A non-invasive continuous glucose monitor (CGM) — a tool that may read your blood sugar without puncturing your skin — is considered one of the holy grails of diabetes research and technology. A biotech firm named Know Labs claims that it’s now on the verge of this breakthrough.

And in contrast to the rumored offerings from firms like Apple and Samsung, Know Labs’ device will likely be submitted for full Food and Drug Administration (FDA) approval. If the corporate succeeds, their non-invasive CGM can be just as useful because 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 Each day concerning the business’ invention: “We’re going to have the option to offer the identical quality of data that you simply see from Dexcom or Abbott Laboratories.”

Bio-RFID

The Know Labs sensor uses a method generally known as radiofrequency spectroscopy. Know Labs has named its spin on the tech “Bio-RFID.”

RFID is “radio frequency identification,” an especially common technology for gathering data wirelessly. RFID uses a radio transponder to emit a signal after which receive the identical signal when it bounces back. The theft prevention tags attached to clothing, for instance, use RFID, as do wireless highway toll collectors.

In Bio-RFID, nevertheless, 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 singular frequency to which it responds.” The brand new CGM will tune its two antennas to send and receive the precise electromagnetic frequencies that resonate once they hit glucose molecules. “We pick up the delta between the sent and received energy at a certain frequency. That permits us, with our machine learning algorithms, to present you a result.”

A Wearable Form

To this point, Know Labs’ results have include a bigger experimental model, pictured at the highest of the article, which looks roughly like a bar of soap. This primary-generation CGM is impractical to wear on the body, and is merely step one towards a final product.

The subsequent generation is the one which will likely be submitted for FDA approval — it would be concerning the size of an AirPods case, but its shape hasn’t been finalized yet. In reality, it’s been designed to be “form-factor agnostic,” and may very well be utilized in several different configurations. It might find form as a watch worn with a band across the wrist, or stuck with an adhesive to the arm or torso just like the leading CGMs.

Fast Results

One bonus of using radio spectroscopy is that it may measure the glucose within the bloodstream directly, potentially avoiding the problem that causes today’s CGMs to lag about 10 minutes behind reality. Current models sample glucose within 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 since it takes a while for glucose to filter into the interstitial fluid.

Erickson says, “We’re not using a proxy. That is real-time. We don’t have that lag, and that’s an enormous deal.”

Actually, the Know Labs CGM can sample “the complete tissue stack” — blood, interstitial fluid, and cells, as much as a depth of about 1 centimeter.

Eventually, the identical technology may very well be used to detect many other substances within 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

Probably the most recent validation of the technology’s accuracy has been released as a preprint. In an experiment, researchers fed 1000’s of radio frequency glucose readings right into a machine learning model to translate them into blood sugar values and compared the outcomes 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 instance, implies that the CGM is on average inside 10 percent of the reference value. The Bio-RFID system scored a MARD of 11.27%.

In reality, this result’s difficult to interpret. Though Bio-RFID’s MARD is just not yet in the identical neighborhood as its competitors’ (the Freestyle Libre 3 and the Dexcom G7 report MARDs of seven.9 percent and eight.7 percent, respectively), the experiment wasn’t a real test of the device’s capabilities, since it didn’t use a lab-drawn glucose measurement as its reference value. The volunteers also didn’t 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 fulfill for devices intended for “nonadjunctive” use and to be used in a closed-loop insulin pump system. Know Labs’ product will need to fulfill these objective standards to be validated as a very 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 likely be needed to indicate that the device works and meets FDA standards. Erickson says “We expect to have an FDA-cleared device in 2025.”

Though the business continues to be finalizing the shape of the following generation, it still expects that it may navigate the FDA approval process quickly. The FDA has already confirmed that RFID is sort of protected and there must be little worry about uncomfortable side effects (though there may very well be a hazard of interference for patients that already using electronic medical devices reminiscent of pacemakers).

A Lower Price?

Erickson is particularly excited concerning the opportunity that Know Labs has to place a cheaper price on its CGM. That’s a possibility just because the device itself — which doesn’t should be replaced — should cost far less to supply than the 25-35 sensors that you simply use in a single yr on the Dexcom or Libre systems. “We’re not replacing stuff,” Erickson says. “There aren’t any disposables!”

A single non-invasive CGM could last for years. Most of the price to patients (and insurers) will likely be upfront, though there could also be a further subscription fee for continuing access to the software.

Today’s continuous glucose monitoring systems are marvelously effective for individuals with diabetes, but they’re also expensive. For those without good medical insurance coverage, or those that don’t qualify for reimbursement, the price may be an excessive amount of to bear. Unfortunately, many studies have shown that access to this vital tech is unequal in america.

As of this writing, the FreeStyle Libre 3 is listed for about $140 monthly without insurance on Amazon Pharmacy, and the Dexcom G7 costs nearly $400 (though discounts can be found). That’s an annual cost of $1700 … or so much more. “We must be well under $1,000 per yr,” Erickson says.

Erickson assured us that he’s “a social activist at heart” and that a part of his motivation is to release a product that might “democratize diabetes care,” not only in america but across the developing world, where a whole bunch of hundreds of thousands of individuals with diabetes cannot afford CGM technology: “We’re focused on making a difference on this planet.”

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 back to market with something that may really make a difference.”