INSIGHT-Diabetes breakthrough stalled in safety debate=2

, have developed the "brain" portion of an artificial pancreas system -- a software program that uses blood sugar readings sent wirelessly from a continuous glucose monitor and tells the pump how much insulin to give.

So far, the software from this team can work with pumps from Insulet Corp and Animas, a unit of Johnson & Johnson . And it works with sensors from Abbott Laboratories , Dexcom Inc and Roche Holding. That allows components from different device makers to become part of one artificial pancreas system, a new approach for medical technology.

In October, Zisser, Doyle and other members of an international consortium won a $4.5 million National Institutes of Health grant to test the technology in challenging settings. The group has run two pilot studies in Italy and in France.

In these trials, study volunteers placed the control of their disease in the hands of the device while they dined in a restaurant and slept overnight in a hotel. Research teams huddled in nearby rooms wirelessly monitoring their progress.

Zisser says it will be challenging for the FDA to feel confident with these kinds of trials. But there has been progress. The agency last month gave the green light for Medtronic to begin an in-home clinical trial of a low glucose suspend system in the United States.

Dr. Francine Kaufman, former president of the American Diabetes Association and chief medical officer for Medtronic's diabetes business, says the company worked hard with the FDA to reach agreement on the trial design.

It will not be easy. The company must find a group of diabetics who are especially prone to hypoglycemia and they will try to show that the device is not only safe, but that it reduces such episodes.

"We've agreed to do it. We'll start that trial and get our way down the path," Kaufman said.


The potential stumbling blocks go beyond the design of clinical trials. Researchers and medical device executives say they still have plenty of work to do to make sure they have a system that functions properly.

While the technology has come a long way from the refrigerator-sized machines developed in the 1970s for hospital use, many of the systems are still using laptops to run the software program instead of more portable devices.

Medtronic Chief Executive Omar Ishrak said the company is committed to developing the technology, but there are many technical and clinical hurdles yet to cross. He says it will take a decade or so before a system is ready.

"It's early enough for me to not even think about products," Ishrak said. "We can do demonstrations and we've done clinical studies here and there, but we don't have a product."

Boston University's Ed Damiano is part of a team developing an artificial pancreas system that uses both insulin and glucagon, a hormone released by the pancreas to raise blood sugar levels when they drop too low. He says blaming the FDA will not help scientists work out the kinks in the devices.

Damiano, like Brewer and Zimliki, has a personal stake in getting an artificial pancreas approved.

His son David, now in middle school, developed type 1 diabetes when he was 11 months old. Since he was a baby, Damiano has crept into his son's room several times a night to check on David's blood sugar.

David's blood sugar levels have been in the normal range for most of his life. Damiano wants him to have a system that helps ensure his good health when David goes off to college.

"We've got seven years," Damiano said. "It's important." (Additional reporting by Janet Roberts in New York and Debra Sherman in Chicago; Editing by Michele Gershberg and Tim Dobbyn)