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February 17, 2022

US FDA approves Tandem Diabetes Care’s insulin dosing through mobile app

The t:connect mobile app displays pump alerts and alarms, as well as glucose trends from the last 24 hours.

The US Food and Drug Administration (FDA) has granted approval for Tandem Diabetes Care’s t:slim X2 insulin pump to bolus using the t:connect mobile app.

The company stated that it is the first smartphone app approved by the FDA for initiating the delivery of insulin from Android or iOS operating systems.

The updated mobile application is intended to allow users of the t:slim X2 insulin pump to easily programme and cancel bolus insulin requests through their smartphone.

The user-friendly and secure mobile application displays pump information on the user’s personal smartphone.

Additionally, the t:connect mobile app displays pump alerts and alarms, as well as glucose trends from the last 24 hours.

It also wirelessly uploads data to the Cloud-based t:connect web application.

The mobile app displays pump status changes and insulin therapy data, which includes suspensions of insulin delivery as well as basal and bolus deliveries.

Tandem Diabetes Care president and CEO John Sheridan said: “This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements.

“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.”

The company plans to launch the new mobile bolus feature in a series of limited launch groups throughout the spring.

Following this, it intends to expand the launch in the summer.

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