Eversense CGM

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Matt Cycle

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Relationship to Diabetes
Type 1
Has anyone heard of this one? One of the cyclists in the T1 Strava group I'm on has one fitted at the moment (he's in Sweden). Different from the normal CGM's in that it has an implantable sensor that lasts for 90 days. The transmitter is attached to your arm and the data sent to an app on your phone via bluetooth. It's a US company but got a CE mark in May this year and has done a deal with Roche to sell it.

No idea on costs although as with all CGM's I imagine it won't be cheap and it states your HCP has to insert the sensor and presumably remove it as well. The 90 day lifespan and the fact it's implanted sounds an attractive proposition.

http://www.senseonics.com/products
 
A bit of an update from the person I mentioned above who is trialling the Eversense. He is one of five Swedes who are the first worldwide to trial it at a clinic. He said it will be rolled out to the rest of Europe this Autumn and into 2017. He will keep us updated on how it is going. Not sure how leaving the EU will affect access in this country to these sorts of technology trials but I can't imagine it will have done much good. :(
 
A further update on this regarding inserting the sensor - apparently a local anaesthetic is needed, they then create a 1cm cut and use a special tool to create a pocket to insert the sensor. Sounds erm, interesting but apparently it was all very simple and straightforward. 🙂 He's unsure at the moment how it's removed. 😱
 
That's the most important bit LOL Plus of course where could you get it done, since my GP doesn't do minor ops now, so isn't set up to cut or even lance anything, any more.
 
A further update on this regarding inserting the sensor - apparently a local anaesthetic is needed, they then create a 1cm cut and use a special tool to create a pocket to insert the sensor. Sounds erm, interesting but apparently it was all very simple and straightforward. 🙂 He's unsure at the moment how it's removed. 😱
Lets hope he doesn't need any xrays or scan because it will have to be removed.
 
It sounds a bit drastic for something that only lasts 3 months, to me ........ I mean fine if it's a trial and the object is to develop it to last like forever (or at least a year/years) and lots of us have had various hormone implants and the sort you need in various cancer treatments but the latter is life and death anyway so different considerations apply - but I'm not sure a lot of folk would opt to go for this long term?
 
The person who was trialling this has written an update of their experiences with it (mainly relating to cycling and exercise). I've taken this from his update on Strava. It sounds like he had issues familiar to all who have used CGM's. It's quite a comprehensive write up and is just his opinion. Thanks to Peter for sharing this:

"As some of you here expressed interest when I started using/testing the Eversense implanted CGM sensor I thought I's share some experiences (cycling/training related) here now that the three months are up and the sensor is no longer under my skin.

Before I start I just wish to state that what I am sharing here is my thoughts on how the Eversense sensor works when training/during physical activity. This was one of my main motivators for partaking in the test. I was hoping that it would be able to help my in my training, as I felt that in the rest of my diabetic life I was quite happy with the tools I was already using. But I am humble before the fact that this is a bit of a "luxurious" way of looking at the system. After all it is not a training tool, but a system for monitoring glucose levels. And as such it may have huge benefits for users with a different set of problems and goals.

The insertion of the sensor under the skin and subsequent "wearing" of it was totally hassle free. To someone the thought of having computer chips under your skin might be alarming but I do not have any issues with that. The heart of the system is the sensor under your skin, but for it to do anything sensible it needs the transmitter on the other side of the skin to function. The transmitter is actually what feeds the sensor energy (The same way wireless phone chargers work). So you still need something attached to you skin: The transmitter, which is taped on to your arm using special adhesive pads. Worth noting is that this is the only insertion point available to the system. It does nor work with abdomen, thigh, back etc.

I found the adhesive pad to work really well even when moving/sweating. Remember that I was using the first version of the transmitter, lovingly refereed to as "the brick", which is quite bulky. There is a new version underway which is a lot sleeker, lighter and also waterproof. The fact that the current transmitter is not waterproof was not problem for me. I used it on really wet rides where I was completely soaked without problem. If your into triathlon there will be problems though.

I did actually drop the transmitter once (https://www.strava.com/activities/656567050): Had to bunny hop onto the pavement when a tricky traffic situation occurred. As I hopped down again, doing maybe 20 km/h the transmitter came flying and bounced over the asphalt at least 15 meters. I thought for sure I had killed it, but It just carried on as nothing had happened. (In fairness the ride took place after a swim in the ocean (remember: not waterproof, you need to take it off for a swim) and I reused the adhesive pad) So for it's lacking appearance, at least the transmitter is rugged.

The fact that you need to take the transmitter off when showering/swimming etc. was something that at first annoyed me, but as time went on this was one of the things I really came to appreciate with the system. That you can remove the transmitter at any time and be truly "naked" whenever you like.

But what of the actual blood glucose monitoring then? Well I have to say this is where the system, in my experience, fails. At least if you look at it from a training perspective(as describe above). What happens is, going into a ride your levels are accurate (I'm not discussing CGM vs blood glucose lag here. It is not worse, nor better than other CGM system in that regard) but as soon as you start depleting stores and blood glucose goes down it keeps going down regardless of what is happening. And once it is down, it stays down and won't come up even if you have refueled and restored levels.

The best example of this is this ten hour ride (https://www.strava.com/activities/634254228): After about 1:30 hrs the sensor deemed that I was below 4.0 mmol/L and then kept the levels there for about 4 hrs. Within those 4 hrs there were long periods that levels were reported as LO (below 2.2 mmol/L) The fact that I was doing well above 30 km/h average during this period is proof enough that the readings are completely off. Blood measurements during the same period hand me in the 5.0 - 10.0 range. The ride refereed to here might be seen as a bit extreme in length, but the same pattern is evident in shorter rides.

The effect of this is of course a distrust in the system and the values it presents. This distrust led me to, as time went by, to go training without the transmitter. I felt more secure and performed better when listening to my body and using my experience. The rides when I did wear it I found myself disregarding and being annoyed by alarms and values.

I have my own theories of why this is happening. Once stored glucose is depleted, any glucose you add will not end up in the interstitial fluid (where the measurement is taken) but it will go straight into your thighs. Perhaps the light-based measuring technique used has a limitation here, perhaps the algorithm and its sample rate plays a part. I've provided the data and discussed this with the Eversense team. They give the theory some credit and believe there are things that could be done to address it. Future will tell.

As the system uses your smartphone and an app for presentation and analysis, there is are of course problems with compatibility and Bluetooth connections and all that stuff, but that is better discussed elsewhere. Having a smartphone as a key component of the system is both a blessing and a curse. One thing I would add regarding this here is that, as so many medical companies do, Eversense believe there is a benefit to keep data and broadcast format proprietary and secret.

To me it's just stupid. I have a sensor that broadcasts values via Bluetooth (Does that sound like something you might already have on your bike?) I have a device on my stem capable of reading data from Bluetooth sensors (Again, sounds familiar, right?) Why on earth are they not allowed to talk to each other? Because someone in a boardroom think they can make some extra bucks by obstructing data. But this is another can of worms, and one that sadly is not exclusive to Eversense."
 
Interesting. Sounds like it needs another year or so work, then another decade for NICE to approve it. More importantly, as it tests interstitial BG, it doesn't seem to offer any benefit over the much simpler Libre system.

We'll see.
 
The article says that the sensor that lasts 180 days, is available in England.

I'd like to know where!
 
Hi was looking up the Libre CGM as thinking about getting it for a two week trip to Florida, nervous about having hypos in the heat and thinking this could help take the anxiety out of managing it in the humidity. Stumbled across the Eversense and then researching it came across this thread. Does anyone have any more news about it and how you go about getting it - I am so clumsy thought this would be better than the libre one. Thanks in advance for any responses.
 
Hi there as far as I know it is available in this country but I don't know anyone who has got it. Unlike the Libre and other CGM's this requires a minor surgical procedure to insert the sensor so it would have to be done through the clinic/doctor etc. You could ask your clinic/DSN about it.
 
I’ve seen a few posts about it on Twitter, but I think it’s still ‘emerging’ rather than an established option.

Im not sure I can think of anyone I know currently using it. I’m not sure what trial data there are about it either.
 
I contacted a private clinic in London to see what the cost would be to have it done privately, to get started and then one removal in 6 months time is around £4.5K. I can't possibly justify this cost. The replacement sensor is around £1.5k thereafter. Fingers crossed it becomes popular and the costs come down and it gets NHS buy-in (which I doubt as not as accurate as Blood monitoring) But all positive steps in tech helping us manage it all. Come a long way since I was diagnosed and I had this massive blue auto-click thing that went straight through the middle of your finger and out the other side and then you compared it to the side of the strip tube.
 
I have had the eversense system for just over 100 days. The sensor insertion takes about 20 minutes and is inserted in the upper arm. The transmitter sits over it and a placement assist which makes the process simple is included in the app. The transmitter is stuck and although fairly secure I place a strip of hypafix for added security. I use it with an apple 5 phone. It requires twice daily calibration. The transmitter neds charging every 24 hours and takes less than 30 minutes to charge. The current sensor lasts 6 months and the transmitter apparently about 2 years. It is at least as accurate as existing systems, though is calibrated against finger prick and meter and measure blood sugar in different fluids which is tries to counteract by allowing calibration when Blood Sugar is not changing rapidly. It tends to read slightly low based on calibration. It is the most easily used system that gives real time monitoring 24/7. The alarm can be modified by the app and even if the phone is out of range it give a series of warning by vibration. It also gives predictive warning that can be turn on. Level of alert can be set (high and low blood sugars). I also have an insulin pump and use the levels increasingly to manage my diabetes, though tend to check those outside the set limits. After 3/12 my HBA1c is 6.1. The support also seems pretty good. The app has a few gliches but can always be solved by turning the phone on and off. I don't think there are many users in the UK currently.

Based on usage of supplies this should be a cheaper way of CGM but is still very small numbers so no reductions because of market size and those doing insertion removal do need training so suspect rise in numbers utilising will be slow.

The indications for this system or non appreciation of hypos to prevent serious hypos, the need for CGM for these is obvious and this system is persistent and can be set loud enough to wake anyone up.
 
An interesting update.
It still sounds prohibitive at present but who knows what will come next.
 
The current app has just indicated that the sensor will cease to operate in 4 days just more than 100 days after fitting. The official information says up 6 months the American version three months. If you are depending on this it may be sensible to change after 3/12 as 4 days isn't long enough to arrange for a replacement. Its good system but the main drawbacks are. The transmitter needs charging 24 hours or less, possibly the life of the transmitter unless Roche is prepared to guarantee it for 2 years. Still committed to it but the sensor will need replacing 4 times per year which is a drawback as it life does seem to be limited to 3/12 reliability. and replacement needs doing at a specialised facility. Also the help-line at Roche only operates 8am-6pm 5 days per week and it came up with its 4 day message at 9pm Friday night, still it said 4 days again but seems to be draining the transmitter battery in about 16-18 hours.
 
I contacted the company and they said they could replace the sensor in about 10 days and remove the original in about 6 weeks. I asked them, to do both together as it takes about a day with travel. The eventually agreed and did both the same day. The new insertion however bled heavily after insertion washing the steri-strips and dressing off and of course no support was available from Roche/Senseonics as OOH. So I dressed it myself and bought some new steri-strips and waterproof plasters and dressed it myself when it stopped bleeding about 24 hours later. Didn't reconnect it immediately as wanted to give it a chance to heal. When I did it booted up ok and calibrated after 4 reading. However the battery on the transmitter drained after less than 20 hours , this was repeated the next day. I tried to contact Roche/Senseonics as just after 4pm no help line available. I think that maybe given my experience this is a product to think very carefully about,. In my experience the sensors don't work as advertised the transmitter life is barely over three months and the service from Roche/senseonics in terms on support is very poor. I appear to be beta testing the system and I am wondering with such poor functionality in my experience why is it marketed in the UK.
 
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