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?