Insulet’s Omnipod 5 ‘significantly Improves’ glycaemic outcomes in very young children.
Insulet has announced that its Omnipod 5 tubeless, wearable, automated insulin delivery system can significantly improve time in range and reduced HbA1c in young children.
The data, collected from a three-month pivotal trial, showed Omnipod 5 to significantly improve time in range and reduce HbA1c in 80 children aged between 2 and 5.9 with Type 1 diabetes. After all of the participants had completed 12 months, average HbA1c was 6.9%, compared with 7.4% at baseline and 6.9% at the end of three months. Time in range during months 10-12 of use was 67.6%, compared to 57.2% during standard therapy and 68.1% during the three-month pivotal trial. Percent time in hypoglycemia was reduced compared with standard therapy, with the median totaling 1.9% during months 10-12 of use, compared to 2.2% during standard therapy and 1.9% during the first three months. Furthermore, there were no episodes of diabetic ketoacidosis (DKA) or severe hypoglycemia.
Insulet SVP and Medical Director Dr. Trang Ly said “With these preschool extension trial results, we have demonstrated improved glycemic results over the long term for very young children managing diabetes. I’m incredibly proud of this remarkable achievement and know that Omnipod 5 will have a big impact on these families.”
Baylor College of Medicine’s Dr. Daniel DeSalvo said. “It is particularly challenging for caregivers to manage diabetes in children under six, given their unpredictable eating habits and activity levels. These results, along with the system’s tubeless form factor and ease of use, make Omnipod 5 an excellent choice for automated insulin delivery in this age group, not only for optimizing glycemic outcomes but for alleviating the burden of diabetes for the entire family.”
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