Just days after unveiling the finalized design of its needle-free blood sugar monitor, Know Labs is delivering some data to back up its approach.
The KnowU device is designed to one day be fitted onto the skin as an adhesive patch or simply worn on the wrist, with sensors that use radio waves to gauge the body’s glucose levels.
This past week at the International Conference on Advanced Technologies & Treatments for Diabetes in Florence, Italy, the company put forward initial clinical data in tracking blood sugar levels among people with prediabetes and Type 2 diabetes.
Know Labs found its noninvasive system achieved an overall mean absolute relative difference of 11.1% when compared to blood samples drawn from a vein. Also referred to as MARD, the common measure of wearable continuous glucose monitors compares their accuracy to a standard approach.
“Achieving this level of accuracy in the first study using a blood reference device is truly remarkable,” said Larry Ellingson, a member of Know Labs’ board of directors and former chair of the board of the American Diabetes Association.
“Despite significant efforts in the development of non-invasive blood glucose monitoring solutions, delivering a highly accurate, economical, FDA-cleared non-invasive continuous glucose monitor still remains to be seen,” Ellingson said in a statement.
In late February, the company said it plans to launch large-scale clinical trials of KnowU throughout this year, to support an eventual submission for an FDA green light.
The initial study (PDF) involved continuously scanning 10 participants’ forearms across 21, three-hour-long sessions—including oral glucose tolerance tests—where venous blood samples were collected every five minutes and analyzed with a hospital-grade meter. The early data were taken from a larger clinical trial with up to 100 participants, the company said, conducted from September 2023 through February of this year.
The latest MARD readings are comparable to results that Know Labs posted in July of last year when an earlier version of its system clocked in at about 11.3% compared to a Dexcom G6 CGM. Prior to that, the company reported a difference of nearly 20% about one year ago.
According to Know Labs, most of its data from previous studies was collected from participants within a healthy glucose range, from 70 to 180 mg/dL. The latest data specifically expands to include readings in the hyperglycemic range, as the company continues down its R&D roadmap and works to refine its machine learning-powered model.
Elsewhere during the ATTD conference, Roche introduced its own artificial intelligence-backed glucose tracker, the Accu-Chek SmartGuide while Dexcom announced it received the FDA’s first clearance for an over-the-counter CGM system.