FDA Approves Watchlike Device for Diabetes
GlucoWatch also is ineffective if the patient's arm is sweaty and is less effective at detecting very low levels of glucose than high levels of glucose, Statland tells WebMD.
Because the new device is not quite perfect, the FDA required Cygnus to provide comprehensive educational materials for both patients and doctors with each device, Statland says. The FDA also required the device be made available by prescription only, he tells WebMD.
In response to the FDA's conditions, Cygnus confirmed that it plans to conduct a pilot marketing program to learn more about patients' and caregivers' firsthand experience using the product before they begin widespread distribution of the monitor.
Despite these apparent shortcomings, Statland says that GlucoWatch still can be considered a major advance.
"I think there are two major advantages: It is much more convenient and less painful, and it provides continuous monitoring data, from which one will be able to get trending data," Statland says.
Although there is greater variability in the results gathered by the device, the continuous monitoring should help balance those results, Statland adds.
The device also has an alarm that can alert patients if their glucose reaches dangerous levels, he points out.
In the meantime, getting a hold of the device may prove problematic. Besides the planned pilot program, Cygnus added that it plans to delay the launch until it can meet the expected demand.
"We must ensure that product supplies are adequate to meet the expected strong demand," explained Craig Carlson, senior vice president of finance at Cygnus. "Therefore, we are finalizing a large-scale manufacturing process for the consumable AutoSensors, and we will complete all related regulatory submissions."
About 100 to 150 people will get the device as part of the pilot program.
The device is expected to sell for about $400, and the 12-hour disposable sensors for $4-5 each.