FDA Panel Approves Watch-Like Blood Sugar Device

About 16 million Americans have diabetes, while an estimated 120 million people have the disease worldwide A US Food and Drug Administration (FDA) panel has recommended approval of the GlucoWatch, a first-of-its-kind, watch-like device that helps diabetics monitor their blood sugar levels. The GlucoWatch, made by Cygnus Inc. of Redwood City, California, would allow type 1 and type 2 adult diabetics to frequently monitor their glucose levels noninvasively. The device would still require diabetics to use the traditional invasive finger stick method in order to calibrate the GlucoWatch. However, type 1 diabetics, who often have to test their glucose levels up to seven times per day, would only have to use the finger-stick meter two times a day to calibrate the GlucoWatch.

If the device receives final FDA approval, Cygnus expects to sell the GlucoWatch for $225 to $250, while pricing the replaceable AutoSensor part of the device in the $4 range, the company said. The hardware component lasts 3 to 5 years, while each AutoSensor lasts 12 hours. The GlucoWatch automatically monitors glucose levels every 20 minutes through intact skin. The device is designed to be used with standard home monitoring kits, Hodgman said. An FDA official said that in clinical studies, the device would automatically report a blood glucose reading on average 26 times a day, out of a possible 36 readings per day. The company said the GlucoWatch is designed to not give readings, or even shut off, in a number of circumstances, including times in which the wearer is perspiring or when there are sharp changes in temperature.

COMMENT: The availability of this device heralds the advent of the artificial pancreas. The only limitation thus far has been a non-invasive sensor and this appears to be the first one. It is a bit pricey at $8..00 per day which would be $2500 per year, but that still is quite a bit less than hemodialysis for an artificial kidney. It is important to recognize that an artificial pancreas is only for type one insulin dependent diabetes. Most adult onset diabetes is type two and the last thing that they need is more insulin as they already have to much. Insulin resistance is the main issue in type two diabetes.

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