Freedom Meditech announces clinical study results of I-SugarX non-invasive glucose monitoring system

Nov 12 2010

Freedom Meditech, Inc., the developer of non-invasive, ophthalmic-based products to detect and manage diabetes, today announced results of a clinical study that showed a high correlation between low to high blood glucose levels and non-invasive glucose measurements in the eye in a live animal model.

“The eye can be thought of as an optical window into to body for the painless measurement of glucose in the ocular fluid as opposed to the blood, and is well suited for our proprietary optical polarimetric based measurements”

Results of the study of Freedom Meditech's I-SugarX™, non-invasive glucose monitoring system were presented at the Diabetes Technology Meeting in Bethesda, Maryland.

The study showed that the I-SugarX™ non-invasive polarimetric based measurements of glucose in the aqueous humor of eye tracked glucose measurements in the blood with 93 percent of readings in the A zone and the remaining seven percent in the B zone of the Clarke Error Grid (CEG). The CEG is a "gold standard" for determining the accuracy of glucose measurements - with zones A and B designated as acceptable for therapy decisions. No data fell outside the acceptable zones. The reference glucose sensors used in the study were the Johnson and Johnson LifeScan One Touch Ultra glucose meter and the Yellow Springs Instrument glucose analyzer. Seven New Zealand White rabbits were tested in the study with 41 data points collected over average study durations of 60 minutes. The average time delay between blood glucose readings and ocular readings was less than four minutes.

"The eye can be thought of as an optical window into to body for the painless measurement of glucose in the ocular fluid as opposed to the blood, and is well suited for our proprietary optical polarimetric based measurements," said John F. Burd, Ph.D., Chief Science Officer of Freedom Meditech. "Based on the results of this, and other studies, we plan to begin human clinical studies as we continue our product development."

The I-SugarX™ is a non-invasive, handheld, ocular glucose measurement device that is intended to provide people with diabetes a convenient, pain-free, and bloodless way to monitor daily glycemic control. The I-SugarX™ aims to become a superior alternative to the current "finger prick" glucose monitoring test. The global market for diabetes glucose monitoring is estimated to be $12 billion annually.