By: Scott M. King
In November 1995, DIABETES HEALTH reported that a company named Cygnus was developing a new wristband device called the GlucoWatch monitor that was to give sugar readings every 20 minutes. Cygnus said they hoped to introduce the GlucoWatch monitor to the market by the end of 1997. Over the years, as we have covered this story, the launch date has crept forward. It has taken much longer than Cygnus had anticipated, but at least they never gave up.
Now it looks like all their hard work may soon pay off.
On December 6, 1999, an FDA advisory panel assigned to review Cygnus’s work gave unanimous approval to the GlucoWatch monitor (see page 15 for our news article). The panel’s recommendation will now be sent to the FDA, which almost always accepts a panel’s findings. It could take four months or more to hear back from the FDA, and Cygnus would still need to gear up for production after getting official approval.
I was lucky enough to be able to attend the FDA hearing on the GlucoWatch monitor, as one of 300 spectators seated in a hotel meeting room in Washington, D.C. It felt a little bit like a trial with Cygnus and their 20 or so people waiting to testify.
The judge-like FDA panel sat in a large, U-shaped configuration of tables that were facing the audience. The folks from Cygnus sat facing the panel members. The audience was filled with members of the press, investors, and other industry representatives. There were microphones and cameras everywhere.
The panel spent 8 hours grilling Cygnus about all their studies and observations of the GlucoWatch monitor. Several very prominent doctors, including Steven Edelman, MD, and Lois Jovonovic, MD, showed up at the hearing to speak in defense of the GlucoWatch.
The Cygnus message to the panel was clear: “It’s not perfect, but it’s safe and the information it provides is extremely valuable.”
Some of Cygnus’s competitors were shocked that the GlucoWatch monitor was approved by the advisory panel. The competitors privately cited Cygnus’s own research which showed that some days the device did not track sugar levels very well. When asked why by the panel, Cygnus did not have an answer. It was agreed that a GlucoWatch user would still need to perform a fingerstick test to determine their insulin dose, as the GlucoWatch is not accurate enough to replace conventional fingerstick testing.
Anyone who wanted to could sign up to speak to the panel. Most were mothers of children with diabetes. Some of us got dewy-eyed as one mom described how her son’s BGs could go from 400 to 40 unexpectedly. She described how she had to get up several times each night to test his blood sugar, and how control was still impossible to achieve. She told the panel that the GlucoWatch could free her and her child from the bondage of fluctuating blood sugars.
All speakers were asked whether they had any connections with Cygnus or any of its competitors. Everyone said they had no ties except for one 11-year-old boy who spoke toward the end of the day. He admitted that he owned Cygnus stock, and that he sold newspapers in front of a Dunkin Donuts to get the money. He said he followed the stock in the news every day. He had diabetes and he wanted a GlucoWatch to help with his control.
A friend of mine, sitting behind me, decided that the hearing was going well and used his cell phone to call his stock broker. His request- “buy Cygnus stock.” The next day the stock had doubled in value, along with his money.
I am very glad that the GlucoWatch monitor got approval. This is good news for all of us with diabetes, even if we choose not to purchase the GlucoWatch. The approval sets a precedent for all of the 40 other companies working on new and better ways for people with diabetes to test their sugar. This opens the door for what is hopefully a stream of new contenders who can provide continuous, painless, more convenient, cheaper and better glucose testing.
Let’s hope that as we plunge into the new millennium we will be able to report even more good news in these pages.
Happy New Year!
If you know anyone with diabetes who has not read DIABETES HEALTH, call us at 800-488-8468 and we will send them out a free sample.