FDA OKs First Interoperable Insulin Pump for Diabetes

FEBRUARY 15, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has permitted marketing for the first interoperable insulin pump designed to provide patients with diabetes a customized therapy regimen.

The t:Slim X2 insulin pump, from Tandem Diabetes Care, has been approved as an insulin delivery system for both children and adults with diabetes. As the first interoperable pump approved by the FDA, the device could be used with differing components from other therapy systems, and allow patients to tailor their diabetes management with individual preferences.

The alternate controller enabled (ACE) infusion pump is compatible with automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters, or other electronic devices.

The t:Slim X2 pump delivers insulin under the patient’s skin at either set or variable rates, and is capable of being digitally connected to and automatically communicate with diabetes management devices, which can share drug dosing demands with the device. When separate from compatible devices, the pump can infuse isulin on its own.

The FDA approved the device based on performance data showing it can dose insulin accurately and reliably, at rates and volumes programmed by participating users. It had also been clinically assessed in communication with external devices, to determine reliability, cybersecurity, and fail-safe measure capabilities.

As a novel, low-to-moderate-risk device of a new type, it was approved on the de novo premarket review pathway. The FDA also announced the establishment of new criteria outlining requirements set to assure the accuracy, reliability, cybersecurity, and clinical relevance of this ACE insulin pumps and any that proceed it.

About 1 in every 10 Americans are diagnosed with diabetes. In a statement addressing t:Slim X2’s approval, FDA Commissioner Scott Gottlieb, MD, said the administration was aware of patients’ need for a customizable diabetes management device.

“Advances in digital health make more tailored approaches to diabetes care possible,” Gottlieb said. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently.”

Through the new regulatory pathway set by t:Slim X2, the FDA is committing towards accelerating and developing innovations designed to improve patient care, Gottlieb said.

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