FDA Expands Use of Insulet SmartAdjust Technology to Adults With Type 2 Diabetes

The FDA has “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.” The agency's website has the release.

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).” Automated insulin dosing technology had previously been available only for people with type 1 diabetes, according to Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.

Over 11% of Americans are diagnosed with diabetes. Patients with type 2 diabetes “may take medications that can help increase insulin secretion or improve insulin sensitivity, in addition to following a healthy eating plan and physical activity. Many patients also need to use insulin therapy to keep their blood sugar in a safe range.” Insulin therapy for people with type 2 diabetes was previously limited to methods such as “injection with a syringe, an insulin pen or an insulin pump, all of which require patients to self-administer insulin one or more times a day and check blood glucose frequently to achieve the best results. Today’s clearance provides a new option that can automate many of these manual tasks, potentially reducing the burden of living with this chronic disease.”

A study showed that, among subjects who used the Insulet SmartAdjust technology, “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.”