FDA Approves First Automated Insulin Dosing Device for Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has broadened the use of Insulet SmartAdjust technology, an automated glycemic controller. Initially approved for managing type 1 diabetes in individuals aged two and older, this technology is now also authorized for managing type 2 diabetes in adults aged 18 and above. This approval marks a significant advancement in diabetes care, extending the benefits of automated insulin dosing to a larger patient population.

Insulin delivery has traditionally involved manual methods such as syringes, insulin pens, or pumps, necessitating frequent blood glucose checks and self-administered insulin doses. The Insulet SmartAdjust technology, however, automates insulin delivery by integrating with an ACE (alternate controller-enabled) pump and an iCGM (integrated continuous glucose monitor). This automation can significantly ease the daily management of diabetes, reducing the effort required from individuals living with the condition.

Dr. Michelle Tarver, Acting Director of the FDA's Center for Devices and Radiological Health, emphasized the agency's commitment to facilitating access to advanced diabetes management tools. She pointed out that the recent approval extends these benefits to millions of U.S. adults living with type 2 diabetes, thereby enhancing their quality of life and health outcomes.

Diabetes affects over 11% of the American population. It results from the body's inability to produce sufficient insulin or properly utilize it, leading to abnormal blood glucose levels. For those with type 2 diabetes, treatment typically includes medications that boost insulin secretion or enhance insulin sensitivity, alongside lifestyle changes such as a healthy diet and regular physical activity. Many patients also require insulin therapy to maintain safe blood glucose levels.

The FDA's decision to expand the indications for the Insulet SmartAdjust technology followed a comprehensive review of clinical data involving 289 adults with type 2 diabetes. Participants in the 13-week study represented diverse racial and ethnic backgrounds, varied age groups, education, and income levels. The study also included individuals with different levels of experience in managing diabetes and using insulin, with many participants also taking common non-insulin diabetes medications such as GLP1 agonists.

The findings from the study were promising, showing significant improvements in blood sugar control across all demographic groups. Importantly, no serious adverse events were linked to the use of SmartAdjust technology. Mild to moderate adverse events were reported, including episodes of hyperglycemia (high blood sugar), hypoglycemia (low blood sugar), and skin irritation, but these were not severe.

The evaluation of the SmartAdjust technology software was conducted through the FDA's 510(k) premarket clearance pathway, which is used to demonstrate that a new device is substantially equivalent to an already legally marketed device.

The FDA's expansion of the Insulet SmartAdjust technology's indications underscores the agency's dedication to advancing medical device innovations that improve the lives of people with chronic conditions requiring ongoing management, such as diabetes. This development promises to alleviate some of the burdens associated with daily diabetes management, offering a more streamlined and automated approach to insulin delivery.