The FDA is on a roll. Fresh off handing down an approval to Medtronic’s latest insulin pump, the agency has doled out a nod for yet another diabetes device, this time to Insulet.
In contrast to Medtronic’s MiniMed 780G pump, which is indicated only for people with Type 1 diabetes, Insulet’s newly cleared Omnipod Go system is aimed specifically at patients managing Type 2. Its tubeless pods are meant to continuously dispense rapid-acting insulin over the course of three days, replacing the doses of long-acting insulin that many people with Type 2 diabetes must manually inject each day.
“Omnipod Go was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes,” Insulet CEO Jim Hollingshead, Ph.D., said in a company release Tuesday announcing the FDA clearance. “Our goal is to help people with type 2 diabetes successfully shift to insulin therapy with a product that fundamentally changes how they feel about diabetes management.”
The Omnipod Go pods are currently indicated for use only by adults with Type 2 diabetes who rely on basal insulin injections to control their glucose levels. Each pod can hold enough insulin to last up to 72 hours and can be filled with a range of currently available U-100 insulins, including NovoLog, Fiasp, Humalog, Admelog and Lyumjev.
Unlike Insulet’s other Omnipod devices, the Go system doesn’t connect to a smartphone or standalone controller. Instead, it works independently throughout each three-day shift, delivering continuous rapid-acting insulin according to one of seven preprogrammed daily rates.
Insulet said in the announcement that it developed Omnipod Go with an eye toward improving the diabetes management process for people with Type 2, who often don’t start using automated technologies like insulin pumps and continuous glucose monitors until well into the disease’s progression—if ever. The company noted that starting with the Omnipod Go will make for an easier transition to other insulin delivery devices if a user’s diabetes progresses to the point of needing both basal and bolus doses of insulin.
Insulet will begin rolling out the Omnipod Go system in the U.S. next year, according to the announcement.
Though Omnipod Go is Insulet’s first insulin pump aimed solely at people with Type 2 diabetes, those who need both basal and bolus insulin are also able to use the Omnipod Dash system, which offers more pared-down features than the company’s flagship Omnipod 5.
Omnipod 5 is currently indicated to help manage only Type 1 diabetes, but Insulet is in the process of testing it out among an expanded user pool. During an earnings call with investors earlier this year, Hollingshead said the company is planning to kick off a trial of the device among participants with Type 2 diabetes this year, which he said will represent “the largest clinical study we’ve conducted to date.”