Tandem Diabetes Receives FDA Clearance for t:connect mobile app

Announced on Feb. 18, the t:connect mobile app, which pairs with the t:slim X2 insulin pump, is the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems, according to Tandem Diabetes Care.

The US Food and Drug Administration (FDA) has granted clearance for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app, according to a press release from Tandem Diabetes Care Incorporated.

In the release, Tandem Diabetes Care pointed out the free t:connect mobile app, which is designed to offer t:slim X2 insulin pump users the ability to program and cancel bolus insulin requests through a smartphone, is the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on 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. “With the improvements in diabetes management provided by Tandem’s Control-IQ technology, 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.”

A secure, mobile application, the t:connect mobile app provides users of the t:slim X2 insulin pump with pump information, including 24-hour trends of glucose, pump status changes, and insulin therapy data. The new bolus feature, which will be offered at no additional cost to users in the US, to program and cancel bolus insulin requests 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.

On the Tandem Diabetes Care website, the company notes 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. The release from Tandem Diabetes Care also pointed out in addition to the first mobile app to receive FDA clearance on both iOS and Android operating systems to deliver insulin from a personal smartphone, Tandem Diabetes Care was also the first to receive an interoperable automated glycemic controller designation with Control-IQ technology in December 2019, the first to receive an alternate controller-enabled infusion pump classification in February 2019, and the first insulin pump designated as compatible with integrated continuous glucose monitoring devices in June 2018.

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