PURPOSE: To assess the diagnostic accuracy measures such as sensitivity and specificity of smartphone-based artificial intelligence (AI) approaches in the detection of diabetic retinopathy (DR). METHODS: A literature search of the EMBASE and MEDLINE databases (up to March 2020) was conducted. Only studies using both smartphone-based cameras and AI software for image analysis were included. The main outcome measures were pooled sensitivity and specificity, diagnostic odds ratios and relative risk of smartphone-based AI approaches in detecting DR (of all types), and referable DR (RDR) (moderate nonproliferative retinopathy or worse and/or the presence of diabetic macular edema). RESULTS: Smartphone-based AI has a pooled sensitivity of 89.5% (95% confidence interval [CI]: 82.3%-94.0%) and pooled specificity of 92.4% (95% CI: 86.4%-95.9%) in detecting DR. For referable disease, sensitivity is 97.9% (95% CI: 92.6%-99.4%), and the pooled specificity is 85.9% (95% CI: 76.5%-91.9%). The technology is better at correctly identifying referable retinopathy. CONCLUSIONS: The smartphone-based AI programs demonstrate high diagnostic accuracy for the detection of DR and RDR and are potentially viable substitutes for conventional diabetic screening approaches. Further, high-quality randomized controlled trials are required to establish the effectiveness of this approach in different populations.