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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Sepsis; Glycemic Control
• Intervention / Treatment: Device: Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Taizhou, Zhejiang, China, 318000
      • Taizhou Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CGM Group (Intervention)	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.
Control Group (Active Comparator)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Taizhou Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Sepsis; Hyperglycemia; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: KTSB-WST-2022-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No