Tidepool Loop Partner Update: ACE pumps

Today, with the exciting announcement of clearance for Tidepool Loop, we wanted to share an update that we know is going to be one of the first questions our community cares about: What devices will I be able to use with Tidepool Loop when it launches?

Back in 2018 and 2019, we shared that we had two ACE pump development partners: Insulet and Medtronic. A lot has changed since then in the landscape of diabetes management options, and companies have made adjustments over the course of the last few years, including Tidepool and some of our partners.

Here is the TL;DR (too long, didn’t read) summary:

• Both Insulet and Medtronic have supported Tidepool Loop development, and we are grateful for their support in getting to this point.
• Medtronic and Tidepool have decided to discontinue the development of a Medtronic insulin pump system compatible with Tidepool Loop.
• As Omnipod 5 is now commercially available, Insulet is devoting all available resources to their Omnipod products, including the global launch and further development of Omnipod 5.
• Tidepool is working closely with other ACE pump partners. At this point in time, we can’t yet share who our first pump partner will be, but we look forward to sharing details in the near future!
• Any ACE Pump that will be commercially compatible with Tidepool Loop will need to be FDA cleared for use with third-party iAGC controllers.
• Dexcom continues to be an outstanding iCGM development partner with Tidepool for Tidepool Loop.
• We have worked hard to build Tidepool Loop as a system that works with any ACE pump cleared for use with third-party iAGC controllers and any iCGM cleared for use with an automated insulin delivery system.

Medtronic

Here is the statement that Medtronic has provided:

As a company committed to meeting customers where they are in their diabetes journey, Medtronic continually assesses its development programs and prioritizations of innovations to serve the needs and expectations of its customers. Due to this and the evolution of product platforms, Medtronic and Tidepool have mutually agreed to discontinue the development of a Medtronic insulin pump system compatible with Tidepool Loop. Medtronic and Tidepool both have customer-centric visions and ambitions to change the course of diabetes management and may collaborate on future programs. Medtronic continues to admire Tidepool as an organization that’s highly attuned to engaging with the diabetes community and devoted to improving the quality of life for those living with diabetes. Tidepool admires Medtronic’s customer-focused innovations and thanks Medtronic for its bold move to explore interoperable technology and for supporting Tidepool’s efforts over the past three years.

Insulet

Here is the statement that Insulet has provided:

At Insulet, we are continuously driven by our mission to improve the lives of people with diabetes. Our new Omnipod 5® Automated Insulin Delivery (AID) System received FDA clearance in January 2022 and is now available to people with type 1 diabetes age 2 years or older with a prescription and insurance coverage. We are focusing our resources on our Omnipod products and further developing our newly commercialized AID system, Omnipod 5. As we continue to innovate our offerings, we celebrate the addition of Tidepool Loop to the AID marketplace as we believe people with diabetes should have access to the technology that works best for their individual needs.

We will continue to provide Omnipod® System and Omnipod® DASH customers with the ability to view their Omnipod data on the Tidepool platform and share with their healthcare provider.

Other Interoperable Devices for Tidepool Loop

“What does it mean to have an FDA cleared product before it has a compatible ACE Pump that it can work with? What device will I be able to use with Tidepool Loop then?”

With FDA clearance of Tidepool Loop, we have demonstrated that the Tidepool Loop app meets all of the regulatory requirements of a truly interoperable iAGC system. That means that once an ACE pump has been cleared for use with third-party iAGC controllers (that’s us!) the FDA does not need anything else from Tidepool to make Tidepool Loop work with said pump, as long as we follow the agreed-upon processes and procedures.

Tidepool Loop sets an important precedent for future innovations as the first iAGC cleared by the agency that was not submitted by an insulin pump manufacturer. The clearance of Tidepool Loop enables pump partners (including the ones we are not working with yet!) to more easily join the ecosystem of options available to the diabetes community.

The work that Tidepool has done over the last few years on Tidepool Loop is in part possible thanks to the willingness to explore interoperable technology and support from both Medtronic and Insulet. We are grateful for the support both organizations have given us, and look forward to opportunities to work together again in the future.

While we cannot announce who they are yet, we are excited to share that we are working closely with various pump partners. We cannot wait to share an official announcement regarding our new commercial launch partners for Tidepool Loop, and you can sign up to be one of the first to know here.

We also continue to collaborate closely with Dexcom. As the only iCGM that is cleared by the FDA for use in interoperable AID systems, Dexcom continues to be an outstanding partner as we work to commercialize Tidepool Loop and make it available in the App Store.

We will share more information about our work with the FDA throughout the review of Tidepool Loop and what we’ve learned along the way that might help others in the diabetes community. We’re also thrilled that we will have news about device partners to share in the future. Thank you again, to all of you who continue to support our work to develop the first fully interoperable AID controller in the diabetes industry.

Key terms that are used throughout our blog posts discussing Tidepool Loop include:

ACE pump: “alternate controller-enabled pump”

What that means: the pump meets FDA criteria to work safely with more than one type of algorithm that adjusts insulin.

iCGM: “integrated continuous glucose monitor”

What that means: the CGM system meets FDA criteria for accuracy and safety for dosing insulin.

iAGC: “interoperable automated glycemic controller”

What that means: The algorithm (computing logic) has been designed to communicate with other compatible diabetes device components in a modular system.

This controller software might be embedded in the insulin pump itself, run from a separate handheld device, or even live inside a smartphone app.

510(k): A 510(k) is a regulatory requirement by the FDA in order to market something considered a medium-risk medical device in the United States.

What that means: A 510(k) filing contains detailed technical, safety and performance information about a medical device. It must demonstrate the device in question is “substantially equivalent” to another medical device already cleared for use by the FDA.