Good control is what diabetes self-management is all about. It means knowing your blood glucose (BG) levels and taking the appropriate steps to keep them within an acceptable range. The Diabetes Control and Complications Trial determined that people with diabetes should test their BG four to seven times every day. Unfortunately, finger pricks are painful and disruptive, which causes many people to monitor their BG less than twice a day.
According to Cygnus spokesperson Craig Carlson, if the GlucoWatch is successfully developed it will offer painless and bloodless extraction of glucose, automatic continuous monitoring, an alarm to indicate potential hypo and hyperglycemic events, and the ability to download and review past measurements on a personal computer.
Patients will be able to monitor their BG by pressing a button on the side of the watch. The GlucoWatch has a display screen that allows patients to scroll through previous and present BG levels and alerts them to changes. The watch measures BG levels every half hour-48 times a day, or twelve times as often as the minimum recommendation.
The GlucoWatch works by using electro-osmosis, a process which extracts glucose molecules through the skin with a low level electric current. The GlucoPad, a patch placed on the back of the watch, collects glucose from fluid drawn through the skin. The pad is disposable, and needs to be changed once every 24 hours.
Cygnus is currently perfecting the GlucoPad and the Biosensor, which detects and measures the glucose through the pad.
The goal is to achieve accuracy equivalent to monitoring devices which have been approved by the FDA. Early-stage clinical testing is in progress using a prototype model of the GlucoWatch, and formal human trials are expected to begin next year. Although it depends on how long the FDA takes to approve the device, the company hopes to introduce the GlucoWatch to the market at the end of 1997.
This is not the first time Cygnus has ventured into transdermal patch technology. The company has also developed nicotine patches for smokers and estrogen patches for women in menopause. These other technologies led the way to the GlucoPad, which is the key to the GlucoWatch.
Cygnus has purchased the worldwide marketing rights from PaineWebber R & D Partners II for approximately 1.5 millions shares of Cygnus stock, worth about $9 million.
Originally, Cygnus introduced several concepts to people with diabetes in a marketing research phase. Based on the research, Cygnus decided to pursue the GlucoWatch.
Cygnus has not said what the GlucoWatch will cost, but according to their spokesperson, it will be affordable for most people with diabetes.