Insulet could face new competition as other insulin pump companies move into tubeless devices, but CEO Jim Hollingshead said he is not concerned in the short term. 

The company currently is the fastest growing in the insulin pump market, but it could face pressure in the next couple of years from Tandem Diabetes Care and Medtronic, which have said they are working on their own patch pumps. 

Hollingshead, in an earnings call last week, said Insulet doesn’t see anything from its competitors in the next year-and-a-half to rival its current Omnipod 5 patch pump. 

“We're never complacent. We have a lot of respect for our competitors and we know that because … Omnipod 5 has been so successful, everybody wants to chase it,” Hollingshead said. “We are very confident in our competitive position. We don't see anything coming in anybody’s pipeline that even matches what we have, and we're going to continue to drive innovation.” 

Tandem is working on a tubeless option for its Mobi insulin pump, a small durable system that it launched earlier this month. 

“It mitigates the tubeless discussion,” CEO John Sheridan told investors on a recent earnings call. “I think that some people are going to want to wear it as a tubed pump at certain times in their day. And they're going to also want to wear it as a patch device.” 

Tandem is also developing a rechargeable patch-pump that uses prefilled cartridges, called Sigi, which the company acquired when it bought Switzerland-based AMF Medical two years ago. 

Sheridan declined to share timelines for the planned products, citing competitive reasons.

Meanwhile, Medtronic diabetes president Que Dallara told investors the company is “aggressively moving” to get next-generation tethered pumps and patch pumps to market. At the end of the year, the company called off plans to buy patch-pump maker EOFlow, which currently is in a patent battle with Insulet. 

Going forward, Insulet plans to expand into the Type 2 market. The company is running a commercial pilot of Omnipod Go, a patch pump that only delivers basal insulin and received FDA clearance last year. Insulet is also nearing the end of a pivotal trial of its Omnipod 5 device in Type 2 patients, and expects to file with the FDA this year, Hollingshead said. 

In the fourth quarter, Type 2 patients accounted for 20% to 25% of new customer starts in the U.S. 

Planned CGM integrations

Insulin pump makers are also looking to integrate with the newest continuous glucose monitors as a way to drive growth.   

Tandem announced integrations for its T:slim X2 pump with Dexcom’s G7 sensor in December and Abbott’s Freestyle Libre 2 Plus CGM in January. 

“We are now the only pump company to offer users choice and CGM integration in the U.S.,” Sheridan said. “The diabetes community has been enthusiastic in response to having choice in their therapy management.” 

Tandem's new Mobi pump is currently compatible with Dexcom’s older G6 CGM, but the company has said it plans to add G7 in the second quarter and integrate with Abbott’s Freestyle Libre 3 afterward. 

Meanwhile, Insulet is in a U.S. limited market release of Omnipod 5 integrated with Dexcom’s G7. In Europe, the company is launching the pump integrated with Abbott’s Libre 2 plus in the first half of 2024, interim CFO Lauren Budden said. The company hasn’t shared when it will integrate the pump with Libre in the U.S. 

Medtronic, which has been working on a turnaround of its diabetes business since it resolved a warning letter last year, hopes that a new sensor will drive more customers to its diabetes products. The company received a CE Mark for its Simplera Sync sensor for use with its 780G pump in January, and plans to begin a limited release this spring, CEO Geoff Martha said. 

The new sensor is disposable, smaller than Medtronic’s last CGM and doesn’t require finger-sticks or tape. In the U.S., the company recently finished a clinical trial of Simplera with 780G and plans to submit it to the FDA in the first half of the year.