Insulet announces partnerships with Abbott, Dexcom for its tubeless artificial pancreas system
Insulet this week announced separate partnerships with Abbott and Dexcom to integrate continuous glucose monitoring technology with its tubeless artificial pancreas system, according to industry press releases.
Dexcom and Insulet announced a global commercialization agreement to combine current and future Dexcom CGMs with Insulet’s Omnipod Horizon system for automated insulin delivery, currently in pivotal trial, according to a press release. Under the terms of the nonexclusive agreement, the Omnipod Horizon automated insulin delivery system will use sensor values from the Dexcom G6 and next-generation G7 CGM, once available, to predict glucose levels and automatically adjust the insulin dose required for optimal glucose management.
“Everyone at Dexcom is excited to be in the final stages of integrating Dexcom CGM technology into the Omnipod Horizon system,” Kevin Sayer, executive chairman, president and CEO of Dexcom, said in a press release. “This system will bring together the demonstrated accuracy of Dexcom CGM with Omnipod’s tubeless insulin delivery pod which provides a simple user experience and freedom from injections and tubes. It will be a truly transformative, automated insulin delivery system giving more options to people with diabetes.”
In a similar announcement, Abbott and Insulet announced a partnership to integrate Abbott’s next-generation Freestyle Libre 2 with the Omnipod Horizon system. The FreeStyle Libre 2 system is currently approved in Europe and offers enhanced accuracy and optional glucose alarms at no additional cost from the first-generation Libre system, according to Abbott. The FreeStyle Libre 2 system can continuously stream glucose data to digitally connected devices.
The integrated platform will consist of the tubeless insulin delivery pod and FreeStyle Libre sensor. Glucose data from the sensor will be sent directly to the pod that is embedded with an algorithm to automatically adjust insulin delivery, without the need for an additional device, connection or tubing, according to the release. The system will be designed to always remain in automated insulin delivery mode and can be controlled through an app on a user’s smartphone to manually take a bolus dose before meals for optimal performance. Additionally, the integrated platform is expected to be the first combined system with a fully disposable wearable sensor and pump.
“Abbott is focused on creating future-forward health technologies that simplify how people living with diabetes manage their condition so they can live their best lives,” Jared Watkin, senior vice president of diabetes care, Abbott, said in a press release. “As diabetes care becomes more interoperable, we’re developing more connected approaches to improve care. Through this partnership, Abbott and Insulet will offer an integrated digital health platform that is simple and accurate and will provide a best-in-class user experience.”
As Healio previously reported, the FDA cleared Insulet to market its tubeless Omnipod DASH insulin management system as an integrated insulin pump, allowing it to be part of an interoperable, automated insulin delivery system. The Omnipod pump is the second device to be classified under a new de novo premarket review pathway, a regulatory pathway for novel, low- to moderate-risk devices of a new type, according to the FDA. The FDA cleared the device as an alternate controller enabled infusion pump, or ACE pump, allowing it to be a part of an interoperable automated insulin delivery system, such as Insulet’s Omnipod Horizon automated insulin delivery system.
Shacey Petrovic, president and CEO of Insulet, said the agreements represent a milestone in realizing the benefits of interoperability.
“As interoperability becomes increasingly important, our approach to automated insulin delivery will change the future of blood glucose management by offering consumers greater choice in algorithms, sensors and overall experience,” Petrovic said in a press release.
With Dexcom CGM integration, the Omnipod Horizon system requires no finger sticks for blood glucose measurement or CGM calibration and will feature an extended 10-day sensor wear, acetaminophen blocking and the ability to share real-time CGM data with up to 10 followers with the Dexcom Follow mobile app.
Insulet plans to commercially launch the Omnipod Horizon system in the second half of 2020, according to the release. – by Regina Schaffer
Disclosures: Petrovic is president and CEO of Insulet. Sayer is executive chairman, president and CEO of Dexcom. Watkin is senior vice president of diabetes care, Abbott.