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The objectives of this study were to assess the health-related quality of life (HRQoL) of patients with type 2 diabetes mellitus (T2DM) in Spain using the EQ-5D, to describe factors associated with patients' HRQoL and to evaluate the agreement between patients' and physicians' HRQoL assessments.A total of 294 T2DM patients were consecutively enrolled at primary care centres. Patients completed the EQ-5D and physicians the EQ-5D proxy version.In univariate analysis, HRQoL scores were significantly lower in patients with higher body mass index, with diabetes complications, with >15 years of diabetes, and in patients taking insulin plus oral treatment (p<0.05). Most EQ-5D dimensions showed good agreement between patients' and physicians' assessments. In patient and physician multivariate models, significant predictors of lower HRQoL included older age, lower education, current insulin use and diabetes complications (p<0.05).A proxy version of the EQ-5D may provide a reasonable assessment of T2DM patients'HRQoL. In addition to patient demographics, HRQoL was associated with diabetes complications and insulin use.