Ultradian’s flagship product, Biologue, is an electrochemical biosensor that measures glucose within interstitial fluid, less invasively, just below the skin surface, in the dermis and transmits the data wirelessly to a proprietary hand-held monitor. The disposable Biologue sensor consists of a small micro-needle coated with an enzyme that reacts specifically with glucose in the interstitial fluid to produce an electrical signal, directly proportional to glucose concentration.
Biologue incorporates methods to minimize biofouling, reduce lag time and remain stable for long periods without the need for frequent recalibration using a fingerstick blood glucose meter. Biofouling is the body’s reaction to a foreign object, similar to how the body reacts to a sliver of wood. This reaction encapsulates the sensor in a fibrin sheath (scar tissue) thus reducing the amount of glucose reaching the active part of the sensor where measurements are made. This leads to inaccurate readings and the need for fingerstick recalibrations many times per day.
Our unique, patent-pending, design of placing a sensor on the skin surface is a significant advance for two reasons:
Only the sensing electrode (enzyme coated biosensor needle) is inserted within the dermis, which reduces the overall size (diameter) of the device and decreases the inflammatory response that causes sensor drift, due to biofouling.
Placing a second sensor on the skin provides a stable, ex vivo, environment, free of biofouling. This unique skin-surface architecture opens the Biologue platform to a variety of new product opportunities for non-invasive diagnostic monitoring.
Biologue’s small size, self-correction capability, and 100-1,000 times higher signal to noise versus competitive systems, are key advancements that increase accuracy and ease of use.
The Biologue continuous glucose monitor represents a breakthrough in terms of accuracy and simplicity. This is supported by independent third party data derived from our recently completed human pilot study, partially funded by the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), at SUNY Upstate Medical University in Syracuse, NY.
It is our belief that collectively these product characteristics position Ultradian’s Biologue at the forefront of minimally invasive continuous glucose monitoring technology as a stand-alone replacement system for fingerstick testing. Additionally, Biologue's advanced features make it an ideal platform for integration with an insulin pump, creating the long-sought-after closed loop artificial pancreas.