Doctors are reporting a major step toward an artificial pancreas, a device that would constantly monitor blood sugar in people with diabetes and automatically supply insulin as needed.
A key component of such a system – an insulin pump programmed to shut down if blood-sugar dips too low while people are sleeping – worked as intended in a three-month study of 247 patients.
This smart pump, made by Minneapolis-based Medtronic Inc., is already sold in Europe, and the U.S. Food and Drug Administration is reviewing it. Whether it also can be programmed to mimic a real pancreas and constantly adjust insulin based on continuous readings from a blood-sugar monitor requires more testing.
This is the first step in the development of the artificial pancreas, said Dr. Richard Bergenstal, diabetes chief at Park Nicollet, a large clinic in St. Louis Park, Minn. Before, we said its a dream. We have the first part of it now, and I really think it will be developed.
He led the company-sponsored study and gave results Saturday at an American Diabetes Association conference in Chicago. They also were published online by the New England Journal of Medicine.
The study involved people with Type 1 diabetes, the kind usually diagnosed during childhood. About 5 percent of the 26 million Americans with diabetes have this type. Their bodies dont make insulin, a hormone needed to turn food into energy.
People with Type 1 must inject insulin several times a day or get it through a pump with a narrow tube that goes under the skin. The pumps give a steady amount of insulin, and patients must monitor their sugar levels.
In the study, all patients had sensors that continuously monitored their blood sugar. Half had ordinary insulin pumps and the others had pumps programmed to stop supplying insulin for two hours when blood-sugar fell to a certain threshold.
Over three months, low-sugar episodes were reduced by about one-third in people using the pump with the shut-off feature. Importantly, these people had no cases of severely low blood sugar – the most dangerous kind.