Sam Brusco, Associate Editor08.22.22
Insulet has earned U.S. Food and Drug Administration (FDA) clearance for its Omnipod 5 automated insulin delivery (AID) system for type 1 diabetes patients aged two years and older.
The tubeless AID system was originally FDA cleared for those aged six and older in January.
“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,” Dr. Trang Ly MBBS, FRACP, Ph.D., Insulet senior VP and medical director told the press. “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.”
Omnipod 5 integrates with the Dexcom G6 continuous glucose monitor (CGM) and a compatible smartphone to adjust insulin. The system is made up of the tubeless Pod with SmartAdjust tech, Omnipod 5 mobile app with SmartBolus Calculator, and the Dexcom 6 CGM.
“Omnipod 5 has allowed our family to think less about diabetes,” said Kara Hornbuckle, an Omnipod 5 user with two children also using the system. “Omnipod 5 has provided more control and greater peace of mind for all three of us, especially during the nighttime when we are all most vulnerable. The impact that this device has had on my family cannot be understated. We are just so grateful!”
A recent study published in Diabetes Care showed Omnipod 5 “significantly improved” time in range, and reduced HbA1c and time in hypoglycemia (<70 mg/dL) in children aged 2-5.9 years) with type 1 diabetes. Parents and caregivers of study participants also reported improved sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI).
Healthcare professionals can now prescribe Omnipod 5 with insurance coverage and patients can access their prescription through the pharmacy channel.
The tubeless AID system was originally FDA cleared for those aged six and older in January.
“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,” Dr. Trang Ly MBBS, FRACP, Ph.D., Insulet senior VP and medical director told the press. “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.”
Omnipod 5 integrates with the Dexcom G6 continuous glucose monitor (CGM) and a compatible smartphone to adjust insulin. The system is made up of the tubeless Pod with SmartAdjust tech, Omnipod 5 mobile app with SmartBolus Calculator, and the Dexcom 6 CGM.
“Omnipod 5 has allowed our family to think less about diabetes,” said Kara Hornbuckle, an Omnipod 5 user with two children also using the system. “Omnipod 5 has provided more control and greater peace of mind for all three of us, especially during the nighttime when we are all most vulnerable. The impact that this device has had on my family cannot be understated. We are just so grateful!”
A recent study published in Diabetes Care showed Omnipod 5 “significantly improved” time in range, and reduced HbA1c and time in hypoglycemia (<70 mg/dL) in children aged 2-5.9 years) with type 1 diabetes. Parents and caregivers of study participants also reported improved sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI).
Healthcare professionals can now prescribe Omnipod 5 with insurance coverage and patients can access their prescription through the pharmacy channel.