FDA approves first smartphone app for bolus insulin delivery


The FDA has approved the first smartphone application capable of initiating insulin delivery for insulin pump wearers, according to a company press release.

Tandem Diabetes Care has received clearance to offer a bolus insulin dosing feature as part of its t:connect mobile application. The app, which connects to the t:slim X2 insulin pump, will include a new feature giving users the ability to program and cancel bolus insulin requests through their smartphone.

Sign outside FDA HQ in Washington, DC.

“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” John Sheridan, president and CEO for Tandem Diabetes Care, said in the release. “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.”

The t:connect mobile app, which is available for iOS and Android devices, provides 24-hour glucose trends, pump status changes and insulin therapy data for users who pair it with the t:slim X2 insulin pump. The insulin pump can function independently from the app, giving users the ability to view pump therapy data, program requests and cancel bolus insulin requests from the pump.

The bolus insulin dosing feature will be offered at no additional cost for new t:slim X2 insulin pump customers as well as existing in-warranty customers through a remote software update, according to the company. The update will be rolled out in a series of limited launch groups in the spring. According to the press release, limited launch participants have already been selected. An expanded launch of the new feature is expected later in the summer.

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