Know Labs finalizes noninvasive glucose sensor design, sets sights on FDA pivotal trial

In the wake of a recent reminder from the FDA that it still has yet to OK any noninvasive devices to measure blood sugar, Know Labs is ramping up its efforts to change that.

The Seattle-based company on Tuesday unveiled the latest iteration of its needle-free glucose monitor device, comprising the version of its internal sensor technology that’ll be included in an eventual submission for FDA clearance.

The new device—dubbed KnowU—builds on the Generation 1 prototype that Know Labs debuted last summer. In the months since, the company said, it has tested out the glucose-sensing technology under a variety of conditions and miniaturized it to fit in a slimmed-down device.

While the previous Generation 1 version of the glucose monitor was meant to be held in the palm of the hand while conducting on-demand blood sugar checks—and slipped into a pocket when not in use—the new KnowU device can be either placed on the body with an adhesive or strapped onto the wrist or arm for continuous use.

The system is designed to last for several years, Steven Kent, Know Labs’ chief product officer, said in a video showing off the KnowU’s features. It’s equipped with a rechargeable battery, with each charge expected to last at least 24 hours.

The noninvasive device relies on the company’s radiofrequency dielectric sensor technology, which sends radio waves through the skin and collects information about how the RF voltage response travels back to the sensor, and its machine learning algorithms, which analyze the sensor’s findings to continuously measure the amount of glucose in the blood.

Those measurements are then sent wirelessly to a connected mobile app, where users can monitor their real-time blood sugar levels throughout the day.

Kent said in the video that Know Labs is planning to further pare down the wearable device housing the sensor, though the company noted in Tuesday’s announcement that the sensor itself is the same one it will eventually be submitting to the FDA for review.

Know Labs is now in the process of testing out how the KnowU device performs when it’s used continuously, worn in different locations on the body and applied to a more diverse range of users. That data collection is part of the company’s preparations for the clinical trials of the technology that will support an FDA submission; Know Labs said in the release that it plans to kick off large-scale trials of the KnowU technology throughout this year while continuing development of the device and its built-in algorithms.

“Know Labs is committed to delivering an accessible, affordable, and accurate solution that improves the current standard of care and enhances the quality of life for those living with diabetes,” said CEO Ron Erickson. “The KnowU brings us closer to a future where equitable care in diabetes management will become a reality.”