Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes

Abstract

Point-of-care (POC) glucose technology is currently considered to be insufficiently accurate for the diagnosis of diabetes. The objective of this study was to investigate the diagnostic accuracy of an innovative, interference-resistant POC glucose meter (StatStrip glucose hospital meter, Nova Biomedical, USA) in subjects with a previous history of dysglycaemia, undergoing a 75 g diagnostic oral glucose tolerance test (oGTT). Venous and capillary blood sampling for the reference laboratory procedure (RLP) and POC-glucose measurement was carried out at fasting and 2 h oGTT, and categories of glucose tolerance were classified according to 2006 WHO diagnostic criteria for the respective sample type. We found an excellent between-method correlation at fasting (r = 0.9681, P < 0.0001) and 2 h oGTT (r = 0.9768, P < 0.0001) and an almost perfect diagnostic agreement (weighted Kappa = 0.858). Within a total of 237 study subjects, 137 were diagnosed with diabetes with RLP, and only 6 of them were reclassified as having glucose intolerance with POC. The diagnostic performance of POC-fasting glucose in discriminating between the normal and any category of disturbed glucose tolerance did not differ from the RLP (P = 0.081). Results of this study indicate that StatStrip POC glucose meter could serve as a reliable tool for the diabetes diagnosis, particularly in primary healthcare facilities with dispersed blood sampling services.

Pregnancy diabetes: A comparison of diagnostic protocols based on point-of-care, routine and optimized laboratory conditions

“…Recently, there has been much debate on the implementation of POC analysis in the context of GDM screening. Studies give a negative advise for the use of POC based on the lack of accuracy 4 , while others argue that it could have its merits 5 6 , or that it should be used in concert with venous glucose determination 7 . In part, the large deviation of POC from venous measurements may be due to the difference in the sampled tissues and the differences in dynamics of the interstitial and venous compartment 8 .…”

Clinical utility of point of care glucose in the assessment of gestational diabetes: Prospective cohort study.

“…(10,11) The Nova StatStrip® Glucose Hospital Meter (Nova Biomedical) is approved by the food and drug administration (FDA) for glucose monitoring in hospital/healthcare settings, including in those critically unwell, (12) and it is also acceptable for the diagnosis of T2DM. (13) Nova StatStrip® directly measures the haematocrit and uses a corrective algorithm for reporting glucose concentrations resulting in minimal interference from haematocrit between 20 to 70%, across a wide analytical range of glucose (3-33mmol/L). (14) Our study objective was to assess the clinical utility of POC-StatStrip® meter in screening for GDM.…”