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Bernard A. Schwetz, DVM,PhD

JAMA. 2001;285:2186.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved the GlucoWatch Biographer (Cygnus Inc, Redwood City, Calif), a device that detects trends and tracks patterns in glucose levels in adults (18 years and older) with diabetes without puncturing skin. The device, which can be used in detection and assessment of episodes of hyperglycemia and hypoglycemia, is intended to supplement, not replace, information from standard home glucose monitoring devices.

It applies a very low electric current to extract glucose samples through intact skin, measures them every 20 minutes, and sounds an alarm if the glucose reaches a preselected level.

The FDA approved the device on the basis of four studies in 480 patients 18 years of age or older with type 1 or type 2 diabetes requiring treatment with insulin. One of the studies, with 129 patients, was conducted in patients' homes and closely reflected real-life use. The studies generated 19 000 glucose . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration

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