Researchers Close to Artificial Pancreas

From The Greenville News:

May 16, 2006

By Mike Foley
STAFF WRITER
mfoley@greenvillenews.com

While the emphasis for so much research worldwide is on a cure for diabetes, that goal hasn't been realized. In the meantime, teams of academicians, physicians and medical device companies are striving to create an artificial pancreas. In many ways, it's already here.

Several clinical trials are under way in the United States and Europe with prototypes of an artificial pancreas, said Dr. Aaron Kowalski, director of Strategic Research Projects for the Juvenile Diabetes Research Foundation in New York City. In those trials, the devices have three parts.

The first is the insulin pump, which is already well established and in widespread use. These are usually external devices, about the size of a pager and worn on the belt or concealed beneath clothing.

The second essential item is a glucose meter with the capability to provide continuous evaluation of blood sugar levels. Called a "continuous glucose monitoring system," the device is marketed by several companies. These largely replace simpler glucose meters which required a finger-prick for every use and gave diabetics information about their blood sugar levels maybe eight or 10 times day. The CGMS devices report findings every five minutes, all day and night.

Last, is the software or interface that allows the two to connect. This essentially allows the meter to supply the pump with information, including the current sugar level so it can rapidly supply insulin to counteract it. In the trials, this information is captured on a laptop computer.

So far, the software is the most problematic item, Kowalski said. Also needed is a faster-acting insulin so the artificial pancreas can function as closely as possible to a human pancreas.

While those trials move forward, Kowalski said, Medtronic has some people ó about 50 in the United States and roughly 400 in Europe ó with fully implanted systems. Most of the European systems are in use in France.

Here's how those clinical trials are performed:

* During a minor surgical procedure, an implantable sensor, about the size of half a toothpick, is inserted into a neck vein leading to the heart.

* The sensor is connected by a wire under the skin to an implanted insulin pump, about the size of a hockey puck, but maybe half the thickness.

* The sensor relays blood sugars constantly, and as those fluctuate due to food being digested, or because the person is exercising, a signal tells the pump how much insulin to deliver, or whether to deliver any at all.

At that point, the person must administer the medication himself. But Kowalski said the key is getting to the point where that responsibility can be handled completely via computer, or for just part of the day, maybe during the night.

Toward that end, a large-scale "initiative" has been launched to "close the loop" between insulin pumps and the newfangled continuous glucose monitoring systems that are already revolutionizing diabetes care and control.

Dr. Robert Rizza, president of the American Diabetes Association, said an artificial pancreas is not the ultimate goal, but a welcomed step.

"It's not a cure, but it's a big advance," he said. "No question about it."

That's why research continues. Kowalski said $125 million is going toward the effort this year.

"The first generation will be external," Kowalski said, much like the first heart pacemakers were in the late 1950s. "We want to see the first phase of the artificial pancreas within five years."

While Kowalski realizes the artificial pancreas is not the cure millions of diabetics worldwide desire, it would greatly improve their lives.

"The problem with diabetes is the daily burden of dealing with it," said Kowalski, who is a Type I diabetic himself. "The worry of: Am I going to go low? Did I eat enough? Can I exercise? How much insulin should I take? "To relieve that daily grind of worry would be tremendous."