Tandem App Cleared for Bolus Insulin Dosing

FDA has cleared a Tandem Diabetes Care 510(k) for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app. The company says this is the only FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems. “The updated t:connect mobile app is designed to offer t:slim X2 insulin pump users the ability to program and cancel bolus insulin requests through the convenience of their compatible smartphone,” it says.

The mobile app discreetly displays the user’s pump information on their personal smartphone, and it displays the last 24 hours of glucose trends, pump status changes, and insulin therapy data, including basal and bolus deliveries and suspensions of insulin delivery, according to Tandem. It also displays pump alerts and alarms, and it securely uploads data into the cloud-based t:connect Web application wirelessly.