FDA Expands Use of Omnipod 5 for Younger Children

FDA has approved Insulet’s Omnipod 5 automated insulin delivery system for children aged two years and older with type 1 diabetes. Omnipod 5, the first tubeless automated insulin delivery (AID) system in the United States, was approved in January 2022 for use in individuals aged six and older.

Omnipod 5 is a system that integrates with the Dexcom G6 CGM system and a compatible smartphone to automatically adjust insulin. The system consists of the tubeless Pod enhanced with SmartAdjust technology, the Omnipod 5 mobile app with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.

In a recent publication in Diabetes Care, a study found that use of Omnipod 5 in patients 2 years of age to 5.9 years of age experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline. There were no episodes of severe hypoglycemia or diabetic ketoacidosis, and children spent 2.6 more hours per day in a specified glucose level range. After 12 months of Omnipod 5 use, average HbA1c was 6.9%, compared with 7.4% at baseline and 6.9% at the end of the three-month pivotal trial. Similarly, percent time in range during months 10 to 12 of use was 67.6%, compared with 57.2% during standard therapy and 68.1% during the three-month pivotal trial.

In addition, parents and caregivers of study participants reported improved sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI), a questionnaire considered to be the gold standard in measuring subjective sleep quality.

“It is particularly challenging for caregivers to manage diabetes in children under six, given their unpredictable eating habits and activity levels,” investigator Daniel DeSalvo, M.D., associate professor, pediatrics-diabetes-endocrinology, at Baylor College of Medicine, said in a press release. “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.”

Omnipod 5 is now available through retail pharmacies, as well as specialty and mail-order pharmacies to anyone with a prescription and coverage.