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

NCT07686939 | Completed

• 1 other identifier: KTSB-WST-2022-014
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Hyperglycemia; Glycemic Control

Outcome Measures

Primary Outcomes (1)

• Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B)

  Throughout the 1-2 week ICU stay

Secondary Outcomes (5)

• Protocol Adherence Rate

  Throughout the 1-2 week ICU stay

• Target Glucose Achievement Rate

  Throughout the 1- to 2-week ICU stay.

• Hypoglycemia Detection Rate

  Throughout the 1- to 2-week ICU stay.

• Hyperglycemia Detection Rate

  hroughout the 1- to 2-week ICU stay.

• Nursing Time per Measurement

  Throughout the 1- to 2-week ICU stay.

Study Arms (2)

CGM Group (Intervention)

Device: Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System

Control Group (Active Comparator)

Interventions

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.

CGM Group (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taizhou Hospital: lead

Study Sites (1)

Taizhou Municipal Hospital

Taizhou, Zhejiang, 318000, China

Location

MeSH Terms

Conditions

Sepsis; Hyperglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)