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Objective To establish a diagnostic scale of TCM pattern elements of type 2 diabetes mellitus (T2DM) by introducing the scale development method into the diagnosis of TCM patterns and to explore the standardization of TCM pattern by developing relevant scale. Methods Data obtained with TCM four diagnostic methods was collected from 249 qualified patients with T2DM in five grade 3 and first-class hospitals around the country by using a multi-center clinical epidemiology survey. Pattern differentiation was centrally made after all the information was collected. The entry pool of four TCM diagnostic methods of each pattern was initially identified on the basis of literature research. Correlation coefficient, stepwise regression and factor analysis methods were jointly used to do entry screening on the data of 179 samples. Logistic regression was conducted to do entry assignment, and ROC curve was used to determine the diagnostic threshold to establish the diagnosis scale of T2DM TCM pattern elements. 70 samples were used to do reliability and validity evaluation of the scale. Results There were nine pattern elements in T2DM Diagnostic Scale of TCM patterns, namely, pattern of qi deficiency, yin deficiency, internal dampness，dryness-heat，yang deficiency，blood stasis，liquid depletion，phlegm turbidity and qi stagnation，whose diagnostic threshold were ： 11 points，9 points，8 points，13 points，8 points，10 points，12 points，7 points and 4 points respectively. The split-half reliability of the scale was 0. 878， and its Cronbach' sa was 0. 844. Three common factors were extracted with factor analysis. The cumulative variance contribution rate was 69. 123% and the correlation coefficient of the score of each pattern element to the total score was 0. 471 - 0. 794. Conclusions There are nine pattern elements in the diagnostic scale of T2DM TCM factors，which is of good reliability and validity，and can be used for clinical or research pattern diagnosis. It provides new ideas and methods for the study of TCM pattern standardization. [ABSTRACT FROM AUTHOR]