Medtronic plc and Tidepool have agreed to work together to create an interoperable automated insulin pump system. Medtronic will develop a future Bluetooth-enabled MiniMed(TM) pump that would be compatible with Tidepool Loop, a future FDA-regulated, open source automated insulin delivery app for iPhone® and Apple Watch® currently in development.
“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,” said Howard Look, founder and CEO of Tidepool. “Medtronic makes incredibly robust and reliable pump hardware, and they have extensive marketing, sales, and support organizations for people with diabetes and for healthcare 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 Food and Drug Administration (FDA) through the regulatory process to garner approvals for both the Tidepool Loop app and the future Bluetooth-enabled MiniMed(TM) pump that will work with Tidepool Loop. This includes pursuing iCGM (Integrated Continuous Glucose Monitoring) classification for the Guardian(TM) Sensor 3 and ACE (Alternate Controller Enabled) 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.
“We have been listening and engaging with the diabetes community to understand what is important to them. We recognize that collaboration with Tidepool is a way to further drive industry innovation,” said Ali Dianaty, vice president of research and development for the Diabetes Group at Medtronic. “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.”
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 five minutes to adjust a user’s basal rate for the next 30 minutes, with the goal to help reduce or avoid high and low blood glucose. 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.
Tidepool is a 501(c)(3) nonprofit organization with the mission of making diabetes data more accessible, actionable, and meaningful by liberating data from diabetes devices, supporting researchers, and providing great software to the entire diabetes community, including people living with diabetes and their healthcare providers. Tidepool currently provides free software to help import, manage, store, and gain insights from diabetes device data. Tidepool’s software and HIPAA-compliant data services are provided for free to end users and clinicians including: Tidepool Web, Tidepool Uploader, TIdepool Mobile, and the Tidepool Platform.
Tidepool Loop is a project to build and support an FDA-regulated version of Loop, to be available in the iOS App Store, intended to work with commercially available insulin pumps and CGMs. Learn more at www.tidepool.org/loop.
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.