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Diabetes Monitor Approved For Children
GlucoWatch Not Meant To Replace Finger-Prick Tests
POSTED: 4:30 p.m. EDT August 27, 2002
WASHINGTON -- A wrist device that uses tiny electric currents to painlessly monitor diabetics' blood sugar now is officially available for children.
The Food and Drug Administration approved the GlucoWatch for children ages 7 to 17. The agency approved the device for adults in March 2001.
The watch allows more frequent monitoring. Manufactured by Cygnus, Inc., of Redwood City, Calif., the device works by extracting fluid through the skin and then measuring 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.
And it has an alarm that sounds if blood sugar hits dangerous levels. This could be lifesaving if levels spike while a child is asleep.
FDA officials said the GlucoWatch is not perfect and doesn't replace the painful finger-prick tests that diabetics must do to check blood sugar levels. The agency says people should never use insulin or make medication adjustments without first double-checking a GlucoWatch reading with a fingerstick test.
"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," said Health and Human Services Secretary Tommy Thompson.
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, according to the FDA. While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have fewer complications from the disease.
Uncontrolled, diabetes can result in such serious outcomes as blindness, serious infection, amputation of limbs, coma, and death.
The Food and Drug Administration approved the GlucoWatch for children ages 7 to 17. The agency approved the device for adults in March 2001.
The watch allows more frequent monitoring. Manufactured by Cygnus, Inc., of Redwood City, Calif., the device works by extracting fluid through the skin and then measuring 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.
And it has an alarm that sounds if blood sugar hits dangerous levels. This could be lifesaving if levels spike while a child is asleep.
FDA officials said the GlucoWatch is not perfect and doesn't replace the painful finger-prick tests that diabetics must do to check blood sugar levels. The agency says people should never use insulin or make medication adjustments without first double-checking a GlucoWatch reading with a fingerstick test.
"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," said Health and Human Services Secretary Tommy Thompson.
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, according to the FDA. While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have fewer 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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Additional Resources:- May 7, 2002: Device May Help Children With Diabetes
- April 10, 2002: GlucoWatch Will Help Control Diabetes
Copyright 2002 by TheBostonChannel.com. The Associated Press contributed to this report. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
