FDA Grants Clearance to First Smartphone App for Programming Insulin Dosing

The US Food and Drug Administration (FDA) recently granted clearance of bolus insulin dosing on Tandem Diabetes Care’s t:slim X2 insulin pump using the t:connect mobile app, according to a company statement.

The t:connect app, which already connects t:slim X2 insulin pumps to a user’s smartphone, serving as a private secondary data display, will allow them now to program or cancel bolus insulin requests from the phone without needing to interact with the pump itself. According to the company statement, this marks the first time the FDA has cleared a smartphone application for initiating insulin dosing. The t:connect app is compatible with both iOS and Android operating systems.

“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” said John Sheridan, president and CEO of Tandem Diabetes Care. “Giving a meal bolus is now the most common reason a person interacts with their pump, and the ability to do so using a smartphone app offers a convenient and discrete solution.”

The secure mobile t:connect application displays t:slim X2 insulin pump information privately on a user’s phone, including 24-hour glucose trends, changes in pump status, and critical insulin therapy data such as basal and bolus deliveries as well as insulin suspensions. The company emphasizes in the press statement that the t:slim X2 insulin pump functions independently from the app so users are always able to view data and program requests directly from the pump.

The new bolus feature will be offered at no additional cost to users in the US, and rollout is expected to occur in phases, with a series of limited group launches during the spring followed by an expanded launch later in the summer of 2022. The company noted participants for the limited launch have already been selected.

Tandem Diabetes Care emphasizes on its website that the t:connect mobile app is not intended to be a replacement for the information displayed on insulin pumps and is not intended to replace self-monitoring practices advised by a physician.

According to Tandem, the bolus dosing feature is currently compatible only with an iPhone 12 running iOS 14 or a Samsung Galaxy S20 on Android 11, although the company is working to add more smartphone models and operating systems to the software.

More information on the t:slim X2 insulin pump and the t:connect mobile app is available at TandemDiabetes.com.