FDA paves way for new mobile insulin delivery app
The Food and Drug Administration on Wednesday paved the way for a mobile app that will allow people with diabetes to initiate insulin delivery from their smartphone.
The technology, developed by Tandem diabetes care, will allow users to schedule or cancel insulin injections at specific times of the day. The app, which will work on select iPhones and Androids, is specifically designed to insulin bolus injections – the fast-acting version of insulin taken directly before food intake in order to regulate blood sugar levels after eating.
Currently, the app will only work on an iPhone 12 with iOS 14 software or a Samsung Galaxy S20 with OS 11. It is only approved for ages 6 and up.
While there are plenty of other apps that can help people with diabetes track their blood sugar, enter health information, and even set test reminders, Tandem says their app is the first-ever that will allow humans to activate their insulin pump remotely during certain periods.
“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 discreet solution,’ John Sheridan, president and CEO of Tandem Diabetes Care, wrote in a statement.
The FDA allowed last year the Omnipod 5, an automated insulin delivery system with a smartphone app. Unlike the Tandem app, users cannot schedule insulin injections through Omnipod; instead, the app constantly monitors users’ blood sugar levels and automatically makes adjustments throughout the day.
Tandem plans to roll out the new feature to its app this spring in a series of limited launches for pre-screened entrants, with a larger launch expected later in the summer.
The new app functionality will be available free of charge to current users and warranty customers of Tandem’s t:slim X2 insulin pump. It will also display data from the previous 24 hours regarding glucose levels, insulin injections, pump status changes and more.
App users will also be able to access their health data directly from the pump, as the app and the pump can be used independently of each other.
The app could be a game-changer for some of the Over 34 million Americans living with diabetes, as Tandem aims to reduce the number of times users have to interact with their pump.
Spectrum News has contacted the FDA for comment.