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

• Published in: Diabetes technology & therapeutics Vol. 26; no. 8; pp. 514 - 525
• Main Authors: Forlenza, Gregory P, DeSalvo, Daniel J, Aleppo, Grazia, Wilmot, Emma G, Berget, Cari, Huyett, Lauren M, Hadjiyianni, Irene, Méndez, José J, Conroy, Lindsey R, Ly, Trang T, Sherr, Jennifer L
• Format: Journal Article
• Language: English
• Published: United States Mary Ann Liebert, Inc., publishers 01.08.2024
• Subjects: Adolescent; Adult; Aged; Blood Glucose - analysis; Blood Glucose Self-Monitoring; Child; Child, Preschool; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Female; Glycemic Control - methods; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - therapeutic use; Insulin - administration & dosage; Insulin - therapeutic use; Insulin Infusion Systems; Male; Middle Aged; Original Articles; Retrospective Studies; United States; Young Adult; United States; Artificial pancreas; Closed-loop systems; Type 1 diabetes; Insulin pumps; Real-world evidence
• ISSN: 1520-9156; 1557-8593
• DOI: 10.1089/dia.2023.0578

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.