Medtronic has been given the FDA greenlight to launch a pivotal trial to test the safety and effectiveness of an infusion set designed for seven days of continuous use, according to a press release.
The experimental infusion sets (not pictured here) are designed to improve insulin delivery stability during the life of the sets, as well as utilize better adhesive technology, according to Medtronic. If these design changes prove successful, Medtronic could bring to market infusion set technology that would more than double the recommended wear time of standard sets currently on the market.
Medtronic now plans to enroll up to 150 adult patients with type 1 diabetes on pump therapy for a multicenter trial of the infusion set technology. In this study, participants will be asked to wear the seven-day infusion sets to test for safety and effectiveness of the experimental technology. This is a single-arm study, which means there will be no control group of patients wearing standard infusion sets for comparison in the study.
While it is recommended that people with type 1 diabetes on insulin pump therapy change their infusion set sites every two to three days, some choose to extend the life of the infusion sets. In a recent T1D Exchange study, for example, some 64% of respondents who changed their pump therapy behavior because of issues with Medicare coverage reported leaving their infusion sites in place for more than three days.
Unfortunately, attempts to extend infusion set sites may lead to uneven insulin delivery and skin irritation issues. A small multinational study of insulin pump users, for example, found that there was a 19% increase in treatment-related issues for those patients who wore infusion sets for four days or more versus those who changed their sets after two days. Wearing an infusion set longer than necessary can increase the risks of skin infection and insulin flow blockage, according to diabetes health care practitioners.
As of August 19th, 2019, a link has not yet been posted on clinicaltrials.gov with information about this impending trial.
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Please note: The photo above is not of the experimental infusion set. This photo is of a Medtronic infusion set currently on the market.