Relief From Pin-Pricking May Be at Hand

Diabetes is a complex disease with complex causes and complex treatment regimens. In the end, though, it comes down to this: to stay well, a person with Diabetes A has to draw blood four times a day.

“It’s painful and it’s stressful,” says Matt Petersen, the director of information services in the American Diabetes Association’s Medical and Science Division. “If anyone can come up with a cost-effective, safe, non-invasive way to measure glucose, I can’t imagine the world not beating a path to their door.”

Ron Nagar and Benny Pesach, the founders of Glucon, Inc., have created a watch-like device that reads blood glucose levels without the need to stick, poke, or prick the skin. Based on photo-acoustics research first done at Tel Aviv University in Israel, their device uses lasers, ultrasound, and advanced software algorithms to get a reading that is as efficient and accurate as pin-prick tests. And, says Glucon’s CEO, Dan Goldberger, it won’t be any more costly than testing kits, which today average between $1,500 and $2,000 per year for a patient.

At the heart of the Glucon device is a laser tuned to a frequency that resonates with blood glucose. When the laser comes into contact with blood glucose, it creates sound waves emanating from the molecule. Then a miniaturized ultrasound sensor detects those sound waves and a computer chip translates the raw signals into usable data. The device is worn like a wristwatch. Data and warning signals – say, “Sudden glucose drop” – would appear on the faceplate of the device.

While other non-invasive technologies have been able to read glucose levels to a rough level, Glucon’s early tests show that it reaches the same efficiency levels as blood-strip tests. The only one of Glucon’s tests to have been published was a four-hour measurement of nine diabetic patients done in 2002 with an earlier prototype. The results were compared to traditional pinprick tests and matched them well. Goldberger points out that since that paper was published, his researchers have made big strides in improving the device’s efficacy even further, although he won’t release specific numbers.

Before they release numbers to the public, they must obtain Food and Drug Administration approval – a process that can take years. Because of the non-invasive nature of the technology, though, Glucon’s regulatory process is much less arduous than for implantable or skin-puncture medical devices.

If Glucon succeeds in getting FDA approval, its device could revolutionize diabetes management for both the individual patient and the health-care industry. Of the 18 million diabetics in the United States, roughly three million need constant surveillance to prevent extreme hypoglycemic events. Yet more than half of those three million make mistakes on a regular basis in glucose monitoring or insulin administration, errors that can lead to insulin shock and a diabetic coma. Having a 24-hour, real-time readout of glucose levels in the blood would ensure that the patient always knows exactly his or her glucose level. What’s more, later generations of the device could wirelessly transmit the data to a doctor’s office or central database.

It’s not just the diabetic patients who are excited about the prospect. Health insurance companies would be willing to pay a premium for such a device if it keeps down the costs of emergency-room visits and long-term health crises, such as diabetic blindness, says the ADA’s Petersen.

Glucon Inc. isn’t alone in its efforts to develop a better glucose monitoring system. More than a dozen startups and academic labs are working on competing technologies. But none of them has a working prototype on the verge of clinical studies that is both non-invasive and offers the ability to monitor constantly.

Glucon’s most likely competitor is medical-device giant Medtronic (a company that’s a member of the TR Large Cap 100 Index in the health-care sector). Medtronic’s core strength in the diabetes market is an insulin pump that offers a less painful and less intrusive way to disburse insulin into the body, compared with direct injections. The company is also in clinical trials for a sensor that measures blood glucose indirectly by reading marker chemicals in the interstitial fluid (located a fraction of a millimeter below the skin’s surface).

“You can barely feel the pin prick,” says Medtronic spokesperson Deanne McLaughlin. Yet because it involves puncturing the skin, the device has to overcome many more regulatory hurdles than Glucon’s device.

Goldberger understands the challenges his tiny company, with 20 fulltime employees, is facing – namely, the lack of a manufacturing base, easy access to capital, and a distribution network. A large pharmaceutical company partner would solve these problems. And the company recently added Ephraim Heller to its board of directors, the man who built his diabetes management startup TheraSense into an international firm that generated hundreds of millions of dollars in revenue before being bought out in 2004 by Abbott Laboratories.

“It’s not impossible to recreate the TheraSense model,” Goldberger says, adding that the company could build its own manufacturing, distribution, and sales channels.

Meanwhile, Glucon has a clinical trial underway, with others set to launch soon, to prove the accuracy of their device to regulators. Goldberger hopes to see Glucon “watches” on the arms of diabetics within three years.