ADA: Medtronic steps toward diabetes interoperability with Tidepool collaboration

Medtronic is teaming up with the diabetes data nonprofit outfit Tidepool to create a new, interoperable version of its MiniMed insulin pump—and in return, the medtech giant will help Tidepool work to secure the FDA’s blessing for its open-source insulin delivery app.

Tidepool’s Loop app, currently under development for the iPhone and Apple Watch, is designed to algorithmically adjust basal insulin rates every five minutes, projecting the user’s needs over the next half-hour to help keep blood sugar levels in range. The nonprofit hopes to make it compatible with multiple pumps and continuous glucose monitoring (CGM) systems.

Under the agreement, Medtronic will provide financial support for the work and help build a software development kit to allow the app to communicate with different, Bluetooth-enabled pumps using a smartphone.

"We have been listening and engaging with the diabetes community to understand what is important to them,” Ali Dianaty, vice president of R&D for Medtronic’s diabetes group, said in a statement. “We recognize that collaboration with Tidepool is a way to further drive industry innovation.”

Earlier this year, The Atlantic published an article examining the do-it-yourself culture among some patients with diabetes involving old, discontinued models of Medtronic insulin pumps that can be reprogrammed to build automated delivery systems when paired with software and CGMs.

The FDA recently warned the public against using homemade treatment devices, saying hardware and software combinations have not been evaluated or approved and citing an adverse event report linked to an insulin overdose.

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Some people with diabetes have gone DIY in response to the higher prices of fully approved platforms that may not be interchangeable or customizable, requiring all the components to be bought from a single manufacturer.

"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.

The project also includes pursuing an FDA integrated CGM classification, or iCGM, for Medtronic’s Guardian Sensor 3 system, as well as an alternate controller-enabled (ACE) stamp for the new version of its MiniMed pump. The agency cleared its first ACE pump in February, Tandem Diabetes Care’s t:Slim X2, which lets patients pair it with different monitoring hardware and dosing systems.

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These classifications would allow Medtronic to offer its own FDA-cleared interoperable system, including future pump and sensor components that the user can connect with the Tidepool Loop app if needed.

"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,” Look said. “This network can help bring closed-loop systems to more people living with diabetes.”

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But before reaching that interoperable future, Medtronic aims to advance the development of its MiniMed 780G pump, a newer generation of its hybrid closed-loop system. The device is designed to automate the delivery of correction boluses in response to high glucose readings.

Medtronic launched a pivotal trial that plans to enroll up to 350 adult and pediatric participants with Type 1 diabetes, studying the device’s use at home and work during daily activities including exercise.

"We are excited to begin enrollment in this trial as we continue to advance our phased approach towards the development of a fully closed loop system,” said Robert Vigersky, chief medical officer of the diabetes group.

“The MiniMed 780G system is designed to take our MiniMed 670G system with automated basal insulin delivery one step further so that people living with Type 1 diabetes can enjoy greater freedom and less burden from their daily diabetes management."

The company also initiated a study of its Guardian CGM sensor designed to reduce the number of necessary calibrations. That trial aims to enroll 460 patients with Type 1 or Type 2 diabetes, with randomized sensor wear locations and testing days and times over a weeklong period.