The thin plastic tubing of infusion sets that connect insulin pumps to the body typically need to be changed every two or three days—but a new version in the U.S. more than doubles that timespan.
The extended infusion set is the brainchild of Convatec Infusion Care and Medtronic, and will be distributed by the medtech giant, which announced the product’s U.S. rollout this week. It can be worn for up to seven days, leading to what the company estimates could be cost savings of up to 25% as users reduce the amount of leftover insulin that must be discarded as they swap out the tubing and reservoir.
Infusion sets have to be changed out regularly to avoid risks of infection and other potential safety issues, according to Robert Vigersky, M.D., chief medical officer of Medtronic’s diabetes division.
“For many people, this means scheduling life around infusion set changes, which may not be at the most convenient times—turning around as you are headed out the door when you suddenly remember to change your infusion set or adding a few minutes to a tired child’s bedtime routine with an infusion set change,” Vigersky said. “With the Medtronic Extended infusion set, these life interruptions are reduced with an innovation that doubles the wear.”
The Extended set’s longer lifespan is credited to the use of “advanced materials” in its construction. A new adhesive patch, for example, is meant to stay comfortably on the skin for several days longer than previous iterations, while the updated tubing connector helps keep insulin stable for the entire week-long period and, per Medtronic, cuts down on the risk of blockages in the tubing.
The set’s reservoir has also undergone a makeover: It can be switched out mid-wear to replenish a user’s stock of insulin without completely changing tubing sets, as was previously required.
And even though those new materials will be thrown away just like other available infusion sets, Medtronic noted that the doubled use period means plastic waste could be reduced by around 50%.
As with the technology’s European launch last year, the Extended infusion set will be available exclusively to current users of Medtronic’s MiniMed 600 and 700 series insulin pumps.
The Extended set was cleared by the FDA last July. That ruling came down not long after Medtronic unveiled study results showing that the system was not only safe for seven-day use but also scored high with users in terms of comfort and overall usability.
In one clinical trial of 259 individuals who underwent 12 consecutive wears of the Extended set, there were no significant increases in the participants’ total daily dose of insulin, indicating that the technology was able to deliver insulin successfully throughout the entire wear period, Medtronic said at the time.
Those patients were also asked to compare their experiences with the Extended system and a traditional two- or three-day infusion set. Overall, the seven-day version scored higher on metrics including ease of insertion, comfort of wear, duration of wear, time required to change infusion set and convenience.