Clinical Overview: Omnipod 5 Automated Tubeless Insulin Dispensing System

Insulet’s Omnipod 5 was approved by the FDA in January 2022 for the treatment of type 1 diabetes mellitus in people 6 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 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.¹ Omnipod 5 can be combined with the Dexcom G6 Continuous Glucose Monitoring System and a smartphone for easy access.²

Clinical Trials

In 3 trials completed in 2018, 2019, and 2020, researchers tested Omnipod 5 clinically for efficacy in 60 patients. In each trial, patients were challenged with either meal or exercise challenges to assess the efficacy of the 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.¹

Mechanism of Action

Omnipod 5 uses internal data to calculate micro boluses and then deliver them to the patient every 5 minutes.¹ During the cannula insertion, the infusion needle inserts 6 mm deep into the subcutaneous tissue.

When in the tissue, the cannula is disconnected from the insertion needle and left under the skin. Omnipod 5’s mechanism allows continuous injection of insulin throughout the day.¹

System Use

To use Omnipod 5, the patient fills the insulin reservoir with 85 to 200 units of rapid-acting insulin.¹ Examples of rapid-acting insulin are insulin aspart (Novolog) and insulin lispro (Humalog). The patient will then pair the pod with the remote or a smartphone, remove the adhesive on the back of the pod, and stick the pod to the skin.

Adverse Effects and Risks

There have been no adverse effects reported at this time. Some potential risks are infection, skin irritation, pod failure, and dislodging of the cannula.³

Warnings

Patients should be advised against changing settings unless directed by a provider.³ Administering additional insulin by injection or inhalation can lead to hypoglycemia and should not be recommended. Pharmacists should counsel patients on treating their hypoglycemia and hyperglycemia immediately despite wearing the pod.³

Contraindications

Omnipod 5 should not be used in the following populations:³

• Patients who are not able to monitor their glucose as directed by their provider.
• Patients who are not able to regularly contact their provider.
• Patients who cannot use Omnipod 5 as directed.
• Patients who are taking hydroxyurea because it can cause excessive insulin delivery.
• Patients who do not have adequate vision and hearing for the alerts and reminders of Omnipod 5.

Pregnancy and Lactation

This technology should not be used in these populations.³ The efficact of Omnipod 5 has not yet been assessed in these populations.

Cost

Most insurers cover Omnipod 5 and allow most users to purchase the pod for less than $50 a month.⁴ Additionally, the manufacturer has a program called the OmnipodPromise through which any current user of the Omnipod DASH can upgrade to the Omnipod 5 for free.

About the Author

Lauryn Silva is a 2024 PharmD candidate at the University of Connecticut.

References

1. Cobry EC, Berget C, Messer LH, Forlenza GP. Review of the Omnipod® 5 Automated Glucose Control System Powered by Horizon™ for the treatment of Type 1 diabetes. Ther Deliv. 2020;11(8):507-519. doi:10.4155/tde-2020-0055. https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC8097502/. Accessed March 7, 2022.
2. Insulet Announces FDA Clearance of its Omnipod 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control. News release. Insulet; January 28, 2022. https://investor.insulet.com/news-releases/news-release-details/insulet-announces-fda-clearance-its-omnipodr-5-automated-insulin. Accessed March 7, 2022.
3. Omnipod 5 Autonmated Insulin Delivery System Important Safety Information. Insulet. https://www.omnipod.com/safety. Accessed March 7, 2022.
4. Omnipod 5 Cleared by the FDA. DiaTribe Learn: January 28, 2022. https://diatribe.org/omnipod-5-approved-fda. Accessed March 7, 2022.