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Background: Health literacy (HL) skills are essential to enable self-management and shared decision-making in patients with type 2 diabetes mellitus (T2DM). Limited HL in these patients is associated with poorer outcomes. It is not clear what the burden of limited HL in patients with T2DM across countries and what factors influence it. Methods: A systematic review was conducted according to the PRISMA guidelines. The study protocol was registered with PROSPERO (CRD42017056150). We searched MEDLINE, EMBASE, PsycINFO, CINAHL and ERIC for articles published up to January 2017. Articles that measured HL levels in adult patients with T2DM; that used validated HL tools; and that were reported in English were included. Two reviewers assessed studies for eligibility and quality, and extracted the data. Prevalence of limited HL is calculated from the number of patients with less than adequate HL over the total number of patients with T2DM in the study. Meta-analysis and meta-regression analysis were conducted using the Open Meta-analyst software. Results: Twenty-nine studies involving 13,457 patients with T2DM from seven countries were included. In total, seven different HL measurement tools were used. The prevalence of limited HL ranged from 7.3% to 82%, lowest in Switzerland and the highest in Taiwan. Meta-regression analysis of all included studies showed the country of study (p<0.001), HL tool used (p = 0.002), and the country’s region (p<0.001) contributed to the variation findings. Thirteen studies in the USA measured functional HL. The pooled prevalence of inadequate functional HL among patients with T2DM in the USA was 28.9% (95% CI: 20.4–37.3), with high heterogeneity (I2 = 97.9%, p <0.001). Studies were done in the community as opposed to a hospital or primary care (p = 0.005) and populations with education level lower than high school education (p = 0.009) reported a higher prevalence of limited HL. Conclusion: The prevalence of limited HL in patients with T2DM varied widely between countries, HL tools used and the country’s region. Pooled prevalence showed nearly one in three patients with T2DM in the USA had limited functional HL. Interactions with healthcare providers and educational attainment were associated with reported of prevalence in the USA. [ABSTRACT FROM AUTHOR]