Insulet Corp. (PODD) has secured approval from the U.S. Food and Drug Administration for its revolutionary SmartAdjust Omnipod 5 automated insulin delivery system, designed specifically for adults aged 18 and over with Type 2 diabetes.This pioneering device marks the first of its kind for automated insulin dosing aimed at individuals with Type 2 diabetes. The Omnipod is an advanced, tubeless wearable device that can continuously deliver insulin for up to 72 hours, eliminating the need for traditional needles.One of the standout features of the Omnipod 5 is its integration with a continuous glucose monitor, allowing users to manage their blood sugar levels without the hassle of daily injections or finger pricks. Users can operate the system via a compatible smartphone or a separate controller within the U.S.Jim Hollingshead, President and CEO of Insulet, highlighted the significance of this development: “Omnipod 5 is setting a new benchmark in diabetes management, and we are excited to have the opportunity to make a lasting impact on the community of individuals with insulin-requiring Type 2 diabetes.”The FDA’s approval followed a thorough evaluation process based on data from an extensive clinical study involving 289 adults with Type 2 diabetes, all of whom were already using insulin and had applied the SmartAdjust technology for a period of 13 weeks.Participants in the study had varied experiences in managing their insulin and diabetes, including those using common diabetes medications like GLP1 agonists. The results demonstrated marked improvements in blood sugar control across all demographic groups. On average, there was a reduction in HbA1c levels of 0.8 percentage points, while participants with baseline HbA1c levels of 9.0% or higher experienced a significant decrease of 2.1 points. No serious adverse events or complications were reported throughout the study, with only mild to moderate side effects observed, such as episodes of low and high blood sugar and skin irritation.The material has been provided by InstaForex Company – www.instaforex.com
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