New Innovative Extended Wear Infusion Set

Medtronic recently announced the launch of its new extended wear infusion set, which offers the same duration of wear for both CGM and insulin infusion sets.

Standard insulin infusion sets are indicated to be worn for two to three days; therefore, they must be switched out every two to three days. Current real-time continuous glucose monitoring (CGM) sensors are indicated to be worn for seven days. Therefore, there has been a need for a closed-loop control system that offers the duration of wear for both CGM and insulin infusion sets. Medtronic recently announced the release of their new extended infusion set, which can be worn for up to seven days, reducing the required amount of changes and making the management of diabetes more convenient. The Medtronic Extended wear infusion set is compatible with various automated insulin delivery systems. A study assessed the newly designed Extended Wear Set’s (EWIS) safety and efficacy.

This innovation is designed to improve insulin stability and the infusion site performance reliability, and to maintain insulin flow for reliably longer. Longer wear time would reduce the amount of insulin wasted yearly, as well as money. In addition, users would safely stay on insulin with minimal interruptions and insertions. A single-center feasibility study surveyed 26 adults ages 22 to 75 years. Each participant wore four trial devices until the seven-day use was reached or until the infusion set failed. As a result, 20 completed the study with positive feedback. With a total of 82 insertions and 78 wear counts, at seven days of wear, the overall failure rate was 19.5% versus the 23% failure rate when using the three-day infusion set by Medtronic. Therefore, 81% of users were able to use the infusion set successfully for the entire seven days.

During the trial, there was no significant increase in hyperglycemia or total daily insulin requirements. The results were promising, with no events of diabetic ketoacidosis or infusion set blockage. The new infusion set was piloted in Finland with over 100 insulin pump users, and many reported the infusion set was more comfortable than previous models. Overall, participants expressed a positive experience and believed there was a reduction in the overall burden of insulin pump therapy. Julie Foster, the vice president of customer experience for Medtronic Diabetes Business, stated, “Our goal with this latest innovation is to make insulin pump therapy easier for people living with diabetes.”

The results of the EWIS across the seven days were equivalent to that of the three-day infusion set. The management of diabetes can become a considerable burden for many; this innovation introduces simplicity and convenience for patients during their journey of managing diabetes. The design will be released later this year in other European countries. Currently, the Medtronic Extended infusion set is only approved for investigational use in the United States.

Practice Pearls:

• This device will allow patients with diabetes the opportunity to live with greater freedom and better health conveniently.
• The new Medtronic Extended infusion set is showing promising results in the management of diabetes
• The performance of the seven-day infusion is equivalent to the three days with more convenience.

Medtronic Announces European Launch of World’s First Infusion Set with Wear up to Seven Days to Help Reduce Burden for People with Diabetes. Medtronic; April 2021.

Cai, Albert. Medtronic Launches Seven-Day Infusion Set in Europe. Diatribe; April 2021.

ILany, Jacob et al. 994-P: Clinical Study of a New Extended Wear Infusion Set. American Diabetes Association; June 2020.

Brenda Oppong, PharmD Candidate, LECOM School of Pharmacy