Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis Patients

Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis Patients: A Prospective Randomized Clinical Study

Poor glycemic control is common in critically ill patients with sepsis and is associated with increased morbidity and mortality; however, achieving safe and effective glucose management in the ICU remains challenging with conventional intermittent monitoring. Continuous glucose monitoring (CGM) offers real-time interstitial glucose readings and has the potential to improve detection of dysglycemic events, enhance adherence to glycemic protocols, and reduce nursing workload. This prospective, randomized controlled trial was designed to evaluate the accuracy, clinical effectiveness, and operational utility of a factory-calibrated CGM system (FreeStyle Libre II) compared with standard blood glucose monitoring (fingerstick, arterial, and venous measurements) in septic ICU patients. The primary outcomes include CGM accuracy against reference methods, protocol adherence rates, time efficiency, and the incidence of hypoglycemic and hyperglycemic events. The findings of this trial will help determine whether CGM can provide a reliable, clinically feasible, and time-saving alternative for glycemic management in this high-risk population, thereby supporting its integration into routine ICU practice and informing future larger-scale studies on long-term outcomes and cost-effectiveness.

Inclusion Criteria:

• Age ≥ 18 years.
• Confirmed infection accompanied by an increase in Sequential Organ Failure Assessment (SOFA) score of ≥ 2 points.
• Written informed consent provided by the patient or legally authorized representative.

Exclusion Criteria:

• Discharge against medical advice or transfer to another facility before study completion, leading to incomplete data.
• Non-cooperation with study procedures.
• Contraindications to the application of the flash glucose monitoring sensor (e.g., severe skin disease at insertion site, known allergy to sensor components).