FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes

FDA News Release

• For Immediate Release: August 26, 2024

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Today, 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 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 U.S. 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.” 

More than 11% of Americans are diagnosed with diabetes, a condition in which the body does not make enough or properly use the blood glucose-regulating hormone insulin. In people with type 2 diabetes, patients 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.

Previously, insulin therapy options for people with type 2 diabetes were 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.

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.