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[IP] Artificial Pancreas

Trial of Artificial Pancreas Set for Launch
Fri May 10, 5:46 PM ET
By Manfreda Cavezza

LONDON (Reuters Health) - Clinical trials will begin next month for a
prototype artificial pancreas designed for use in patients with type 1

Scientists at City University here say the artificial organ should be able to
help patients with the disease, whose bodies do not produce the blood
sugar-processing hormone insulin, to have better controlled blood sugar and
fewer episodes of dangerously low blood sugar, or hypoglycemia, than are
achievable with insulin pumps.

The prototype pancreas delivers insulin continuously under the skin and
maintains blood sugar, or glucose, at a constant level, Dr. Roman Hovorka told
Reuters Health in an interview. "It has the potential to reduce the most
dangerous aspects of diabetes such as hypoglycemia, amputations and
blindness," Hovorka said.

The prototype is made up of three parts: a sensor placed on the skin that
measures blood glucose levels, a hand-held computer that analyses this
information, and a small pump that infuses glucose into the body.

"It will be small enough for men to fit it on their belts or women to place it
inside their bras," said Hovorka. He hopes the product will be on the market
in 5 years.

Funded by the European Commission (news - web sites) and insulin pump
manufacturer Dietronic, the project is believed to be at a further stage than
similar versions in the US. Hovorka said that US competitors have still not
begun clinical trials.

The first randomised controlled trial for the prototype takes place next month
in a hospital in Austria. Twelve patients will be maintained in the hospital
for 24 hours on two occasions. They will first be given treatment via insulin
pumps currently used in Europe, and will then use the artificial pancreas.

Since January 2000, Hovorka has tested the prototype on over 20 volunteers in
Austria and Italy, achieving "very promising results." Their glucose levels
were maintained at an average of 6.2 mmol/L (125 mg/dL). The normal level is
about 5.5 mmol/L (111 mg/dL), and most patients with type 1 or
insulin-dependent diabetes can only maintain an average of 8.9 mmol/L (179
mg/dL) using the methods currently available, he noted.

A unique computer model of the disease, on display at City University on
Friday, has also aided research. Nicknamed Bina, the computer holds data on a
number of diabetic profiles. The scientists were able to evaluate various
components of the prototype without the need for animal testing using the
computer model.

"We believe this product will have a significant and important effect on the
lives of people with type 1 diabetes. But the technology is expensive, so we
will not be able to help everyone," added Hovorka.
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