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TheClinical Research Tool: a high-performance microdialysis-based system for reliably measuring interstitial fluid
Gregor Ocvirk1, Martin Hajnsek, Ralph Gillen
1Roche Diagnostics GmbH, Diabetes Care, Technology Development, Mannheim, Germany. gregor.ocvirk@roche.com
Journal of Diabetes Science and Technology
|February 11, 2010
Summary
This study introduces a novel microdialysis continuous glucose monitoring system (CRT) designed for high accuracy and reliability in clinical research. The CRT effectively distinguishes between physiological glucose changes and system artifacts, proving its value as a reference tool.
Area of Science:
- Biomedical Engineering
- Medical Devices
- Diabetes Technology
Background:
- A novel microdialysis-based continuous glucose monitoring system, the Clinical Research Tool (CRT), was developed for investigational use.
- The CRT is engineered for high analytical accuracy and reliability, specifically designed to mitigate common artifacts like catheter clogging and flow obstruction.
- System parameters including sensor current, electrode voltage, battery voltage, temperature, and flow rate are logged at 1 Hz for artifact differentiation.
Purpose of the Study:
- To present and characterize a novel microdialysis-based continuous glucose monitoring system (CRT).
- To evaluate the accuracy and reliability of the CRT for investigational use in glucose monitoring.
- To assess the system's ability to differentiate physiological glucose variations from system-induced artifacts.
Main Methods:
- In vitro characterization involved testing with buffered glucose solutions over 120 hours.
- In vivo testing was conducted over 120 hours with five type 1 diabetes subjects, each using two CRT systems.
- System performance was assessed by recording sensor current, voltage, temperature, and flow rate, with retrospective calibration using blood glucose measurements.
Main Results:
- In vitro testing showed a mean absolute relative error (MARE) of 2.9 +/- 0.9% with minimal periodic flow rate variation.
- In vivo testing recorded mean flow rates of 350 +/- 59 nl/min with periodic variation of 22 +/- 6%.
- Retrospective calibration of in vivo experiments yielded a MARE of 12.4 +/- 5.7%, with 81.0% of readings in region A of the Clarke error grid.
Conclusions:
- The Clinical Research Tool (CRT) demonstrates exceptional operational reliability and strong measurement performance.
- The system's capability to differentiate artifacts from physiological signals supports its use as a reference tool in clinical investigations.
- The CRT offers a reliable platform for advanced glucose monitoring research.

