Watch This! 13 Months After Its Approval, Noninvasive Glucose Monitor is Now Available
If patience is a virtue, then millions of people with diabetes who have been anxiously awaiting the arrival of the GlucoWatch Biographer can now enjoy their just deserts.
However, are you willing to pay many times more than the cost of a regular blood-glucose monitor, without the promise of reimbursement from an insurance company?
A Long Time Coming
The U.S. Food and Drug Administration granted marketing clearance to the GlucoWatch Biographer on March 22, 2001, "for use along with, not as a replacement for, finger-prick blood tests to monitor glucose." Cries of "when can I get one?" immediately went up throughout the diabetes community. On April 15, 2002, Cygnus, Inc., of Redwood City, California, answered that question.
"We are very excited about making the GlucoWatch Biographer available in the United States," stated John C. Hodgman, chairperson, chief executive officer and president of Cygnus. "It represents the most significant technological breakthrough in glucose monitoring since the transition from urine dip sticks to blood meters about twenty years ago. There is an unmet need for a product that can readily provide frequent glucose measurements. The Gluco-Watch Biographer can be the solution for millions of people with diabetes."
Worn Like a Wristwatch
The GlucoWatch Biographer, which is worn like a wristwatch, consists of two main parts:
- The Biographer, a watch-like device that attaches to the individual's forearm
- The AutoSensor, a disposable component that attaches to the back of the Biographer and allows glucose monitoring for up to 12 hours
Measures Glucose From Interstitial Fluid
The GlucoWatch Biographer is noninvasive and does not measure glucose from the blood.
Instead, following a three-hour warm-up period (during which the device does not provide any readings), the GlucoWatch collects glucose from interstitial fluid—the clear fluid just underneath the surface of the skin. The monitor measures and displays glucose levels automatically—a maximum of three times an hour—during the 12 hours when the AutoSensor is active. It also creates an "electronic diary," storing up to 4,000 blood-glucose readings that can be reviewed at the touch of a button.
According to its manufacturer, the GlucoWatch Biographer should be used to catch and assess high and low blood-glucose levels to help determine both immediate and long-term adjustments. In addition, Cygnus adds, "interpretation of Biographer results should be based on the trends and patterns seen within several sequential readings over time."
Alerts Users to Highs and Lows
GlucoWatch Biographer users can also set personal glucose-alert levels to have an alarm sound if readings are too high or low, or if readings decline rapidly.
In data submitted before an FDA advisory panel in December 1999, it was noted that higher alarm settings resulted in greater accuracy in detecting low blood-glucose episodes. When the GlucoWatch alarm was set at 90 mg/dl, only 62 percent of low blood-glucose episodes were detected. However, when the alarm was set at 100 mg/dl, users were warned of lows 75 percent of the time; and when it was set at 110 mg/dl, the alert sounded for 86 percent of lows.
Russell Potts, MD, vice president of research at Cygnus, recommends setting the GlucoWatch alarm at 90 mg/dl so that you are notified if you go below 70 mg/dl.
How Reliable Is It?
The FDA confirms that GlucoWatch blood-glucose results differ by more than 30 percent up to 25 percent of the time. In addition, the FDA admits that the GlucoWatch "sometimes gave erroneous readings [and] was less effective at detecting very low blood sugars than very high levels."
Rapid temperature changes, excessive sweat, electrical noise, high background currents and open and short circuits can cause the GlucoWatch to skip tests. Furthermore, users should be aware that GlucoWatch blood-glucose readings lag behind the readings obtained from a standard meter by about 20 minutes.
Side effects of the monitor include mild skin irritation, edema (accumulation of fluid) and erythema (redness of the skin). In clinical studies, these side effects disappeared after the GlucoWatch was removed.
The price of a starter kit, which includes the GlucoWatch Biographer, instructional video, user guide, battery charger and two rechargeable batteries, as well as other accessories, is $595. AutoSensors are sold in cartons of 16 and sell for $69.75. Two AutoSensors are required per 24-hour period.
Also available for sale at $35 is the GlucoWatch Analyzer. This FDA-approved software downloads data retrieved by an individual's Biographer into a personal computer for display and storage. The software uses the data to generate statistical reports and graphs that are designed to create a comprehensive picture of an individual's recent glucose-level history and to allow analysis of trends and patterns in those levels.
On April 15, Craig Carlson, chief financial officer for Cygnus, told the San Francisco Chronicle that Cygnus is "talking to insurers about getting coverage" but that for now patients will have to foot the bill.
Available Through Direct Mail Only
To obtain a GlucoWatch Biographer, adults with diabetes must consult a healthcare professional to get a prescription. (The GlucoWatch is not approved for children ages 18 and under.) The prospective users must then complete the order form contained in the Introductory Training Brochure and fill out a questionnaire to be sure the device is right for them.
Cygnus says the GlucoWatch Biographer will be available for sale through direct mail—not through retail pharmacies—using Visa or MasterCard credit cards. Cygnus will ship the GlucoWatch Biographer and associated products directly to the consumer.
People interested in learning more about the GlucoWatch Biographer and how to order it can request information by calling (866) 459-2824 or by visiting www.glucowatch.com.Click Here To View Or Post Comments