Pendra goes Dutch; lessons for the CE mark in Europe

Diabetes Research and Clinical Practice

Volumn 74, Issue SUPPL. 2, 2006, Pages

  DeVries, J H ^a   Wentholt, I M E ^a   Zwart, A ^a   Hoekstra, J B ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

Artificial pancreas; Continuous glucose monitoring; Diabetes; Glucose sensor; Impedance spectroscopy; Metabolic control

Indexed keywords

ANALYTICAL ERROR; ARTICLE; ARTIFICIAL PANCREAS; BLOOD GLUCOSE MONITORING; CALIBRATION; CERTIFICATION; CONSENSUS; CORRELATION COEFFICIENT; COST EFFECTIVENESS ANALYSIS; DEVICE; DIAGNOSTIC ACCURACY; DIAGNOSTIC VALUE; EUROPE; GLUCOSE BLOOD LEVEL; HUMAN; IMPEDANCE SPECTROSCOPY; INSULIN DEPENDENT DIABETES MELLITUS; MARKET; METABOLIC REGULATION; NETHERLANDS; NON INVASIVE PROCEDURE; PUBLICATION; RELIABILITY; SAFETY; SELF MONITORING; SENSOR; SPECTROSCOPY; SYSTEM ANALYSIS;

EID: 33845484245     PISSN: 01688227     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-8227(06)70006-7     Document Type: Article

References (11)

1. Bao J., and Davis C. Frequency domain impedance measurements of erythrocytes. Constant phase angle impedance characteristics and a phase transition. Biophys J 61 (1992) 1427-1434
2. Beving H., and Eriksson G. Dielectric spectroscopy of human blood. Eur J Surg Suppl 574 (1994) 87-89
3. Zhao T., and Lockner D. Electrical impedance and erythrocyte sedimentation rate (ESR) of blood. Biochim Biophys Acta 1153 (1993) 243-248
4. Pfutzner A., Caduff A., Larbig M., Schrepfer T., and Forst T. Impact of posture and fixation technique on impedance spectroscopy used for continuous and noninvasive glucose monitoring. Diabetes Technol Ther 6 (2004) 435-441
5. Caduff A., Hirt E., Feldman Y., Ali Z., and Heinemann L. First human experiments with a novel non-invasive, non-optical continuous glucose monitoring system. Biosens Bioeiectron 19 (2003) 209-217
6. Scheffler M., Hirt E., and Caduff A. Wrist-wearable medical devices: technologies and applications. Med Device Technol 14 (2003) 26-30
7. Guerci B., Floriot M., Bohme P., Durain D., Benichou M., Jellimann S., et al. Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insuiin analogs. Diabetes Care 26 (2003) 582-589
8. Varalli M., Marelli G., Maran A., Bistoni S., Luzzana M., Cremonesi P., et al. A microdialysis technique for continuous subcutaneous glucose monitoring in diabetic patients (part 2). Biosens Bioelectron 18 (2003) 899-905
9. Maran A., Crepaldi C., Tiengo A., Grassi G., Vitali E., Pagano G., et al. Continuous subcutaneous glucose monitoring in diabetic patients: a multicenter analysis. Diabetes Care 25 (2002) 347-352
10. Foreman J. Hope or hype: the obsession with medical advances and the high cost of false promises. New Engl J Med 352 (2005) 1615-1616
11. Koschinsky T., and Heinemann L. Sensors for glucose monitoring: technical and clinical aspects. Diabetes Metab Res Rev 17 (2001) 113-123