FDA Approves First Interoperable Insulin Pump

Miriam E. Tucker

February 19, 2019

The US Food and Drug Administration (FDA) has approved the first insulin pump that can be used with different components of diabetes management systems.

Tandem Diabetes Care's interoperable t:slim X2 is the first in a new FDA device category, called alternate controller enabled (ACE) infusion pumps. Such devices can communicate with other compatible devices, such as continuous glucose monitors, blood glucose meters, or automated insulin dosing systems.

Thus far, insulin pumps have been cleared by the FDA either as stand-alone devices with a class II (moderate-risk) designation or as part of a predefined diabetes management system with a class III (high-risk) designation.

The t:slim X2 was reviewed through the de novo premarket review pathway for novel low- to moderate-risk devices. Going forward, other ACE pump manufacturers will be able to go through the more efficient 510(k) review process as long as they meet general requirements, as well as newly designated "special controls" that outline requirements for accuracy, reliability, cybersecurity, and clinical relevance.

The new indication means that "the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices," according to a Tandem statement.

Asked to comment, Boris P. Kovatchev, PhD, founding director of the University of Virginia Center for Diabetes Technology, Charlottesville, called the development "a very big deal." He noted that availability of the new interoperable pump follows the March 2018 FDA approval of the Dexcom G6 as an integrated continuous glucose monitoring system, which is also capable of working with different types of compatible devices and electronic interfaces.

"This has been a process for quite a while to put together a designation on both the sensor side and the pump side for interchangeable devices, meaning that an artificial closed-loop [insulin delivery] system could use these devices interchangeably," said Kovatchev, who is a consultant for Tandem. "That's a very serious achievement because it signifies that the device has appropriate security in place to be interchangeable and is capable of handling more than one peripheral device, control algorithm, or whatever comes about."

In June 2018, the FDA approved the t:slim X2 insulin pump with Basal-IQ technology. It was the second insulin-delivery system that suspends delivery of insulin in anticipation of hypoglycemia. The first such device, the Medtronic 670G, was the first to integrate an insulin pump with the Dexcom G6.

Kovatchev is leading a 6-month trial of a new algorithm, called Control-IQ, which is embedded into the t:slim X2 pump and is integrated with the Dexcom G6 sensor. With this investigational system, the Control-IQ algorithm automatically adjusts basal doses, as does the Medtronic 670G. It also automatically delivers correction boluses for high blood glucose levels, which the 670G does not do. The study is expected to be completed in April 2019.

Speaking about the new FDA approval, Kovatchev said, "I think it's a big deal because it will give people choice. It will democratize closed-loop control. It may improve [glycemic] control, because each person is different. If they select the most appropriate control algorithm for them, that may be an advantage. It would be more personalized."

Kovatchev is a consultant for Tandem and Sanofi and is on the speaker's bureau for Dexcom. His institution, the University of Virginia, has received research support from Dexcom, Roche, Sanofi, and Tandem.

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