The Food and Drug Administration has cleared Tandem Diabetes Care’s mobile app capable of initiating insulin delivery from the company’s t:slim X2 insulin pump on both iOS and Android. Tandem claims it is the first time the FDA has cleared a smartphone application for such a purpose.
Tandem Diabetes Care’s insulin delivery mobile app approved by FDA
Pumps typically require individuals to dial in insulin doses manually. However, with Tandem’s app, users will be able to “program or cancel bolus doses of insulin” on both iOS and Android. Previously, the app could only be used for looking at trends and historical data. From Tandem Diabetes Care’s press release:
“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.”
The company plans to offer the feature to existing users at no additional cost. The app’s ability to administer insulin doses will be made available this spring with a series of “limited launch groups,” with a wider rollout later in the summer.
When released, this new feature will be offered in the United States for no additional cost to new t:slim X2 insulin pump customers and to in-warranty customers through a remote software update for the t:slim X2 insulin pump and the updated t:connect mobile app. 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. Limited launch participants have already been selected.
This approval from the Food and Drug Administration comes as Apple is rumored to be researching the ability of the Apple Watch to measure blood glucose through an optical sensor. However, recent reports suggest that progress on this feature has hit a halt until further notice.