RENSSELAER, N.Y.--(BUSINESS WIRE)--Ultradian Diagnostics LLC, based in Rensselaer, New York, announced the results of a 5-day clinical study of their Biologue minimally invasive continuous glucose monitoring (CGM) system. The study was completed at SUNY Upstate Medical University in Syracuse, NY under the direction of Ruth Weinstock, MD, PhD.
The study was funded by a $1.3 million, Phase 2 SBIR grant from the National Institutes of Diabetes, Digestive & Kidney Disease. The study included 35 subjects: 20 with type 1 diabetes, 10 with type 2 diabetes, and 5 with normal glycemia. Subjects wore the Gen 2 Biologue CGM for a period of 5-days while in the clinic and at home. The Nova Biomedical StatStrip Xpress glucose meter served as the reference method. A total of 2,038 paired data points were obtained from 33 of 35 subjects. Statistical analysis yielded a mean absolute relative difference (MARD) of 11.3 % and a mean absolute difference (MAD) of 20.0 mg/dl. Continuous glucose error grid analysis (CG-EGA) showed the point accuracy was 84.1 % in zone A, 15.9 % in zone B (100.0% A+B).
The study demonstrated proof of concept for Ultradian’s single-point calibration method and proprietary technology for extracting glucose frequency and amplitude data for the purpose of factory calibration and developing insulin pump control algorithms. “The data from this study represents a significant milestone on our path to develop a user calibration-free CGM capable of interfacing with an insulin pump to form a closed-loop artificial pancreas”, said Dr. John Willis, CEO of Ultradian Diagnostics.
About Ultradian Diagnostics
Ultradian is a medical device company developing wireless, wearable biosensors for monitoring chronic illnesses. The Company was founded to improve the accuracy of minimally invasive biosensors so they may be used at the bedside in hospitals and by people for self-monitoring of chronic illnesses. Ultradian's initial product, called Biologue, is a minimally invasive biosensor system that continuously measures glucose within the dermis of the skin. Biologue is a platform technology whereby components of the core system can be leveraged into other product opportunities. Ultradian is actively seeking strategic partners to accelerate commercial introduction of their continuous monitoring technologies. For more information about Ultradian Diagnostics, please visit www.ultradian.com.
