If you’re on Social Media, and follow diabetes, you can’t fail to have seen the noise from GlucoRX and the JDRF about BioXensor, a new, non-invasive Continuous Glucose Monitor (NICGM).
While there’re plenty of exciting soundbytes relating to this brand new products, as is often the case with NICGM, there’s not a lot of detail.
So, what is it?
Apparently, it’s been developed by Cardiff University in conjunction with GlucoRX and is a multisensor, as their website states here:
The noise in the press suggests a MARD of 10.4%, but with no supporting data to back that up. Remember. We’ve been here before.
Their website (www.bioxensor.com) highlights a number of clinical studies, but the only one with published data had 24 participants, with 8 non-diabetic, 4 type 1 and 12 type 2.
It measured data for 5 hours vs YSI in a lab, and tested using an oral glucose tolerance test, testing high rather than low values, where accuracy is notoriously hardest for invasive sensors, and resulted in a MARD of 12.4%.
They mention a 5th clinical study that had 50 participants, which I assume is where the headline MARD came from, but again, no details of methods or participants.
How does the sensor work?
This one is a microwave based sensor that appeared on the BBC back in 2016.
In their own words:
At the heart of BIOXENSOR is a non-invasive, low power, resonant radio frequency (RF) sensor whose electronic drive circuit generates RF electromagnetic (EM) fields of tiny amplitudes which penetrate deep beneath the skin, allowing access to peripheral blood vessels. The subject wears the sensor discreetly, simply attached to the skin via adhesive, and there is no sensation other than touch. The interaction of the RF EM fields with blood is measured by the change of resonant properties of the RF sensor, allowing the prevailing glucose concentration to be measured by purely non-invasive, electronic means in real time, limited to once per minute but averaged over a much shorter time interval.www.bioxensor.com
It can, apparently, sense many things. And is a low cost, remotely monitored system that provides many advantages. Rather than describe them all, I leave you to go and take a look at their website, which is high on marketing and low on detail.
GlucoRX and Cardiff University will be presenting something at EASD, and I’m hopeful it something of value regarding the studies they have done, and what they plan to do in a forthcoming pivotal trial. This take a good 18 months, after which approvals are required.
There are both patents and studies that reference their work available on the Cardiff University Website, so there appears to be a good scientific and engineering background to this.
However, we see these types of device appear, make headlines, and then disappear with nothing in production.
This has been well documented by John Smith, in his book “The pursuit of non-invasive glucose monitoring”, where so far there’s been nothing that’s really made it.
I hope this time that we see a real product that’s accurate and works properly.
But the past doesn’t suggest that hope will get us very far.