FDA clears first automated device to deliver insulin to people with type 2 diabetes  

Key Takeaways

• The FDA approved the first automated insulin system for people with type 2 diabetes.
• Such systems were previously only available to patients with type 1 diabetes.

The U.S. Food and Drug Administration approved the expanded use of an automated insulin pump system to include people who have type 2 diabetes. It’s the first such system approved for use by people with the more prevalent type 2 form of the disease. The FDA first signed off on the system, which automatically adjusts insulin delivery as needed, for type 1 diabetes in 2022. In approving Insulet’s Omnipod 5 insulin delivery system for type 2 diabetes patients, the FDA said the clearance “provides a new option that can automate many of these manual tasks [of tracking and managing blood sugar levels], potentially reducing the burden of living with this chronic disease.” 

Insulin options for people with type 2 diabetes have been limited to injection with a syringe, an insulin pen, or an insulin pump. These all require patients to administer insulin one or more times a day and to check their blood sugar levels frequently. 

Now, they have a simpler alternative. With the new system, the wearable product provides up to three days of non-stop insulin delivery without the need to handle a needle. The Omnipod 5 works in concert with a continuous glucose monitor to manage blood sugar with no daily injections and no finger pricks. 

In approving the expanded use, the FDA reviewed data from a clinical study of 289 individuals 18 years and older with type 2 diabetes for 13 weeks. The study found that volunteers’ blood sugar control improved, and these improvements were seen across all demographic groups. Adverse events were generally mild to moderate and included hyperglycemia (high blood sugar); hypoglycemia (low blood sugar) and skin irritation.

Edited by Miriam Kaplan, PhD

Source:

Robin Foster, Medical Xpress, August 237, 2024; see source article