USFDA nod to t:connect, first app for insulin delivery

The move is seen as a big relief for people who prefer not to have insulin pumps out in public settings or attach them to undergarments like bras.

Tandem Diabetes Care, a leading insulin delivery and diabetes technology company, announced that FDA has cleared 'bolus insulin' dosing on the 't:slim X2' insulin pump using the 't:connect' mobile app.

The updated t:connect mobile app is designed to offer insulin pump users the ability to programme and cancel bolus insulin requests through the convenience of their compatible smartphone. Previously, delivery had to be handled through the pump itself.

"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," said John Sheridan, president and CEO of Tandem Diabetes Care.

The company intends to roll out the mobile bolus feature update throughout the spring in a series of limited launch groups, followed by an expanded launch later this summer. The mobile app is a secure, user-friendly mobile application that, when paired with the insulin pump, discreetly displays the user's pump information on their personal smartphone.

In addition to the newly-cleared bolus feature, the mobile app 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.

The app also displays pump alerts and alarms, and it securely uploads data into the cloud-based t:connect web application wirelessly.

"Importantly, the t:slim X2 insulin pump functions independently from the t:connect mobile app, therefore a user always retains the freedom to view pump therapy data, programme requests and cancel bolus insulin requests from their pump," said the company.