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Validating Step For Continued "Artificial Pancreas" Development

Posted Feb 06 2010 12:00am

A recent study assessing the management of Type 1 diabetics has been published in this week's issue of the British medical journal Lancet.

Results suggest a medical computer algorithm, driving an insulin pump device based on analysis of children’s blood glucose levels via continuous glucose monitor (CGM) input, helped decrease frequency of overnight hypoglycemia (low blood sugar) as compared to a pre-programmed insulin pump used in the absence of a CGM device.

It's what you would expect, but things don't move forward very often until these seemingly "common sense" ideas are validated.

There were no incidents of hypoglycemia in the children wearing the CGM-supported pumps versus 9 episodes in those wearing pre-programmed insulin pumps alone.

“This is an important step in diabetes control because it shows that, with this system, people can sleep safely with minimized risk of hypoglycemia,” said Dr. Eric Renard, a professor of diabetology at Montpellier University Hospital in Montpellier, France.

These new-generation devices represent a significant advance over older products, said Aaron J. Kowalski, the assistant senior vice president of glucose control research at the Juvenile Diabetes Research Foundation in Manhattan, one of the largest nonprofit patient advocacy and research groups for diabetes.

Even so, Dr. Kowalski said, using separate devices that are not designed to work in concert poses limits to treatment, particularly overnight. If a diabetic person’s blood sugar drops during the night and the glucose monitor alarm goes off, for example, that person may not wake up and the preprogrammed pump, operating separately, could continue to deliver insulin, making the problem worse, Dr. Kowalski said. (His group was one of the sponsors of the Lancet study.)

The race to develop the "artificial pancreas", a wireless external glucose monitor integrated with an insulin pumping device, continues. The goal is to miniaturize such a device to the size of a cell phone. I worked, often, during my diabetes fellowship training in the late 1980s, with an "artificial pancreas" during research studies. However, it was a bit larger than a cell phone, as can be seen here, and it wasn't wireless.

Last month, as part of an effort called the Artificial Pancreas Project, the Juvenile Diabetes Research Foundation announced an $8 million partnership with Animas to develop a first-generation combined system. Meanwhile the European Union has just started its own project, called Artificial Pancreas at Home, which involves a grant of 10.5 million euros to research teams across Europe to create a prototype combined device over the next four years, Dr. Renard said.

The new study in The Lancet, proponents say, represents a proof-of-concept milestone in the quest to develop such a system.

“The significance is in showing that the existing devices, which are available commercially, can be combined to create the first version of an artificial pancreas,” said Dr. Roman Hovorka, the lead author of the study.

Although the Lancet study was small — only 17 children completed the entire protocol — it is significant because it demonstrated that a computer algorithm could safely interpret glucose data and calculate appropriate insulin doses for a pump, he said.

The study not only indicated that the algorithm system prevented very low glucose overnight, Dr. Hovorka said, but it also indicated that the experimental system was better able to keep blood glucose in an acceptable range.

So, the quest for the "artificial pancreas" has some documentation to validate that it should continue. The big question now? Will we have a workable oral form of insulin before we have a cell phone-sized artificial pancreas?

Read the full New York Times article.

Believe it or not -- former President George Bush was, once again, not blamed for ANYTHING in this article!

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