On August 26, the U.S. Food and Drug Administration (FDA) approved Insulet’s SmartAdjust technology for managing type 2 diabetes in patients aged 18 and above. Earlier, this interoperable automated glycemic controller software was authorized for treating type 1 diabetes in individuals two years and older. The SmartAdjust technology automatically regulates insulin delivery by integrating an alternate controller-enabled insulin pump (ACE pump) and a continuous glucose monitor (iCGM).

Before this approval, type 2 diabetes patients relied on syringes, pens, or pumps for insulin intake, which required continuous blood sugar monitoring. Automated insulin delivery (AID) systems, while commonly used for type 1 diabetes, were sometimes prescribed off-label for type 2 patients. Type 1 diabetes, an autoimmune disorder, is less common than type 2 diabetes, where the body struggles to use insulin effectively. However, this FDA clearance offers a significant advancement, simplifying the management of type 2 diabetes by automating many of the manual tasks associated with this chronic condition.

The FDA’s decision was based on a clinical trial involving 289 type 2 diabetes patients aged 18 and above who used the SmartAdjust technology for 13 weeks. Participants came from diverse racial and ethnic backgrounds and had varying levels of experience with diabetes and insulin use. Many were also on other diabetes medications, such as GLP-1 agonists. The study revealed that blood sugar control improved significantly across all demographic groups, with no serious complications related to the SmartAdjust system. Reported side effects, such as hyperglycemia, hypoglycemia, and skin irritation, were generally mild to moderate.

The FDA reviewed the SmartAdjust technology through the 510(k) premarket clearance pathway, confirming that a new device is substantially equivalent to an existing, legally marketed one. This approval marks a critical milestone, offering a new automated solution for managing type 2 diabetes, reducing the burden on patients, and enhancing their quality of life.

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