Article

Biomedical Microdevices

, Volume 12, Issue 3, pp 399-407

Microdialysis based device for continuous extravascular monitoring of blood glucose

  • Franz FeichtnerAffiliated withInstitute of Medical Technologies and Health Management, Joanneum Research GmbH Email author 
  • , Roland SchallerAffiliated withInstitute of Medical Technologies and Health Management, Joanneum Research GmbH
  • , Andreas FercherAffiliated withInstitute of Medical Technologies and Health Management, Joanneum Research GmbH
  • , Maria RatzerAffiliated withInstitute of Medical Technologies and Health Management, Joanneum Research GmbH
  • , Martin EllmererAffiliated withDivision of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz
  • , Johannes PlankAffiliated withDivision of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz
  • , Bernd KrauseAffiliated withGambro Dialysatoren GmbH
  • , Thomas PieberAffiliated withInstitute of Medical Technologies and Health Management, Joanneum Research GmbHDivision of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz
  • , Lukas SchauppAffiliated withInstitute of Medical Technologies and Health Management, Joanneum Research GmbHDivision of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz

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Abstract

Glycemic control of intensive care patients can be beneficial for this patient group but the continuous determination of their glucose concentration is challenging. Current continuous glucose monitoring systems based on the measurement of interstitial fluid glucose concentration struggle with sensitivity losses, resulting from biofouling or inflammation reactions. Their use as decision support systems for the therapeutic treatment is moreover hampered by physiological time delays as well as gradients in glucose concentration between plasma and interstitial fluid. To overcome these drawbacks, we developed and clinically evaluated a system based on microdialysis of whole blood. Venous blood is heparinised at the tip of a double lumen catheter and pumped through a membrane based micro-fluidic device where protein-free microdialysate samples are extracted. Glucose recovery as an indicator of long term stability was studied in vitro with heparinised bovine blood and remained highly stable for 72 h. Clinical performance was tested in a clinical trial in eight healthy volunteers undergoing an oral glucose tolerance test. Glucose concentrations of the new system and the reference method correlated at a level of 0.96 and their mean relative difference was 1.9 ± 11.2%. Clinical evaluation using Clark’s Error Grid analysis revealed that the obtained glucose concentrations were accurate and clinically acceptable in 99.6% of all cases. In conclusion, results of the technical and clinical evaluation suggest that the presented device delivers microdialysate samples suitable for accurate and long term stable continuous glucose monitoring in blood.

Keywords

Microdialysis Sampling Glucose monitoring Extravascular In vitro study Clinical trial