USBC Inc (USBC)

[RMacchio]

the G7 and it seems to be able to give a MARD # of 8.5 and our Uband comes in at 11.1

You can find the details of the Dexcom G7 study at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9208857/ and, if you review the study you will see that the the 8.2% MARD they report is based on a much different study than was conducted by KNW. I'm not a medical researcher but there seems to be enough of a difference in the testing to suggest that the two MARD values should not be compared - a couple of differences that seemed to jump out are:

- The Dexcom study used only participants that "had T1D, intensive insulin therapy T2D (T2D-IIT), or nonintensive insulin therapy T2D (T2D-NIIT)". Essentially, their study only involved Type 1 or Type 2 diabetics that were receiving treatment. The Know Labs MARD seems to include non-diabetics, pre-diabetics, Type 1 diabetics, and Type 2 diabetics. I would expect different MARD readings based on the population differences

- Most of the G7 MARD was based on normal usage across the 11 days that the device is working (the device has to be replaced on day 11). The MARD for the G7 was as high as 12.9% on the first day and tended to drop significantly by day 11 - the 8.2% MARD that they report is an average MARD across different days. The KNW MARD was based on readings after a glucose tolerance test. Again, you would expect different MARD readings as a result of different test protocols

I'm guessing that the testing that will be performed by KNW for FDA approval will be more rigorous and should provide results that can better compare to the performance reported for other devices on the market. In addition, the G7 device is the latest generation of Dexcom devices so you would hope that significant improvement has been made in the accuracy of the technology... the KnowU device is still undergoing development and should also continue to improve in accuracy. Finally, I don't think the KnowU needs to be the most accurate CGM device right out of the gate - if the accuracy is in the same ballpark then the cost and convenience benefits will probably be the biggest drivers of approval and adoption.