Just a few weeks into the full-scale rollout of its Omnipod 5 insulin pump, Insulet has gotten the green light to expand the device’s reach even further.
When the FDA originally cleared the automated, tubeless system in January of this year, Omnipod 5 was made available for use by people with Type 1 diabetes who were at least 6 years old. A new nod from the agency, however, brings the technology to the preschool level: It’s now available to Type 1 patients as young as 2, Insulet announced Monday.
The company has been aiming for the expansion ever since it received the initial go-ahead from the FDA. At the time, Insulet said it already had plans to petition the FDA to add toddlers to Omnipod 5’s user base; it’s also still working on adding people with Type 2 diabetes to that group.
The Omnipod 5 system relies on disposable wearable “pods,” each of which provides up to three days’ worth of insulin. That insulin delivery can be completely automated if the pump is connected to a wearer’s Dexcom G6 continuous glucose monitor, and it doesn’t require any fingersticks or manual injections for calibration. It can also be monitored and controlled by the user’s own smartphone, though the system is currently only compatible with Android devices.
The pump has proven to be a boon in helping manage diabetes in adults and children alike. Insulet shared results of a study at the American Diabetes Association’s annual scientific sessions in June focusing specifically on the use of Omnipod 5 in children between the ages of 2 and 6.
After three months of using the technology, the kids’ average HbA1c levels dropped to 6.9% from a starting baseline of 7.4%—and they remained at the lower level one year into the study. Meanwhile, after recording an average time in range of just over 57% at the start of the study, the young participants saw that number jump to 68.1% after using Omnipod 5 for three months—then fall just a bit, to 67.6%, by the one-year mark.
“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,” Insulet’s medical director, Trang Ly, Ph.D., said in Monday’s announcement.
The device’s latest FDA nod comes shortly after Insulet widened the original limited launch of Omnipod 5. At the beginning of this month, the Massachusetts-based company made the system available to all eligible diabetes patients in the U.S.
Those patients can access the pump via retail, specialty and mail-order pharmacy channels. Making it available through the pharmacy helps customers avoid high upfront costs—because standard insurance coverage will apply and they can opt for a pay-as-you-go plan—and allows them to test out the device on a trial basis, Eric Benjamin, Insulet’s executive vice president of innovation, strategy and digital products, told Fierce Medtech during the June conference.