The Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients
- Conditions
- Hyperglycemia in Critically Ill Patients
- Registration Number
- NCT07201155
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MARD From enrollment to discharge/completion of 14-day CGMS wear. MARD was calculated as the average of absolute percentage differences between paired glucose measurements: MARD = (1/n) × Σ(\|CGMS-Reference\|/Reference) × 100%.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University🇨🇳Guangzhou, Guangdong, China