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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Group (Intervention) |
| ||
| Control Group (Active Comparator) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B) | Throughout the 1-2 week ICU stay |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol Adherence Rate | Percentage of completed glucose measurements relative to the total prescribed tests per protocol.Unit of Measure: % (percentage) | Throughout the 1-2 week ICU stay |
| Target Glucose Achievement Rate |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Municipal Hospital | Taizhou | Zhejiang | 318000 | China |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
Proportion of glucose readings falling within the target range of 7.8-10.0 mmol/L.Unit of Measure: % (percentage)
| 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) | 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) | 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) | Throughout the 1- to 2-week ICU stay. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |