On October 25, 2011, Ultradian successfully completed testing of its Biologue CGM on fifteen study participants at SUNY Upstate Medical University in Syracuse, NY under the direction of our collaborator Dr. Ruth Weinstock. The plot below shows Biologue data from 15 participants compared to the reference method, a Yellow Springs Instruments 2300 STAT PLUS glucose analyzer.
The Clarke Error Grid is a standard method for gauging the accuracy of continuous glucose monitoring systems versus a reference method. For all subjects, 100% of the data points fell within the clinically accurate A+B zones (87% A, 13% B). This third-party clinical study confirms that our Biologue continuous glucose monitor can accurately measure glucose in humans. This data will allow us to make design improvements to the prototype, enabling us to conduct additional clinical studies on the path to FDA regulatory approval.