title: Microdialysis-based 48-hour continuous glucose monitoring with GlucoDay: clinical performance and patients' acceptance.
abstract: BACKGROUND
  This study was designed to assess clinical performance and patients' acceptance of the minimally invasive microdialysis-based continuous glucose monitoring system Gluco- Day() (Menarini Diagnostics, Florence, Italy) with a targeted monitoring time of 48 h.
  
  
  METHODS
  An inpatient sample of 28 patients with diabetes was studied. The analysis of clinical performance was performed using mean absolute differences (MAD) (in percent), Pearson correlations, the Bland-Altman analysis, and Clarke Error Grid Analysis (EGA). GlucoDay glucose values were compared with laboratory standard blood glucose measurements (glucohexokinase assay). The patients' acceptance of the monitoring device was assessed via two self-report scales (pain during application and discomfort while wearing device).
  
  
  RESULTS
  A mean (+/- SD) monitoring time of 45.7 +/- 3.3 h with a total of 484 paired readings could be achieved. A correlation of r (average) = 0.91 and a MAD of 19.9% indicated satisfactory to good clinical performance. Of the paired readings, 95.5% fell into the acceptable A and B zones of the EGA. Rather wide 95% limits of agreement were revealed in the Bland-Altman analysis. Whereas virtually no pain was experienced during sensor application, discomfort associated with wearing the device was rather high. All of the participants, however, stated that they would wear the device again.
  
  
  CONCLUSIONS
  Satisfactory to good performance of the GlucoDay monitor was observed, indicating the device to be suitable for routine clinical use. In particular, however, the discomfort experienced during wearing requires further improvements in its usability.
authors.affiliation: Institute of Psychology, University of Greifswald, Greifswald, Germany. kubiak@uni-greifswald.de
authors.forename: T
authors.initials: T
authors.lastname: Kubiak
authors.forename: B
authors.initials: B
authors.lastname: Wörle
authors.forename: B
authors.initials: B
authors.lastname: Kuhr
authors.forename: I
authors.initials: I
authors.lastname: Nied
authors.forename: G
authors.initials: G
authors.lastname: Gläsner
authors.forename: N
authors.initials: N
authors.lastname: Hermanns
authors.forename: B
authors.initials: B
authors.lastname: Kulzer
authors.forename: T
authors.initials: T
authors.lastname: Haak
mesh_terms: D000328:Adult; D015374:Biosensing Techniques / Q000295:instrumentation*; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D017551:Microdialysis / Q000295:instrumentation*; D008875:Middle Aged; D017060:Patient Satisfaction; D013997:Time Factors
chemical_list: D001786:Blood Glucose