Washington — Diabetics are about to get a science fiction-like way to measure their blood sugar painlessly: The government approved a wristwatch-looking device Thursday that uses tiny electric currents to monitor diabetes.
The long-awaited GlucoWatch won't completely replace diabetics' dread finger-prick blood tests because it's not perfect, the Food and Drug Administration warned. Nor is it for children, a disappointment to parents anxiously awaiting pain-free alternatives to sticking little fingers.
But it does promise adult diabetics important benefits: supplementing finger testing for more frequent glucose monitoring that may keep them healthier, and sounding an alarm if blood sugar hits dangerous levels possibly lifesaving if that happens during sleep.
"This particular device is going to allow patients to have an early warning signal" that less frequent blood tests don't allow, explained Dr. Bernard Statland, FDA's medical device evaluation chief.
Manufacturer Cygnus Inc., which struggled three years to win FDA approval of the prescription-only GlucoWatch, revealed Thursday that most people will have to wait until around year's end to buy it. Cygnus hasn't scaled up manufacturing to make enough, so immediate sales will be to about 150 patients in test marketing to ensure diabetics use it properly.
The GlucoWatch will cost $400, plus a $4 to $5 disposable sensor that the patient must replace every 12 hours. To get a doctor's prescription for a watch, the FDA is requiring that patients be trained to use it and pass a quiz.
The GlucoWatch is a good first step toward diabetics' ultimate goal of continual, painless glucose monitoring, said Dr. Christopher Saudek, president-elect of the American Diabetes Assn. Supplementing fingerstick tests can be very helpful, and some diabetics have longed for the watch, he said. But, Saudek cautioned, "it still has development to go before it becomes something that would be used for all comers."
About 16 million Americans have diabetes, meaning their bodies cannot properly regulate blood sugar, or glucose.
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