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Pendra goes Dutch: lessons for the CE mark in Europe
I M E Wentholt1, J B L Hoekstra, A Zwart
1Department of Internal Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Diabetologia
|May 5, 2005
Summary
The Pendra device, a non-invasive continuous glucose monitor, failed post-marketing reliability studies. Its inaccuracy highlights the need for transparent CE certification and clear requirements for glucose monitoring devices.
Area of Science:
- Biomedical Engineering
- Medical Device Technology
- Diabetes Management
Background:
- Developing non-invasive continuous glucose sensors remains a significant challenge in diabetes care.
- The Pendra device, introduced in 2000, aimed to provide a truly non-invasive continuous glucose monitoring solution using impedance spectroscopy.
Purpose of the Study:
- To evaluate the performance and reliability of the Pendra non-invasive continuous glucose monitoring device.
- To assess the accuracy of the Pendra device compared to standard blood glucose monitoring methods in type 1 diabetes patients.
Main Methods:
- A post-marketing reliability study was conducted involving six type 1 diabetes patients.
- Pendra device glucose readings were compared against self-monitoring of blood glucose values.
- Statistical analysis included mean absolute difference and Pearson's correlation coefficient; Clarke error grid analysis was also performed.
Main Results:
- The Pendra device exhibited a mean absolute difference of 52% compared to self-monitoring of blood glucose.
- A low Pearson's correlation coefficient of 35.1% indicated poor agreement between the devices.
- Clarke error grid analysis revealed 4.3% of Pendra readings fell into the potentially dangerous Zone E.
Conclusions:
- The Pendra device demonstrated significant inaccuracies, posing potential risks to patients.
- There is a critical need for enhanced transparency in the Conformité Européenne (CE) certification process for continuous glucose sensors.
- Establishing consensus on specific performance requirements for continuous glucose sensors is essential to ensure patient safety.
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