USA – Insulet announced that the FDA has cleared its Omnipod 5 automated insulin delivery (AID) system for patients with type 1 diabetes aged six years and older.

According to the company, the Omnipod 5 is the first tubeless AID product that integrates with the Dexcom G6 CGM system and a compatible smartphone to automatically adjust insulin.

CEO Shacey Petrovic remarked that this “simple-to-use, elegant system, [is] designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”

The Omnipod 5 was supposed to be cleared and launched in the first half of last year, but it was delayed several times before CEO Shacey Petrovic told investors in December that the agency’s decision would most likely come in 2022.

The Omnipod 5 is an important product for Insulet as the use of wearable diabetes devices such as insulin pumps and continuous glucose monitors grows.

The product has the potential to create an automated insulin delivery (AID) system, in which a pump and CGM collaborate to deliver insulin doses, better positioning Insulet to compete with Tandem Diabetes Care, which has had an AID system on the market for years.

The pump also comes at a time when competitor Medtronic is dealing with product safety issues with its diabetes group.

Last month, the medtech giant received an FDA warning letter about a number of safety issues that could delay the review of its 780G MiniMed pump.

Insulet’s Petrovic previously stated that after Omnipod 5 clearance, the company will conduct a more limited launch before expanding the rollout.

The company will provide an update on the product, during its earnings call on February 23.

Limited market release

Insulet stated that Omnipod 5 will initially be available in a limited market, but that the system will be “widely available shortly.”

Insulet’s AID system includes a tubeless pod with SmartAdjust technology, a mobile app with an integrated SmartBolus calculator, and the Dexcom G6 CGM.

Users can install the app on a compatible personal smartphone or use the Omnipod 5 controller, which comes free with the first prescription.

SmartAdjust receives a Dexcom CGM value and trend every five minutes and predicts the glucose level 60 minutes in advance using the system.

After that, Omnipod 5 adjusts insulin delivery based on the user’s desired and customized glucose target.

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