By Jeanne Whalen and Kate Linebaugh 

The Food and Drug Administration approved for sale a significant advance toward a so-called artificial pancreas for Type 1 diabetes patients, a long-awaited insulin pump that aims to take some of the guesswork out of blood-sugar control.

The product from Medtronic PLC, called the MiniMed 670G, combines two devices that attach to the outside of the body -- a pump that delivers insulin through a tiny tube inserted under the skin, and a sensor that monitors blood glucose levels. The monitor tells the pump when to increase or decrease insulin flow to keep a person's blood sugar in a healthy range.

The device isn't fully automated -- users must enter their planned carbohydrate intake at each mealtime, and adjust the sensor twice a day by carrying out finger-prick tests to measure blood sugar.

But doctors and patients called the MiniMed an important breakthrough likely to improve glucose control, reduce complications and lessen the constant worry of controlling Type 1 diabetes.

Existing diabetes pumps and monitors can automatically shut off insulin flow when a person's blood sugar levels veer toward being too low. But they can't automatically deliver insulin when a person has high blood sugar, doctors said.

"We've been looking forward to a day like this for a long time," Derek Rapp, chief executive of the Juvenile Diabetes Research Foundation, or JDRF, said in an interview. "Ultimately it means less concern, less burden, more freedom and less fear."

Lori Laffel, a pediatric endocrinologist at the Joslin Diabetes Center at Harvard University, said the approval was a big step forward. Even so, she said patients still need to be able to take care of their diabetes and know how to operate the pump and sensor. "It doesn't make diabetes simply go away."

A clinical trial involving 124 patients who used the product for three months reported no episodes of severe hypoglycemia or a metabolic complication called ketoacidosis -- two serious complications of Type 1 diabetes, according to results published this month in the Journal of the American Medical Association.

There were 28 "device-related events," such as hardware or software issues, that were "resolved at home," the study authors wrote.

There were four serious adverse events, including appendicitis and bacterial arthritis.

The Food and Drug Administration approved the product to treat Type 1 diabetics 14 years and older. The agency carried out its review in under four months, a speedy pace that Medtronic and others called unusual.

"This first-of-its-kind technology can provide people with Type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

In part because the FDA review progressed more quickly than expected, Medtronic won't be ready to begin selling the MiniMed 670G until next spring, Hooman Hakami, head of the company's diabetes group, said in an interview. With the FDA approval in hand, Medtronic will now begin approaching insurers to pitch them on covering the product, he said.

He declined to give a price range for the MiniMed 670G, saying it would vary depending on the payer.

Satish Garg, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado in Denver, who helped conduct trials for the MiniMed 670G, said he is concerned about whether insurance companies will pay for the new system.

Dr. Garg said he lobbied for patients in the study to be able to continue using the product after the trial concluded because the results were so compelling. "It is going to change life with people diabetes if it is properly instituted," he said.

Angie Platt, whose 13-year-old son participated in a clinical trial of the product, said it allowed her and her husband to sleep through the night for the first time in years, without having to wake up periodically to check their son's blood sugar. The MiniMed 670G has also helped her son maintain healthier glucose levels, and feel more energetic, she said.

"It has eased the burden of this disease tremendously," she said.

Write to Jeanne Whalen at jeanne.whalen@wsj.com and Kate Linebaugh at kate.linebaugh@wsj.com

 

(END) Dow Jones Newswires

September 28, 2016 18:31 ET (22:31 GMT)

Copyright (c) 2016 Dow Jones & Company, Inc.
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