The dream of a completely closed-loop system for diabetes management is now closer than ever for many Type 1 diabetes patients, thanks to the widespread U.S. launch of a completely automated, continuous glucose monitor-compatible insulin delivery device.
Just a few months after beginning a limited release of its Omnipod 5 insulin pump, Insulet is making the tubeless system available to all eligible diabetes patients in the U.S., the company announced Monday.
Adults and children as young as 6 years old with Type 1 diabetes can now access the Omnipod 5 device through retail, specialty and mail-order pharmacy channels, where their standard insurance coverage will apply. Through that channel, customers can avoid the high upfront costs that come with purchasing other insulin pumps through durable medical equipment suppliers and are also able to test out the device on a trial basis.
As Eric Benjamin, Insulet’s executive vice president of innovation, strategy and digital products, told Fierce Medtech during the American Diabetes Association’s (ADA's) annual conference in early June, “What that means is that folks with pharmacy benefits can typically get access to Omnipod for about the same cost as multiple daily injections, even though it delivers a dramatically better experience.”
He continued, “It’s really affordable, and it’s pay-as-you-go, so folks can try out Omnipod—if it works for them, they keep using it, and if it doesn’t, they can try something else.”
Omnipod 5 was cleared by the FDA at the end of January. Though initially cleared only for people ages 6 and up with Type 1 diabetes, Insulet said at the time that it was already eyeing expansions to that indication that would make the device available first to children as young as 2 years old, then to people with Type 2 diabetes, who typically don’t use automated insulin delivery systems to manage their diabetes.
Insulet reported promising results in both of those groups at the ADA conference earlier this year. In one study, Type 1 patients between the ages of 2 and 6 saw their average HbA1c levels drop from a baseline of 7.4% to 6.9% within three months of using the Omnipod 5 then stay at that level for the entire first year of use.
Meanwhile, a small group of adult Type 2 patients used the insulin pump for eight weeks and saw their A1C levels drop from a starting average of 9.4% to 8%. After about three more months of use, those readings had dropped to an average of about 7.7%.
Insulet’s technology centers on disposable “pods” that can provide up to three days’ worth of insulin without requiring fingersticks or manual injections. That insulin delivery is fully automated, since the Omnipod 5 can be linked to a user’s Dexcom continuous glucose monitor.
The entire closed-loop system can be monitored and controlled either by the separate Omnipod 5 controller or a user’s own smartphone. The insulin pump is currently compatible with many Android devices, and Benjamin told Fierce Medtech that Insulet is currently working on an iPhone-friendly version of the app.