For Diabetics, Still No Easy Way Out
Jan. 25, 2000 (Washington) -- A device being hailed as a breakthrough in terms of helping America's almost 16 million diabetic patients check their bloodglucose levels may not be as exciting of a discovery as its maker, TheraSense of Alameda, Calif., and recent press reports say. The device, called FreeStyle, is a breakthrough because it is "virtually pain-free," these reports say.
FreeStyle is "less painful because it allows for samples to be taken from the forearm, which contains less sensitive tissue than the fingertips, and because it requires only 0.3 microliters of blood for an accurate reading," Holly Kulp, vice president of professional relations and customer service for TheraSense, tells WebMD. This is approximately one-tenth the amount of blood needed for conventional sugar monitors. In a study of 200 patients, she adds, nine out of 10 said they experienced no pain at all, and the other 10% said they experienced significantly less pain.
But while pain is one reason that diabetic patients do not test their blood glucose levels as often as recommended, "it is not the sole reason," Marian Parrott, MD, MPH, tells WebMD. Parrott, who is vice president of clinical affairs at the American Diabetes Association, says a larger reason may be inconvenience, which is an issue that this device does not uniquely address.
A more exciting development in the field of diabetes, Parrott adds, is the development of continuous monitoring systems such as Cygnus Inc.'s GlucoWatch. That device recently was the subject of a FDA expert panel meeting, after which members of the panel recommended that the agency approve the wristwatch-like device to supplement finger-pricks for adult diabetics.
GlucoWatch also does not use blood samples. It checks patients' blood glucose levels by sending tiny electrical currents through the skin. But finger-pricks and other blood extracting devices currently are the FDA's "gold standard," and it probably will be another 10 years before these devices are perfected, Parrott says.
In the meantime, it is fair to say that devices such as FreeStyle do represent major breakthroughs because they are less invasive, says Kulp. There is also a similar monitoring device that can take samples from the forearm, made by Amira Medical of Scotts Valley, Calif. But that device, while somewhat similar, requires a larger blood sample, Kulp says. Amira's device, AtLast, uses about a 2 microliter sample and delivers the results in 15 seconds.
For Diabetics, Still No Easy Way Out
Jan. 25, 2000 (Washington) -- A device being hailed as a breakthrough in terms of helping America's almost 16 million diabetic patients check their bloodglucose levels may not be as exciting of a discovery as its maker, TheraSense of Alameda, Calif., and recent press reports say. The device, called FreeStyle, is a breakthrough because it is "virtually pain-free," these reports say.
FreeStyle is "less painful because it allows for samples to be taken from the forearm, which contains less sensitive tissue than the fingertips, and because it requires only 0.3 microliters of blood for an accurate reading," Holly Kulp, vice president of professional relations and customer service for TheraSense, tells WebMD. This is approximately one-tenth the amount of blood needed for conventional sugar monitors. In a study of 200 patients, she adds, nine out of 10 said they experienced no pain at all, and the other 10% said they experienced significantly less pain.
But while pain is one reason that diabetic patients do not test their blood glucose levels as often as recommended, "it is not the sole reason," Marian Parrott, MD, MPH, tells WebMD. Parrott, who is vice president of clinical affairs at the American Diabetes Association, says a larger reason may be inconvenience, which is an issue that this device does not uniquely address.
A more exciting development in the field of diabetes, Parrott adds, is the development of continuous monitoring systems such as Cygnus Inc.'s GlucoWatch. That device recently was the subject of a FDA expert panel meeting, after which members of the panel recommended that the agency approve the wristwatch-like device to supplement finger-pricks for adult diabetics.
GlucoWatch also does not use blood samples. It checks patients' blood glucose levels by sending tiny electrical currents through the skin. But finger-pricks and other blood extracting devices currently are the FDA's "gold standard," and it probably will be another 10 years before these devices are perfected, Parrott says.
In the meantime, it is fair to say that devices such as FreeStyle do represent major breakthroughs because they are less invasive, says Kulp. There is also a similar monitoring device that can take samples from the forearm, made by Amira Medical of Scotts Valley, Calif. But that device, while somewhat similar, requires a larger blood sample, Kulp says. Amira's device, AtLast, uses about a 2 microliter sample and delivers the results in 15 seconds.