The Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Hyperglycemia in Critically Ill Patients

Treatments: Device: Continuous Glucose Monitoring; Device: CGMS; Device: Continuous Glucose Monitoring Systems

Study type: Observational

Funder types: Other

Identifiers

NCT07201155

NFEC-2025-052

Details and patient eligibility

About

Abstract: Hyperglycemia, hypoglycemia, and glucose variability in ICU patients are associated with adverse outcomes. Continuous Glucose Monitoring Systems (CGMS) offer dynamic glucose monitoring and early warnings to improve glucose management. This study aims to evaluate the accuracy and reliability of the CGMS (Microtech AiDEX®) in critically ill patients and its performance under acidosis conditions, providing evidence for its application in the ICU.

Methods: This prospective observational study included patients with BG>180 mg/dL on intravenous insulin therapy. Blood glucose was monitored using point-of-care (POC), arterial blood gas analysis (aBG), and CGMS. CGMS values were paired 1:1 with POC and aBG values. CGMS accuracy was evaluated using MARD, ISO 15197-2013, CLSI POCT12-A3, and Clarke Error Grid Analysis.

Enrollment: 55 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria included

1. Age ≥18 years and ≤75 years;
2. Expected ICU stay of at least 3 days;
3. Elevated blood glucose (BG >180 mg/dL) requiring intravenous insulin therapy;
4. Informed consent obtained from the patient or their legally authorized representative.

Exclusion criteria included

1. Severe hepatic failure (Child-Pugh class C) or marked liver dysfunction (total bilirubin ≥50 μmol/L and alanine aminotransferase ≥3 times the upper limit of normal);
2. Uncorrected diabetic ketoacidosis; ability to self-feed; planned magnetic resonance imaging (MRI) examination;
3. Pregnancy or breastfeeding;
4. Extensive skin burns, dermatitis, or severe infections precluding the use of a continuous glucose monitoring system;
5. Severe brain injury, brain death, or moribund state;
6. Deemed unsuitable for study participation by the investigator.