U.S. Food and Drug Administration02.15.19
The U.S. Food and Drug Administration today 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.
“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,” said 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.
Nearly 10 percent 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 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 the 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.
“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,” said 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.
Nearly 10 percent 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 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 the 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.
