Omnipod DASH System from Insulet Receives FDA Clearance
Editor’s Note: This piece has been updated to include the most current information and announcements about the Omnipod DASH System.
June 4, 2018 – Insulet Corporation announced today that the Omnipod DASHTM Insulin Management System has received 510(K) clearance from the FDA. This clearance allows Insulet to commercialize this product in the United States, though Insulet has announced that it will begin roll-out through a limited market launch. Full market release is estimated to begin in early 2019 in the United States.
Omnipod plans to unveil the new DASH system at the American Diabetes Association’s 78th Scientific Sessions June 22-25.
The Omnipod DASH system lays the groundwork for the future of insulin pump technology out of Insulet Corporation – adding Bluetooth, smartphone integrations, and more. Here’s what’s new.
What’s New in the DASH System?
- Updated PDM (Personal Diabetes Manager) – the handheld portion of the Omnipod Insulin Management System got an update. DASH PDM will be a color touch-screen display.
- Bluetooth wireless technology – DASH PDM and Pod will communicate via Bluetooth, laying the groundwork for current and future integrations with compatible technology – like meters, CGM, and management apps.
- Meter integration – DASH will be optimized for use with CONTOUR® NEXT ONE Blood Glucose (BG) Meter for the transfer of blood glucose readings to the PDM’s bolus calculator via Bluetooth. The PDM will no longer have a built-in blood glucose meter
- Diabetes management app integrations – The Omnipod DISPLAY and Omnipod VIEW apps will provide users and their caregivers easy access to their insulin therapy information on their smartphones.
- Omnipod DISPLAY allows users to discreetly monitor their PDM data on their smartphones.
- Omnipod DISPLAY on a smartphone will include a “Find My PDM” feature.
- Omnipod VIEW allows parents and caregivers to monitor their loved ones’ diabetes more easily. The iOS Today View widget allows users and their care teams to see their or their loved ones’ PDM and continuous glucose monitor (CGM) data on one smartphone screen with one swipe.
- New Pods – the DASH pods will look and work the same, but have been updated for Bluetooth compatibility with the DASH PDM. Old pods will not work with the new PDM.
- Rechargeable Battery – The DASH PDM will require recharging of its lithium ion battery, replacing the AAA batteries used in current Omnipod PDMs.
- Payment Structure – The DASH PDM will be offered at no cost with the purchase of Pods.
“Omnipod DASH was inspired by Podders and embodies what users on multiple daily injections have been asking for in a diabetes management system,” said Patrick Sullivan, Chairman and Chief Executive Officer. “Our number one priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that.”
“I’m thrilled with the new Omnipod DASH System,” said Tessa Mellinger, a college student with Type 1 diabetes who was part of the DASH user testing and development. “The PDM display is easy to read, the steps to managing basal rates are user friendly, and the food library is really helpful. The fact that it looks like a smartphone makes it cool to carry and may help eliminate those awkward questions from strangers.”
The Omnipod DASH system represents the latest technology update pushing Insulet’s Omnipod closer to the Horizon Hybrid Closed Loop System currently being developed in clinical trials.
The timeline for commercial availability of the Omnipod DASH remains uncertain – Insulet has announced a limited launch for the first six months, starting in July. During this time, DASH PDMs will be made available via a select group of endocrinologists participating in the “Omnipod DASH AHEAD program”. The product is expected to be fully commercially available in the United States early in 2019.