Pendra goes Dutch: lessons for the CE mark in Europe.
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.
Wentholt
I M E
IM
Department of Internal Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Hoekstra
J B L
JB
Zwart
A
A
DeVries
J H
JH
D001786:Blood Glucose / Q000032:analysis*; D004867:Equipment Design; D005060:Europe; D005062:European Union; D006801:Humans; D018670:Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods*; D009426:Netherlands
D001786:Blood Glucose