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(R) device. In 2000 the company Pendragon Medical introduced a truly non-invasive continuous glucose monitoring device. This system was based on impedance spectroscopy. Pendra was 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 6 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 Clark 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 patients from exposure to potentially dangerous situations. This manuscript is a shortened and adapted version of Wentholt IM, Zwart A, Hoekstra JB, DeVries JH. Pendra goes Dutch; lessons for the CE mark in Europe. Diabetologia 2005; 48: 1055-8 and is published with consent of the editor of Diabetologia. [ABSTRACT FROM AUTHOR]