FDA Approves 7-day Infusion Set

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One of the largest pain points (literally) for people with type 1 diabetes (T1D) is difficulties with infusion sites. They can be uncomfortable, become infected, and need to be changed at least every three days—until now.

The U.S. Food and Drug Administration (FDA) has approved Medtronic’s Extended Wear Infusion Set (EWIS), which is the first infusion set approved for seven days. The EWIS is approved for a significantly longer duration; no other infusion set is currently approved for more than 3 days.

“Infusion sets that last longer, perform better, and are more comfortable to wear are critically important to creating better devices to manage type 1 diabetes,” said JDRF Vice President of Research, Sanjoy Dutta, Ph.D. “JDRF applauds the FDA for approving Medtronic’s EWIS, which has demonstrated significant benefits that will help people with type 1 diabetes achieve better glycemic control and improve their quality of life.”

EWIS data were presented this summer at the American Diabetes Association 81st Scientific Sessions (listen to JDRF CEO Aaron Kowalski, Ph.D., discuss it in his Happy Hour), showing the EWIS is safe and performs better than 2-3 day sets. Aside from the 7-day wear, other positive data include:

  • Improved glycemic outcomes for people wearing the EWIS; and
  • Increased survival compared to 2-3 days sensors (74.7% to 67.7%).

JDRF’s improving lives portfolio is committed to making it easier for people with T1D to achieve ideal blood-glucose levels—which includes making wearable devices smaller, better, and more comfortable. JDRF has funded several million dollars in research grants to address this specific issue. This includes our initiative on “Extended Wear Infusion Sets” that has funded several projects to unlock the potential of longer lasting disposables. One example is JDRF’s partnership with Becton Dickinson to create an extended wear infusion set to be worn for more than 3 days, that was also supported by the Helmsley Charitable Trust. The JDRF T1D Fund is an investor in Capillary Bio, a biomedical company developing a novel 7-day infusion set. Learn more about JDRF’s efforts in improving lives here.

Learn more from Medtronic.