Medical Innovation Exchange

Insulet wins CE mark for integration of insulin pump with Abbott CGM

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Dive Brief:

  • Insulet has received a CE mark for the integration of its Omnipod 5 insulin pump and Abbott’s Freestyle Libre 2 Plus continuous glucose monitor (CGM) sensor.
  • The clearance positions Insulet to begin selling the integrated Type 1 diabetes product in Europe in the first half of 2024, starting with a phased launch in the United Kingdom and Netherlands.
  • Both companies have talked up the potential of insulin pump-CGM integration, with Insulet saying “there’s a huge open market” and Abbott calling it “a great opportunity” at recent investor events.

Dive Insight:

Omnipod 5 is a tubeless, wearable pump that delivers insulin to give patients an alternative to multiple daily injections. By integrating the pump with CGMs, Insulet and its partners have created automated insulin delivery systems that adjust dosing based on blood glucose every five minutes. When Insulet launched the pump in 2022, the device integrated with Dexcom’s G6 CGM. 

Since the launch, Insulet has worked to integrate the pump with devices from Abbott, Dexcom’s main competitor for the CGM market. The work has resulted in a CE mark, which Insulet announced Wednesday. 

The CE mark covers Abbott’s older Libre 2 device, but Insulet plans to add integration with Libre 3, James Hollingshead, CEO of the insulin delivery company, said at the J.P. Morgan Healthcare Conference last month. Hollingshead also used the event to discuss the importance of Libre integration and the CGM opportunity more broadly.

“We think the Libre integration is a great catalyst for us,” the CEO said. “There’s a huge open market waiting for us. Anybody that’s using the CGM is used to having a wearable on their body, so Omnipod is not a leap for them. That’s why we think that it’s such an obvious solution for us.”

Hollingshead added that Abbott has “a huge installed base,” although he said the company tends to lead in Type 2 diabetes while Dexcom tends to lead in Type 1. The new Omnipod-Libre CE mark covers Type 1 diabetes.

Abbott discussed what integration means for its business on its fourth-quarter results conference call last month. CEO Robert Ford called integration “a market conversion opportunity,” explaining that there are “150,000 to 200,000 … new pumpers every year,” and Abbott has lacked a way to target that population. Abbott and Tandem Diabetes Care launched a CGM-pump integration in the U.S. in early January.

Ford called pump integration and basal insulin “good drivers” for Abbott in 2024 and 2025. Adding those drivers could help Abbott build on another year of growth for Libre, which saw sales rise more than 25% year over year in the fourth quarter to hit $1.4 billion.

Insulet is scheduled to report its fourth-quarter and full-year results on Feb. 22.

Nick Paul Taylor

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