There’s been a lot discussed recently about the Abbott Freestyle Libre and how the 4,000+ members of the Facebook group that is dedicated to it want to see it on the NHS in the UK. We already know it’s available on Swedish (and I think German?) insurance policies. Most of us liked it as it was a much cheaper way to get into Continuous Data recording, something that I’ve wanted for ages, when compared to the Dexcom system (and others) which were just too expensive.
And then we get something new, due in 2016! I’d been speaking to a couple of industry insiders on the topic of CGM type systems, and they had assured me that there was more coming in 2016. It looks as though that More includes the Nemaura SugarBEAT device. Now I’m not sure which play on words Nemaura are using here, but I rather like the idea of a root vegetable helping to monitor my blood glucose levels…
What is it? A simple patch that speaks Bluetooth to your phone (or a SugarBEAT reader) and that’s it!
They’ve a number of patents on the technologies involved and all of them look interesting – worth a google trawl and read if that’s your thing…
What’s important, of course, is that this product has been or is being clinically trialled, The data we have was published in October 2015 as an interim analysis of the ongoing trial amongst 540 patients, showing a MARD of 11.8%. This is in line with what we see from the Libre (at 11.4%), better than the Dexcom G4 and slightly behind the Dexcom G5, which quotes single figure MARD of 9%. In a system where lower is better, and MARD on test strips has an ISO standard of 15%, this is a very usable number.
On March 15th this year, they also achieved that all important standard, the CE mark. This means that they are effectively licensed for use across all European territories that use the CE mark. Even more interesting. It can only be a matter of time before this product starts to be marketed, both by the company via various advertising routes, and if the model that Abbott used is followed, trialling by various bloggers (to which I’ll put my hand up and see “Me, me, me”, although I’ve no idea whether that will have any effect!). Now the launch was supposed to take place in Q1 2016, so there have obviously been some minor delays, but potentially this means a launch will be sooner in 2016 than perhaps we think.
The market is very clearly there, the interest is piqued. The question on everyone’s lips is “What price point?”. Will they go in with something like the Libre (which is a top seller for Abbott, in spite of its price) or look at something different. If you look at the way the product works, it requires 30-odd adhesive patches a month, a transmitter of some sort and the watch/handset. The details are scant, but the idea doesn’t look like it would be any cheaper than the Libre. Having said that, the marketing material that Nemaura presented at the ROTH conference in 2015 suggested that competitor products were all “Much more expensive”…
So, the product itself? What is it? Well, after a bit of a Google, I’ve found what follows.
The technical basis on which this works is to use a current to pull glucose out of interstitial fluid and measure it as follows:
- Works by passing a mild current across the skin that is barely perceptible, or non-perceptible.
- This current pulls the glucose out of interstitial fluid, which is found just below the top layer of skin, into a reservoir in the patch.
- The patch contains a sensor, which measures the amount of glucose analyzed.
- An algorithm within the device converts this reading to a glucose concentration value.
- This reading is displayed on the device with sound and / or buzzer alert
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– Daily disposable skin patch and adhesive sensor patch
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– User’s Smartwatch/Smartphone (Bluetooth-enabled device with LCD display and alarm) or SugarBEAT® handheld reader
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– SugarBEAT® Smartphone App (Android and iOS)
Certainly a very interesting technology and given the requirement for a reasonable level of conduction to the skin I suspect a significantly different adhesive to the Libre sensor. Great news for all of us who get the Libre "burn"
It's certainly interesting news. One thing I'd be wary of though, is that it uses the same technology as the Glucowatch used, and users of that reported burns from the measurement method. That's why the clinical trial results are of interest. To see whether any users experienced a similar level of discomfort or whether the technology has been improved enough.
This is really great review and it will be very interesting end of the year 2016. Only, just few days ago there was a news from Nemaura that MARD of the SugarBEATS is 14.05%… http://www.nemauramedical.com/news/2016/interim-clinical-data-increased-measurement-frequency-sugarbeat-cgm-released-nemaura-medical/
Yes, I saw that press release. It was interesting for a couple of reasons.
One was the MARD score that it showed, which at 14.05% is rather worse than the data we'd seen so far.
The second was that it revealed that the sampling mechanism was running every twenty minutes originally and managed a MARD of around 11% at that rate. When they moved it to every five minutes, in line with other CGMs, this result nearer 15% was attained. With the sampling every 20 mins, the data isn't as much use to type 1 diabetics, so you can see why they made the change.
I suspect this means they will tweak the algorithm as a result and I expect to see further studies highlighting improvements.
Thank you for your answer. Logically if you use interstitial fluid taken from under the skin (like Dexcom and Libre) results could be more precise than if you extract the interstitial fluid from the skin itself (SugarBEATS). Although SigarBEATS is definitely less invasive then. Let's just hope that precision will be better.
Una informacin muy buena, es lo que estaba buscando. Millones de gracias. Saludos.
I just wanna know where is it put on market already
Not to my knowledge. The last press release we saw said that it is coming in 2017.
Okay, thanks, but is it sell anywhere else?
As I said last time, not to my knowledge. You’re probably better asking the company than me though!
I am starting the Libre in a weeks time. Anxious, I have unawareness of hypo’s . Would the sugarBEAT have a signal/alarm? Hurry up and good luck. If you ever need anyone to trial for you get hold of me.
Hi Judy, I took the liberty or removing your email address from your comment to avoid it getting picked up by something nefarious. I’m not associated with Nemaura, so I’m afraid I can’t help you with that. It’s probably worth reaching out to them directly.
I’m watching this product with interest for my son. Yes the non invasive part is fabulous but I love that it can be worn adhoc, for a teen that is body conscious, and after wearing Libre then Dex for the last 2 years, he now won’t wear one as he doesn’t want friends to see it, this he could wear just overnight or on days he’s not at school. Plus it looks less bulky than Dex which is another bonus.
Any updpate on this? where did you get the Clarke Chart? I would like to see more update Clarke Chart.
I’ve not seen anything further (aside from a news flash on seeking alpha suggesting a recent trial had had good results: http://sugarbeat.com/faq/
If you look further into the trial, they reported data from 25 participants (ie not statistically significant) who wore the device for 14 hours per day. Quoting from Nemaura’s website:
“Results indicate an overall MARD (Mean Absolute Relative Difference) of 13.76% over a broad dynamic glucose concentration range. However, up to 70% of the data from the study paired between sugarBEAT® and the venous blood glucose concentration achieved an average MARD of 10.28%, denoting even greater accuracy. A MARD of 10% is deemed to be sufficient for making therapeutic decisions. No serious or major device related adverse events were noted.”
You can interpret that in multiple different ways, but for me, 70% of the data for a continuous monitor worn for 58% of the day amounts to a roughly 40% period of time in which the MARD was at the 10.28% level. Which is pretty poor really.