For those monitoring their blood glucose levels, including the 537 million people living with diabetes worldwide, there are limited options to test their levels at home. That means most only capture blood glucose readings at doctors’ offices or use a medical device under a physician’s recommendation. With the movement toward at-home health management, however, a growing number of patients and lifestyle- and fitness-based consumers are leveraging an off-the-shelf technology to monitor their glucose. These at-home kits require either pricking a finger to draw blood, or using disposable probes on patches that pierce the outer layer of skin.
Know Labs, a Seattle-based technology company, has developed an alternative that it calls the Bio-RFID platform, which leverages RF signals to transmit a signal directly into the body of an individual and measure the response, enabling it to identify glucose levels without breaking the skin. The company has completed a set of studies to validate its sensor technology throughout the past three years. Know Labs is still in the R&D stage and has validated the technology internally and externally through clinical research, and the solution is now on the path toward potential FDA evaluation, though clearance is not yet imminent. For now, the company is continuing its own product development and validations. In the long term, says Steve Kent, Know Labs’ chief product officer, the system is intended for consumer-level monitoring of sugar levels.
Testing Broadband RF Transmissions
Ron Erickson founded Know Labs with an early vision of using sensing technologies and measurement to better inform human health. The company’s goal was to provide a non-invasive alternative to glucose-monitoring systems that require a subdermal connection to fluids under the skin. It started with a Chroma ID optical-based sensing technology, Kent says, with a configuration of LEDs that demonstrated some early potential to measure glucose in the human body. However, he notes, limitations within optics created some obstacles.
Know Labs’ Generation 1 Device
Power requirements were too high, for instance, and the system was not flexible enough to measure different analytes within the same configuration. “So it wasn’t feasible to launch that as a commercial and scalable product,” Kent explains. The technical team revisited electromagnetic energy and landed on radio frequency with the first iteration in 2018, using components from Wi-Fi routers and off-the-shelf wireless systems. A rapid prototyping process followed, during which Know Labs developed and tested different types of antenna arrays.
Ultimately, the company created a system that employs RF without antennas, instead using a decoupled electrode array that creates an energy field immediately around the sensor and can both emit and receive RF energy across a wide bandwidth. The system was internally tested with five participants and 92 samples. The participants consumed 37.5 grams (1.3 ounces) of liquid D-Glucose and placed their forearms on the Bio-RFID sensor. The system then monitored their glucose levels for three hours, using Dexcom‘s G6 solution, the predominant glucose-monitoring system, as the comparison reference.
The company observed a mean absolute relative difference (MARD) of 20.6 percent. It also conducted a proof-of-principle study with Mayo Clinic, which included the measurement of responses when water is used with isopropyl alcohol, when salt is used in water, and when commercial bleach is used in water. The system detected concentrations of 2,000 parts per million (ppm), though the team claims detection could be accomplished up to 10,000 ppm.
How the Technology Works
The technology could be built into a pocket-sized sensor device that uses battery power, which could include a screen on which individuals could view glucose measurements, as well as via an app on their phone. Those who wish to take measurements, such as after a meal or following exercise, could turn on the device and hold it against the skin. The device would then transmit its RF signal, and the responses would be affected by molecules in the blood vessels near the skin’s surface. The sensor’s decoupled electrode array sends data sweeps on a continual basis across the 500 to 1,500 MHz range at 0.1 MHz intervals, thereby collecting values at 10,001 frequencies per sweep.
Steve Kent
The algorithms tested to date have been designed based on a neural network model to predict the glucose readings. The software displays the results, known as the Bio-RFID signature, of the measurements. The device could be built into a pocket-sized meter that a user could carry with them, or into another consumer device such as a watch. “It’s a form factor-agnostic system,” Kent explains. The company is focused on building a standalone business to manufacture and sell the resulting product, and it intends to collaborate with strategic partnerships for product integration.
“Our focus is very much on building the best non-invasive sensor,” Kent says, adding, “I think this technology is such a profound step in progressing human measurement and health forward that it could be a standalone device.” Once released, the technology could provide benefits at both the consumer and patient levels. The immediate benefit is the non-invasive measuring of glucose, the company reports, but it could also reduce waste. While at-home kits such as pin-prick systems, as well as continuous glucose monitoring, have limited lifespans, the Bio-RFID system does not, since it does not require a patch or device that pierces the skin.
The proof-of-concept, technical feasibility and proof-of-principle studies have been completed, Kent reports, and Know Labs’ studies continue to be ongoing. The latter are focused on data-collection algorithm refinements and development, as well as on understanding all scenarios in which the product may be used. Exact pricing has yet to be determined, though he expects the lack of consumables to keep the cost down. The company has more than 150 patents based on the technology, including the decoupled electrode array.
Key Takeaways:
- The RF-based blood glucose monitoring system provides measurements in real time without requiring a prick to the skin.
- Know Labs will undertake additional development and testing before releasing its first product.