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America is approaching a diabetes tipping point, with diagnoses of type 1 and type 2 diabetes increasing at alarming rates. More than one in 10 Americans has been diagnosed with the disease, another 8.5 million people have it but are undiagnosed, and one in three is living with prediabetes. In total, almost half of the U.S. population is affected, pointing to the need to democratize diabetes care and make tools for proactive management more accessible and affordable to all.

With the growing incidence of diabetes, the medical community’s major concern is how to best assist and treat patients with the disease, as well as slow or prevent the associated complications, including blood vessel damage causing heart and brain injury, blindness, kidney failure, and nerve damage. Large clinical studies have shown that keeping blood glucose levels within a range closer to normal can reduce these complications. Monitoring blood glucose is critical not only for adjusting medications, but also for encouraging adherence to meal plans and regular physical activity. The availability of an accurate, convenient, and affordable solution to measure blood glucose levels is critical for addressing the diabetes pandemic.

Since 1999, continuous glucose monitors (CGMs) have helped to revolutionize diabetes management. Primarily intended for people with type 1 diabetes who require more frequent blood sugar level checks, CGMs can also be used to help manage type 2 diabetes and improve the lifestyles of individuals with prediabetes, recent studies have found. Prior to CGMs, inconvenient and painful fingersticks were the only available option for blood glucose self-monitoring.

While CGMs are a godsend for millions, they are expensive, require consumable supplies and remain minimally invasive. CGMs still require a small flexible needle continuously inserted in the subject’s arm or abdomen, or an implanted sensor.

The booming CGM market

Unsurprisingly, blood glucose monitoring investment is booming. From large medical device incumbents to major tech players, companies around the world want a piece of this market, which is expected to reach a value of $31.5 billion by 2028, with CGMs representing approximately $13.2 billion of this total.

Fingersticks are expected to maintain the highest market share, but CGMs will rapidly gain speed. While companies like Abbott Labs, Dexcom, and Senseonics offer FDA-cleared CGM devices, they are still minimally invasive. The real race is to bring to market the first completely non-invasive, accurate and affordable glucose monitoring solution that doesn’t require drawing blood, microneedles, or flexible needle insertion.

Leading the way is Seattle-based Know Labs, which has developed a proprietary non-invasive diagnostic technology platform using radio waves to identify and measure analytes like glucose in the blood. Glucose monitoring devices powered by Know Labs’ Bio-Radio Frequency Identification (Bio-RFIDTM), are under development and aim to be convenient, affordable and pain-free.

Not all devices are created equal

So, if the technology already exists, what’s the hold up? While wellness coaching devices like fitness and sleep trackers are intended to help maintain a state of health or activity, medical devices diagnose, treat, or manage a specific condition, and must perform at a higher, more reliable level. If certain regulatory controls are not applied, medical devices can pose a significant danger to their users, unlike common wellness devices.

When it comes to the risks involved in diabetes care, it’s not enough to simply develop the technology. Rather, the technology must be put through rigorous testing and proven safe and effective by the manufacturer to garner FDA clearance. Wellness devices are typically exempt from that level of regulatory scrutiny.

While this can be lengthy and cumbersome, there are approaches that can streamline and expedite FDA clearance. Know Labs, for example, will likely apply for a Breakthrough Designation to expedite the process. This program is for medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It also allows for interaction with FDA experts to efficiently address topics as they arise during the pre-market review phase, and can promote priority review of the submission. This means relief may be near for the millions of Americans with diabetes.

Know Labs is currently developing two devices: the first provides spot readings through measurements taken on the palm of your hand, called the KnowU™, as well as the UBand™, a wearable wristband-like device, that delivers continuous blood glucose readings. Internal trials are underway, with the FDA pre-submission process expected to begin next year.

The estimated annual cost for a KnowU or UBand user is expected to be significantly less than the thousands spent annually for minimally invasive glucose monitors and supplies. The technology will be widely available and affordable, and not limited to patients with generous health insurance plans. While these devices are Know Labs’ top priority, other analytes like ketones, hormones, minerals and medications will be added to the Bio-RFID platform, enhancing the technology’s potential to revolutionize real-time and predictive healthcare.

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