Dive Brief:
- Insulet received Food and Drug Administration clearance on Monday for its newest insulin pump to be used by people with Type 2 diabetes.
- The regulatory decision will bring to market the first automated insulin delivery (AID) system, also known as an “artificial pancreas,” for both Type 1 and Type 2 patients. By pairing Insulet’s Omnipod 5 pump with a continuous glucose monitor, the device will automatically adjust insulin delivery based on a person’s blood glucose levels.
- Insulet’s new indication comes as other diabetes device makers target the Type 2 market. Tandem Diabetes Care is running a randomized controlled trial of its Control IQ AID system in people with Type 2 diabetes, which could lead to an expanded indication for its t:slim X2 and Mobi pumps. Meanwhile, Medtronic struck a partnership with Abbott to make a sensor that would pair with Medtronic’s insulin pumps, with the goal of expanding access to its AID algorithms.
Dive Insight:
Insulet first launched its Omnipod 5 patch-pump for people with Type 1 diabetes in 2022. Now, the device is also indicated for people with Type 2 diabetes ages 18 years and older.
There are roughly 6 million people with Type 2 diabetes in the U.S. who take insulin, and roughly 2.5 million people in that group take multiple daily injections of insulin, the company said.
In clinical trial results shared in June, Insulet said it tested its AID system in people with Type 2 diabetes who take multiple daily shots of insulin, as well as people who only take basal, or daily, insulin.
The company said it observed significant improvements in participants’ hemoglobin A1C levels, “regardless of prior therapy at the start of the trial.”
On average, Omnipod 5 users’ HbA1C levels fell by 0.8% after 13 weeks using the system. Participants’ time in range also improved by about 20%.
Insulet expects the new clearance will make it easier for people to meet their blood glucose targets. CEO Jim Hollingshead told investors earlier this month that the company is “excited about the huge opportunity for us in Type 2,” and that Omnipod 5 will replace Omnipod Go as the company’s device for people with Type 2 on basal-only insulin.
The company also plans this year to integrate its Omnipod 5 pump with Abbott’s Freestyle Libre 2 Plus glucose sensor.
Insulet reported second quarter revenue of $488.5 million, up 23% compared to the prior-year period. The company raised its revenue growth forecast for the year to a range of from 16% to 19%, compared to a previous range of from 14% to 18%.