The FDA has cleared its first automated insulin pump for adults with Type 2 diabetes, with Insulet’s Omnipod 5 delivery system opening the door to a population of more than 6 million people.
That includes about 2.5 million people who require multiple injections of insulin per day, according to Insulet. The company also estimates that only a quarter of people taking insulin to manage their Type 2 diabetes are meeting their HbA1c goals of 7% or less.
Now, they will have access to the same technology employed by people with Type 1 diabetes, with Insulet’s tubeless Omnipod system being able to connect with a wearable continuous glucose monitor to automatically detect blood sugar levels and adjust insulin doses accordingly.
“The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management,” Michelle Tarver, M.D., Ph.D., the FDA’s device center acting director, said in an agency statement. “Automated insulin dosing technology has previously been available only for people with type 1 diabetes.”
Insulet adds that, despite advances in therapies over the past two decades, adults have not seen significant increases in their control of Type 2 diabetes; the company said about half of those 6 million people have HbA1c readings above 8%, while more than 30 million people in the U.S. are currently living with Type 2 diabetes.
“Omnipod 5 is setting a new standard in diabetes management, and we are thrilled with the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community,” said Insulet President and CEO Jim Hollingshead, with the company’s wearable pump being the first automated insulin delivery system to garner FDA green lights in both Type 1 and Type 2 diabetes.
In a clinical trial, Omnipod 5 was able to lower HbA1c by 0.8 percentage points overall and by 2.1 points among adults with Type 2 diabetes who started the study at 9% or higher. According to Insulet, its system also reduced total daily insulin doses, with a 20% increase in the daily amount of time spent in a healthy blood sugar range compared to manual injections with an insulin pen or syringe.
The 510(k) clearance follows the move of CGM sensors into the same territory. Companies such as Dexcom have been working to expand the use of their wearable blood sugar trackers from Type 1 diabetes into Type 2—including the millions more people who have a diagnosis but do not need to take insulin.
Most recently, Dexcom this week launched its first over-the-counter CGM, the Stelo, aimed at offering a more “health-focused” sensor to people that may be curious about how diet and exercise affect their glucose levels.
Meanwhile, earlier this year, Abbott gathered a pair of FDA clearances for its over-the-counter Libre Rio and Lingo CGMs. The Libre Rio is designed for adults with Type 2 diabetes that are not taking insulin, while the Lingo looks to compete in the health and wellness market.