US FDA clears Insulet SmartAdjust technology, a device to power automated insulin dosing for individuals with type 2 diabetes

The FDA has expanded the use of Insulet SmartAdjust technology to manage type 2 diabetes in individuals 18 and older. Previously approved only for type 1 diabetes, SmartAdjust automatically adjusts insulin delivery by connecting to an alternate controller-enabled insulin pump (ACE pump) and an integrated continuous glucose monitor (iCGM).

Diabetes affects over 11% of Americans, requiring effective management. While traditional insulin therapies involve manual tasks like injections and frequent glucose checks, SmartAdjust offers an automated solution, potentially reducing this burden.

A study of 289 adults with type 2 diabetes showed that SmartAdjust improved blood sugar control over 13 weeks without serious complications. The FDA approved the technology through the 510(k) pathway, confirming its equivalence to existing devices.

The FDA, part of the US Department of Health and Human Services, oversees the safety and effectiveness of medical products and regulates various health-related sectors.