Insulet, a maker of tubeless insulin pump technology, has received clearance from the US Food and Drugs Administration (USFDA) for the use of fast-acting insulin aspart (Fiasp) with its Omnipod Insulin Management System and the Omnipod DASH Insulin Management System for adults in the US.

Developed by Novo Nordisk, Fiasp is claimed to be an ultra fast-acting insulin that enters the bloodstream twice as much speed than Novo Nordisk’s NovoLog, so it can closely match a body’s typical insulin response to a meal, thereby improving glycemic control.

This results in Fiasp being the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.

Insulet claims to have completed an extensive testing, with support from Novo Nordisk, to show that Fiasp is safe and can be used with both the Omnipod System, as well as the Omnipod DASH Insulin Management System.

Fiasp was indicated for use in Omnipod in Europe since last October

Insulet claims to the first insulin pump in the US to have secured the indication. The Omnipod Insulin Management System has been indicated for use with Fiasp in Europe since last October.

Insulet senior vice president, medical director Dr. Trang Ly said: “Omnipod can now be used with the full spectrum of insulin, from generic to branded to ultra-fast-acting, and we are thrilled to deliver this additional flexibility for people to use their insulin of choice with the Omnipod System.

“Expanding our labeling to include Fiasp also opens the door for existing Fiasp users to seamlessly transition to an Omnipod System for their insulin delivery needs and further demonstrates our commitment to innovation.”

Insulet’s Omnipod DASH System was designed with user discretion and convenience in mind. It is a continuous insulin delivery system that has two simple components, a tubeless, waterproof, Bluetooth wireless technology Pod that holds up to 200 units of U-100 insulin and a colour touch-screen Personal Diabetes Manager (PDM) that controls the Pod.

The system is also supported by optional mobile apps for users, caregivers and HCPs to help simplify diabetes management. The device secured FDA clearance in last June.