Artificial pancreas trial
Trial of Artificial Pancreas Set for Launch
May 10, 2002 05:42 PM ET Email this article Printer friendly version
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 diabetes.
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 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.
Melissa