The Artificial Pancreas Works!

Dr. Steven Russell, an instructor at Harvard Medical School stated that, "For three days, the device did the work Elle's pancreas can no longer do." "It went very smoothly -- her blood sugar control was really very, very good, and we were really very pleased by what we saw with Elle."

Russell's research partner, Edward Diamano, an associate professor of biomedical engineering at Boston University, says the device learned Elle's blood sugar patterns and made changes accordingly. "It's making adjustments every five minutes," he says.

For that one weekend, Elle didn't have to draw blood, and she could eat foods she hadn't eaten in large quantities for four years. "She ate Spaghetti-O's and grilled cheese and French fries and hamburgers," her mother, Stefany Shaheen, said. "She ate between 67 and 100 grams of carbs [every meal], and usually she can only eat between 40 and 50."

Then, after the experiment, Elle had to leave the artificial pancreas behind, and it was back to counting carbs and poking herself every couple of hours. Her mother reset the nighttime alarm clock.

"We're extraordinarily impatient for access to the device," Shaheen says. "I think it will revolutionize the way she lives."

Two weeks ago, Russell and Damiano visited the Food and Drug Administration offices, to show regulators a prototype for the artificial pancreas. The device itself can be worn in a pocket or clipped to a belt. Two tiny pieces go under the skin, one to detect glucose levels in the blood and another to deliver insulin and glucagon, a drug used to raise very low blood sugar.

Algorithms determine how much insulin and glucagon the patient needs, and if necessary the patient can manually override the device.

So far, the FDA has required doctors to keep patients inside the hospital while they're using the device.

Dr. Charles Zimliki, who chairs the FDA's Artificial Pancreas Critical Path Initiative, testified before a Senate committee last year. The potential benefits are enormous but, he said, "if not properly designed, use of an artificial pancreas device in an outpatient setting can place patients at significant risk."

Russell said he hopes that by the fall, the FDA will give him permission to allow adult diabetic patients to leave the building and walk the grounds of the Massachusetts General Hospital campus accompanied by a nurse, eating as they like and using the hospital's gym.

Then by the summer of 2013, he hopes to give the artificial pancreas to children attending a summer camp. "These are all baby steps towards what we ultimately want to do, which is give them the device and say, 'Go home and check back with us in a week,' " Russell says.

JDRF.org JDRF is funding artificial pancreas trials at 13 sites worldwide, including Yale University, Stanford University, the University of Virginia and the University of Colorado.