FDA clears first tubeless hybrid closed-loop insulin delivery system
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The FDA has cleared the first tubeless hybrid closed-loop insulin delivery system for people with type 1 diabetes aged 6 years and older, according to a press release from Insulet.
The Omnipod 5 combines Insulet’s tubeless patch insulin pump with the Dexcom G6 continuous glucose monitoring system and a compatible smartphone with the Omnipod 5 mobile app to allow for automatic insulin adjustments for people with type 1 diabetes.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” Shacey Petrovic, president and CEO of Insulet, said in the release. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”
As Healio previously reported, the Omnipod 5 will allow users to adjust glucose targets based on the time of day and has a feature called HypoProtect for times when the wearer has a reduced need for insulin. The mobile app comes with an integrated SmartBolus Calculator that receives CGM data from the Dexcom G6 and can adjust insulin delivery based on where it predicts glucose levels will be in 60 minutes.
“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” Kevin Sayer, chairman, president and CEO of Dexcom said in the release. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”
In an official statement, JDRF International praised the approval of the Omnipod 5 as a device that can further assist people with type 1 diabetes with glucose management.
“Authorization of the Insulet Omnipod 5 is a huge win for the type 1 diabetes community,” JDRF International said. “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.”
According to Insulet’s press release, the Omnipod 5 will initially be available through pharmacies as part of a limited market release. The company plans to make the device more broadly available shortly after the limited market release.
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