Medtronic and Tidepool announced a partnership to create an interoperable automated insulin pump system, according to a press release from the two companies.
Medtronic plans to develop a Bluetooth-enabled MiniMed pump that would be compatible with Tidepool Loop, an open-source, automated insulin delivery app for iPhone and Apple Watch, which is currently in development, according to the release.
As Endocrine Today reported in November, Tidepool launched a project last year to officially support Loop, an app designed for do-it-yourself automated insulin delivery devices. The initiative, first announced on the company’s blog Oct. 8, includes plans to submit the app to the FDA and an observational study of Loop users. The project is the first of its kind, Tidepool founder and CEO Howard Look said at the time, and would allow people with diabetes to potentially create their own closed-loop insulin delivery system using the latest, in-warranty insulin pumps and continuous glucose monitors — no “hacking” of older devices required.
"We think that Medtronic is making a very bold and important move here that shows tremendous courage and is the absolutely right thing for the diabetes community," Look said in the release. "Medtronic makes incredibly robust and reliable pump hardware, and they have extensive marketing, sales, and support organizations for people with diabetes and for health care providers. This network can help bring closed-loop systems to more people living with diabetes."
As part of the agreement, Medtronic will contribute financial support to Tidepool for the integration development effort and develop a software development kit to enable iPhone-to-pump communication. Both companies will be working closely with the FDA through the regulatory process to garner approvals for both the Tidepool Loop app and the future Bluetooth-enabled MiniMed pump that will work with Tidepool Loop. This includes pursuing integrated continuous glucose monitoring (iCGM) classification for the Guardian Sensor 3 and alternate controller enabled (ACE) pump classification for a future Bluetooth-enabled MiniMed pump.
“This would enable an FDA-cleared interoperable system — with ACE pump and iCGM sensor components — that may be mixed and matched with the Tidepool Loop app as the user chooses,” the companies stated in the release.
In the release, Ali Dianaty, vice president of research and development for the diabetes group at Medtronic, said the collaboration with Tidepool is a way to further drive industry innovation.
"Working with Tidepool and supporting interoperability, we can increase the options available for people with diabetes to manage their condition as they seek out solutions that help them achieve better health and improve quality of life," Dianaty said.
Tidepool Loop will be an automated insulin delivery app for iPhone and Apple Watch that connects to an insulin pump and CGM using Bluetooth LE. It runs an algorithm every 5 minutes to adjust a user's basal rate for the next 30 minutes, with the goal to help reduce or avoid hyperglycemia and hypoglycemia.
According to the release, Tidepool intends to deliver Tidepool Loop as an FDA-regulated product, broadly available via the iOS App Store, compatible with multiple, in-warranty pumps and CGMs. – by Regina Schaffer
Disclosures: Dianaty is vice president of research and development for the diabetes group at Medtronic. Look is president and CEO of Tidepool.