Glycemic Control, Hyperglycemia, Sepsis
Conditions
Brief summary
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.
Interventions
DEVICEContinuous 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.
Sponsors
Taizhou Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B) | Throughout the 1-2 week ICU stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Adherence Rate | Throughout the 1-2 week ICU stay | Percentage of completed glucose measurements relative to the total prescribed tests per protocol.Unit of Measure: % (percentage) |
| Target Glucose Achievement Rate | Throughout the 1- to 2-week ICU stay. | Proportion of glucose readings falling within the target range of 7.8-10.0 mmol/L.Unit of Measure: % (percentage) |
| Hypoglycemia Detection Rate | Throughout the 1- to 2-week ICU stay. | 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) |
| Hyperglycemia Detection Rate | hroughout the 1- to 2-week ICU stay. | 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) |
| Nursing Time per Measurement | Throughout the 1- to 2-week ICU stay. | 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) |
Countries
China
Outcome results
None listed