Competitor Medtronic also received a CE mark for a new CGM sensor that can integrate with its 780G pump.
- Tandem Diabetes Care integrated its t:slim X2 insulin pump with Abbott’s Freestyle Libre 2 Plus sensor, paving the way for the first automated insulin delivery system available to Abbott’s U.S. customers.
- The launch is a “major milestone” for Abbott, as Tandem’s device is “the first hybrid closed-loop system to integrate with Libre after years of development,” BTIG analyst Marie Thibault wrote in a research note.
- Competitor Medtronic also announced on Monday it received a CE mark for a new sensor called Simplera Sync, approved to work with its MiniMed 780G pump.
Abbott and Tandem’s combined launch has been an anticipated event for both companies. The integration marks the first time Abbott has offered a hybrid-closed loop system in the U.S., while Tandem could benefit from more customers in the long term.
Last year, Abbott received clearance from the Food and Drug Administration for a modified version of its Freestyle Libre 2 sensor that can be used with automated insulin delivery systems. The sensor can be worn for 15 days, by both adults and children.
Tandem is now selling t:slim X2 pumps pre-loaded with the new software. Patients who already have a t:slim X2 pump can add the feature for free via a remote software update.
In late 2022, Abbott launched a hybrid-closed loop partnership in Europe with Ypsomed’s and CamDiab’s algorithm. Abbott CEO Robert Ford told investors in a third-quarter earnings call that the partnership had resulted in “tremendous” growth for the pump company, and that Abbott also hopes to offer a dual analyte glucose-ketone sensor with an insulin pump in the future.
In the meantime, Medtronic is also working toward offering an integrated system based on its newest CGM in Europe. On Monday, the company announced it had received a CE mark for its 780G insulin pump to be used with its Simplera Sync CGM.
Simplera Sync is based on Medtronic’s Simplera sensor, which received a CE mark last year. The CGM was an important launch for Medtronic because it brought the company more in line with its competition by offering a disposable sensor that doesn’t require fingersticks for calibration and doesn’t require tape to hold it in place. However, it has a shorter wear time of seven days.
Medtronic said it plans to offer the 780G with Simplera Sync through a limited launch this spring, with a phased commercial launch in Europe over the summer. The Simplera Sync system is not currently approved by the FDA.