US FDA Nods SmartAdjust technology for Individuals with type 2 Diabetes

The FDA broadened the uses of Insulet SmartAdjust, a technology for diabetes management, to include type 2 diabetes in adults over 18 years old, in addition to type 1 diabetes in individuals aged two and older. Software that automatically adjusts insulin delivery to a person with diabetes by connecting to an ACE pump and iCGM is known as an interoperable automated glycaemic controller.

“The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “Automated insulin dosing technology has previously been available only for people with type 1 diabetes. Today’s action helps expand access to this important diabetes management tool to millions of adults living in the US with type 2 diabetes.  The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes.”

Over 11% of the American population has been diagnosed with diabetes, a medical condition characterized by insufficient production or utilization of the hormone insulin, which regulates blood glucose levels. Patients with type 2 diabetes can take medications to boost insulin secretion or enhance insulin sensitivity, in combination with maintaining a balanced diet and engaging in regular physical activity. A lot of patients require insulin therapy to maintain their blood sugar levels within a safe range.