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FDA Approves Watch-Like Device to Monitor Glucose in Diabetic Children
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FDA Approves Watch-Like Device to Monitor Glucose in Diabetic Children
FDA has approved the GlucoWatch G2 Biographer for monitoring glucose levels in children and adolescents with diabetes. The device does not replace standard finger stick blood tests, but it is capable of providing up to six painless glucose measurements per hour for 13 hours. The GlucoWatch has been approved for adults since March 2001.
FDA Approves GlucoWatch Device for Children with Diabetes.
The Food and Drug Administration (FDA) HAS approved a wrist-watch-like glucose monitoring device for use by children and adolescents with diabetes. The device, which was approved for adult use in March 2001, provides information that can be used to detect trends and track patterns in glucose levels.The GlucoWatch G2 Biographer, manufactured by Cygnus, Inc., of Redwood City, Calif., extracts fluid through the skin and then measures the glucose in the fluid. Once the device has been warmed up and calibrated through the use of a finger stick blood glucose test, it is capable of providing up to six painless glucose measurements per hour for 13 hours. The device sounds an alarm if the glucose reaches dangerous levels, alerting patients to a potential problem.
"We are pleased that this new technology has now been shown to meet FDA's safety and effectiveness standards for children and teens with diabetes," said HHS Secretary Tommy Thompson. "Although it is not a replacement for standard finger stick blood tests, this device can help improve the quality of life of children with diabetes."
"FDA will continue to work with companies to bring safe and effective new technologies for monitoring glucose levels to market," said Dr. Lester Crawford, FDA Deputy Commissioner. "These types of products may one day completely eliminate the need for daily finger-prick blood tests."
Currently the GlucoWatch measurements must be used along with finger stick blood tests to ensure accurate results.
- FDA approval of the GlucoWatch for use in children and adolescents was based on results of a study conducted by Cygnus that evaluated use of the Biographer in 66 Type I diabetics between ages 7 and 17.
- The study was conducted at a clinic in a home-simulated environment where the participants could go about various normal daily activities.
- The study showed that the product was safe and effective for detecting trends and tracking patterns in glucose levels in children and adolescents.
Diabetes is a chronic disease that affects the body's ability to produce or respond to insulin. This can cause wide fluctuations in blood glucose levels, from extremely high to extremely low.
More than 150,000 children in the United States have diabetes. While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have a lower incidence of complications from the disease. Uncontrolled, diabetes can result in such serious outcomes as blindness, serious infection, amputation of limbs, coma, and death.
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