The first tubeless Automated Insulin Delivery (AID) System, was just approved by the Food and Drug Administration (FDA).

The Omnipod 5 hybrid closed-loop system (Insulet Corporation) links with Dexcom’s G6 Continuous Glucose Monitor and is now FDA approved for people with type 1 diabetes age six and older.

This anxiously awaited approval now means that there are 3 semi-automated closed-loop insulin delivery systems in the United States.

A unique feature of the Omnipod 5 system, is that it includes the first approved tubing free insulin delivery device that is paired with the Dexcom G6 continuous glucose monitor (CGM). The Omnipod holds up to 3 days of insulin and is worn directly on the body.

Omnipod 5 Users can monitor glucose trends and deliver insulin using a smartphone app or a separate controller device. Plus, this SmartAdjust technology automatically adjusts insulin to keep glucose on target and minimize hypo and hyperglycemic events.

Included in the app is a SmartBolus calculator that receives Dexcom CGM values every 5 minutes and automatically adjusts insulin based on predicted values for 60 minutes into the future and the individual’s customized glucose targets.

Insulet said it will begin selling the prescription Omnipod 5 device through U.S. pharmacies, starting with an initially limited release before expanding its commercial reach. The company is also offering users of its current Omnipod DASH system—a more manual tubeless pump—an upgrade to the Omnipod 5 at no additional cost once insurance coverage becomes available.

Read more here Omniopod approved by FDA.

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