MDT Medtronic PLC

By Ezequiel Minaya 

The U.S. Food and Drug Administration said Wednesday it has approved an insulin pump by medical device company Medtronic PLC that automatically manages glucose levels within a target range.

The device, known as the MiniMed 670G, is designed to work with less monitoring from patients, compared with previous models that called for more vigilance.

Insulin works to lower blood sugar, but it also can cause sugar levels to fall too low. The condition, called hypoglycemia, can be fatal, especially at night when patients aren't aware their blood sugar is low.

The MiniMed 670G "works by measuring glucose levels every five minutes and automatically administering or withholding insulin," the FDA said in a prepared statement. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin.

A Medtronic spokeswoman said the MiniMed 670G would have similar pricing to models already in the market, though further details weren't immediately available, she said.

The FDA evaluated data from a clinical trial of the device that included 123 participants with Type 1 diabetes. The agency added that while the device is being approved for use in people 14 years of age and older with Type 1 diabetes, Medtronic is currently performing clinical studies to evaluate the device for use by diabetic children seven to 13 years old.

Blood-sugar sensors have been available to help diabetics program pumps to deliver the proper amount of insulin. Researchers have been working for years to link the two technologies to automate insulin delivery as part of an effort often referred to as an artificial pancreas.

The MiniMed 670G "is designed to learn what an individual's insulin needs are and to take action to minimize both high and low glucose levels," Medtronic said in a news release. As a result, Medtronic said, the system requires minimal input -- patients only need to enter mealtime carbohydrates, accept bolus correction recommendations and periodically calibrate the sensor.

Shares of the company edged up 0.1% to $86.74 in afternoon trading in New York.

The device is geared toward patients with Type 1 diabetes, commonly known as juvenile diabetes, though the disease can occur at any age. Type 1 diabetes is triggered when the cells that produce the hormone insulin in the pancreas are destroyed. Patients with Type 1 diabetes must have insulin delivered by injection or pump.

According to the National Diabetes Statistics report of 2014, put out by the U.S. Centers for Disease Control and Prevention, Type 1 diabetes accounts for about 5% of all diagnosed cases of diabetes in adults.

Write to Ezequiel Minaya at ezequiel.minaya@wsj.com

(END) Dow Jones Newswires

September 28, 2016 16:27 ET (20:27 GMT)

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