FDA Okays Omnipod 5 — First Automated Insulin Delivery Device for T2D

The recent US Food and Drug Administration (FDA) clearance of the Omnipod 5 Automated Insulin Delivery (AID) System for people with type 2 diabetes marks a significant milestone in diabetes care. Developed by Insulet Corporation, the Omnipod 5 is the first and only tubeless AID system approved for both type 1 and type 2 diabetes, expanding its reach to a broader patient population.

Earlier in 2024, Insulet secured CE Mark approval for integrating the Abbott FreeStyle Libre 2 Plus with Omnipod 5, making it the first tubeless hybrid system in Europe compatible with multiple continuous glucose monitoring (CGM) brands.

The FDA’s approval is timely, given the rising prevalence of type 2 diabetes in the US. The Omnipod 5 system offers a personalized approach to insulin delivery, integrating CGM with adaptive insulin administration. This closed-loop system automatically adjusts insulin delivery based on real-time glucose readings, reducing the burden of manual insulin management and potentially improving glycemic control.

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In the SECURE-T2D clinical study, the Omnipod 5 system demonstrated substantial improvements in glycemic outcomes, particularly in hemoglobin A1c (HbA1c) levels. Participants using the Omnipod 5 experienced an average reduction of 0.8 percent in HbA1c, a key marker of blood glucose concentration. Those with higher baseline HbA1c levels (nine percent or higher) saw a more substantial reduction of 2.1 percent, bringing them closer to a prediabetic range.

Participants spent 20 percent more of their day, which is about 4.8 more hours each day, within their target blood sugar range, with less time within high blood sugar levels, and less insulin needed throughout the day.

Balancing insulin administration multiple times a day requires careful monitoring and, with manual variability, higher risks of hypoglycemia or hyperglycemia.

Dr. Anne L. Peters, director of the University of Southern California Westside Center for Diabetes, noted the challenges faced by patients, saying in the press release “I’ve seen first-hand how difficult it is for patients to reach their targets with injections. Omnipod 5 makes it easier for people with type 2 diabetes to take their insulin and stay in range, leading to remarkable improvements in clinical outcomes and overall quality of life.”

Related: Abbott’s FreeStyle Libre CGM Meets Medtronic’s Insulin Delivery

Unlike traditional insulin pumps tethered by tubes, the Omnipod 5 is tubeless, offering greater convenience and discretion. Its real-time adaptability makes it a convenient and effective tool for managing blood glucose levels, reducing the risk of complications.

Besides being waterproof and wearable, the Omnipod 5 removes the need for multiple daily injections (MDI) and automatically adjusts insulin delivery every five minutes with its SmartAdjust technology. It is also compatible with the Dexcom G6 and G7 CGM systems.