The dream of being able to monitor blood sugar without poking the skin (known as “noninvasive” glucose monitoring) has been discussed for decades, with little real progress. But now, a Seattle-based startup believes it has the recipe for an innovative new approach for what it claims could become the “holy grail of medical industry and patient care.”
Know Labs is developing two devices that use Bio-RFID technology, or Body-Radio Frequency Identification, which uses radio waves to measure specific molecular signatures in the blood through the skin.
“Accuracy will be comparable, probably even exceed, the ability of glucose measurement devices available right now,” said Dr. James Anderson, chief medical officer at Know Labs whose industry experience includes a quarter-century at Lilly Diabetes.
Formerly known as Visualant, this tech company changed its name in 2018 and is developing both a wristband-style device as well as a finger-scanning device that eliminate the need to pierce the skin to get glucose readings.
UBand is a wristband with a built-in biosensor designed to continuously monitor glucose levels. It won’t have a display screen, but instead, the readings will be sent directly to a smartphone app. They’re expecting it to have a battery life of 7 days before you would need to recharge it. This product is aimed at people with diabetes who are interested in a noninvasive continuous glucose monitor (CGM).
Previewed publicly in September 2021, the KnowU device sort of resembles a traditional fingerstick glucose meter that is small enough to fit into your pocket — but it doesn’t require test strips. Instead, you’d take the sensor off the base and scan it over your palm to generate readings that would then display on the base device itself or be beamed wirelessly to a smartphone app. This is more aimed at people with diabetes who aren’t interested in a CGM, but want more of a traditional meter for on-the-go use without the finger pokes.
Know Labs is using a proprietary application of Bio-RFID technology that emits radio waves onto the skin. It captures glucose readings and other molecule signatures in the blood using spectroscopy. In this case it’s the process of shining light or electromagnic energy directly into the skin. LED wavelengths are emitted onto the skin, and it measures the color variations reflected back to generate the health data.
Spectroscopy has been around for a long time, used in space astronomy and MRI and X-ray technology. If successfully developed by Know Labs, this would be the first time using this technology for diabetes glucose monitoring.
“This is an exciting development for healthcare,” Anderson told DiabetesMine. “If you look at the economics of diabetes care itself, we would have no strips, transmitters, or sensors needing to be replaced or disposed of. So, this technology is a significant cost-savings and that’s a big contribution to society itself.”
Early studies show that Know Labs’ Bio-RFID technology works just as well, if not even better, than existing CGM products like the Abbott FreeStyle Libre flash glucose monitoring system.
Specifically, a 2018 study on the UBand device shows the accuracy is comparable to that of the FreeStyle Libre, with 180 differing paired glucose readings collected over the course of 3 hours being within the safe “green zone” range of the Surveillance Error Grid (SEG), the standard tool for measuring clinical accuracy of blood glucose monitors.
That data showed 97 percent of UBand’s readings being within 15 percent of those generated by the Libre, and 100 percent were within the 20 percent range.
Anderson is excited to report that other early data shows their prototype devices have a 5 percent
The company aims to begin the Food and Drug Administration (FDA) pre-approval process in 2022.
The company says it is actively working to commercialize the UBand, and the newer KnowU product shouldn’t be far behind.
Know Labs leadership tells DiabetesMine it’s too early to talk potential pricing, but they are considering a subscription model where you’d pay a monthly fee to access data analytics and other yet-to-be determined services from Know Labs.
While Know Labs has largely been off the grid in “stealth mode,” they’re now starting to make headlines with early data and these prototype designs. That also means they’re looking for investors to support their regulatory and manufacturing efforts.
“We know that not all people with diabetes are looking for a wearable continuous glucose monitoring device to manage their diabetes. Some simply want to replace the painful, inconvenient, and expensive fingersticks they currently rely on,” CEO Phil Bosua said in a statement. “The Bio-RFID sensor we currently use for our internal product testing fits in your pocket and is ready for final use. So, we decided to create the KnowU as a portable, affordable, and convenient alternative requiring no disposable items, such as test strips and lancets.”
There’s been a longstanding debate over whether it’s really possible to create an effective and accurate noninvasive glucose monitoring system. Over the years, many have tried and failed, including Google Verily, with their failed idea for glucose-sensing contact lenses.
In the early 2000s, one product called the GlucoWatch actually made it through the FDA approval, but it was later pulled from the market because the device was burning people’s skin.
In June 2021, a 47-page article on this topic was published in the Journal of Diabetes Science and Technology, written by experts across the world associated with the Diabetes Technology Society led by Dr. David Klonoff. It constitutes the most comprehensive resource on the topic that, for the first time, classified bloodless monitoring products into three categories:
- noninvasive optical
- noninvasive fluid sampling
- minimally invasive devices (i.e. current CGM devices, like Dexcom and FreeStyle Libre)
“A few of these products have been cleared by the FDA and many other products might eventually be cleared by the FDA if they can overcome technical hurdles,” said Kevin Nguyen, bioengineering administrator at the Diabetes Technology Society.
Overcoming technical hurdles is of course the rub. We at DiabetesMine are rooting for Know Labs and all of their competitors who aim to improve life with diabetes by finally removing needles from the equation for good.