- The Food and Drug Administration (FDA) has approved the first interoperable insulin pump, which enables patients to customize treatment using their diabetes management devices.
The alternate controller-enabled (ACE) insulin pump, made by Tandem Diabetes Care, can be used with different components making up diabetes therapy systems. With the pump, patients can tailor their diabetes management to their individual device preferences.
A diabetes therapy system can include an insulin pump, an automated insulin dosing (AID) system, a continuous glucose monitor, a blood glucose meter, and other medical devices used for diabetes management.
The Tandem Diabetes Care t:Slim X2 pump delivers insulin under the skin at set or variable rates and can be connected to automatically communicate with and receive drug dosing commands from other diabetes management devices, such as an AID system.
When not connected to other devices, the t:Slim X2 pump can be used to infuse insulin on its own.
“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,” commented FDA Commissioner Scott 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,” Gottlieb observed.
Traditionally, insulin pumps have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or as part of a single, predefined diabetes management system (class III, highest-risk devices).
Since the t:Slim X2 insulin pump is interoperable with other diabetes device components, the FDA reviewed the pump through the de novo premarket review pathway for novel, low-to-moderate-risk devices of a new type.
The FDA has also established special controls that outline requirements for ensuring the accuracy, reliability, security, and clinical relevance of ACE infusion pumps and that 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 t:Slim X2 insulin pump and the establishment of special controls, the FDA has created a new regulatory classification, which provides more efficient patient access for this type of device. Future ACE insulin pumps that comply with the general and special controls can go through a quicker premarket review known as 510(k) clearance.
The FDA reviewed 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 agency also gauged the ability of the pump to communicate with external devices with appropriate reliability, security, and fail-safe modes.
Risks associated with t:Slim X2 pump use are similar to other infusion pumps and 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.
Incorrect drug delivery could result in low or high blood glucose levels and a dangerous rate of fat metabolization that could 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 or cybersecurity vulnerabilities.
“We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and postmarket tools for determining the safety and effectiveness of these new technologies,” concluded Gottlieb.