Where Do We Stand With the Noninvasive Dream?

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It has long been our dream to have somesort of device that would test bloodglucose without breaking the skin to take adrop of blood.

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

Many have tried and failed to make anoninvasive blood glucose meter—fewmore spectacularly than Futrex MedicalInstrumentation’s aptly named “DreamBeam.” The name was a lot better thanthe product. The Securities and ExchangeCommission stopped Futrex with a successfulfraud action.

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

The GlucoWatch Biographer, acclaimedby Cygnus, its manufacturer, as the firstnoninvasive meter, isn’t. The companyitself admits that the device causes mild tomoderate skin irritation in most users. Somepeople get blisters and others experienceredness or itching.

Current Approaches to Noninvasive Testing

Two of today’s primary approaches tononinvasive testing are using most ofthe near-infrared spectrum and usingmultivariate analysis to extract glucoseinformation from tissue.

Companies using these methods includeactive investigators like InLight Solutions(formerly Rio Grande Medical Technologies),LifeTrac Systems, NIR Diagnostics (formerlyCME Telemetrix), Oculir and Sensys Medical(formerly Instrumentation Metrics), plus theill-fated Futrex.

Another new method measures glucose inthe eye, using contact lenses. Fovioptics is anew company taking this approach. Anotheris Visual Pathways.

In the past two years Infratec has generatedsome of the greatest excitement in the fieldof noninvasive testing. This company isdeveloping a device that measures bloodglucose levels from the eardrum, using thebody’s natural heat emission.

Several researchers are using a lightscattering/Raman spectroscopy/photoacoustic approach. These include GlucoLight,Glucon Medical, LighTouch Medical andOrSense.

Other approaches include those of FluentBiomedical, using spectroscopy and signalanalysis techniques, MedOptix, usingoptical technology based on mid-infraredlight reflection from the skin surface andPendragon Medical, using radio frequencyimpedance.

Samsung Fine Chemicals has said that ituses an electromagnetic radiant ray. Finally,just this year Hitachi announced that it isworking on a device that uses special sensorsto detect physiological parameters, such asthermal energy, oxygen supply and bloodflow.

Until Then—Test Strips and Fingersticks

With so many people working on noninvasivemeters, it’s very likely that eventually we willhave a successful “dream beam.” But teststrips and fingersticks are certain to figure inour immediate future.

Patents for Noninvasive Meters

Since the U.S. Patent andTrademark Office (USPTO)issued the first noninvasiveglucose device patent toWayne March in 1976,hundreds of other developersthought they had the winningformula.

A search of the USPTO’s Website (at www.uspto.gov) for“glucose and noninvasive ornon-invasive” shows thatbetween 1976 and 2003, theoffice issued 2,161 patentswith these terms. The trend inthe number of patents issuedsince 1976 shows amazingexponential growth.

Until 1987, the office issuedno more than eight patentsper year. Between 1988 and1996 the numbers were inthe double-digit range. Andbetween 1997 and 2003 theyincreased from 125 to 297per year.

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