OBJECTIVES: The EAGLE (Economic Assessment of Glycemic Control and Longterm Effects) model was developed to simulate long-term effects of diabetes therapies on diabetes-related complications and costs. METHODS: Based on a systematic review of published data for type-1 and type-2 diabetes; the EAGLE model is a stand-alone computer simulation program providing micro-simulations of virtual patient cohorts over n years in 1-year cycles with a maximum of 1000 iterations. Subsequent health economic (HE) calculations are constructed from the simulation results. For internal validation the model event rates were compared with rates of study data used to build the model. Respective deviations with confidence intervals were calculated. RESULTS: Results from DCCT, UKPDS, and WESDR studies were used for model calculations. Complications include micro- and macrovascular events (e.g. neuroathy, end stage renal disease, cardiovascular complications, stroke etc) and death, and are calculated over time as cumulative incidence. Risk equations for the probability of complications are based on regression analysis using linear, exponential, as well as quadratic regression formulae. Risk equations for probability of events include demographic (e.g. age, gender, duration of diabetes since diagnosis, type of diabetes) and physiological parameters (e.g. A1c, systolic blood pressure, triglycerides, HDL, LDL, albumin excretion rate). The course of A1c over time is simulated in relation to the treatment regimen. Country specific costs for diabetes treatments and complications can be assigned. HE calculations include cost of complications, cost of illness, cost-effectiveness, cost-utility and cost consequence analysis. Output data provide incidence per year, cumulative incidence after n years, all demographic and physiological parameters, and results of the health economic analyses. Internal validation demonstrated a deviation of less then 25% from original study data for all simulated events. CONCLUSIONS: The EAGLE model is a valid tool for the analysis of long-term effects of diabetes treatment and related costs.