| Autor: |
Forlenza GP; Department of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA., DeSalvo DJ; Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA., Aleppo G; Division of Endocrinology, Metabolism, and Molecular Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA., Wilmot EG; Translational Medical Sciences, University of Nottingham, School of Medicine, Royal Derby Hospital, Derby, United Kingdom., Berget C; Department of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA., Huyett LM; Insulet Corporation, Acton, Massachusetts, USA., Hadjiyianni I; Insulet Corporation, Acton, Massachusetts, USA., Méndez JJ; Insulet Corporation, Acton, Massachusetts, USA., Conroy LR; Insulet Corporation, Acton, Massachusetts, USA., Ly TT; Insulet Corporation, Acton, Massachusetts, USA., Sherr JL; Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, USA. |
| Abstrakt: |
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. |
