FDA Clears Omnipod 5 Automated Insulin Delivery System for Type 1 Diabetes Patients 2 Years of Age and Older


Omnipod 5 is an automated, tubeless insulin dispensing system that allows for continuous infusion and bolus dosing as needed.

The FDA has granted clearance to the Omnipod 5 Automated Insulin Delivery System (Insulet Corporation) for patients 2 years of age and older with type 1 diabetes (T1D). Omnipod 5 is the first tubeless automated insulin delivery (AID) system to be cleared in the United States, following its initial clearance by the FDA for use in patients 6 years of age and older for T1D in January 2022.

Omnipod 5 integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically alter insulin and to aid in protection vs high and low glucose levels.

“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,” said Trang Ly, MBBS, FRACP, PhD, Insulet senior vice president and medical director, in a press release. “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.”

The Omnipod 5 system is comprised of a tubeless pod bolstered by SmartAdjust technology, the Omnipod 5 mobile app with its integrated SmartBolus Calculator, and the Dexcom G6 CGM System.

The tubing in the system is waterproof and patients can wear the pod anywhere they normally inject insulin. Omnipod 5 allows patients to receive 72 hours of continuous, automated insulin administration, reducing the number of injections significantly.

In a clinical study published in in Diabetes Care, Omnipod 5 was found to significantly improve time in range and lower HbA1c and time in hypoglycemia (<70 mg/dL) in children from 2 to 5.9 years of with T1D. Study participants showed improved sleep quality as assessed by the Pittsburgh Sleep Quality Index.

In 3 trials completed in 2018, 2019, and 2020, researchers tested Omnipod 5 clinically for efficacy in 60 older patients. In each trial, patients were challenged with either meal or exercise challenges to assess the efficacy of continuous dosing.

The 2018 and 2019 trials included only adults, whereas the 2020 trial included people aged 6 to 65 years. The adult-only studies found that patients remained in normal glucose range 76.1% and 85.1%, respectively. The 2020 trial produced similar results across age ranges at 73.7% (adults), 79.0% (adolescents), and 69.2% (children). The results of each trial were deemed significant.

There have been no adverse effects reported at this time. Some potential risks are infection, skin irritation, pod failure, and dislodging of the cannula.

Health care providers can prescribe Omnipod 5 to patients with insurance coverage, who are able to access prescriptions through the pharmacy channel, which means there is no contract and no commitment.

“Omnipod 5 has allowed our family to think less about diabetes,” said Omnipod 5 user Kara Hornbuckle, in a press release. “Omnipod 5 has provided more control and greater peace of mind for all 3 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.”


Insulet Announces FDA Clearance of Omnipod® 5 for Children Aged Two Years and Older with Type 1 Diabetes. Insulet Corporation. News release. August 22, 2022. https://investor.insulet.com/news-releases/news-release-details/insulet-announces-fda-clearance-omnipodr-5-children-aged-two

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