The Glucowatch, whose electric currents can replace the constant finger-pricking needed to ensure a proper blood sugar reading, can now be marketed to pediatricians to sell to parents of children who have Type I (insulin dependent) diabetes.
The U.S. Food and Drug Administration has given its approval after clinical trials on 66 Type I diabetics between the ages of 7 and 17 showed that its results "were effective for detecting trends and tracking patterns in glucose levels in children and adolescents."But with the approval comes an FDA warning. The Glucowatch should not be used to replace the finger prick when an accurate glucose reading is needed to confirm a sugar level.
However, it's a big improvement over the way most diabetics -- children and adults alike -- have to check their blood sugar. Often, the only way for Type I diabetics to get an accurate reading is by pricking a finger and placing a drop of blood on reactive strips. And this has to be done many times a day.
The Glucowatch, made by Cygnus, Inc., sounds an alarm when it detects an abnormal reading. It is available only through a doctor.
There are an estimated 17 million diabetics in the United States. The FDA says 150,000 children suffer from Type I diabetes.
Here is the FDA Talk Paper announcing the Glucowatch approval.
And here are the clinical trial test results for the Glucowatch when it was first introduced in 1999.