VivaChek® Ino Blood Glucose Monitoring System accuracy met the DIN EN ISO 15197:2013 in an independent clinical study by IDK Germany - Institute of Diabetes »Gerhardt Katsch« Karlsburg (www.diabetes-karlsburg.de) !
The evaluation protocol had been submitted as an amendment to the Independent Ethics Committee Greifswald University, and the study has been announced to the Health Authority according to §20 MPG. The study was performed between 30th June and 17th July 2015. A total of 100 patient sample data which fulfilled the inclusion criteria, were included in the statistical analysis. YSI 2300 STAT PLUS has been used as reference.
- Overall 100% of the results were within ±20% and ±15 mg/dL (0.83 mmo/L) as to the ISO 15197:2003 standard
- Overall 98.8% of the results were within ±15% and ±15 mg/dL (0.83 mmo/L) as to the ISO 15197:2013 standard
- Overall 87% of the results were within ±10% for glucose concentrations >100 mg/dL (5.55 mmol/L)
In summary, for the VivaChek® Ino system, the criteria of the DIN EN ISO 15197:2013 were met by the study data.