It has long been our dream to have some sort of device that would test blood glucose without breaking the skin to take a drop of blood.

I would argue that no one has yet been successful at developing such a device.

Many have tried and failed to make a noninvasive blood glucose meter—few more spectacularly than Futrex Medical Instrumentation’s aptly named “Dream Beam.” The name was a lot better than the product. The Securities and Exchange Commission stopped Futrex with a successful fraud action.

Biocontrol Technology (now known as BICO) was perhaps an even more spectacular failure. After the company raised more than $184 million by selling 3.4 billion shares of stock to unsuspecting investors, its shares last sold for $0.0019 each, and a bankruptcy court has just approved its Chapter 11 reorganization.

The GlucoWatch Biographer, acclaimed by Cygnus, its manufacturer, as the first noninvasive meter, isn’t. The company itself admits that the device causes mild to moderate skin irritation in most users. Some people get blisters and others experience redness or itching.

Current Approaches to Noninvasive Testing

Two of today’s primary approaches to noninvasive testing are using most of the near-infrared spectrum and using multivariate analysis to extract glucose information from tissue.

Companies using these methods include active investigators like InLight Solutions (formerly Rio Grande Medical Technologies), LifeTrac Systems, NIR Diagnostics (formerly CME Telemetrix), Oculir and Sensys Medical (formerly Instrumentation Metrics), plus the ill-fated Futrex.

Another new method measures glucose in the eye, using contact lenses. Fovioptics is a new company taking this approach. Another is Visual Pathways.

In the past two years Infratec has generated some of the greatest excitement in the field of noninvasive testing. This company is developing a device that measures blood glucose levels from the eardrum, using the body’s natural heat emission.

Several researchers are using a light scattering/Raman spectroscopy/photo acoustic approach. These include GlucoLight, Glucon Medical, LighTouch Medical and OrSense.

Other approaches include those of Fluent Biomedical, using spectroscopy and signal analysis techniques, MedOptix, using optical technology based on mid-infrared light reflection from the skin surface and Pendragon Medical, using radio frequency impedance.

Samsung Fine Chemicals has said that it uses an electromagnetic radiant ray. Finally, just this year Hitachi announced that it is working on a device that uses special sensors to detect physiological parameters, such as thermal energy, oxygen supply and blood flow.

Until Then—Test Strips and Fingersticks

With so many people working on noninvasive meters, it’s very likely that eventually we will have a successful “dream beam.” But test strips and fingersticks are certain to figure in our immediate future.

Patents for Noninvasive Meters

Since the U.S. Patent and Trademark Office (USPTO) issued the first noninvasive glucose device patent to Wayne March in 1976, hundreds of other developers thought they had the winning formula.

A search of the USPTO’s Web site (at www.uspto.gov) for “glucose and noninvasive or non-invasive” shows that between 1976 and 2003, the office issued 2,161 patents with these terms. The trend in the number of patents issued since 1976 shows amazing exponential growth.

Until 1987, the office issued no more than eight patents per year. Between 1988 and 1996 the numbers were in the double-digit range. And between 1997 and 2003 they increased from 125 to 297 per year.