28 Aug 2024 • The U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older.

An interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).

The FDA reviewed data from a clinical study in which 289 individuals 18 years and older with type 2 diabetes on insulin used the Insulet SmartAdjust technology for 13 weeks. Encouragingly, the study showed that subjects’ blood sugar control improved compared to before the study and these improvements were seen across all demographic groups.

Adverse events reported during the study were generally mild to moderate, and included hyperglycemia, hypoglycemia and skin irritation.

Source: FDA | Read full story