‘Artificial pancreas’ for type 1 diabetes gets FDA approval

Doctors are hailing federal regulatory approval of a so-called artificial pancreas, an electronic system for people with type 1 diabetes that constantly monitors sugar levels and automatically supplies lifesaving insulin.

The electronic system, experts say, mimics a key function of the human pancreas — delivering insulin automatically around the clock with little or no effort by patients.

Doctors say it could help a vast number of people with type 1 diabetes, the form of the disease in which the pancreas is incapable of producing insulin, a hormone that keeps blood glucose in check. The disease affects about 5 percent of the 29 million people in the United States diagnosed as diabetic.

“I would very much like to try it myself,” said Dr. Josh Miller, who has type 1 diabetes and is medical director of diabetes care at Stony Brook Medicine.

Miller said the system, which was designed by medical devicemaker Medtronic, “is the biggest step we have been able to take toward true insulin delivery.”

Known as a hybrid closed loop insulin delivery device, the system was approved late Wednesday by the U.S. Food and Drug Administration, months ahead of schedule and to the surprise of doctors and patients on Long Island and beyond.

The system consists of an insulin pump and catheter, which delivers the hormone, and an under-the-skin sensor, or continuous glucose monitoring processor, that measures “interstitial glucose.” This form of glucose, located in the space between cells under the skin, is believed to be a proxy for levels of sugar in the blood.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “first-of-its-kind technology,” and underscored that it was tested in type 1 diabetics between ages 14 and 75. Research found the device to be safe for people in that age range. The device is not approved for children younger than 14 or for people with type 2 diabetes.

Type 1 diabetics are unable to produce insulin because cells in the pancreas that normally release the hormone do not function. The disease usually is diagnosed in childhood and once was known as juvenile diabetes. Doctors often refer to the disease as an autoimmune condition, which means the immune system somehow damages insulin-producing cells.

Type 2 diabetics can manufacture insulin but cannot properly use it, a condition known as insulin resistance. Type 2 diabetes is marked by elevated blood sugar levels, which can be controlled by diet and exercise in early phases of the disease. If the condition advances, some type 2 diabetics also require insulin.

Dr. Minisha Sood, a professor at Hofstra School of Medicine and director of inpatient diabetes at Lenox Hill Hospital in Manhattan, said the new treatment system differs from insulin pumps now on the market, which require manual calibration. The new device has internal electronics that allow the pump to communicate wirelessly with the sensor.

“They talk to each other,” Sood said Thursday. The system has a sophisticated algorithm that allows it to monitor glucose levels and to adjust insulin based on the amount of sugar detected.

“This is a game-changer and something we anticipated for several years,” Sood said. The transformative system is probably not the last effort toward an artificial pancreas, she added.

“This isn’t a true artificial pancreas because it delivers only one hormone,” Sood said. To be a genuine artificial pancreas, she said, the device would have to secrete the hormone glucagon, which raises glucose levels in the blood.

Miller also noted the device requires some effort by users who must adjust it at meal and snack time to maintain a proper glucose level.

Despite the caveats, doctors generally waxed poetic Thursday about a device expected to cost between $6,000 and $9,000.

“I think it’s revolutionary,” said Dr. Robert Courgi, an endocrinologist and hospitalist at South Side Hospital in Bay Shore. “We have been waiting for this development for a long time.

“I was at an Endocrine Society meeting in March and the main lecture was about the bionic pancreas. Now the device is available and I am thrilled,” he said.