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- Title
Pendra goes Dutch: lessons for the CE mark in Europe.
- Authors
Wentholt, I. M. E.; Hoekstra, J. B. L.; Zwart, A.; DeVries, J. H.
- 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 Conformité Européenne (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 situations.
- Subjects
EUROPE; NETHERLANDS; GLUCOSE; MEDICAL equipment; DIAGNOSIS of diabetes; PENDRAGON Medical (Company); EQUIPMENT &; supplies
- Publication
Diabetologia, 2005, Vol 48, Issue 6, p1055
- ISSN
0012-186X
- Publication type
Article
- DOI
10.1007/s00125-005-1754-y