Continuous Subcutaneous Glucose Monitoring in Diabetic Patients
A multicenter analysis
- Alberto Maran, MD1,
- Cristina Crepaldi, MD1,
- Antonio Tiengo, MD1,
- Giorgio Grassi, MD2,
- Emanuela Vitali, MD2,
- Gianfranco Pagano, MD2,
- Sergio Bistoni, MD3,
- Giuseppe Calabrese, MD3,
- Fausto Santeusanio, MD3,
- Frida Leonetti, MD4,
- Maria Ribaudo, MD4,
- Umberto Di Mario, MD4,
- Giovanni Annuzzi, MD5,
- Salvatore Genovese, MD5,
- Gabriele Riccardi, MD5,
- Marcello Previti, MD6,
- Domenico Cucinotta, MD6,
- Francesco Giorgino, MD7,
- Aurelia Bellomo, MD7,
- Riccardo Giorgino, MD7,
- Alessandro Poscia8 and
- Maurizio Varalli8
- 1Dipartimento di Medicina Clinica e Sperimentale, Cattedra di Malattie del Metabolismo, Universita di Padova, Padova, Italy
- 2Dipartimento di Medicina Interna, Ospedale “Le Molinette,” Torino, Italy
- 3Dipartimento di Medicina Interna, Scienze Endocrine e Metaboliche, Universita di Perugina, Perugina, Italy
- 4Clinica Medica II, Policlinico Umberto I, Universita degli Studi di Roma “La Sapienza,” Rome, Italy
- 5Dipartimento Medicina Interna e Sperimentale, Universita degli Studi di Napoli “Federico II,” Naples, Italy
- 6Policlinico Universitario, Messina, Italy
- 7Istituto Clinico Medico e Malattie del Metabolismo, Universita di Bari, Bari, Italy
- 8A. Menarini Diagnostics, Florence, Italy
Abstract
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.
RESEARCH DESIGN—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.
Footnotes
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Address correspondence and reprint requests to Alberto Maran, MD, Cattedra di Malattie del Metabolismo, Via Giustiniani 2, 35123 Padova, Italy. E-mail: alberto.maran{at}unipd.it.
Received for publication 14 May 2001 and accepted in revised form 24 October 2001.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
