Know Labs has put forward additional proof-of-concept data from its needle-free blood sugar monitor, designed to continuously scan the blood through a person’s skin.
The company said its digital, noninvasive and machine-learning-driven approach can correctly determine whether a user’s glucose levels are too high, too low or just right 93.37% of the time, when compared to analyses of blood drawn from a vein.
Earlier this year, shortly after announcing that it had finalized the design of its reader, Know Labs presented initial clinical data taken from 10 study participants with Type 2 diabetes.
The most recent peer-reviewed data—published in the Diabetes Technology & Therapeutics Journal—spans 31 adults with either Type 2 diabetes or prediabetes. The radiofrequency sensor was worn for hours at a time during oral glucose tolerance tests, while venous blood samples were collected every five minutes.
That offered more than 2,600 pairs of observations, which the company used to train an artificial intelligence model and then separately test the sensor’s performance.
When glucose levels were within a healthy range, the system delivered a false-negative rate of less than 4%, alongside a false-positive rate of about 15%. During episodes of hyperglycemia, false negatives were reported about 15% of the time, while false positives dropped to nearly 3%.
There were no instances of the sensor mistaking low blood sugar readings with high blood sugar readings, or vice versa. However, only four samples in the study were classified as hypoglycemic.
According to Know Labs, its approach has the potential to serve as a screening device used to help diagnose people with diabetes in the first place or to alert them of the need for additional checkups.
“Early diagnosis and intervention for diabetes are critical to both improving patient outcomes and enabling healthcare systems to allocate resources more economically and efficiently,” Know Labs CEO Ron Erickson said in a statement. “This proof-of-concept for the use of our novel RF sensor as a glycemic status screening tool indicates the device’s potential to help funnel previously undiagnosed patients more effectively into the healthcare system.”
The company said that while further research is needed to enrich its data sets and improve the device’s sensitivity, it plans to tap strategic partners to help develop the system as a “rest of the world” screening device—in a parallel effort alongside its work on obtaining an FDA clearance as a noninvasive continuous glucose monitor.
Know Labs estimates that of the more than 500 million people living with diabetes worldwide, 75% reside in low- and middle-income countries, with about half of the total going undiagnosed.