Effects of insulin initiation on patient-reported outcomes in patients with type 2 diabetes: Results from the DURABLE trial
Aim: To examine changes in patient-reported outcome (PRO) measures in patients with type 2 diabetes (T2DM) on oral agents who initiated insulin (insulin lispro mix 25/75 [LM25] or insulin glargine) in the DURABLE trial (n = 580).
Methods: Subjects completed generic and diabetes-specific health-related quality-of-life measures (RAND-36 and Diabetes-39) and a symptom assessment measure (DSC-Revised) at baseline and 6 months post insulin initiation. Mean score change was evaluated. Effect size (ES; Cohen's d) and analysis of covariance were used to examine extent and significance of change both within and between treatment groups.
Results: Subject characteristics were mean age 57 years, males 59%, duration of diabetes 9.6 years, and baseline HbA1c 8.9%. In the total sample, significant (P < 0.01) improvements (with small ES) were observed in four of eight RAND-36 subscales (ES range: 0.13-0.24), three of five Diabetes-39 subscales (ES range: 0.09-0.34), and five of eight DSC-Revised subscales (ES range: 0.15-0.38). While significance of within-group changes varied by treatment, only one subscale (physical functioning for LM25) showed deterioration. The changes were not significantly different (P > 0.01) between regimens for any subscales.
Conclusions: Our findings suggest that insulin initiation improves selective PRO in patients with poorly controlled T2DM. (C) 2010 Elsevier Ireland Ltd. All rights reserved.
Lee, L. J., Fahrbach, J. L., Nelson, L., McLeod, L., Martin, S. A., Sun, P., & Weinstock, R. S. (2010). Effects of insulin initiation on patient-reported outcomes in patients with type 2 diabetes: Results from the DURABLE trial. Diabetes Research and Clinical Practice, 89(2), 157-166. DOI: 10.1016/j.diabres.2010.04.002