Tandem Diabetes Care has received the US Food and Drug Administration (FDA) approval for bolus insulin dosing with its t:slim X2 insulin pump using the t:connect mobile app.
The t:connect is a secure and easy-to-use mobile app that pairs with t:slim X2 insulin pump, and displays the user’s pump information on their personal smartphone.
It is the first smartphone application approved by the FDA, capable of initiating insulin delivery on both iOS and Android operating systems.
The mobile app enables t:slim X2 insulin pump users to programme and cancel bolus insulin requests using their compatible smartphones, said the company.
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.”
Tandem Diabetes Care intends to offer the new programmable app feature to all new t:slim X2 insulin pump customers in the US, at no additional cost.
Also, the diabetes technology company will offer the feature to its existing customers through a remote software update for the t:slim X2 insulin pump and the updated t:connect mobile app.
It is planning to roll out the mobile bolus feature update in a series of limited launch groups through the spring, followed by an expanded launch later in summer.
In addition to the new bolus feature, the mobile app displays the glucose trends, pump status changes, and insulin therapy data for the last 24 hours.
Also, the app displays pump alerts and alarms, and uploads data securely and wirelessly into the cloud-based t:connect web application.
According to the company, the t:slim X2 insulin pump functions independently from the t:connect mobile app to allow users to view pump therapy data, programme requests and cancel bolus insulin requests from their pump.
