Patient Reported Outcomes (PRO) in a Study of Human Regular U-500 Insulin (U-500R) Delivered by Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injections (MDI) in Patients with T2D

Abstract

Persons with T2D treated with U-500R have shown improved glycemic control. This prospective analysis evaluated the impact on PRO of U-500R delivered by CSII (using an investigational Omnipod U-500TM Insulin Management System) or MDI (using a U-100 syringe). In this 26-week (week), open-label, parallel trial, 420 patients treated with >200 units/day of insulin for T2D were randomized to CSII (n=209) or MDI (n=211) treatment groups. The Treatment-Related Impact Measure for Diabetes (TRIM-D) and Diabetes Device (TRIM-DD) questionnaires were assessed at baseline, week 14, and week 26. Results are shown in Table 1. TRIM-D scores (overall score and all 5 domain scores) and TRIM-DD overall score in both groups improved significantly from baseline to week 26 (p<0.05). At week 26, change in baseline score for the CSII group was significantly higher than the MDI group in all TRIM-D measures (p<0.05). At week 26, there were no significant differences in the change from baseline score between the CSII and MDI groups in TRIM-DD overall or its domains. In summary, the U-500R CSII device scored significantly better than MDI in the perceived impact on diabetes treatment (TRIM-D) but not for diabetes device (TRIM-DD). PROs for diabetes treatment improved significantly from baseline to week 26 in patients treated with U-500R by either CSII or MDI. Disclosure X. Peng: Employee; Self; Eli Lilly and Company. J. Chen: None. L. Fan: Employee; Self; Eli Lilly and Company. L. Ilag: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. T.T. Ly: Employee; Self; Insulet Corporation. J. Johnson: Employee; Self; Eli Lilly and Company.