Evaluating the precision and reliability of real-time continuous glucose monitoring systems in ambulatory settings: a systematic review

Abstract

Background: Continuous glucose monitoring (CGM) with minimally invasive devices plays a key role in the assessment of daily diabetes management by detecting and alerting to potentially dangerous trends in glucose levels, improving quality of life, and treatment adherence. However, there is still uncertainty as to whether CGMs are accurate enough to replace self-monitoring of blood glucose, especially in detecting episodes of hypoglycemia. Objectives: Evaluate clinical, numerical accuracy, sensitivity, and specificity of the CGM devices commercially available when compared to the reference standard of arterial or venous blood glucose. Data sources and methods: We searched the Cochrane Library, PubMed, EMBASE, and LILACS databases. The quality was assessed with the Quality Assessment Diagnostic Accuracy Studies (QUADAS-2) tool. Clinical and numerical accuracy data were extracted. Sensitivity and specificity were calculated using Review Manager software. Heterogeneity was assessed by visual examination of forest plot and summary receiver operating characteristic curves. Results: Twenty-two studies with a total of 2294 patients were included. The average mean absolute relative difference for overall diagnostic accuracy was 9.4%. None of the devices evaluated with ISO 15197:2013 criteria achieved values ⩾95% of measurements in the stipulated ranges in hypoglycemia (±15 mg/dL), but two devices did achieve it in hyperglycemia (±15%; Dexcom G6 and G7). Most of the devices evaluated with consensus error grids reached values above 99% in zones A and B only in overall accuracy and hyperglycemia. For hypoglycemia, the average sensitivity was 85.7% and specificity 95.33%, and for hyperglycemia was 97.45% and 96% respectively. Conclusion: Currently available CGM devices have adequate accuracy for euglycemia and hyperglycemia; however, it is still inadequate for hypoglycemia, although it has improved over time. Trial registration: Prospero registration ID CRD42023399767.