Posted by on Saturday, 1 September 2012

C8 MediSensors - A bright future for CGMs?

Some months ago I was made aware of a new piece of diabetes techno-gubbins in the pipeline which sounded really interesting. Any poor souls who have read these ramblings before will probably already know my interest in continuous glucose monitors (CGMs). So I was delighted to be invited by the lovely Andrew to a little round-table chinwag with various other diabetes bloggers, campaigners, movers and shakers along with a couple of people from C8 MediSensors who have developed an entirely new approach to CGM which has the potential to be a complete game-changer. A non-invasive, optical CGM. It is currently classed as an 'investigational device', so it's available for use in clinical trials, but not yet available for sale anywhere in the world.

In proper 'disclosure' style I'll mention at this point that my train fare was covered, they laid on some tasty sandwiches and I was offered a modest amount to cover attending the day. I wasn't asked or paid to write anything about it, but I wasn't forbidden from doing so either and as I say - this is already a proposition that interests me (and I suspect, some of you) very much.

What C8 MediSensors hoped to gain, I think, was some end-user input for the potential UK market. The device is not yet available anywhere (they hope to have European CE mark approval by the end of the year and plan to launch in the UK and Europe first). This wasn't a marketing push, or a sales pitch, not yet anyway - this was much more of a two-way dialogue. Picking our collective brains about what we thought would be important to UK punters, how well understood we thought the concept of CGM was in the UK. What potential attributes of app and interface we felt would be welcome and/or irrelevant.

What on earth are you talking about?
The device being developed is one of those rare things. A real first. It's a non-invasive continuous glucose monitor (nCGM). It measures glucose concentration not with an inserted sensor beneath the skin, but with a small beam of light. Let me say that again. No sensors. No sensor stabbiness every 3-7 days. No sensor cost. No consumables at all of any note. As someone who has looked into the challenging financial implications of self-funding a CGM in the UK you can see why this would attract my attention.

Essentially the nCGM is the world's smallest Raman spectrometer. Apparently the initial 'proof of concept' device was about the size of a sideboard, but you'll be pleased to hear that they have managed some ingenious Wayne Szalinski style miniaturisation since then and the current device and rechargeable battery are each roughly matchbox-sized and together weigh a little more than an iPhone. Not exactly nano-technology, but certainly viable. If you are interested in a bit more nitty gritty on the device itself we were shown a short video which shows the CGM in use.

There are still some wrinkles to consider of course. The 'belt' that holds the device against you is not the most beautiful fashion accessory you could imagine. You can't immerse the device in water. You can't really use it while running, leaping and turning somersaults (the light sensor needs gentle but consistent contact with the skin to take its readings every 6 minutes and might complain if it gets jiggled about a lot). There are even 'light screen'/dark shirt precautions that might need to be made if travelling alternately from bright sunshine to deep shadow since light can 'leak' horizontally under the skin. Currently the device is intended/tested for over 18s only, though young people and other user groups are certainly being considered for the future when research data/regulatory approval permits. Data display is currently only available via an Android smartphone, though an iPhone version is on the cards.

Crucially, with this CGM you just put it on and it begins collecting data within minutes. If you want a break, even for just a few hours, you can just take the whole thing off for a short while. It's still a CGM of course, so it's more 'trend' information than definitive BG levels and occasional fingersticks will still be part of the picture, but if you've looked into CGM before you'll know that already. Interestingly, the plan is to launch with a 30-day money back scheme allowing users to try it for themselves before they commit to permanent ownership.

I came away from the meeting very excited. After 8 years of development, and many clinical trials they have data that shows the C8 MediSensors Monitor to give results comparable in accuracy to 'traditional' CGMs, but without the ongoing sensor cost. In fact the suggested price point of the device ($4,000 or roughly £2,500 at the time of writing) is somewhat cheaper than one year's worth of full-time sensors, theoretically putting it within reach of many more people than can currently self-fund. In a clinic environment I would imagine this is a device that makes perfect sense. How many CGMs stay on clinic shelves, I wonder, for want of sensors to offer patients?

Encouragingly C8 MediSensors also seemed keen to build a relationship with users, foster something of a user community. Founded by a parent of a T1 child and his two college room-mates, they seem to have something of a patient's eye-view mentality. Essentially wanting to engage not just with Healthcare Professionals, but with the Diabetes Online Community. With us as end-users.

It will be very interesting to see what happens next. Whether CE approval is forthcoming, and quite how the launched device performs in the wild.

Hold on to you hats. This could completely change the landscape.

EDIT: C8 Medisensors announced that they had received CE Mark approval on 25th October 2012. Things seem to be getting a little more interesting!

UPDATE: Has the light gone out on C8 Medisensors optical CGM?

16 comments:

  1. That sounds really interesting. It's reassuring that the manufacturers have got lots of user input. Thanks for the update!

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  2. Very interested in this. Would love for this to become a reality. The benefits of temporary removal without needing a new sensor are huge.

    Did they say if the sensor had a lifespan? ie how long would the £2:5k investment last?

    I really look forward to hearing more about this if they can get through regulatory hurdles.

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  3. Haha! I asked that very question :) their expectation is approx 4 year lifespan (though I dont think it would necessarily be warrantied through that whole period). No movin parts though, and separate battery packs, so I suppose no reason why it might not last longer

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  4. As you suggest, clinics waste CGMs because they don't give consistent results over the few days they lend them out. My clinic has one but refuses to use it. This sounds as if it would enable ordinary 'poor' people to access CGM. Will be watching with great interest. Thanks for the heads up Mike. Rob

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  5. WHEN CAN I HAVE ONE???
    I trialled a Glucowatch (in what seems like a previous lifetime) a CGM designed to strap on like a normal watch. I loved it, despite the fact it switched off nearly every time I exercised or went low, and burnt the skin on my arm, so sent it back somewhat reluctantly due to all the snags. I am so positive about CGMs (as you know!); my husband, a materials engineer, continually asks how can anyone be expected to control the process (of metabolising food to glucose) when not given the data. Why can’t HPs see that? This has got to be beneficial for so many people with diabetes

    I am now off to follow your links and google the product – keep us informed!

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  6. I would also like to be able to download the information to my computer so that I can look at the results at my leisure (!)- eg when seeing the effects of something on 2 separate days, I could produce 2 separate graphs. Did anyone suggest similar?

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  7. Great idea! And yes we did have a very thorough 'wishlist' conversation for the smartphone app, including tha ability to overlay/record meals/carbs/doses/activity and fingerstick BG results and view them alongside the CGM data. Plus the ability to export that data out and/or perhaps allow for some sort of cloud storage for access/sharing across multiple devices (phone/tablet). What was discussed was pretty much D-geek heaven, though of course some of the suggestions may not make it through the development maze (I think the app is still a work in progress). What was suggested though, was that app development/updates would be ongoing, so additional functionality and snazziness may be added to the core app at a later date depending (presumably) on user demand and practicality.

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  8. Great post and convo, Mike. Thanks.

    As someone who can't usually manage to remember what they had for breakfast, props to you for recounting the meeting in so much detail.

    Thanks also for introducing me to today's new hashtag: #dgeek ;)

    Oh, and extra points for the 'lovely'.

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  9. Great post Mike - sums up the day and the product very well.

    Anna

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  10. Good to have proof that it really exists! Let's hope it's as good as it sounds.

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  11. Haha! Good to hear from you again Bob. I mentioned you to the guys at C8 and my initial (mistaken) impression that you might be connected with the product.

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  12. It would be interesting to be involved.
    Did you actually see the device in action in (on) the flesh, as it were?

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  13. Yes indeed. One of the guys from C8 MediSensors was wearing one the whole time and handed round his phone for people to look at the graphed data coming in (doesn't have D, so as you can imagine it was pretty good!). There was also another handed round so we could feel the weight/take a closer look etc.

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  14. Hi Mike,
    Just wondering if you've heard anything about this recently? Their website seems to have disappeared.. or am I missing something?
    Regards
    Bob Slack

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  15. Unfortunately I don't have any more up to date information. The European launch was intended to be spring this year, but the last I heard they put it on hold. I did try to email some of the people I met earlier this year, but those emails bounced. The disappearance of the website is a very bad sign. Such a shame - I really hope the product and all the thousands of hours it represents is able to make it to the market in some from or other at some point.

    I was absolutely ready to take the plunge.

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  16. It does seem odd, though I'm sure the conspiracy theorists would have an explanation!
    I'll keep my fingers crossed that something comes of it. Thank you for the reply,
    Bob

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