A wristwatch-looking device that uses tiny electric currents to painlessly monitor diabetics' blood sugar now is officially available for children to use.
The Food and Drug Administration first approved the GlucoWatch last year for adult diabetics.
Tuesday, the FDA said GlucoWatch maker Cygnus Inc. proved the device works in diabetic children ages 7 to 17, too, and allowed the company to begin marketing the watch for pediatricians to prescribe.
The GlucoWatch is not perfect, so it doesn't replace those painful finger-prick blood tests that diabetics must do to check their blood sugar levels, the FDA warned. It said people should never use insulin or make medication adjustments without first double-checking a GlucoWatch reading with a fingerstick test.
But by supplementing finger testing with up to six painless glucose measurements an hour, the GlucoWatch allows more frequent monitoring, which may help prevent dangerous diabetes complications. Plus, the GlucoWatch sounds an alarm if blood sugar hits dangerous levels — possibly lifesaving if that happens while a child is asleep.
More than 150,000 U.S. children have diabetes, meaning their bodies cannot properly regulate blood sugar, or glucose. They check their glucose levels by pricking a finger and placing a drop of blood on reactive strips. The tests are painful and inconvenient, so many diabetics don't perform them as often as recommended, and even frequent testers cannot know if glucose soars or drops between testing or during sleep.
To use the GlucoWatch, patients slide a thin plastic sensor onto the watch's back. Small electric currents extract a tiny portion of glucose from fluid in skin cells instead of blood, measuring it every 20 minutes.
The GlucoWatch costs $595, 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 requires that patients be trained to use it and pass a quiz.