Diabetes Dateline

New Products Offer Blood Glucose Testing Without Lancets

A Food and Drug Administration (FDA) panel has recommended approval of the GlucoWatch, a new watch-like device that in addition to telling time, displays blood sugar levels painlessly at the touch of a button.

According to company officials of Cygnus Inc. of Redwood City, CA, the GlucoWatch would allow people with diabetes to monitor their glucose levels every 20 minutes through a small disposable pad worn between the watch and the wrist. Through battery-generated electric impulses, the GlucoWatch attracts glucose molecules up through the sweat glands into the pad, where a chemical reacts with them and generates a minute electric current. A sensor inside the GlucoWatch then measures the intensity of the current and calculates the blood glucose level.

Alarms sound if blood sugar gets too low or too high, and these limits can be programmed according to individual needs. Memory chips inside the GlucoWatch can store 3 months' worth of data, which can then be transferred to a computer and printed or transmitted (to a doctor's office).

If the device receives final approval from the FDA, it could be available to consumers, 18 and older, by the end of this year. According to Cygnus, the GlucoWatch will sell for several hundred dollars.

The FDA panel recommended that the device be approved with the following conditions: an extensive education program for patients and health care providers, specific labeling modifications suggested by the panel, and a study on the effect of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) detection.

Several other companies are working on new products as alternatives to finger-prick testing. The FDA has recently approved a new type of blood glucose monitor developed by TheraSense, a company based in Alameda, CA. This new monitor requires a smaller blood sample than other devices, so a patient can take blood samples from different parts of the body, not just the fingertips. The company maintains that the test is pain free.

The FDA has also approved another continuous glucose monitor, manufactured by MiniMed Inc. of Sylmar, CA. It has a sensor that the doctor usually inserts surgically just under the skin in the abdomen. A wire attached to the sensor goes to a small computer that can be clipped to a belt loop.

Like the GlucoWatch, the MiniMed sensor measures the glucose level in tissue rather than blood. MiniMed is developing a version in which continuous glucose readings are transmitted wirelessly.

Last year, the FDA also approved a laser device called the Lasette, which is manufactured by Cell Robotics Inc. of Albuquerque, NM. It is a portable, battery-operated device that uses a laser to pierce the skin, offering patients another almost painless means of drawing blood for glucose testing.

Finally, researchers from the Massachusetts Institute of Technology and colleagues in Pennsylvania, California, Texas, and Israel have conducted the first human trials on a new, painless noninvasive way to measure glucose levels through ultrasound. Study results were published in the March issue of Nature Medicine.

Researchers hope that the new technique, which uses ultrasound to monitor glucose levels, can one day replace blood tests to measure other things as well, such as cholesterol and bilirubin. Although tests were conducted using an ultrasound machine typically found in a hospital, researchers have developed a handheld device that patients will be able to use at home. Scientists hope to study the method on a larger group as soon as next year.

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