Study Validates Feasibility of Know Labs Sensor for Non-Invasive Glucose Monitoring

Know Labs Inc. has released results of its latest technical feasibility study that demonstrate the accuracy of its Bio-RFID sensor technology.
 
From December 2022 through February, Know Labs conducted a series of internal studies to validate the technical feasibility of its Bio-RFID sensor technology at quantifying blood glucose concentration (BGC) in five healthy participants, using the Dexcom G6 as a reference device. Bio-RFID is a platform technology using electromagnetic energy in the form of radio waves to non-invasively capture molecular signatures and convert them into physiologically meaningful information.
 
The study’s purpose was to demonstrate hardware and software infrastructure stability, and to collect additional data to determine the sensor’s accuracy at quantifying BGC in vivo non-invasively using radio frequency, by means of training a neural network (NN) model to predict readings of the Dexcom G6 as a proxy for BGC.
 
In the aggregate—across five individual participants, 46 tests and 92 samples, which collected 4.7 million data points per sample or roughly 430 million data points for all samples—the study resulted in a 20.6% mean absolute relative difference (MARD) and performed with 46% of predictions within the U.S. Food and Drug Administration’s (FDA) recommended limit for accuracy for new blood glucose monitors.
 
“We have successfully completed our foundational studies, we have a stable sensor that delivers repeatable results, and we have developed software infrastructure to manage and interpret large, novel datasets,” Know Labs Chief Product Officer Steve Kent said. “As you increase sample size, it is expected that there are changes in accuracy, resulting from variability in testing conditions, biological diversity, and other factors. This is the goal of expanded data collection, and we will continue to share results as we collect more high resolution data, from more participants, across more testing scenarios.”
 
During the data collection period, participants placed their forearms on the Bio-RFID sensor and consumed liquid D-Glucose to simulate a glucose spike. Participants’ BGC was monitored for three hours while readings from the Bio-RFID sensor and the Dexcom G6® were simultaneously logged. Data were collected on a continuous basis, using sweeps across the 500 MHz to 1500 MHz range at 0.1 MHz intervals, collecting values at 10,001 frequencies per sweep. Know Labs then used these data from the Bio-RFID sensor to train a NN model to predict BGC readings of the Dexcom G6 reference device.
 
“Today’s methods of testing BGC come with several disadvantages, from the pain of finger pricks and inserting probes for continuous monitors to the high cost and environmental waste these methods produce,” Know Labs Chairman/CEO Ron Erickson stated. “This study demonstrates our progress toward getting the first FDA-cleared non-invasive glucose monitoring device in the hands of the nearly 40 million people living with diabetes in the U.S. We’ve achieved so much over the last several months. We’ve refined data collection methods and increased our participant population, with our dataset growing from three in our exploratory study to 92 in this study, a 30-fold increase in the sample size. To-date, we’ve collected 1.4 billion data points that are now being used to refine our glucose value prediction algorithm.”
 
The technical feasibility study, “Technical Feasibility of a Novel Sensor for Non-Invasive Blood Glucose Monitoring Compared to Dexcom G6,” is part of ongoing clinical research that Know Labs is conducting as the company prioritizes validation of the Bio-RFID technology. A Technical Report of the company’s Proof of Concept (N=1) results is publicly available. 
 
Know Labs Inc. is a public company whose shares trade on the NYSE American Exchange under the stock symbol “KNW.” The company’s technology uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. Know Labs refers to its technology as Bio-RFID, which can be integrated into a variety of wearable, mobile or bench-top form factors. This patented and patent-pending technology makes it possible to effectively identify and monitor analytes that could only previously be performed by invasive and/or expensive and time-consuming lab-based tests. The first application of the firm’s Bio-RFID technology will be in a product marketed as a non-invasive glucose monitor. It will provide the user with real-time information on blood glucose levels.