A non-invasive continuous glucose monitor (CGM) — a device that can read your blood sugar without puncturing your skin — is one of the holy grails of diabetes research and technology. A biotech firm named Know Labs claims that it is now on the verge of this breakthrough.
And unlike the rumored offerings from companies like Apple and Samsung, Know Labs’ device will be submitted for full Food and Drug Administration (FDA) approval. If the company succeeds, their non-invasive CGM would be just as useful as the leading CGMs. It could offer accuracy, glucose alerts, insulin pump interoperability, and other leading CGM features — all at a lower cost.
Ron Erickson, the Chairman and CEO of Know Labs, spoke with Diabetes Daily about the business’ invention: “We’re going to be able to provide the same quality of information that you see from Dexcom or Abbott Laboratories.”
Bio-RFID
The Know Labs sensor uses a technique known as radiofrequency spectroscopy. Know Labs has named its spin on the tech “Bio-RFID.”
RFID is “radio frequency identification,” an extremely common technology for gathering data wirelessly. RFID uses a radio transponder to emit a signal and then receive the same signal when it bounces back. The theft prevention tags attached to clothing, for example, use RFID, as do wireless highway toll collectors.
In Bio-RFID, however, the radio signal isn’t bouncing off of a manufactured identification tag — it’s bouncing off of the organic material in your body.
Erickson explains: “Every molecule has a unique frequency to which it responds.” The new CGM will tune its two antennas to send and receive the exact electromagnetic frequencies that resonate when they hit glucose molecules. “We pick up the delta between the sent and received energy at a certain frequency. That allows us, with our machine learning algorithms, to give you a result.”
A Wearable Form
So far, Know Labs’ results have come with a larger experimental model, pictured at the top of the article, which looks more or less like a bar of soap. This first-generation CGM is impractical to wear on the body, and is merely the first step towards a final product.
The next generation is the one that will be submitted for FDA approval — it will be about the size of an AirPods case, but its shape hasn’t been finalized yet. In fact, it’s been designed to be “form-factor agnostic,” and could be utilized in several different configurations. It may find form as a watch worn with a band around the wrist, or stuck with an adhesive to the arm or torso like the leading CGMs.
Instant Results
One bonus of using radio spectroscopy is that it can measure the glucose in the bloodstream directly, potentially avoiding the issue that causes today’s CGMs to lag about 10 minutes behind reality. Current models sample glucose in the interstitial fluid, the fluid between the cells and the blood vessels, and apply an equation to estimate blood sugar levels. CGM measurements lag about 10 minutes behind reality because it takes some time for glucose to filter into the interstitial fluid.
Erickson says, “We’re not using a proxy. This is real-time. We don’t have that lag, and that’s a big deal.”
Actually, the Know Labs CGM can sample “the entire tissue stack” — blood, interstitial fluid, and cells, up to a depth of about 1 centimeter.
Eventually, the same technology could be used to detect many other substances in the body — “ketones, luteinizing hormone, progesterone, c-reactive protein” — but for now, Know Labs is concentrating on blood sugar. “Our first focus is on glucose,” says Erickson.
The Results So Far
The most recent validation of the technology’s accuracy has been released as a preprint. In an experiment, researchers fed thousands of radio frequency glucose readings into a machine learning model to translate them into blood sugar values and compared the results against those from a Dexcom G6.
CGM accuracy is judged by mean absolute relative difference, or MARD. The statistic is reported as a percentage: a MARD of 10 percent, for example, means that the CGM is on average within 10 percent of the reference value. The Bio-RFID system scored a MARD of 11.27%.
In truth, this result is difficult to interpret. Though Bio-RFID’s MARD is not yet in the same neighborhood as its competitors’ (the Freestyle Libre 3 and the Dexcom G7 report MARDs of 7.9 percent and 8.7 percent, respectively), the experiment wasn’t a true test of the device’s capabilities, because it didn’t use a lab-drawn glucose measurement as its reference value. The volunteers also did not have diabetes, which meant that their blood sugar levels were likely more stable than those of most future customers.
The FDA has specific accuracy standards that it expects CGM manufacturers to meet for devices intended for “nonadjunctive” use and for use in a closed-loop insulin pump system. Know Labs’ product will need to meet these objective standards to be validated as a truly reliable CGM.
The Path to Approval
“Our expectation is that we’ll be in front of the FDA as we move into the second half of 2024,” says Erickson.
Much larger trials will be needed to show that the device works and meets FDA standards. Erickson says “We expect to have an FDA-cleared device in 2025.”
Though the business is still finalizing the form of the next generation, it still expects that it can navigate the FDA approval process quickly. The FDA has already confirmed that RFID is quite safe and there should be little worry about side effects (though there could be a hazard of interference for patients that already using electronic medical devices such as pacemakers).
A Lower Price?
Erickson is especially excited about the opportunity that Know Labs has to put a lower price on its CGM. That’s a possibility simply because the device itself — which does not need to be replaced — should cost far less to produce than the 25-35 sensors that you use in one year on the Dexcom or Libre systems. “We’re not replacing stuff,” Erickson says. “There are no disposables!”
A single non-invasive CGM could last for years. Most of the cost to patients (and insurers) will be upfront, though there may be an additional subscription fee for continuing access to the software.
Today’s continuous glucose monitoring systems are marvelously effective for people with diabetes, but they’re also expensive. For those without good health insurance coverage, or those who do not qualify for reimbursement, the cost can be too much to bear. Unfortunately, many studies have shown that access to this vital tech is unequal in the United States.
As of this writing, the FreeStyle Libre 3 is listed for about $140 per month without insurance on Amazon Pharmacy, and the Dexcom G7 costs nearly $400 (though discounts are available). That’s an annual cost of $1700 … or a lot more. “We ought to be well under $1,000 per year,” Erickson says.
Erickson assured us that he’s “a social activist at heart” and that part of his motivation is to release a product that could “democratize diabetes care,” not just in the United States but across the developing world, where hundreds of millions of people with diabetes cannot afford CGM technology: “We are focused on making a difference in the world.”
A reliable non-invasive continuous glucose monitor is a billion-dollar invention, but there’s still work to be done. “We’re doing what we’re doing, refining our technology and moving toward FDA approval,” Erickson says. “We’re going to come to market with something that can really make a difference.”