Medtronic has received investigational approval from the U.S. Food and Drug Administration (FDA) to proceed with a pivotal trial for a new extended wear infusion set.
Infusion sets allow people on insulin pump therapy to deliver insulin under the skin to maintain healthy blood glucose levels.
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 multi-center, non-randomized, prospective single-arm study will enroll up to 150 subjects, aged 18 to 80, with Type 1 diabetes on insulin pump therapy.
Current generation infusion sets must be changed every two to three days.
Using proprietary technology and developed in partnership 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.
An extended wear infusion set could solve a key unmet need in insulin pump therapy by reducing the time and effort currently spent on changing infusion sets.
When used with Medtronic insulin pump systems that include 7-day continuous glucose monitors, this new infusion set could allow coordination of changing of the infusion set and sensor at the same time, a feature that would address making insulin pump systems more convenient to use.
“There have been significant advances made in the three-plus decades with insulin pumps and continuous glucose monitoring (CGM). However, we are still stuck with having patients change the insulin delivery sets every 2-3 days whereas most CGMs are now used longer,” said Dr. Satish Garg, professor of Medicine and Pediatrics and director of the Adult Diabetes Division of Barbara Davis Center of the University of Colorado. “It is time for an infusion set to extend wear to a week and beyond.”
Garg said extended wear infusion sets are long overdue and will likely improve quality of life for patients on insulin pumps, and many more patients may accept insulin pump as an option.
- Medtronic. (2019, August 16). Medtronic Approved to Start Pivotal Trial to Evaluate New Extended Wear Infusion Set. Globe Newswire. Retrieved from https://www.globenewswire.com/news-release/2019/08/16/1903094/0/en/Medtronic-Approved-to-Start-Pivotal-Trial-to-Evaluate-New-Extended-Wear-Infusion-Set.html