New Attempts At Non-Invasive Glucose Monitoring: SugarBEAT CGM and HELO Extense

People living with diabetes often roll their eyes at the notion of new products that promise non-invasive glucose sensing — devices that would not need to pierce the skin with any type of needle. That’s because there’s been so much hype and unfulfilled promises over the years.

Now, two recent products under development are again promising to revolutionize diabetes care by taking glucose readings without drawing blood. One is a sticky patch CGM sensor that has a small transmitter worn over it, both on top of the skin; the other is a gadget that clips onto a finger and tracks glucose externally, without poking the skin.

Of course, it all comes to hype vs hope. Both of these new D-tech products look cool, but as always it remains to be seen whether they are anything to be taken seriously that could actually make a difference in the market.

SugarBEAT Sticky Patch CGM

Made by UK-based Nemaura Medical, the SugarBEAT Continuous Glucose Monitor is a skin patch that’s unlike any other CGM on the market. It works by “passing a mild, non-perceptible electric current across the skin, (which) draws a small amount of selected molecules, such as glucose, into a patch placed on the skin. These molecules are drawn out of the interstitial fluid which naturally sits just below the top layer of skin.

The sensor, a disposable 1mm-thick patch that lasts 24 hours, measures the amount of that molecule present to take readings electrochemically every 5 minutes. Those readings are sent via Bluetooth Low Energy in the transmitter to a mobile phone app on either Android or iOS, where it’s converted to glucose level data using a proprietary algorithm. The system’s transmitter device is non-disposable, rechargeable and lasts for up to two years.

SugarBEAT CEO Dr. Faz Chowdhury says: “Having personally worn the device for trial purposes for over 55 days, I can say that there is no skin sensation or irritation associated with the device. Nor have we observed any such issues in over 1,000 patient day studies thus far conducted in Europe. The app will allow other manual inputs such as food, medicine, and exercise, thus giving a snapshot of how different lifestyle activities are impacting one’s sugar profile.”

While the tech itself seems pretty cool compared to what we’ve traditionally seen on the CGM scene, the accuracy is… well, what you might expect from a first-gen product. Recent clinical data from Europe released in early 2018 shows an overall MARD (Mean Absolute Relative Difference,the current standard for evaluating CGM accuracy) of 13.76%. The hight the MARD score, the less accurate — and this score is definitely higher than the three competing CGM products on the market; Dexcom, Abbott Libre, and Medtronic Guardian all come in between 9-10%.

It is worth noting that in the early days of CGM tech, those D-devices had much higher MARDs too, so it’s best to compare apples to apples here… It’s also worth noting that SugarBEAT CGM that 70% of the data in studies show that when compared to BG concentrations obtained from the vein, the MARD looks more like 10.28%. It’s tough to interpret what what all that means exactly, but clearly the accuracy isn’t as good as existing CGM but can and likely will improve as time goes on.

Nemaura is awaiting CE Mark approval overseas at any moment now, and is prepped for launch already. The company tells us they have already placed an initial order with its UK-based contract manufacturer for 12,500 of the rechargeable transmitters that are a key component of the SugarBEAT system. They have also already started US clinical studies as part of the process for FDA filing in mid-2019.

The one-off cost of the transmitter is expected to be roughly $50. The target cost for sensors is less than $3 a day, but that’s yet to be finalized, and they expect the cost will decrease post-launch, based on large-scale production leading to more cost efficiency, Chowdhury tells us. “This will be the first time such affordable monitoring will be introduced to the market, which we anticipate will broaden further the user uptake, building on the huge success that we have seen the likes of Abbott achieve, allowing more patients to be empowered with CGM data.”

SugarBEAT certainly appears to have potential, and we are cautiously optimistic that it will succeed.

HELO Extense Sugar Trends Monitor

HELO Extense is a little rectangular device that somewhat resembles an old- school flip phone, but instead has a slot where it slips over a fingertip to take a glucose reading after about 30 seconds. LED optical technology

What’s different is that it offers a “wellness” level rather than a traditional BG number result, so it displays a color-coded result ranging from Low/High/ VeryHigh/etc.

There’s very little detail available about the how glucose reading technology actually works, but given the cursory mentions of LED optical technology, we can only assume that like other attempts in the past, this gadget uses light to identify and analyze glucose molecules under the skin — and the resulting vibrations of the molecules are monitored by the sensor. The demo shows readings being sent to a software platform and app.

The inventor behind this, Fabio Galdi, is on record saying he’s a type 2 PWD himself. Unfortunately, World Global Network did not respond to our queries for more information, despite the considerable effort that’s obviously gone into the many marketing videos they have produced and posted.

Note that a London-based company called GlucoWise appears to be working on something quite similar.

So there you have it. As The Scientist reported recently, the long-suffering non-invasive dream is still very much alive and kicking — with new companies continuing to invest in finding the elusive “relevant technology to replace finger pricks.” Here’s to those efforts, as prickly as they may be…!

This content is created for Diabetes Mine, a leading consumer health blog focused on the diabetes community that joined ishonest Media in 2015. The Diabetes Mine team is made up of informed patient advocates who are also trained journalists. We focus on providing content that informs and inspires people affected by diabetes.

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