FDA clears first smartphone app for insulin delivery for IOS and Android.
SAN DIEGO Feb. 16, 2022 – Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, said today that bolus insulin dosing on the t:slim X2 insulin pump via the t:connect mobile app has been cleared by the US Food and Drug Administration (FDA). On both the iOS and Android operating systems, this is the first-ever FDA-cleared smartphone application capable of commencing insulin delivery. The revised t:connect mobile software is meant to allow users of the t:slim X2 insulin pump to program and cancel bolus insulin requests using their compatible smartphone.
“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” said John Sheridan, president, and CEO of Tandem Diabetes Care. “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.”
This new functionality will be available in the United States for no additional charge to new t:slim X2 insulin pump customers and in-warranty customers via a remote software update for the t:slim X2 insulin pump and the updated t:connect mobile app when it becomes available. The Company plans to roll out the mobile bolus feature upgrade in a series of limited launch groups throughout the spring, followed by a larger launch later this summer. Only a few people have been chosen to participate in the launch.
When linked with a t:slim X2 insulin pump, the t:connect mobile app is a safe, user-friendly mobile application that discreetly displays the user’s pump information on their personal smartphone. The mobile app also shows glucose trends, pump status changes, and insulin therapy data, including basal and bolus deliveries and suspensions of insulin delivery, in addition to the newly cleared bolus capability. The app also shows pump warnings and alarms and securely transfers data to the t:connect web application, which is hosted in the cloud. Importantly, the t:slim X2 insulin pump operates independently of the t:connect mobile app, giving users complete control over their pump therapy data, programming requests, and canceling bolus insulin requests.
The t:connect mobile app is compatible with select versions of both iOS and Android operating systems in the United States. To ensure compatibility, Tandem verifies each combination of device and operating system works as intended to program and cancel a bolus from your smartphone. This means that not every smartphone will be able to use the bolus feature within the t:connect mobile app. More information is available at www.tandemdiabetes.com.
In addition to the t:connect mobile app being the first to receive FDA clearance on both iOS and Android operating systems to deliver insulin from a personal smartphone, Tandem was also the first to receive an interoperable automated glycemic controller designation with Control-IQ technology in December 2019, the first to receive an alternate controller-enabled infusion pump classification in February 2019, and the first insulin pump designated as compatible with integrated continuous glucose monitoring devices in June 2018.
Source: Tandem Diabetes Care, Inc.