Insulet tubeless insulin pump cleared by FDA for children two years and older
Photo | Courtesy Insulet
Insulet's Omnipod 5
The U.S. Food and Drug Administration has cleared an insulin delivery system from Acton medical device firm Insulet Corp. for children two years and older with type 1 diabetes.
The Omnipod 5 Automated Insulin Delivery System, which unlike other insulin pumps requires no tubing from the device to the patient to deliver insulin, was approved for patients six years and older in January.
"We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements as well," Trang Ly, Insulet senior vice president and medical director, said in a Monday press release
Type 1 diabetes is an autoimmune disorder, formerly known as juvenile diabetes, in which cells that produce insulin in the body are attacked by the body’s immune system and rendered unable to perform their function, leaving the body without the insulin needed to process sugar.
It differs from type 2 diabetes in that patients with type 2 diabetes still produce insulin, but perhaps not enough, or the body is not able to use it efficiently.
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