The U.S. Food and Drug Administration (FDA) has approved Insulet Corporation’s new Omnipod 5 Automated Insulin Delivery System for people ages 6 and older with type 1 diabetes, according to an announcement from the company.
As the announcement notes, Omnipod 5 is the first tubeless automated insulin delivery system that lets you use a smartphone as the control device. The system integrates the Dexcom G6 Continuous Glucose Monitoring (CGM) System with a compatible smartphone, and automatically adjusts insulin delivery to help maintain stable blood glucose levels and avoid episodes of high or low glucose. The system is approved as part of a management protocol that doesn’t require finger-stick blood glucose tests, unless you have reason to believe that your CGM reading isn’t correct. Like most insulin pump systems, Omnipod 5 eliminates the need for multiple daily insulin injections, as users receive both basal (background) and bolus (mealtime) insulin from a pod that adheres to the skin’s surface, and contains a tiny cannula (similar to a tube) that is inserted into the skin.
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“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, president and chief executive officer of Insulet, in the announcement. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”
Omnipod 5 components
While the Omnipod 5 system is compatible with several smartphones, users can instead choose to use the Omnipod 5 Controller, which is provided with the first prescription as part of the system. Users can use this controller, or the Omnipod smartphone app, to calculate insulin boluses based on what they eat — through what the company dubs its SmartBolus Calculator. Aside from boluses, though, the system is designed to automatically regulate blood glucose levels. Every five minutes, the system receives a CGM reading and compares it with previous readings to maintain or adjust insulin delivery — including completely pausing insulin delivery, if necessary — based on the user’s predetermined target blood glucose range.
Omnipod 5 launch
Insulet will begin its launch of Omnipod 5 within a limited market, in order to gain user feedback and update the system’s software as needed. The system’s release will take place through pharmacies, which means that when people sign up, there is no contract or obligation to continue using the system is it’s not the right fit. More details about the Omnipod 5 product launch will be shared later this month as part of Insulet’s quarterly earnings conference call. In the meantime, the company notes, people with diabetes can start using the Omnipod DASH system and upgrade to Omnipod 5 at no extra cost when the new system becomes available.
Want to learn more about insulin pumps? Read “How to Pick an Insulin Pump or CGM” and “Ways to Deliver Insulin: Inhalers and Insulin Pumps.”
