Clinical validation of continuous glucose monitoring in glycemic management of critically ill sepsis patients: A prospective randomized clinical study.

ObjectiveThis study assessed the accuracy, clinical effectiveness, and utility of continuous glucose monitoring compared with conventional methods in critically ill patients with sepsis.MethodsFrom July 2023 to July 2025, 60 patients with sepsis (mean age, 75.6 ± 27.107 years; mean body mass index, 22.4 ± 2.960 kg/m2) were randomized to the continuous glucose monitoring (FreeStyle Libre II system) or conventional monitoring group in this prospective randomized trial. Conventional monitoring (self-monitoring of blood glucose using a glucometer with fingertip capillary samples, plus arterial/venous measurements) was applied in the control group, whereas the intervention group additionally received continuous glucose monitoring. Outcomes included glucose measurement results, protocol adherence, efficiency, and accuracy, assessed using correlation analysis, the Diabetes Technology Society error grid, and International Standardization Organization conformity.ResultsContinuous glucose monitoring demonstrated a high correlation (r = 0.986, p < 0.001), a low mean absolute relative deviation (11.44%), and 100% of readings fell within the clinically acceptable Zones A (91.9%) and B (8.1%) on the Diabetes Technology Society error grid analysis. The continuous glucose monitoring group showed significantly higher glycemic protocol adherence (73.91% vs. 48.16%, p < 0.001) and a shorter measurement time (41.33 vs. 63.67 s). Continuous glucose monitoring detected more hypoglycemic events (2.46% vs. 0.28%, p < 0.001) and fewer hyperglycemic events (44.38% vs. 50.88%, p < 0.001), with a higher time in the target range (33.23% vs. 26.26%).ConclusionsContinuous glucose monitoring is an accurate and clinically feasible method for real-time glucose monitoring in critically ill patients with sepsis in the intensive care unit. It enhances protocol adherence, improves dysglycemia detection, reduces nursing workload, and enables more precise insulin titration. Larger multicenter studies are warranted to confirm its long-term effects and cost-effectiveness.