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The dream of being able to measure the blood sugar level without pricking the skin (so-called “non-invasive” 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 that could supposedly become the “holy grail of the 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.
“The accuracy will be comparable to, and probably better than, the blood glucose meters currently available,” said Dr. James Anderson, Chief Medical Officer at Know Labs, whose industry experience spans a quarter of a century with Lilly Diabetes.
This technology company, formerly known as Visualant, changed its name in 2018 and is developing both a wristband-style device and a fingerscan device that eliminates the need to pierce the skin to measure blood glucose.
UBand
UBand is a bracelet with an integrated biosensor for continuous monitoring of the glucose level. It will not have a screen, but the readings will be sent directly to a smartphone app. You expect 7 days of battery life before you need to charge it. This product is intended for people with diabetes who are interested in a non-invasive continuous glucose monitor (CGM).
Know you
The KnowU device, which was unveiled to the public in September 2021, is similar to a traditional fingertip glucose meter that is small enough to fit in your pocket – but it doesn’t require test strips. Instead, you take the sensor off the base and scan it with the palm of your hand to generate readings, which are then displayed on the base device itself or transmitted wirelessly to a smartphone app. This is more aimed at people with diabetes who are not interested in a CGM, but rather want a traditional measuring device for use on the go without fingertips.
Know Labs uses a proprietary application of Bio-RFID technology that emits radio waves onto the skin. It records glucose levels and other molecular signatures in the blood using spectroscopy. In this case, it is the act of projecting light or electromagnetic 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; it is used in space astronomy and in MRI and X-ray technology. If successfully developed by Know Labs, this would be the first time this technology has been used for diabetes glucose monitoring.
“This is an exciting development for the healthcare industry,” Anderson told DiabetesMine. “If you look at the economics of diabetes care for yourself, we wouldn’t have strips, transmitters, or sensors to replace or dispose of. So this technology is a significant cost saving and a great contribution to society itself. “
Early studies show that Know Labs Bio-RFID technology works as well, if not better, than existing CGM products such as the Abbott FreeStyle Libre Flash glucose monitoring system.
In particular, a 2018 study of the UBand device shows that accuracy is comparable to that of the FreeStyle Libre, with 180 different paired glucose readings collected over the course of 3 hours within the safe “green area” of the Surveillance Error Grid (SEG.)), The standard tool for measuring the clinical accuracy of blood glucose meters.
These data showed that 97 percent of UBand’s readings were within 15 percent of the values ​​generated by the Libre and 100 percent were within the 20 percent range.
Anderson is pleased to announce that other early data shows that their prototype devices account for 5 percent
The company plans 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 discuss possible 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 was largely offline in “stealth modeâ€, they are now making headlines with early data and these prototype designs. That also means they are looking for investors to support their regulatory and manufacturing efforts.
“We know that not all people with diabetes are looking for a portable continuous glucose monitor to help manage their diabetes. Some just want to replace the painful, uncomfortable and expensive fingertips they currently rely on, “CEO Phil Bosua said in a statement. “The bio-RFID sensor that we are currently using for our internal product tests fits in your pocket and is ready for final use. That is why we decided to develop the KnowU as a portable, affordable and practical alternative that does not require disposable items such as test strips and lancets. “
There has long been a debate about whether it is really possible to develop an effective and accurate non-invasive glucose monitoring system. Over the years many have tried and failed, including Google Verily, with their failed glucose sensor contact lens idea.
In the early 2000s, a product called GlucoWatch actually made it through FDA approval, but it was later withdrawn from the market because the device burned people’s skin.
In June 2021, a 47-page article on the subject was published in the Journal of Diabetes Science and Technology, written by experts from around the world working with the Diabetes Technology Society, led by Dr. David Klonoff are connected. It is the most comprehensive resource on the subject, dividing bloodless monitoring products into three categories for the first time:
- non-invasive optical
- non-invasive fluid sampling
- minimally invasive devices (i.e. current CGM devices such as Dexcom and FreeStyle Libre)
“Some of these products have been approved by the FDA and many other products could eventually be approved by the FDA if they can overcome technical hurdles,” said Kevin Nguyen, bioengineering administrator for the Diabetes Technology Society.
Overcoming technical hurdles is of course the crux of the matter. At DiabetesMine, we are committed to helping Know Labs and all of their competitors who want to improve life with diabetes by finally removing needles from the equation.
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