Dive Brief:
- Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
- Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
- The FDA decision also expands the insulin pump to adults with Type 2 diabetes.
Dive Insight:
A year ago, Medtronic and Abbott announced a partnership where Abbott would make a continuous glucose monitor to pair only with Medtronic’s insulin pumps, pens and automated insulin delivery algorithms. Up to this point, all of Medtronic’s insulin pumps have only paired with the company’s own glucose sensors.
The companies shared more details about the partnership on Tuesday, following an expanded indication from the FDA that would designate Medtronic’s SmartGuard algorithm as an interoperable automated glycemic controller, or iAGC, meaning it can be paired with CGMs made by other manufacturers. The iAGC designation is currently for Type 1 diabetes, although Medtronic hopes to expand it to people with Type 2 diabetes in a future submission.
Que Dallara, president of Medtronic Diabetes, said in a statement that the integration will provide patients with more choice and flexibility, and a more seamless experience.
Earlier this month, Medtronic unveiled the name of the new Abbott sensor. The Instinct sensor will have a wear time of 15 days, and the companies claim it will be the smallest, thinnest integrated CGM on the market.
Medtronic’s newest CGM, the Simplera Sync, has a six-day wear time and is expected to start a limited launch this fall.
The FDA made a separate decision to expand Medtronic’s MiniMed 780G pump to people with Type 2 diabetes, following similar label expansions for competitors Insulet and Tandem Diabetes Care. For people with Type 2 diabetes, the 780G can be paired only with Medtronic’s sensors, including its Guardian 4 CGM and the Simplera Sync sensor, after Medtronic opens pre-orders later this month.
The FDA decisions come ahead of Medtronic’s plans to spin out its diabetes business into a separate, publicly traded company. Dallara will become CEO of the standalone firm, which will be named MiniMed.
In an August earnings call, CFO Thierry Piéton said Medtronic’s planned separation of MiniMed is “on track,” with the company expecting to have completed the IPO and split within 15 months.
