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# Omnipod 5 Expanded Clearance for Type 2 Diabetes
- URL: https://www.fdaweb.com/omnipod-5-expanded-clearance-for-type-2-diabetes/
- Published: 2024-08-26T12:00:00.000Z
- Updated: 2026-09-14T14:39:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157650

FDA has cleared an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes (ages 18 years and older). Previously, the insulin pump was FDA-cleared for Type 1 diabetes management.

The clearance is based on recent data showing that Omnipod 5 significantly improves health outcomes for people with Type 2 diabetes. “The [SECURE-T2D clinical study](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestors.insulet.com%2Fnews%2Fnews-details%2F2024%2FInsulets-SECURE-T2D-Pivotal-Trial-Results-Demonstrate-Omnipod-5-Improves-Clinical-Outcomes-and-Quality-of-Life-in-Type-2-Diabetes%2Fdefault.aspx&esheet=54112863&newsitemid=20240826534708&lan=en-US&anchor=SECURE-T2D+clinical+study&index=2&md5=52aea8fc7ec83a4faf2fa2b5cb53c982&ref=fdaweb.com) demonstrated that compared to prior insulin therapy methods in adults with Type 2 diabetes, Omnipod 5 use resulted in considerable reductions in HbA1c \[glucose level\]: 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher,” the company says. “Time in hyperglycemia and total daily insulin dose were also reduced, and there was a 20% improvement in time in range, increasing by 4.8 hours per day, without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.”