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On February 8, the Children with Diabetes Foundation (CWDF) announced it will be funding a study to test the efficacy of the GlucoWatch Biographer on children with diabetes.
The CWDF, a non-profit organization dedicated to helping children and adults with diabetes and their families, is funding the study with the help of childrenwithdiabetes.com, an on-line community for people with diabetes that provides grants for diabetes research.
The trial, which will test the GlucoWatch Biographer on children and adolescents with type 1 between the ages of seven and 17, is being led by Peter Chase, MD, a leader in pediatric diabetes and clinical director of the Barbara Davis Center in Denver, Colorado.
"We are pleased to be supporting work in this important area of research," said Harriet Austin, PhD and vice president of the CWDF during the announcement. "Often times, the pain and inconvenience of finger-stick BG testing results in too few tests and potentially insufficient information for optimal control. Additional information may lead to better control, and we know that better control can lead to vastly improved long-term outcomes."
Matthew Ryan Cooper, a 10-year-old from Boulder, Colorado, is one of the patients in the study. Diagnosed with type 1 since the age of one, Matthew plays sports and wears an insulin pump.
"The GlucoWatch has really helped him adjust the basals on his pump," says Sonia Cooper, president of childrenwithdiabetes.com and Matthew's mother. "So he has fewer highs and lows."
Not Approved for Kids, but Does That Matter?
Researchers anticipate sending clinical data from the CWDF study to the FDA by the end of the year. For the time being, parents of diabetic children have expressed dismay that their children are not able to benefit from the GlucoWatch Biographer.
The GlucoWatch Biographer was approved by the FDA for use by adults, but has not been condoned for use by people with diabetes under 18 years of age. The fast-acting insulin Humalog, however, was only approved for patients between 12 and 65, but was often prescribed to diabetic children. Was this illegal? Furthermore, can physicians exploit loopholes to get the GlucoWatch into the hands (and onto the wrists) of diabetic children, much like Humalog?
Jose F. Cara, MD, section head of pediatric endocrinology and diabetes for Henry Ford Health System in Detroit, Michigan, does not think so.
"Outside of somebody breaking the law somewhere, I just don't know how a physician could get away with it," says Cara, who admits that he wrote Humalog prescriptions for diabetic children, despite the FDA recommending that he not do so.
Cara says once a drug is approved by the FDA, "any physician can use an approved drug any way they see fit." Because of Cygnus's direct-to-consumer sales model (see main article), however, Cara agrees it will be more difficult to write a prescription for the GlucoWatch Biographer.
"From a personal standpoint, if I thought there was a chance that pediatric patients of mine could get the GlucoWatch, I would write a prescription," says Cara.
Sonia Cooper adds that Cygnus will not provide the watch for children before it is FDA-approved for them.
"They really are a very by-the-book company," she says. "They play it real straight. Cygnus doesn't want to step on any toes. They are going to be very appropriate."
Spokespersons at Cygnus confirmed with DIABETES HEALTH that the GlucoWatch Biographer will only be sold to people over the age of 18.
1 comment - May 1, 2001
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.