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FDA Approves Marketing of First Intraoperable Insulin Pump Device

On February 14, 2019, the United States Food and Drug Administration (FDA) announced that it has approved marketing of a new insulin pump for children and adults with diabetes. The new pump is the t:Slim X2 by Tandem Diabetes Care, and it is the first insulin pump to receive a low-to-moderate risk device classification by the FDA. While most other insulin pumps are either considered stand alone devices (moderate risk devices) or part of a diabetes management system (high-risk devices), the t:Slim X2 is the first insulin pump built with interoperable technology.

ACE infusion pumps

This new, interoperable technology is referred to as an “alternate controller enabled” infusion pump or ACE infusion pump. This means that it can be used with different components that make up diabetes management systems, and a patient can use an ACE infusion pump with other systems to customize the preferences of their individual diabetic care regimen. For example, an ACE pump can be used with an automated insulin dosing system, blood glucose monitors including continuous glucose monitors, or other electronic devices and software that help manage a patient’s diabetes care.

The t:Slim X2 pump works like most other insulin pumps to deliver insulin through a catheter under the skin. The t:Slim X2 can give insulin at set and variable rates, but it can also be connected to work to receive dosing commands from automated dosing systems and other dosing devices. The pump can also work independently of these systems and be set to give insulin doses on its own. The FDA has reviewed the t:Slim X2’s ability to work independently and with other devices; the FDA has also reviewed the reliability and cyber security of the device.

Possible risks

Like any other medical device, the t:Slim X2 is not without risks. Like most other infusion pumps, there is a risk of infection, bleeding, pain or skin irritations (including redness, swelling, bruising, itching, scarring and discolorations). There is also a risk of air bubbles or blockages in the tubing, or pump failures that can lead to incorrect dosing. Incorrect dosing of insulin can lead to dangerously high or low blood sugar and can put a patient at risk for diabetic ketoacidosis. There is also always a risk of communication loss between ACE infusion pumps and other insulin dosing devices, either through command miscommunication or security vulnerabilities. These communication malfunctions can lead to incorrect drug delivery and the health risks related to incorrect insulin dosing.

About 1 in 10 Americans (almost 10%) have diabetes, and the FDA acknowledges the need for adaptable and individualized care for these patients. Diabetes can have many complications and there is a need for customizable treatment options. Devices like the ACE insulin pumps allow for patients to have choices in their therapy options, and their approval paves the way for new technology in diabetes treatment to have a more expedited FDA approval process. As ACE infusion pumps fall under new regulatory classification, the FDA can now accelerate the review process of future ACE devices, allowing effective, safe and innovative care for diabetic patients.

  1. FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Published 2019. Accessed February 20, 2019.