FDA clears Tandem's smartphone app for programming insulin doses

There’s an app for just about everything these days, and now, that even includes one to program insulin doses throughout the day—though only for a very specific cross-section of insulin pump users and smartphone owners.

The t:connect mobile app from Tandem Diabetes Care received an FDA clearance to control bolus insulin dosing, the San Diego-based diabetes tech maker announced Wednesday. Individuals who use Tandem’s t:slim X2 insulin pump will now be able to use the app to either program or cancel bolus requests, which deliver an extra dose of short- or rapid-acting insulin at mealtimes to regulate blood sugar levels.

The newly cleared app feature will begin its U.S. rollout in a limited launch this spring before expanding to other eligible t:slim X2 users throughout the summer. The update will be available to new and in-warranty pump owners at no cost and will be added to the pump and smartphone app via remote updates.

Currently, the bolus dosing feature is compatible only with an iPhone 12 running iOS 14 or a Samsung Galaxy S20 on Android 11, though Tandem said it’s working on adding more smartphone models and operating systems to the software.

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The t:connect app can already be used by diabetes patients with the t:slim X2 pump. It not only gives them a clear view of their last 24 hours of blood glucose measurements and insulin deliveries but also acts as an extension of the pump, providing mobile push notifications alongside the pump’s alerts.

The app is meant to reduce the number of direct interactions with the pump and make diabetes management both easier and more discreet by allowing users to monitor alerts and blood sugar levels from their phones. That holds true for the new bolus dosing feature, Tandem CEO John Sheridan said in a statement, since meting out a meal bolus is the most common reason for a patient to interact with their insulin pump.

However, the app won’t completely replace those interactions. It operates independently from the pump, meaning that users will still be able to program dosages, check alerts and monitor their blood sugar levels on the pump itself.

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Tandem isn’t the only medtech maker aiming to make diabetes management more compatible with the mobile devices found in practically everyone’s pocket.

Novo Nordisk partner Amalgam Rx, for one, scored its own green light from the agency in 2017 for an app that helps Type 2 diabetes patients calculate their insulin dosages. Though it doesn’t actually control delivery of the medication like the new t:connect feature—and is directed toward patients who self-administer insulin, rather than relying on automated pumps—the iSage Rx app connects to glucose meters and applies its algorithms to their readings to determine how much basal insulin should be taken.