The FDA has expanded the indications for the Insulet SmartAdjust technology to include management of type 2 diabetes in individuals 18 years and older. This marks the first clearance of an automated insulin dosing device for individuals with type 2 diabetes. The technology, an interoperable automated glycemic controller, was previously indicated only for the management of type 1 diabetes in individuals two years and older.
The SmartAdjust technology is software that automatically adjusts insulin delivery by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor. Michelle Tarver, MD, PhD., acting director of the FDA's Center for Devices and Radiological Health, stated that this action expands access to automated insulin dosing technology to millions of adults with type 2 diabetes in the U.S.
The FDA reviewed data from a clinical study involving 289 individuals aged 18 years and older with type 2 diabetes. Participants used the Insulet SmartAdjust technology for 13 weeks. The study included a diverse group of subjects with varying levels of diabetes management experience and concurrent use of non-insulin diabetes medications. Overall, the study showed improvement in blood sugar control compared to baseline across all demographic groups. No complications or serious adverse events related to the SmartAdjust technology were reported. Adverse events were generally mild to moderate, including hyperglycemia, hypoglycemia, and skin irritation.
Approximately 11.3% of the U.S. population is diagnosed with diabetes. For patients with type 2 diabetes mellitus (T2DM), management typically includes oral hypoglycemic agents, injectable incretin mimetics, and lifestyle modifications. A significant proportion of T2DM patients eventually require exogenous insulin therapy to achieve glycemic targets. Prior to this FDA clearance, insulin delivery options for T2DM were limited to subcutaneous injections via syringes or pens, or continuous subcutaneous insulin infusion via pumps. These methods necessitated patient-initiated dosing and frequent blood glucose monitoring or continuous glucose monitoring for optimal glycemic control.
The FDA reviewed the SmartAdjust technology software through the 510(k) premarket clearance pathway, which requires demonstration of substantial equivalence to a legally marketed predicate device. This new option automates many manual tasks associated with insulin therapy for type 2 diabetes patients.
