On December 6, 1999, an advisory panel for the Food and Drug Administration (FDA) recommended approval of the Gluco Watch monitor with certain conditions (i.e. education program, label revisions). Cygnus, manufacturer of the Gluco Watch, anticipates final approval within 4 months and expects the product to be available by the middle of the year.

The Gluco Watch monitor is intended for use by those persons with diabetes who are 18 years of age or older. It is available only by prescription, and its use is intended for home or health care facilities.

The monitor measures glucose from interstitial fluid located just underneath the skin by sending a tiny electric current through the skin. The Glucose Watch has a 3-hour warm-up period and could provide painless, noninvasive measurements of blood sugar every 20 minutes for up to 12 hours. The Glucose Watch is not intended to replace traditional finger stick glucose monitoring, instead it should be used to supplement monitoring. Also, the Glucose Watch should not be used as the sole determinant of insulin dose adjustment; a finger stick test should also be done.

How accurate is the Glucose Watch? In a study published in the October 1999 issue of DIABETES CARE the Glucose Watch monitor compared well with blood sugar measurements obtained using a HemoCue blood glucose analyzer and a One Touch Profile meter. The meter performed well at the high level (240 mg/dl) and the low level (70 mg/dl) as well as all points in between. However, it was noted that a 20-minute lag occurred between the Gluco Watch and the glucose meter. Also, certain events caused the monitor to skip tests (i.e. excessive seat). In home tests, 26% of all tests were skipped. The Glucose Watch is also less effective at detecting life-threatening low blood sugar than at detecting dangerously high blood sugar levels. Gluco Watch readings can differ from blood test 25% of the time and the readings were off by about 30%. The FDA officials feel this may be a problem when it comes to detecting hypoglycemia. However, the Gluco Watch can be programmed to sound an alarm prior to blood glucose levels dropping that low, so that a finger stick reading can be done to verify the level.

Mild skin irritations, edema, and erythema were the side effects that occurred when using the Gluco Watch. However, once the Gluco Watch was removed, the side effects went away. What about the cost? The cost of the Gluco Watch is approximately $250 to $350 and the disposable sensor pads, which last for 12 hours, cost between $4 and $5 a piece. For more information, contact Cygnus at 650-369-4300 or visit their Web site at http://www.cygn.com.

Brought to you by TENDON (Ten Counties in Central & Western Michigan Diabetes Outreach Network)