FDA Approves Watchlike Device for Diabetes
Studies have shown that patients who monitor and regulate their glucose levels have a lower incidence of disease-related complications, such as heart disease, stroke, vision loss, leg amputation, and kidney disease. In the U.S., complications associated with uncontrolled diabetes have been estimated to result in $100 billion a year in medical costs.
While hailing the device as major step towards eliminating the need for fingerpricks, government officials also warned Thursday that GlucoWatch is still a far shot from actually replacing the daily fingerpricks.
Although clinical studies showed that the GlucoWatch results generally were consistent with the results derived from fingerpricks, the results differed from the fingerpricks up to 25% of the time, explains Bernard Statland, MD, PhD, director of the FDA's Office of Device Evaluation.
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.