Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes

Gregory P. Forlenza, Daniel J. DeSalvo, Grazia Aleppo, Emma G. Wilmot, Cari Berget, Lauren M. Huyett, Irene Hadjiyianni, José J. Méndez, Lindsey R. Conroy, Trang T. Ly*, Jennifer L. Sherr

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Background: The Omnipod® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ‡2 years) with T1D and sufficient data (‡90 days of data; ‡75% of days with ‡220 continuous glucose monitor readings/day) available in Insulet Corporation’s device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110–150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. Results: In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70–180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130–150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL (n = 37,640), median TIR was 65.0% in children and adolescents (2–17 years) and 69.9% in adults (‡18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. Conclusion: These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.

Original languageEnglish (US)
JournalDiabetes Technology and Therapeutics
StateAccepted/In press - 2024


  • Artificial pancreas
  • Closed-loop systems
  • Insulin pumps
  • Real-world evidence
  • Type 1 diabetes

ASJC Scopus subject areas

  • Medical Laboratory Technology
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism


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