Interoperable insulin pump approved for adults and children
In another big step forward for both choice and customization, the U.S. Federal Drug Administration (FDA) authorized the first interoperable insulin pump that can digitally interact with devices made by other manufacturers.
Clearance of the pump—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.
Tandem’s t:slim X2 Insulin Pump features Basal-IQ technology, which predicts low levels of glucose and suspends the delivery of insulin. It uses Bluetooth wireless to connect to a smartphone that can display the status of the accompanying glucose monitor and what the pump has been up to.
Breakthrough T1D, the Helmsley Charitable Trust, and other technology companies have been championing open protocol for nearly two years. Breakthrough T1D 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.
“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 Scott Gottlieb, M.D., said in FDA’s announcement.
With its approval, the FDA also created a new category for insulin pumps: alternate controller enabled (ACE) infusion pumps, and established criteria, called special controls, that outline requirements for future ACE insulin pumps to follow. Importantly, the new category of pumps will allow for more efficient patient access to such pumps in the future.
“Diabetes isn’t a one size fits all disease. We are thrilled to see 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 Breakthrough T1D Chief Mission Officer Aaron Kowalski, Ph.D.
This approval follows the FDA clearance in March 2018 of the first interoperable CGM—the Dexcom G6 Continuous Glucose Monitor System by Dexcom. Additionally, Breakthrough T1D and the Helmsley Trust recently announced funding the not-for-profit company Tidepool to develop an FDA-regulated insulin delivery app.
“With all this work moving forward, we hope an interoperable ecosystem of diabetes therapy devices is closer to becoming reality,” Kowalski said.
Read the FDA announcement.
