for *dosing* in the US. Ask a rep, get the “6 months from now” runaround.

    Any real, true updates?

  7. Interesting as I have a like hate relationship with my CGM. Type 1 highs and lows and journaling
    through out each day to follow what works and doesn’t. Live in heat with current CGM coming off with sweating. Extra cover patch (Dexcom 6) and the mefix material created a rash.

    What do you do in 6 months of wearing this new device with insertion. How is it removed at the end of time? Looked in video like the transmitter is another adhesive device. How much scar tissue is developed possibly after many insertions. Has your’s malfunctioned?
    I hate the high low alarms with Dexcom 6 and have turned sound off at night and covered with a towel but can hear vibration.
    The 365 would be ok. And where is this developed? IN USA?

    • At the end of 6 months, you have a new sensor put in, typically in the opposite arm. The sensor itself is placed with a special tool that keeps it superficial, which makes it easy to come out with another special removal tool. The procedure takes about ten minutes. There’s typically no scarring, however, if you’re a keloid former, you may get scar tissue, but I have not heard of it. The device has internal quality control measures, so if for some reason the sensor is not providing accurate values before the 180 days is up, it will warn you and shut off so you won’t get abnormal values. If that happens, the company will put a new one in for you. Research and development is conducted by Senseonics, which is in Germantown, MD.

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    Is it replaced after the 6 months in the same spot or new area?

    • They put the new one on the other arm..so to rotate.There is a tool for insertion and removal and trained professionals on doing the procedure.

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        I think he’s asking, and I’m asking, what about the eventual build up of scar tissue over time?

        • You implant new ones in different areas, so if you’re not a keloid former, there aren’t any issues at all.

  9. Thank you guys for telling me about the part that goes on the outside and how you change it everyday. Thank you for telling me about the Eversense in the first place! You are the ones that give me the latest on Type one devices then I take it to my doctors and they scramble to catch up. You are wonderful, thank you so much!!

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      Yes, I concur. Seems like some Endo’s just aren’t keeping up with what’s happening.

      Our son was diagnosed in April and we didn’t first hear about Dexcom, or any CGM, from his Endo.

      We only first really learned about Dexcom when we went to a TCOYD conference the following November. After we learned about CGM’s from TCOYD, my wife said, we _need_ that, NOW! Then we went to Leonard’s Endo, who only then said, “Oh sure, we can give you a Rx.” Like they knew about it all the time, but didn’t think to tell us.

      I think that informing their patients about CGM’s should be something every Endo should do, without having to be asked. Even though some patients might not be able to afford it and their insurance won’t cover it, they should at least be told it exists.

    • Haha! I love that, Robyn!

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    I like the idea! Thanks for sharing. Do they have different colors of tape for the transmitter? You can’t be less discrete with your Diabetes when you’re wearing a short sleeve shirt and you have a large piece of tape and transmitter attached to it. I use Dexcom now and cannot “hide” it on your arm, but I love this CGM. An insertion type looks very promising. Again, Thanks for sharing!

    • They basically have two types of adhesives. One that’s perfectly clear, and the other is white like in the video.

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    How is the Eversense removed? Was it painful? Also, I’m looking forward to an in person San Diego TCOYD! 🙂

    • It’s not painful. They put lidocaine under the skin and sometimes you feel it and sometimes you don’t, but it’s minimal.

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    Thank u so much for all the info. I’m going to see my diabetologist for the first time in 15 months! I’m still waiting for an insulin pump although I have had type 1 for 55 yrs . However I’m armed with lots of info now. Thank u.

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    Regarding scar tissue, etc.: I’ve had a subcutaneous “loop recorder” inserted just below the skin of my chest, to record heart arrhythmia; it’s like a one-contact EKG, about the size of a glucose-test strip but a bit thicker. I’ve had two of these; they last well over a year. There is some scarring: I have tiny bumps of skin over each insertion, so this might be an issue for the Eversense since it’s inserted twice as often (right now).
    Regarding the insertion: it really is painless, as is the extraction, and doesn’t take longer than ten minutes. No general anesthesia. A dedicated insertion device and removal device are used. Of course the doctor has to be trained. My one problem: since I’m on a blood thinner, I had some long-term (hours) slow bleeding on the first one; had to visit an emergency room. Didn’t happen on the second one.
    So: Will the Eversense process be like this? I’m guessing there is more available territory on your arms than the restricted area where the loop recorder can be placed. And you only have one chest, but two arms!

    • As you know, insertion is for six months, and it is possible to get some scar tissue. But most folks do not have an issue. It is not unsightly, but if that would bother you, the Eversense may not be for you. Subcutaneous tissue in the arm does not have a tendency to bleed excessively, but for sure you need to discuss with the Eversense folks, and they can ask their medical director.

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    Can this Eversense CGM be paired with a closed loop pumping system like the Dexcom and my Tandem.

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