Evaluation of a New Diabetes Mellitus Index Based on Measurements Using the Scheimpflug Analyzer Corvis ST.

Purpose: Chronic hyperglycemia causes changes in corneal biomechanics that can be measured with the Scheimpflug Analyzer Corvis ST. The diagnostic reliability of the new diabetes mellitus (DM) index developed based on this should be evaluated.

Methods: In a prospective cross-sectional study, the index was initially developed using data from 81 patients with DM and 75 healthy subjects based on logistic regression analysis. The reliability of the DM index was subsequently assessed using data from another 61 patients and 37 healthy individuals. In addition, the dependence of the DM index on indicators of disease severity was analyzed.

Results: The index initially achieved a sensitivity of 79% and specificity of 80% with a cutoff value of 0.58. The evaluation showed a sensitivity of 67% and specificity of 76% with an optimized cutoff of 0.51 (area under the curve = 0.737, P < 0.001). The DM index correlated weakly with the severity of diabetic retinopathy (r = 0.209, P = 0.014). It was increased in the presence of diabetic maculopathy (P = 0.037) and in type 1 DM compared with patients with type 2 disease (P = 0.039).

Conclusions: In this first evaluation, the new DM index achieved sufficiently good sensitivity and specificity and was weakly associated with disease-specific factors. With further improvements, it could complement the diagnostic options in DM with a simple, rapid, and noninvasive assessment method.