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FDA Approved the Use of Omnipod 5 for Children Over 2
Recently, the FDA approved the use of Omnipod 5 for children over 2 with type 1 diabetes, expanding on its previous approval, which only allowed for use in people over 6 years old.
In January 2022, Omnipod 5 was first approved for anyone over six. Omnipod 5 is the first tubeless automated insulin delivery (AID) made available in the United States for a broad age range. Recently, the FDA approved the expansion of Omnipod 5 for use in people over two years old with type 1 diabetes (T1D), providing an additional resource for patients and parents of kids with T1D.
The CDC defines type 1 diabetes as a chronic illness in which the pancreas makes little to no insulin. Approximately 5–10% of people who have diabetes have T1D. The primary treatment for T1D is synthetic insulin used to manage blood sugar.
Left untreated, T1D can lead to diabetic ketoacidosis (DKA), which is potentially fatal. The CDC states that “DKA develops when you don’t have enough insulin to let blood sugar into your cells. Very high blood sugar and low insulin levels lead to DKA. The two most common causes are illness and missing insulin shots. Talk with your doctor and make sure you understand how you can prevent and treat DKA.”
Traditional insulin delivery mechanisms include syringes, insulin pens, and insulin pumps. The type of insulin delivery is determined by lifestyle and the type of insulin needed.
According to its website, “Omnipod provides non-stop insulin delivery through a tubeless, waterproof insulin pump called a Pod — all with no multiple daily injections.” There are multiple different benefits of Omnipod, including the fact that it is wearable, waterproof, and does not have any external wires.
The press release by Insulet Corporation highlights the benefits of using Omnipod 5 in pediatric patients. It states that children between the ages of two and six using Omnipod 5 spend more time with in-range blood sugar and less time with hypoglycemic ranges.
“We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements as well,” said Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director, in the press statement. “This expanded indication for younger children gives us great pride, knowing we can further ease the burden of glucose management for these children and their caregivers with our simple to use, elegant, automated insulin delivery system.”
