Insulin Pump Nears Approval In The US
June 23, 2013

Automatic Insulin Pump Proven Safe In Clinical Trial

redOrbit Staff & Wire Reports - Your Universe Online

An artificial pancreas is one step closer to receiving approval for sale in the US after a clinical trial showed the device, which can read a person’s blood sugar levels and supply insulin as needed, is safe.

The MiniMed Integrated System, which is manufactured by Minneapolis-based Medtronic, is for use by type 1 diabetics. It features an insulin pump designed to halt the release of the hormone if a patient’s blood sugar levels drop too low while he or she is sleeping, AP Chief Medical Writer Marilynn Marchione explained.

A three-month study of 247 patients found the instrument, which is already on sale in Europe, worked as intended, Marchione said. The results of the trial were published Saturday in the New England Journal of Medicine and will be presented at the American Diabetes Association's annual meeting, which runs through June 25.

The “long-awaited results” of that trial could “pave the way” for the device’s approval by regulators in the US, according to Julie Steenhuysen of Reuters. American health officials have thus far refused to allow the domestic sale of insulin pumps with automatic shutoff features without a “large, carefully controlled clinical trial proving they are safe” – even though Medtronic currently markets their artificial pancreas in 50 countries worldwide, she added.

This latest study “showed the device reduced the amount of time and the duration that a diabetic's blood sugar fell below a certain threshold - a measure known as area under the curve - by 37.5 percent,” Steenhuysen said. She added that the device “reduced the overall number of low blood sugar episodes by 31.8 percent compared to diabetics using an insulin pump without the shutoff feature.”

Medtronic’s sensor is a small patch that includes a thin needle, the Wall Street Journal’s Jennifer Corbett Dooren explained. That needle is inserted into the patient’s skin so that the device can constantly monitor his or her blood glucose levels.

Meanwhile, the pump is a small device which is connected to a catheter inserted into the abdomen. When necessary, it delivers insulin into the patient’s system in order to reduce his or her blood sugar.

Dr. Anne Peters, the director of clinical diabetes programs at USC’s Keck School of Medicine, was not involved in the study. Nonetheless, she told Dooren the success of the device during the trial “represents a major step forward in the development of an artificial pancreas.”

Likewise, Dr. Richard Bergenstal, the executive director of the International Diabetes Center at Park Nicollet Health Services in Minnesota and the study’s lead researcher, told the AP that this marked “the first step” in the development of such a device. “Before we said it's a dream. We have the first part of it now and I really think it will be developed,” he added.