By Michael Dabaie

Medtronic PLC (MDT) said it received investigational approval from the U.S. Food and Drug Administration to proceed with a pivotal trial for a new extended wear infusion set.

The goal of the study will be to collect clinical data to support the use of the extended wear infusion set for up to seven days--more than twice the length of time that any infusion set can currently be used. The study will enroll up to 150 subjects, aged 18 to 80, with type 1 diabetes on insulin pump therapy.

Infusion sets allow people on insulin pump therapy to deliver insulin under the skin to maintain healthy blood glucose levels. Current generation infusion sets must be changed every two to three days, Medtronic said.

Developed with ConvaTec's Unomedical subsidiary, this new infusion set aims to extend patient wear time by using new adhesive technology as well as maintaining insulin stability, the company said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

August 16, 2019 09:43 ET (13:43 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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