Early failure has a lasting impact
In the beginning, there was Glucowatch. And it was not good.
The GlucoWatch G2 Biographer product received approval from the Food and Drug Administration back in 2001 and touted as a high-tech tool to monitor glucose levels via interstitial concentrations every 10 minutes. The device promised to draw glucose to the skin surface for measurement via electric shocks, and alarms were to go off when hypoglycemia or hyperglycemia was detected.
But numerous problems cropped up. There was a time lag, with the device estimating glucose levels that actually occurred 15-20 minutes earlier. Some patients couldn’t tolerate wearing the watch, and some were burned by the electric current.
And perhaps worst of all, the measurements often weren’t accurate, with one study finding that more than half of 240 nighttime alarms incorrectly warned children with diabetes of dangerously high or low glucose. (Diabetes Technol Ther. 2005 June; 7[3]:440-7).
As a result of the Glucowatch debacle, the FDA “become a little gun shy about approving anything. It made it even harder to approve something,” said Mark J. Rice, MD, of Vanderbilt University, Nashville, Tenn., who has tried to develop glucose-measuring technology.
Dr. Mark J. Rice
“If a device were to be commercialized, it would be hugely disruptive to the industry,” according to Dr. Baers, who said that she expects a device eventually will lead to higher levels of diabetes control and fewer side effects. “This would result in billion-dollar savings for the health care industry and reduced complications,” she said.