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The trial aims to refine the technology and algorithm that controls and enables Bio-RFID to precisely measure the body's glucose.
By: Michael Barbella
Managing Editor
Know Labs Inc. is providing an update on the progress of its internal trial for non-invasive glucose monitoring devices. The company received Institutional Review Board approval in February to begin the internal trial at its Seattle laboratory. The study aims to further refine the algorithm that controls and enables Bio-RFID to identify and measure glucose in the body accurately. “Our clinical team collects thousands of data points each time the test is performed. Once the data is validated, Know Labs data scientists apply complex methodologies to improve the algorithm’s accuracy and stability,” Chief Product Officer Steve Kent said. “It is a lot of work, but we are taking every step to ensure we get this right and create a production-ready algorithm for the clinical trials we will use in the application to the FDA.” The Know Labs team continues to focus on delivering the first FDA-cleared non-invasive blood glucose monitoring device. The internal trial involves 200 participants whose blood glucose readings are taken every five minutes with a Bio-RFID prototype, an Accu-Chekâ fingerstick device, and a continuous glucose monitor (CGM) such as Dexcomâ G6 or Abbott FreeStyleâLibre, if the participant is already prescribed a CGM, over a period of three to five hours. During the test, participants drink a glucola drink with 75 grams of sugar, which should change participants’ blood glucose levels and provide Bio-RFID with the opportunity to accurately measure the changes. Know Labs’ technology uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. The company 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 our 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.
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