‘Artificial Pancreas’ To Manage Diabetes Receives FDA Approval

The FDA has approved Medtronic’s MiniMed 670G pump, a first-of-a-kind “artificial pancreas” that can help some diabetes patients manage their disease by constantly monitoring their blood sugar and delivering insulin as needed. The device helps patients with Type 1 diabetes, the kind usually diagnosed during childhood. About 5 percent of the nation’s 29 million Americans with diabetes have this type.

Type 1 diabetes patients now have to manage their insulin through multiple injections throughout the day or a drug pump that delivers it through a tube. Even with insulin injections, they face increased risks of dangerously high blood-sugar levels, heart disease and many other health problems because doses cannot monitor their blood sugar and deliver insulin as needed. Another risk is having too much insulin in the body overnight, when blood-sugar levels naturally fall. People can go into comas, suffer seizures and even die.

The MiniMed 670G sensor measures sugar levels every 5 minutes, infusing or withholding insulin as needed. Patients still have to manually increase insulin before meals.

The Food and Drug Administration said it approved the device based on a three-month study of 120 patients. The study reported no major adverse events. The pump is about the size of a deck of cards and can be worn on a belt or carried in a pocket.

The device “can provide people with Type 1 diabetes greater freedom to live their lives,” said Dr. Jeffrey Shuren, director of the FDA’s device center.
The company is doing further search so the device could eventually be used by those with Type 2 diabetes, and children ages 7 to 13.