Digital solution for detection of undiagnosed diabetes using machine learning-based retinal image analysis.

Introduction: Undiagnosed diabetes is a global health issue. Previous studies have estimated that about 24.1%-75.1% of all diabetes cases are undiagnosed, leading to more diabetic complications and inducing huge healthcare costs. Many current methods for diabetes diagnosis rely on metabolic indices and are subject to considerable variability. In contrast, a digital approach based on retinal image represents a stable marker of overall glycemic status.
Research Design and Methods: Our study involves 2221 subjects for developing a classification model, with 945 subjects with diabetes and 1276 controls. The training data included 70% and the testing data 30% of the subjects. All subjects had their retinal images taken using a non-mydriatic fundus camera. Two separate data sets were used for external validation. The Hong Kong testing data contain 734 controls without diabetes and 660 subjects with diabetes, and the UK testing data have 1682 subjects with diabetes.
Results: The 10-fold cross-validation using the support vector machine approach has a sensitivity of 92% and a specificity of 96.2%. The separate testing data from Hong Kong provided a sensitivity of 99.5% and a specificity of 91.1%. For the UK testing data, the sensitivity is 98.0%. The accuracy of the Caucasian retinal images is comparable with that of the Asian data. It implies that the digital method can be applied globally. Those with diabetes complications in both Hong Kong and UK data have a higher probability of risk of diabetes compared with diabetes subjects without complications.
Conclusions: A digital machine learning-based method to estimate the risk of diabetes based on retinal images has been developed and validated using both Asian and Caucasian data. Retinal image analysis is a fast, convenient, and non-invasive technique for community health applications. In addition, it is an ideal solution for undiagnosed diabetes prescreening.
Competing Interests: Competing interests: BZ and JL have a patent 'Method and device for retinal image analysis' licensed to Health View Bioanalytic, which received royalties through The Chinese University of Hong Kong. BZ and JL are founders and shareholders of Health View Bioanalytic, Bioanalytic Holdings, and Bioanalytic International Holdings. ML is the director of Bioanalytic Holdings and Bioanalytic International Holdings.
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