An observational study in Sepsis, Hyperglycemia and Glycemic Control, sponsored by Taizhou Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Taizhou Hospital · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 60 is below the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Taizhou Hospital is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill adult patients (≥18 years) with sepsis (infection + SOFA increase ≥2) admitted to the ICU. Total 60 patients (mean age 75.6 years; 42 male/18 female), with or without diabetes. Excludes those with sensor contraindications, non-cooperation, or anticipated incomplete follow-up.
Exclusion Criteria:
Device: Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System
Intervention Group (CGM Group): Patients receive continuous glucose monitoring using the factory-calibrated FreeStyle Libre II system (Abbott Diabetes Care Ltd, UK). A sensor is inserted subcutaneously on the posterior aspect of the upper arm and measures interstitial glucose levels in real time. Glucose values and trend data are displayed on a reader device and are accessible to the clinical team remotely. In addition to CGM, all patients in this group also undergo standard conventional monitoring (fingertip capillary glucose, arterial blood gas, and venous blood glucose measurements) per routine ICU practice. Insulin therapy is initiated when blood glucose reaches ≥10 mmol/L.
Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B)
Time frame: Throughout the 1-2 week ICU stay
Protocol Adherence Rate
Percentage of completed glucose measurements relative to the total prescribed tests per protocol.Unit of Measure: % (percentage)
Time frame: Throughout the 1-2 week ICU stay
Target Glucose Achievement Rate
Proportion of glucose readings falling within the target range of 7.8-10.0 mmol/L.Unit of Measure: % (percentage)
Time frame: Throughout the 1- to 2-week ICU stay.
Hypoglycemia Detection Rate
Incidence of hypoglycemic events (glucose ≤ 3.9 mmol/L) detected, calculated as number of events divided by total number of measurements × 100%.Unit of Measure: % (percentage)
Time frame: Throughout the 1- to 2-week ICU stay.
Hyperglycemia Detection Rate
Incidence of hyperglycemic events (glucose ≥ 11.1 mmol/L) detected, calculated as number of events divided by total number of measurements × 100%.Unit of Measure: % (percentage)
Time frame: hroughout the 1- to 2-week ICU stay.
Nursing Time per Measurement
Average time required for nursing staff to complete a single glucose measurement (from preparation to recording result).seconds (or minutes, as appropriate; your study reports seconds)
Time frame: Throughout the 1- to 2-week ICU stay.
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Taizhou Hospital