Watching the Disease

By Owen C. Franklin

"You have to prick your finger, put the blood in the machine, and if you're in a public place, people will look at you. There was a time I didn't do it at all. I'd go for weeks without checking."

For people with diabetes, four words ring out like a commandeering mantra: check your glucose levels, check your glucose levels, check your glucose levels. This advice, however, is easier to preach than to practice. Each check requires time, attention and — most importantly — blood.

But action from federal legislators could lend a helping hand. On December 6, 1999 the Food and Drug Administration advisory board recommended approval for a new product that offers a quick and non-invasive way to check glucose levels.

GlucoWatch ®, a band worn around the arm, uses a painless electric current to open pores and draw fluid from the skin. This fluid, which surrounds blood vessels, collects glucose that leaks from the bloodstream. A sensor pad on GlucoWatch collects this fluid and uses this sample to gauge a person’s glucose levels. The product works continually for up to 12 hours, and can display measurements every 20 minutes with the touch of a button.

GlucoWatch is nearly 10 years in the making. Researchers at Cygnus Inc. began working on the product after medical studies indicated the importance of checking glucose levels in managing diabetes. This information, however, isn’t helpful unless people with diabetes actually perform the cumbersome, and sometimes painful, glucose checks.

"Many people just won’t do it," said Russ Potts, Ph.D., the vice president of research at Cygnus and a founding developer of GlucoWatch. "Right now, you have to stop what you’re doing, take out a device and stab yourself."

But this problem could become a fading memory if the FDA follows its advisory board’s suggestion.

"It’s very unusual for the FDA to go against the approval of its advisory board," said Dr. Potts.

Before GlucoWatch could be presented to the advisory board, it underwent years of studies, trials and fine-tuning. Unbiased diabetes experts performed detailed research to determine the product’s accuracy.

Researchers performed three separate trials. In the first two, people with diabetes wore GlucoWatch for several hours at a clinic. On the third trial, people could leave the clinic and wear GlucoWatch during their everyday activities. The results from these trials were encouraging.

"It is absolutely accurate," said Dr. Satish Garg, the principle investigator in this research and director of the Adult Diabetes Program at the University of Colorado Health Science Center. "It tracks glucose levels beautifully."

While people with diabetes already have accurate tools to measure glucose levels, the fingerstick treatment isn’t exactly user-friendly. Many doctors say their patients don’t make the recommended four daily checks. GlucoWatch’s automatic and non-invasive technique could encourage people to keep better track of their disease.

"On an average, patients poke themselves two or maybe three times a day," said Dr. Garg. "With GlucoWatch, you’re able to track glucose values every 20 minutes."

For some people with diabetes, even two or three daily fingersticks are a burden. Marialice Kerns was diagnosed with diabetes when she was 18. She explained that after several years, she felt "in-tune" with her disease and didn’t need to endure the painstaking checks.

"You have to prick your finger, put the blood in the machine, and if you’re in a public place, people will look at you," said Kern. "There was a time I didn’t do it at all. I’d go for weeks without checking."

But then Kern took part in the GlucoWatch studies. Kern said that by the third trial, she found GlucoWatch to be an easy and effective way to track her glucose levels.

"It’s there and its always going," said Kern. "You just wear it and see what the numbers are without giving yourself a puncture wound."

While there may be reason for excitement, both GlucoWatch’s creators and medical experts are cautious. There are still adjustments to be made — some patients of the clinical trial experienced skin irritation from the sensor pad. Cygnus representatives said this problem will be addressed before they release the product.

Perhaps a greater issue is the impact GlucoWatch could have on how people manage their diabetes. Some authorities are concerned that GlucoWatch could "distance" people from their illness. Other experts ask if people could become "lazy" or "irresponsible" if an automated measuring tool does the "dirty work."

"This may not be the solution many people want it to be," said Dr. Andrew Ahman, an endocrinologist at the Oregon Health Sciences University. "If people think this product will reduce their need to pay attention to their disease, it’s not going to work."

Principles at Cygnus recognize this risk. If the product is released, Cygnus will recommend that people to use it with an additional glucose-measuring test.

Regardless of the risks and criticisms, most diabetes experts see GlucoWatch as a step in the right direction. And while GlucoWatch may not be the "end-all" solution, innovating and testing new products is the only way to find out what is.

"Every step forward is good," said Dr. Ahman. "It gives people hope, and it reminds them there are people making advances in the care of their disease."

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