Abstract
OBJECTIVE: Hypoglycemia unawareness (HU), also known as impaired awareness of hypoglycemia (IAH), is a significant complication of insulin therapy that increases the risk of severe neuroglycopenic events in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). Research data from Saudi Arabia on this topic is limited and inconsistent. This systematic review and meta-analysis aimed to identify and summarize studies that report the prevalence, risk factors, and clinical outcomes of HU among individuals with T1DM and T2DM in Saudi Arabia. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive search was conducted across PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar up to July 2025 for observational studies that reported the prevalence or risk factors of HU in Saudi adults with diabetes. A total of 11 cross-sectional studies (n = 4,171) met the inclusion criteria. The quality of these studies was appraised using tools from the Joanna Briggs Institute (JBI). Proportions were pooled using a random-effects model (OpenMetaAnalyst), and heterogeneity was assessed using the I-squared (I²) statistic. Leave-one-out sensitivity analyses were performed to evaluate the robustness of the findings. RESULTS: The overall pooled prevalence of HU was found to be 41.9% (95% confidence interval [CI]: 21.2-62.6%), with high heterogeneity (I² = 99.7%, p <0.001). Sensitivity analyses indicated minimal fluctuation in the prevalence estimates (ranging from 36.8% to 45.5%) when excluding any single study, confirming the stability of the pooled estimate. Key risk factors identified included poor diabetes knowledge, specifically a lack of awareness regarding insulin type, dosage, and the most recent glycated hemoglobin (HbA1c) levels, insufficient medical follow-up, and macrovascular complications (such as prior stroke and ischemic heart disease). It was also noted that lower daily insulin doses were associated with HU. CONCLUSION: Nearly half of insulin-treated diabetes patients in Saudi Arabia display impaired awareness of hypoglycemia. Addressing modifiable factors, particularly inadequate patient education and follow-up, is crucial. Implementing standardized screening protocols for HU and structured diabetes self-management education is essential, as these measures may help reduce the risk of severe hypoglycemic events in this population.