Benchmarking Point-of-Care Glucometers: A Comparative Study Using the Hexokinase Test and International Organization...

Area of Science:

• Clinical Chemistry
• Medical Device Accuracy
• Diabetes Management

Background:

• Diabetes self-monitoring of blood glucose is crucial for effective management.
• India has a high prevalence of diabetes, with one in seven adults affected.
• Accuracy of widely used point-of-care glucometers remains a concern.

Purpose of the Study:

• To evaluate the accuracy of three point-of-care glucometers against the ISO15197:2013 standard.
• To compare glucometer performance using glucose dehydrogenase with pyrroloquinoline quinone (GDH-PQQ), glucose dehydrogenase with flavin adenine dinucleotide (GDH-FAD), and glucose oxidase (GOD) methods.
• To assess clinical acceptability of glucometer readings using Clarke error grid analysis.

Main Methods:

• Cross-sectional study at two primary health care centers.
• Inclusion of 73 participants with diabetes and 73 without diabetes.
• Comparison of glucometer readings with the gold standard hexokinase test.
• Statistical analysis using Bland-Altman plots and Clarke error grid analysis.

Main Results:

• Only 78.08% (GOD), 92.4% (GDH-PQQ), and 95.8% (GDH-FAD) of results met ISO15197:2013 accuracy criteria.
• All tested glucometers demonstrated clinically acceptable results within zones A and B of the consensus error grid.
• The GDH-FAD method exhibited the narrowest agreement range and minimal bias (-0.89) in Bland-Altman analysis.

Conclusions:

• Only the GDH-FAD method-based glucometer satisfied the ISO15197:2013 accuracy requirements.
• Ensuring glucometer accuracy is paramount for patient safety in diabetes care.
• Further validation of point-of-care testing devices is recommended.