The U.S. Food and Drug Administration (FDA) today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology 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, or ACE insulin 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 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,” said Dr. Scott Gottlieb, FDA Commissioner. “We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them.”
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.
“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,”said Gottlieb “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.”
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 a 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.
- FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. (2019, February 14). PR Newswire. Retrieved: https://prnmedia.prnewswire.com/news-releases/fda-authorizes-first-interoperable-insulin-pump-intended-to-allow-patients-to-customize-treatment-through-their-individual-diabetes-management-devices-300796216.html