Patient-reported outcomes in a study of human regular U-500 insulin delivered by continuous subcutaneous insulin infusion or multiple daily injections in patients with type 2 diabetes.

Human regular U-500 insulin (U-500R) provides both basal and prandial coverage to people with diabetes. As part of VIVID study, we studied patient-reported outcomes (PRO) of U-500R delivered by multiple daily injections (MDI, n = 211) and continuous subcutaneous infusion using a novel U-500R pump (CSII, n = 209). Treatment-Related Impact Measure for Diabetes (TRIM-D) and for Diabetes Device (TRIM-DD) questionnaires were administered at week 0, 14, and 26. TRIM scores with effect sizes (ES) for within-group and between-group change were reported. All TRIM-D scores significantly improved from baseline for both groups (P < 0.001). Diabetes Management domain had the greatest improvement, 16.3 (ES = 0.85) and 10.6 (ES = 0.51) for CSII and MDI, respectively. At study end, CSII group had significantly higher TRIM-D scores than MDI group (P < 0.05). Most TRIM-DD scores had small within-group improvements and were not different between groups. People with type 2 diabetes on U-500R by either CSII or MDI reported improvement in PRO, especially in Diabetes Management, Treatment Burden, and Psychological Health domains, with greater improvement in CSII group. In terms of delivery device and function, CSII and MDI methods were similarly acceptable. This article is protected by copyright. All rights reserved.