WASHINGTON — The Food and Drug Administration on Thursday approved a wristwatch-like device for adult diabetics that automatically--and painlessly--checks blood sugar levels every 20 minutes by sending tiny electric currents through the skin.
The GlucoWatch Biographer, made by Cygnus Inc. of Redwood City, Calif., won't completely replace those often inconvenient and uncomfortable finger prick tests because it sometimes gives false readings.
But it will supplement them by checking blood glucose more frequently--sounding an alarm if blood sugar reaches dangerous levels, either too high or too low, even when the patient is asleep.
The approval "heralds the advent of new technologies that promise dramatic improvements in the quality of life for millions of Americans who have diabetes," said Health and Human Services Secretary Tommy G. Thompson.
The one major disappointment is for parents of diabetic children, for whom finger prick tests often become a dreaded daily ritual. The device is approved only for people 18 and older because it was studied using just that group.
However, the company said it plans additional studies for its use by children "for the near future."
Dr. Robert Goldstein, chief scientific officer for the New York-based Juvenile Diabetes Research Foundation, predicted it would become available to children "in months, not years."
Diabetes, the seventh-leading cause of death in this country, is a potentially serious disease that can have life-threatening consequences such as heart disease, blindness, kidney failure and lower extremity amputations.
Public health officials believe the nation faces a crisis with diabetes because it has reached epidemic proportions--climbing a striking 6% in 1999 alone following a 33% jump from 1990 to 1998.
An estimated 16 million Americans suffer from the disease, and millions don't know they have it.
Diabetes occurs when too much sugar builds up in the blood and the body either cannot produce enough insulin to break down the sugar (Type I diabetes) or cannot use its own insulin very well (Type II). The majority of cases are Type II.
Type I diabetics require daily doses of replacement insulin, either through injection or the use of a pump; those with Type II do not always use insulin, often treating their disease with other drugs.
The development and licensing of the wristwatch device marks another in a series of major research advances in recent years that have led to improved ways of managing the disease and treating its complications.
These include new drugs to treat Type II diabetes, replacing the need for insulin, as well as better ways to manage this form of diabetes through weight control. Also, quick-acting insulin now is available for those with Type I, as well as external insulin pumps that can deliver the drug, replacing daily injections.
There also have been advances in treating the complications of diabetes, such as laser treatment for diabetes-related eye disease, which reduces the risk of blindness, and the use of antihypertensive drugs called ACE inhibitors to prevent or delay kidney failure.
Promising research also is underway in islet cell transplantation--an attempt to introduce functioning pancreatic cells in Type I patients that will produce insulin, replacing the body's defective cells.
The device approved Thursday works by having the patient slide a thin plastic sensor onto the watch's back each time it is strapped on. Small electric currents then extract fluid from the skin and measure its glucose content. This occurs every 20 minutes for 12 hours.
Traditionally, insulin-dependent diabetics test their blood sugar four to eight times a day by pricking their finger and putting a drop of blood on a reactive strip. The reaction indicates whether blood sugar is at a risky level and helps the patient determine the appropriate insulin dose.
"This test does not replace the finger-prick test--it is an adjunct, an additional tool," said Dr. Bernard Statland, director of the FDA's office of device evaluation. "But it gives the patient much more control, more confidence in the values--and it may pick up deviations that a finger prick won't pick up."