Know Labs, a non-invasive medical diagnostics company, has received an independent Institutional Review Board (IRB) approval for the protocol of its upcoming clinical trial.
IRB is an FDA registered constituted body that works to formally review and monitor biomedical research involving human subjects.
With the IRB approval, the company is enabled to commence the internal clinical trial of its non-invasive glucose monitoring technology, Bio-RFID.
The clinical trial is planned to be conducted at the diagnostic company’s new research and development laboratory in Seattle, US.
The IRB approval will help Know Labs with its FDA pre-submission and to launch its product, which the company claims to be the first non-invasive glucose monitoring device.
Know Labs CEO Phil Bosua said: “Our team has been working diligently on getting ready for this trial. Testing our non-invasive technology with a larger population is a great opportunity to further validate the technology platform to identify and measure blood glucose levels accurately and non-invasively.”
In the clinical trial, the participants’ blood glucose will be measured every five minutes using a Bio-RFID prototype, an Accu-Chek fingerstick device, and a continuous glucose monitor (CGM) system.
CGM devices such as Dexcom G6 or Abbott FreeStyle Libre will be used for the participants who are already prescribed with a CGM, and readings are taken for three to five hours.
The test requires participants to drink a glucola drink that contains 75gr of sugar, to help Bio-RFID accurately measure the changes in participants’ blood glucose levels.
Know Labs is planning to start the trial in a few weeks and is currently enrolling participants, aged between 18 and 65 years of age, living in the Seattle area.
Bosua added: “In our most recent tests, Bio-RFID achieved a 5.8% MARD (mean absolute relative difference, a measure of glucose monitoring accuracy) when compared with other FDA-cleared devices.
“Those tests were performed with a much smaller population, so kicking-off a trial with 200 participants allows us to confirm Bio-RFID’s accuracy at a statistically significant level and also allows us to expand the conditions in which the tests are being performed.”
