Insulet (NSDQ:PODD) announced today that it received FDA clearance for its Omnipod 5 automated insulin delivery system.
FDA clearance for the next-generation version of the company’s wearable insulin delivery pump system covers individuals aged six years and older with type 1 diabetes. The platform provides easier glucose management, with no multiple daily injections, no tubes and zero fingersticks.
Paired with Dexcom’s G6 continuous glucose monitoring (CGM) system, Omnipod 5 will be the first tubeless, wearable, automated insulin delivery system, Insulet President and CEO Shacey Petrovic told Drug Delivery Business News in an interview last year. In addition, patients will be able to use a dedicated handheld controller or control the system with a secure app on their smartphone, marking another first.
Data presented at the European Association for the Study of Diabetes (EASD) 2021 annual meeting demonstrated significantly improved time in range and reduced glycosylated hemoglobin (HbA1c) levels in a clinical trial of the Omnipod 5.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” Petrovic said in a news release today. “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.”
Acton, Massachusetts–based Insulet designed its Omnipod 5 as a tubeless pod enhanced with SmartAdjust technology, the Dexcom 6 CGM and the Omnipod 5 mobile app with an integrated SmartBolus calculator. Users can download the app onto a compatible smartphone or use the Omnipod 5 controller, provided free with the first prescription.
The device provides a Dexcom CGM value and trend to the SmartAdjust technology every 5 minutes. It then predicts where glucose will be 60 minutes into the future before increasing, decreasing or pausing insulin delivery, using the wearer’s desired and customized glucose target to protect against highs and lows.
“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” Dexcom Chair, President and CEO Kevin Sayer said in the release. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”
Insulet plans to launch Omnipod 5 through its pharmacy channel and, in the coming days, will offer it in a limited market release. The company expects Omnipod 5 to be broadly available “shortly after” the limited release.
The company noted that people with diabetes can receive the benefits of its therapy through OmnipodPromise, which allows new and existing users to start on the Omnipod Dash platform and upgrade to Omnipod 5 at no additional cost when coverage is available.
BTIG analyst Marie Thibault wrote in a report that the transition to the full commercial launch for Omnipod 5 should be “somewhat quick” given advancements made during an FDA review period that was delayed. Insulet gained initial coverage from payors, tested internal systems, trained personnel and ramped manufacturing.
“We think this clearance will spur increased adoption of [automated insulin delivery] systems from those using multiple daily injections (MDI) and also allow PODD to take meaningful share from its two competitors in the AID market given the combination of good time-in-range (relatively similar to other systems’ pivotal and real-world data), low rates of hypoglycemia, the intuitive, simple design (no tubing, no calibration needed), and the low barrier business model (no upfront cost, no lock-in period),” Thibault wrote.
The next steps, according to analysts, include smartphone control through an iOS device and integration with other CGMs, including Abbott’s FreeStyle Libre 2 and eventually the Dexcom next-generation G7. (Industry watchers expect GT approval to come soon.) The company will also look to expand the label to ages 2 to 6 and people with type 2 diabetes.