FDA Clears Omnipod 5 Algorithm Updates, Adding 100 mg/dL Target Glucose Option

Insulet Corporation announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for updates to the Omnipod® 5 Automated Insulin Delivery System, including a new 100 mg/dL Target Glucose option and algorithm changes designed to reduce disruptions in Automated Mode. The enhancements are expected to roll out in the United States in the first half of 2026 for individuals aged ≥2 years with type 1 diabetes and adults aged ≥18 years with type 2 diabetes.

According to the announcement, the updated system expands the Target Glucose customization range to 6 options between 100–150 mg/dL in 10 mg/dL increments. Insulet stated that the additional lower Target Glucose setting may support individuals seeking tighter glycemic management, and may improve automated insulin delivery responsiveness. Citing real-world evidence, the company noted that reducing glucose targets has been associated with increased time in range without clinically meaningful changes in Time Below Range (TBR).¹

The updated algorithm is also designed to help users remain in Automated Mode during prolonged periods of hyperglycemia. Insulet reports that these changes are intended to reduce interruptions, simplify daily insulin management, and improve the overall user experience for individuals and caregivers.

Eric Benjamin, Insulet Executive Vice President and Chief Operating Officer, stated that the enhancements represent the most significant algorithm advancement since the Omnipod 5 launch in 2022 and noted that the changes address the two most frequently requested user features.

Pediatric endocrinologist Anita Swamy, MD, Medical Director of the Chicago Children’s Diabetes Center, commented that the enhancements may support strong clinical outcomes while improving patients’ confidence in daily diabetes management.

Real-World Evidence Cited in the Release

Data presented at the 2025 ATTD meeting included findings from:

• 403 individuals with type 1 diabetes (aged ≥2 years) who transitioned from a 150 mg/dL (8.3 mmol/L) to 110 mg/dL (6.1 mmol/L) Target Glucose. Each target was used for 14–90 consecutive days.
  • Median time in range (70–180 mg/dL; 3.8–10 mmol/L) improved 11.8% (p<0.05).
  • Median time <70 mg/dL (<3.8 mmol/L) increased 0.23% (p<0.05).
• 58 adults with type 2 diabetes (aged ≥18 years) who made the same transition from 150 mg/dL to 110 mg/dL.
  • Median time in range improved 10.4% (p<0.05).
  • Median time <70 mg/dL increased 0.04% (non-significant).

Insulet stated that results were based on users with ≥75% of days having ≥220 readings available.

References:

1. Forlenza G, et al. Presented at ATTD; March 19–22, 2025; Amsterdam, NL. Real-world data from individuals with type 1 and type 2 diabetes using the Omnipod 5 System. Data on File. RF-042025-00013.
2. Insulet Announces FDA 510(k) Clearance of Omnipod® 5 Algorithm Enhancements that Redefine Insulin Delivery and Simplify the Pod Experience. News release. Insulet. December 4, 2025. Accessed December 4, 2025. https://www.businesswire.com/news/home/20251204178236/en/Insulet-Announces-FDA-510k-Clearance-of-Omnipod-5-Algorithm-Enhancements-that-Redefine-Insulin-Delivery-and-Simplify-the-Pod-Experience