10th May 2007

Biosign Technologies, a medical technology company, has announced the results of a study showing that blood glucose measurements from its unique, non-invasive monitoring system are not significantly different from laboratory blood analysis.

"The results demonstrate that Biosign's UFIT(R) health monitoring system could also monitor blood glucose, along with heart rate and blood pressure," said Dr. Radu Leca, President and Chief Technology Officer, Biosign. "Our goal is to provide a robust, integrated health monitoring system that can provide valuable information for all parties concerned - patients, physicians, pharmacists, insurers and pharmaceutical companies - with the ability to access this information online in real time."

UFIT(R), which uses a non-invasive, web-enabled device that straps around a patient's wrist, responds to the need for an easy-to-use self-monitoring system that reliably and simultaneously captures key data on heart and blood, including heart rate, blood pressure, blood oxygen and blood glucose. The system is intended to optimize the management of chronic diseases such as high blood pressure, heart disease and diabetes.

The study's findings were presented on May 4th at the Institute of Electrical and Electronics Engineers (IEEE) International Workshop on Medical Measurements and Applications (MeMeA). In a separate development at the workshop, the Group for the Standardization of Blood Pressure Measurement, a working group of the IEEE, met to review its progress in advancing the engineering-based standard for automated blood pressure measurement.

The developments at the MeMeA workshop represent important steps in enabling UFIT(R) to comprehensively serve the multi-billion dollar personal health monitoring market. Ninety percent of chronic disease management takes place in the home.

The need for such services is recognized by large organizations such as the Continua Health Alliance, a collaborative industry organization dedicated to bringing together standards and diverse technology to create new health care solutions. Similarly, the Bill and Melinda Gates Foundation has identified in its "Grand Challenges in Global Health" the need to develop technologies that permit quantitative assessment of health at the point of care.

This Biosign-sponsored study assumed that the arterial pulse, a rich source of clinically relevant information (e.g., rate, rhythm, pattern, pressure and oxygen), could also provide information on blood glucose.

The study gathered glucose measurements from 120 participants with blood glucose levels ranging between 3.5 and 27.4 mmol/L.

The results show a tight statistical correlation (0.998, Pearson substantial equivalence) between UFIT(R) and laboratory analysis of blood glucose, with a low (1.63%) average of the mean percent difference between the UFIT(R) measurements and the laboratory analysis. The correlation was obtained post-hoc by comparing a feature extracted from the radial artery pulse with laboratory blood glucose data. The methodology resembles that used to correlate HbA1C with the direct measurements of glucose in drawn blood.

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