Continuous subcutaneous glucose monitoring in diabetic patients: a multicenter analysis.
OBJECTIVE
To evaluate the accuracy of a new subcutaneous glucose sensor (Glucoday; A. Menarini Diagnostics) compared with venous blood glucose measurement in type 1 and type 2 diabetic patients.


METHODS
A multicenter study was performed in 70 diabetic patients. A microdialysis fiber was inserted subcutaneously into the periumbelical region and perfused with a buffer solution. Glucose concentrations in the dialysate were then measured every 3 min by the glucose sensor over a 24-h period, during which nine venous blood samples were also collected throughout the day.


RESULTS
Both the insertion of the fiber and the wearing of the device were well tolerated by the patients. Subcutaneous glucose levels were well correlated with venous glucose measurements (r = 0.9, P < 0.001) over a wide range (40-400 mg/dl) for up to 24 h, with a single-point calibration. An analysis of 381 data pairs showed a linear relationship between the GlucoDay and serial venous blood glucose levels, and 97% of the data fell in the A and B regions of the error grid analysis. Percentage bias between the GlucoDay and the blood venous levels was -2.0% in the hypoglycemic range (<70 mg/dl), 6.9% in the euglycemic range (70-180 mg/dl), and 11.2% in the hyperglycemic range (>180 mg/dl).


CONCLUSIONS
The GlucoDay system demonstrated high reliability and reported values that closely agreed with venous blood glucose measurements. The system was well tolerated and thus constitutes a relatively easy method to monitor glucose excursions in diabetic patients.
Maran
Alberto
A
Dipartimento di Medicina Clinica e Sperimentale, Cattedra di Malattie del Metabolismo, Universita di Padova, Via Giustiniani 2, 35123 Padua, Italy. alberto.maran@unipd.it
Crepaldi
Cristina
C
Tiengo
Antonio
A
Grassi
Giorgio
G
Vitali
Emanuela
E
Pagano
Gianfranco
G
Bistoni
Sergio
S
Calabrese
Giuseppe
G
Santeusanio
Fausto
F
Leonetti
Frida
F
Ribaudo
Maria
M
Di Mario
Umberto
U
Annuzzi
Giovanni
G
Genovese
Salvatore
S
Riccardi
Gabriele
G
Previti
Marcello
M
Cucinotta
Domenico
D
Giorgino
Francesco
F
Bellomo
Aurelia
A
Giorgino
Riccardo
R
Poscia
Alessandro
A
Varalli
Maurizio
M
D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000175:diagnosis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000175:diagnosis; D005260:Female; D005947:Glucose / Q000032:analysis*; D006801:Humans; D008297:Male; D017551:Microdialysis / Q000295:instrumentation / Q000379:methods / Q000592:standards; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D015203:Reproducibility of Results; D012867:Skin
D005947:Glucose