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. This study enrolled a diverse group of subjects from different racial and ethnic backgrounds, with a wide range of ages, education and income levels. Study participants had varying amounts of experience with diabetes and insulin use, and many subjects were also using common non-insulin diabetes medications like GLP1 agonists. Overall, the study showed that subjects’ blood sugar control improved compared to before the study and these improvements were seen across all demographic groups. There were no complications or serious adverse events related to the use of the SmartAdjust technology. Adverse events reported during the study were generally mild to moderate, and included hyperglycemia (high blood sugar), hypoglycemia (low blood sugar) and skin irritation.
The FDA reviewed the SmartAdjust technology software through the 510(k) premarket clearance pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
