FDA clears first automated insulin dosing for T2D

The U.S. Food and Drug Administration on August 26, 2024 expanded the indication for Insulet's SmartAdjust technology to include adults with type 2 diabetes, clearing the first automated insulin dosing device for that population, the agency said. The software had previously been cleared only for people with type 1 diabetes ages 2 and older. The expanded indication covers adults 18 and older with type 2 diabetes who use insulin. Insulet said the clearance made its Omnipod 5 system the first and only automated insulin delivery system cleared in the United States for both type 1 and type 2 diabetes. ### What exactly did the FDA clear? The FDA said it expanded the indications for Insulet SmartAdjust, an interoperable automated glycemic controller that adjusts insulin delivery by connecting with an alternate controller-enabled insulin pump and an integrated continuous glucose monitor. In practice, that software powers Insulet's Omnipod 5 automated insulin delivery system. (fda.gov) Adults with type 2 diabetes have typically managed insulin with syringes, pens or pumps that still require repeated manual dosing decisions, the agency said. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, said the action would expand access to automated insulin dosing technology to adults with type 2 diabetes, after such systems had previously been available only for type 1 diabetes. (fda.gov) ### What evidence did the agency use? The FDA said it reviewed data from a 13-week clinical study in 289 adults with type 2 diabetes who were already using insulin. The trial included participants from different racial and ethnic backgrounds and across a range of ages, education levels and income levels, according to the agency. (fda.gov) Insulet separately identified that study as SECURE-T2D, a multicenter pivotal trial presented at the American Diabetes Association's 84th Scientific Sessions in Orlando in June 2024. Study chair Francisco Pasquel of Emory University said the findings showed improvements in blood glucose outcomes and quality of life with automated insulin delivery in adults with type 2 diabetes. (fda.gov) ### What changed for patients in the trial? Insulet said results from SECURE-T2D showed time in range increased to 64% from 48% after 13 weeks of Omnipod 5 use. The company also said HbA1c fell to 7.4% from 8.2% overall, and by 2.1 percentage points among participants whose baseline HbA1c was 9.0% or higher. (investor.insulet.com) The FDA said blood sugar control improved across demographic groups and that no complications or serious adverse events related to SmartAdjust were reported in the study. The agency said adverse events were generally mild to moderate and included high blood sugar, low blood sugar and skin irritation. (nasdaq.com) ### Who is the clearance for — and who is left out? The FDA said the expanded indication applies only to people 18 years and older with type 2 diabetes. The prior indication for type 1 diabetes remains in place for patients ages 2 and older, but the new type 2 clearance does not extend to children or to adults with type 2 diabetes who are not using insulin. (fda.gov) More than 11% of Americans are diagnosed with diabetes, the FDA said, and many people with type 2 diabetes eventually need insulin therapy to keep blood sugar in a safe range. Insulet said the label expansion made Omnipod 5 commercially available to about 6 million people in the United States living with insulin-requiring type 2 diabetes. (fda.gov) ### Where does Omnipod 5 fit in Insulet's rollout? Insulet said on June 21, 2024 that it had submitted the SECURE-T2D results to the FDA and, subject to clearance, expected a U.S. commercial launch in early 2025. The company reiterated after clearance that Omnipod 5 was now indicated for people with type 2 diabetes ages 18 and older in the United States. (fda.gov) In February 2026, Insulet described Omnipod 5 as its flagship automated insulin delivery system in full-year results, and in May 2026 the company said U.S. Omnipod revenue growth was driven by demand across both type 1 and type 2 diabetes. Those updates indicate the type 2 expansion had moved from regulatory clearance to commercial sales by 2026. (investor.insulet.com) May 2026 is the latest point confirmed in company disclosures in the materials reviewed here. Insulet's investor releases remain the clearest place to track additional algorithm updates, launch details and U.S. demand disclosures tied to Omnipod 5 in type 2 diabetes. (uk.marketscreener.com) (investors.insulet.com)