The Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients

NCT07201155 | Completed DMC FDA Device

• 1 other identifier: NFEC-2025-052
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia in Critically Ill Patients

Outcome Measures

Primary Outcomes (1)

• MARD

  MARD was calculated as the average of absolute percentage differences between paired glucose measurements: MARD = (1/n) × Σ(\|CGMS-Reference\|/Reference) × 100%.

  From enrollment to discharge/completion of 14-day CGMS wear.

Interventions

Continuous Glucose Monitoring Systems DEVICE

A trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed. Patients monitored their blood glucose using fingerstick point-of-care (POC) measurements every 1-6 hours as needed and had routine arterial blood gas analysis 4-6 times a day. After 24 hours of patient wear, the arterial blood gas glucose (aBG) was used to calibrate the CGMS device at least twice a day. Nurses recorded CGMS data paired with POC values and aBG values in a 1:1 format.

Continuous Glucose Monitoring DEVICE

This study is a single-center, prospective, observational study conducted in the Intensive Care Unit (ICU) of Nanfang Hospital, Southern Medical University, from May 2024 to August 2024. Patients with elevated blood glucose levels (BG\>180 mg/dL) undergoing intravenous insulin therapy were included. Simultaneous blood glucose monitoring was performed using fingerstick blood samples and arterial blood gas analysis, along with the installation of CGMS for concurrent monitoring. CGMS data (CGM values) were recorded in a 1:1 paired format with fingerstick point-of-care (POC) values and arterial blood gas (aBG) values. The correlation of paired blood glucose data was examined using Pearson's correlation coefficient. The accuracy of CGMS was assessed using metrics such as Mean Absolute Relative Difference (MARD), ISO 15197-2013, CLSI POCT12-A3, and Clarke Error Grid Analysis, analyzed with R v.4.4.1 software.

CGMS DEVICE

Patients who met the inclusion and exclusion criteria were enrolled in the study after obtaining informed consent from the patient or their legal representative. A trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

blood glucose (BG\>180 mg/dL) undergoing intravenous insulin therapy

You may qualify if:

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

You may not qualify if:

• 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);
• Uncorrected diabetic ketoacidosis; ability to self-feed; planned magnetic resonance imaging (MRI) examination;
• Pregnancy or breastfeeding;
• Extensive skin burns, dermatitis, or severe infections precluding the use of a continuous glucose monitoring system;
• Severe brain injury, brain death, or moribund state;
• Deemed unsuitable for study participation by the investigator.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

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: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: October 1, 2025
• Study Start: May 1, 2024
• Primary Completion: August 15, 2024
• Study Completion: October 10, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

CN (1)