Ultradian Diagnostics LLC, an early-stage medical device company based in Rensselaer, New York, today announced the publication of clinical study results for Biologue, the Company's minimally invasive continuous glucose monitoring (CGM) system, in the November 2012 issue of the Journal of Diabetes Science and Technology. In the peer-reviewed article entitled "Pilot Study of a Prototype Minimally Invasive Intradermal Continuous Glucose Monitor," the authors report the Biologue provided clinically accurate results 98.9% of the time and was well tolerated by study participants, with no pain and no adverse events observed. The study was funded in part by a National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) Business Catalyst grant and conducted by investigators from the State University of New York Upstate Medical University and Ultradian Diagnostics.
The study demonstrated clinical proof of concept for Ultradian's Biologue CGM using a proprietary single point calibration method and unique biofouling correction algorithm. "We believe this publication validates our novel approach to improved accuracy and methods to mitigate the in vivo effects of sensor biofouling," said Dr. John Willis, CEO of Ultradian Diagnostics. "The accuracy and tolerance data from this pilot study is very positive and represents a significant milestone on our path to develop a user calibration-free CGM capable of interfacing with an insulin pump to form the long-sought, closed-loop Artificial Pancreas."
Ultradian Diagnostics LLC