Clinical Validation

The international standards, ISO 15197, requires that at least 95% of the results from blood glucose meters should to be within 20% of laboratory results when equal to or above 75 mg/dL and within 15 mg/dL when below 75 mg/dL.

A clinical study done in 2010 was conducted by the institute for Diabetes Technology (IDT) at the University of Ulm in Germany, demonstrating that 96% of the FORA Comfort Pro GD40 results were within 15% of laboratory results. The FORA Comfort Pro GD40 Blood-Glucose Monitoring System performs superbly with an accuracy of 15%, exceeding the ISO standards of 20%, which other models from competitors cannot beat.

FORA Comfort Pro GD40 Blood-Glucose Monitoring System complies with the requirements of the ISO 15197 Standards and its system accuracy is proven with:
• 97%results falling within ±0.83mmol/L(±15mg/dL) at glucose concentration < 4.2mmol/L(75mg/dL)
• 99%results falling within ±20% at glucose concentration < 4.2mmol/L(75mg/dL)

Results

Clarke Error Grid graph