The U.S. Food and Drug Administration says the Tandem Diabetes Care t:slim X2™ insulin pump now has an interoperable designation.
“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them,” FDA Commissioner Dr. Scott Gottlieb said in an agency news release. “Advances in digital health make more tailored approaches to diabetes care possible.”
The FDA describes the new designation as an Alternate Controller Enabled Infusion Pump (ACE pump) or an interoperable pump, so it can be used with different components that allow users to tailor diabetes management to their preferences, according to the agency.
“This new classification of the t:slim X2 pump provides more flexibility for us as we make improvements to current products, create new products, and collaborate with best-in-class companies in the development of future automated insulin delivery systems,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care.
Along with this approval, the FDA said it is establishing “special controls” that define requirements for assuring the accuracy, reliability, and cybersecurity of ACE infusion pumps. These controls also describe the type of studies and data required to demonstrate acceptable performance.
“The FDA’s special controls set a new standard in our industry and define another component of the regulatory process for future automated insulin delivery systems,” said John Sheridan, executive vice president and COO of Tandem Diabetes Care.
“Having the t:slim X2 pump approved with this new designation, combined with its ability for remote software updates, will enable more efficient and predictable development of new systems with current and future technology partners, and allow faster delivery of new innovations to our customers.”
JDRF statement on FDA authorization of the t:slim X2™ insulin pump
The U.S. Federal Drug Administration (FDA) authorization of the t:slim X2™ insulin pump by Tandem Diabetes Care, based in California – is a substantial step forward for the “open protocol” approach, which allows people with T1D to connect their preferred devices – even if made by different manufacturers – to create and customize a diabetes therapy system that best works for them.
“Diabetes isn’t a one size fits all disease. We are thrilled to see the FDA and manufacturers moving to allow communications between different diabetes devices. This will provide people with diabetes more options, accelerate innovation, and most importantly improve diabetes outcomes,” said JDRF Chief Mission Officer Aaron Kowalski, Ph.D. “With all this work moving forward, we hope an interoperable ecosystem of diabetes therapy devices is closer to becoming reality.”
JDRF, the Helmsley Charitable Trust and other technology companies have been championing open protocol for nearly two years. JDRF launched an Open Protocol Initiative, which included bringing the T1D community together with regulators and legal experts to explore the technical, regulatory and liability landscape for interoperable systems at a workshop in April 2018 where the need for such a pump was discussed.
iCGM was First Interoperable Device
This authorization follows the FDA clearance in March 2018 of the first interoperable CGM – the Dexcom G6 Continuous Glucose Monitor System by Dexcom. Additionally, JDRF and the Helmsley Trust recently announced funding the not-for-profit company Tidepool to develop an FDA-regulated insulin delivery app.