Omnipod® 5 FAQs: Pod quality and manufacturing

Below are answers to commonly asked questions about how Omnipod Pods are manufactured, tested, and monitored for quality. For help or to report a Pod concern, visit Omnipod® 5 FAQs: Troubleshooting or contact Product Support.

What quality controls are in place during Pod manufacturing?

How does Omnipod make insulin delivery decisions?

The Omnipod® 5 Automated Insulin Delivery System uses the Omnipod 5 algorithm to automatically adjust insulin delivery every 5 minutes based on your sensor glucose values. Clinical studies have shown it helps protect against highs and lows, day and night, across children, adolescents, adults with type 1 diabetes and adults with type 2 diabetes. ^1-3

To learn more about how the system works, explore Omnipod 5.

1. Brown et al. Diabetes Care (2021). Study in 240 people with T1D aged 6 - 70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average overnight time (12AM-6AM) with high glucose in adults/adolescents and children for standard therapy vs Omnipod 5 = 32.1% vs. 20.7%; 42.2% vs. 20.7%. Average day time (6AM-12AM) with high glucose in adults/adolescents and children for standard therapy vs Omnipod 5 = 32.6% vs. 26.1%; 46.4% vs. 33.4%. Average overnight time (12AM-6AM) with low glucose in adults/adolescents and children for standard therapy vs Omnipod 5 = 3.6% vs. 1.2%; 2.5% vs. 1.2%. Average day time (6AM-12AM) with low glucose in adults/adolescents and children for standard therapy vs Omnipod 5 = 2.6% vs. 1.4%; 2.1% vs. 2.0%.

2. Sherr J, et al. Diabetes Care (2022). Study in 80 children with T1D aged 2 to 5.9 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average overnight time (12AM-6AM) with high glucose in children for standard therapy vs Omnipod 5 = 38.4% vs. 16.9%. Average day time (6AM-12AM) with high glucose in children for standard therapy vs Omnipod 5 = 39.7% vs. 33.7%. Average overnight time (12AM-6AM) with low glucose in children for standard therapy vs Omnipod 5 = 3.4% vs. 2.1%. Average day time (6AM-12AM) with low glucose in children for standard therapy vs Omnipod 5 = 3.4% vs. 2.6%.

3. Pasquel FJ, et al. JAMA Network Open (2025). Prospective pivotal trial in 305 participants with T2D aged 18-75 yrs. Study included a 14-day standard therapy (ST) phase followed by a 13-week Omnipod 5 hybrid closed-loop phase. Mean overnight time >180 mg/dL (12AM-6AM) as measured by CGM: ST = 50%, 3-mo Omnipod 5 = 30%. Mean daytime >180 mg/dL (6AM-12AM) as measured by CGM: ST = 55%, 3-mo Omnipod 5 = 36%. Mean overnight time in <70 mg/dL (12AM-6AM) as measured by CGM: ST = 0.10%, 3-mo Omnipod 5 = 0.22%. Mean daytime <70 mg/dL (6AM-12AM) as measured by CGM: ST = 0.16%, 3-mo Omnipod 5 = 0.17%. Statistical testing not done to assess significance of change between ST phase and Omnipod 5 System phase.

What should I do if I receive a Pod that seems damaged or defective?

How does Insulet respond when a quality concern is identified after Pods are already in use?

How long has Insulet been manufacturing tubeless insulin pumps?

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Omnipod® 5 FAQs: Pod quality and manufacturing

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