The U.S. Food and Drug Administration (FDA) has granted approval to Insulet’s Omnipod 5 automated insulin delivery system for individuals with Type 2 diabetes. This marks a significant expansion from the system’s previous authorization, which was limited to Type 1 diabetes patients aged 2 and older.
The FDA’s approval, announced on August 26, extends the use of the Omnipod 5 to adults 18 and older with Type 2 diabetes. This innovative system, which integrates with a continuous glucose monitor (CGM) and an alternate controller-enabled insulin pump, automates insulin delivery to maintain optimal blood glucose levels.
Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, emphasized the agency’s commitment to enhancing diabetes management options. “The FDA is dedicated to advancing new device innovations that can improve the health and quality of life for individuals managing chronic conditions like diabetes,” she stated.
Insulet, a leading company in diabetes management technology, hailed the approval as a milestone. Chief Executive Jim Hollingshead praised the development, highlighting the system’s ease of use and patient-centric design. Today’s announcement represents a significant advancement in providing user-friendly technology for Type 2 diabetes treatment,” Hollingshead said.
The Omnipod 5 builds on the original Omnipod Insulin Management System, first cleared by the FDA in 2003. Unlike its predecessor, the new system features a tubeless, wearable device that delivers insulin continuously for up to three days without the need for injections or frequent blood glucose checks. Users can manage the system through a compatible smartphone or dedicated controller, eliminating the need for multiple daily injections and fingerstick tests.
The FDA’s decision followed a clinical trial involving 289 adults with Type 2 diabetes. The study, which spanned 13 weeks, demonstrated improved blood sugar control across all demographic groups. The trial included a diverse range of participants, reflecting various racial, ethnic, and socioeconomic backgrounds. No serious adverse events were reported, though some mild to moderate issues such as hyperglycemia, hypoglycemia, and skin irritation were noted.
In the U.S., diabetes affects approximately 11.6% of the population, or about 38.4 million people, according to the Centers for Disease Control and Prevention (CDC). Type 2 diabetes, characterized by the body’s reduced insulin production and insulin resistance, is the most common form of the disease. In contrast, Type 1 diabetes results from an autoimmune attack on insulin-producing cells in the pancreas.
While medications and lifestyle changes are commonly used to manage Type 2 diabetes, the Omnipod 5 offers a novel approach to automating insulin delivery, potentially reducing the manual burden of diabetes management. The recent FDA approval follows the March introduction of the Dexcom Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor, designed to provide insight into blood sugar levels for both diabetic and non-diabetic individuals.
This approval represents a critical step forward in diabetes care, providing new options for managing Type 2 diabetes with advanced technology.
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