The US Food and Drug Administration (FDA) has cleared the Omnipod 5 Automated Insulin Delivery System (Insulet Corporation), the third semi-automated closed-loop insulin delivery system in the United States and the first that is tubing-free.
Omnipod 5 is cleared for people aged 6 years and older with type 1 diabetes. The system integrates the tubeless insulin delivery Pods with Dexcom G6 continuous glucose monitors (CGM) and a smartphone app or a separate controller device to automatically adjust insulin to minimize high and low blood glucose levels via SmartAdjust technology.
Within the app is a SmartBolus calculator that receives Dexcom CGM values every 5 minutes and automatically adjusts insulin up or down or pauses it based on predicted values for 60 minutes into the future and the individual’s customized glucose targets.
The Omnipod 5 becomes the third FDA-cleared semi-automated insulin delivery system in the United States, along with systems by Tandem and Medtronic. Others are available outside the United States. All of the currently marketed systems incorporate insulin pumps with tubing, whereas the tubeless Pods are worn directly on the body and changed every 3 days.
In a statement, JDRF, the type 1 diabetes advocacy organization, said: “Authorization of the Insulet Omnipod 5 is a huge win for the type 1 diabetes community. As the first tubeless hybrid closed-loop system to receive FDA clearance, this is a critical step forward in making day-to-day life better for people living with the disease.”
JDRF, which worked with the FDA to establish regulatory pathways for artificial pancreas technology, supported the development of the Omnipod 5 control algorithm through investigators in the JDRF Artificial Pancreas Consortium.
The Omnipod 5 will be available as a pharmacy product. It will be launched soon in limited market release and broadly thereafter.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.
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