t:slim X2 insulin pump first to receive FDA's ACE classification

The U.S. Food and Drug Administration (FDA) has permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual medical device preferences. Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters, or other electronic devices used for diabetes management.

“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. Advances in digital health make more tailored approaches to diabetes care possible,” says FDA Commissioner Scott Gottlieb, M.D. “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. Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology. We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies.”

The approved indication for the t:slim X2 pump states 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.

“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,” says Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “This further establishes the role Tandem Diabetes Care has taken as a key innovator in the insulin pump industry, having launched the first touchscreen pump in the United States, the first pump capable of remote feature updates, the first pump approved as iCGM compatible, and now the first in this new interoperable pump category.”

Nearly 10% of Americans are diagnosed with diabetes, which impairs the body’s ability to make or properly use the blood glucose-regulating hormone insulin.

The interoperable t:Slim X2 pump works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug dosing commands from other diabetes management devices, such as AID systems, or, when not connected to other devices, the interoperable t:Slim X2 pump can be used to infuse insulin on its own. AID systems typically consist of a pump, CGM, and software to control the system.

Insulin pumps to date have either been cleared by the FDA as stand-alone devices (Class II, moderate risk devices) or approved by the FDA as part of a single, predefined diabetes management system (Class III, highest-risk devices). Because the interoperable t:Slim X2 insulin pump is interoperable with other diabetes device components, the pump was reviewed through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type.

Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. With the authorization of the interoperable t:Slim X2 insulin pump and the establishment of these special controls, the FDA’s action also created a new regulatory classification, which provides more efficient patient access for this type of device in the future, because future ACE insulin pumps that comply with the general and special controls can go through a more efficient premarket review known as 510(k) clearance.

“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,” says 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.”

The FDA reviewed interoperable t:Slim X2 pump performance data demonstrating that the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity, and fail-safe modes.

Risks associated with use of the interoperable t:Slim X2 pump are similar to other infusion pumps and may include infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring, or skin discoloration). Other risks can include blockages and air bubbles in the tubing, which can affect drug delivery. Risks that could result from incorrect drug delivery include low blood glucose (hypoglycemia), high blood glucose (hyperglycemia), and a dangerous rate of fat metabolization that may make the blood slightly acidic (diabetic ketoacidosis). Risks associated with connected ACE insulin pumps can include incorrect drug delivery as a result of loss of communication between devices, such as the pump misunderstanding commands it receives, or cybersecurity vulnerabilities.

About the t:slim X2 insulin pump
The t:slim X2 insulin pump includes advanced features such as a large color touchscreen, rechargeable battery, Bluetooth wireless technology, USB connectivity, and watertight construction (IPX7). It is capable of remote software updates using a personal computer, offering the potential for users to access new features as they meet necessary regulatory requirements. The t:slim X2 Pump is up to 38% smaller than other insulin pumps and holds up to 300 units of insulin.

About ACE pumps
According to the FDA, ACE pumps are devices intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with compatible external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.