The Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients

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

Interventions

DEVICE

Continuous Glucose Monitoring Systems

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.

DEVICE

Continuous Glucose Monitoring

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.

DEVICE

Continuous Glucose Monitoring

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.

DEVICE

CGMS

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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2024-08-15

Completion

2024-10-10

FDA Device

Yes

Countries

• China

Study Locations