FDA Greenlights Tandem’s Insulin Dose-Programming t:connect Mobile App

San Diego-based tech maker Tandem Diabetes Care has scored FDA clearance for its t:connect mobile application to control bolus insulin dosing. Users of the company's t:slim X2 insulin pump can now program or cancel bolus requests through the paired app. Bolus dosing, which consists of short or rapid-acting insulin, is typically done at mealtimes to help individuals regulate their blood sugar levels. Discretion as well as the chance to reduce the amount of direct pump interactions makes the app and bolus dosing feature a major win for diabetics.

The FDA-approved t:connect app is set for a limited launch in the U.S. in the spring, with the plan to extend the offering to other eligible t:slim X2 users over summer. It provides a 24-hour overview of blood glucose measurements and insulin deliveries, and it also functions as an extension of the pump with mobile device push notifications that match the pump's alerts. New and in-warranty pump users will see hassle-free remote updates that link the feature with the pump and smartphone—without any additional fees. As of now, only an iPhone 12 running iOS 14 or a Samsung Galaxy S20 on Android 11 are compatible with this bolus dosing capability. Tandem is exploring which other smartphone models and operating systems can be added to the software.

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