Know Labs, Inc, a developer of non-invasive medical diagnostic technology, announced the KnowU, a wearable non-invasive continuous glucose monitor (CGM).

The company announced its first prototype in June 2023. The KnowU is the result of an accelerated development process over the last eight months.

The KnowU incorporates a sensor that the company plans to submit to the FDA for clearance. This proprietary sensor has been through testing where it was shown to be stable and accurate in the lab setting, according to the company. It was included in the Know Labs’ prototype to validate stability outside of the lab, and is now miniaturized and wearable.

The KnowU can be worn with an adhesive, allowing the user to clip the sensor on and off, or on the wrist or forearm with a strap. The device, which is significantly smaller and lighter than the prototype, includes on-board computing power and built-in machine learning capabilities. The KnowU is designed to last for years, has a rechargeable battery, and can connect with a companion mobile app.

The KnowU brings Know Labs closer to delivering what it says will be the first non-invasive blood glucose monitor. As the company prepares for FDA clinical trials, the KnowU device will support accelerated data collection, including determining the technology’s performance throughout continuous wear, on different locations on the body, and within more expansive glycemic ranges and diverse populations.

“The prevalence of diabetes is growing globally at an alarming rate. Millions of people face significant barriers in accessing the technology and treatment they need to effectively manage their diabetes,” said Ron Erickson, CEO and chairman at Know Labs. “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. The KnowU brings us closer to a future where equitable care in diabetes management will become a reality.”

KnowU features Know Labs’ radiofrequency (RF) sensor, which measures glucose levels using dielectric spectroscopy by rapidly scanning a large range of RF frequencies. It records voltage values detected at each frequency to quantify, with trade-secret machine learning algorithms, real-time continuous blood glucose levels. The KnowU exploits the dielectric properties of glucose, a polar molecule in the body, including its ability to store electrical energy in an electrical field (known as permittivity) as measured through a voltage reading received after broadcasting each frequency.