Jan. 31. 2022 -- The FDA has cleared the Omnipod 5 automated insulin delivery system, the third semi-automated closed-loop insulin delivery system in the U.S. and the first that is tubing-free.
The device is cleared for people ages 6 years and older with type 1 diabetes. The system uses tubeless insulin delivery “pods,” continuous glucose monitors, and a smartphone app or a separate device to automatically adjust insulin to lessen high and low blood sugar levels.
Within the app, a calculator receives blood sugar values every 5 minutes and automatically adjusts insulin or pauses it based on predicted values for 60 minutes into the future and the user’s blood sugar targets.
Other semi-automated insulin delivery systems are available outside the U.S. All the current systems use insulin pumps with tubing, while the tubeless “pods” are worn directly on the body and changed every 3 days.
“Authorization of the Insulet Omnipod 5 is a huge win for the type 1 diabetes (T1D) 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,” the type 1 diabetes advocacy organization JDRF said in a statement
JDRF, which worked with the FDA to establish rules for “artificial pancreas” technology, supported the development of the Omnipod 5 control algorithm through the JDRF Artificial Pancreas Consortium.
The Omnipod 5 will be available through pharmacies. It will be launched soon in limited markets and broadly later.