Tandem Diabetes Care (NASDAQ:TNDM) today announced FDA clearance of bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app.
Company officials said the t:connect mobile app is now the first FDA-cleared smartphone app for insulin delivery on both the iOS and Android operating systems.
Tandem Diabetes Care plans to roll out the mobile bolus feature update in the U.S. throughout the spring in a series of limited launch groups that it has already selected. The company plans an expanded launch later this summer.
“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” Tandem Diabetes Care CEO John Sheridan said in a news release. “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.”
Along with the newly cleared bolus feature, the mobile app shows the last 24 hours of glucose trends, pump status changes and insulin therapy data. Data on the app includes basal and bolus deliveries and suspensions of insulin delivery.
The app also displays pump alerts and alarms.
Since the t:slim X2 insulin pump functions independently from the t:connect mobile app, users can still view pump therapy data, program requests and cancel bolus insulin requests from their pump.
To ensure compatibility, Tandem verifies each combination of device and operating system works as intended to program and cancel a bolus. So not every smartphone will be able to use the bolus feature within the mobile app.