The U.S. Food and Drug Administration 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, 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.
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.
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.
The FDA granted marketing authorization of the t:Slim X2 insulin pump with interoperable technology to Tandem Diabetes Care Inc.