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Pendra goes Dutch: lessons for the CE mark in Europe

By I. M. E. Wentholt, J. B. L. Hoekstra, A. Zwart and J. H. DeVries

Abstract

The development of a truly non-invasive continuous glucose sensor is an elusive goal. We describe the rise and fall of the Pendra device. In 2000 the company Pendragon Medical introduced a truly non-invasive continuous glucose-monitoring device. This system was supposed to work through so-called impedance spectroscopy. Pendra was Conformite Europeenne (CE) approved in May 2003. For a short time the Pendra was available on the Dutch direct-to-consumer market. A post-marketing reliability study was performed in six type 1 diabetes patients. Mean absolute difference between Pendra glucose values and values obtained through self-monitoring of blood glucose was 52%; the Pearson's correlation coefficient was 35.1%; and a Clarke error grid showed 4.3% of the Pendra readings in the potentially dangerous zone E. We argue that the CE certification process for continuous glucose sensors should be made more transparent, and that a consensus on specific requirements for continuous glucose sensors is needed to prevent patient exposure to potentially dangerous situation

Year: 2005
DOI identifier: 10.1007/s00125-005-1754-y
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Provided by: NARCIS
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