- Insulet won an expanded indication from the FDA for the Omnipod 5 automated insulin delivery system, allowing it to be prescribed for children aged two years and older with Type 1 diabetes.
- Insulet, which received clearance in people aged six years and up in January, hailed the decision as the first time the Food and Drug Administration has authorized the use of a tubeless automated insulin delivery system in preschoolers.
- The clearance follows the publication of results from a clinical trial of children aged two to five years that linked Omnipod 5 to a 10.9% increase in time with sensor glucose levels in target range.
Insulet CEO Jim Hollingshead recently said “the value that Omnipod 5 can deliver to young children and their families is abundantly clear.” The value rests on the difficulties of achieving glycemic targets in very young children with Type 1 diabetes, who are reliant on others for the management of their conditions and often unable to self-identify hypo- or hyperglycemia and communicate their needs.
Automating insulin delivery could theoretically address those challenges, thereby sparing children from the long-term complications of being outside the target range and partly lifting the burden the condition puts on caregivers. Omnipod 5 combines a tubeless pump, embedded insulin delivery algorithm, Dexcom G6 continuous glucose monitor and a mobile app to try to realize those benefits.
The launch of the device in people aged six years and older helped Insulet to achieve 31% growth in U.S. Omnipod sales in the second quarter, prompting the company to raise its revenue forecast for the year. The expanded label revealed on Monday clears Insulet to broaden its commercialization strategy further.
In making the case for use of Omnipod 5 in younger children, Insulet can point to the findings of a trial that trained the caregivers of 80 people aged two to five years to use the device. After spending 14 days on standard therapy, the participants began using Omnipod 5. The switch led to statistically significant improvements in blood glucose levels and time in target glycemic range.