The importance of glucose meter accuracy
Accurate blood glucose meter measurements ensure that patients with diabetes make the same clinical decisions (e.g., amount of insulin to be injected) as would be made after measurements in a clinical setting. Therefore, blood glucose meter development must involve careful accuracy evaluations in accordance with standard guideline.
These devices are considered accurate if both the random error (measurement imprecision or variability) and the systematic error (measurement bias) are sufficiently low. Glucose meter test procedures specify the allowed measurement deviation from a reference value and the maximum number of inaccurate results or outliers for the whole test. The analytical goals defined by the International Organization for Standardization (ISO 15197:2013 In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus) are now widely adopted by glucose meter manufacturers and regulatory authorities.
Controversy about glucose meters
Despite the prerequisite of demonstrating compliance with the ISO 15197 standard before the market introduction of a new blood glucose meter, the performance of currently available devices has come into fierce debate after reports of failing blood glucose meters and test strips. The European Association has published urgent calls to action for the Study of Diabetes (EASD) and the Diabetes Technology Society (DTS), advocating the need for surveillance programs and development of test protocols to assess blood glucose meter performance.
Profil and blood glucose meter tests
Profil’s automated clamp technology provides unique opportunities for a glucose meter tests to evaluate the performance of glucose monitoring devices at pre-defined blood glucose levels.
In a recent performance evaluation of five blood glucose meters, the clamp technology was applied to stabilize the blood glucose of subjects with type 1 diabetes at a hypoglycemic (60 mg/dL), normoglycemic (100 mg/dL) and hyperglycemic (200 mg/dL) level. Capillary samples were taken frequently at each blood glucose level for blood glucose meter measurements and plasma glucose reference measurements using the YSI 2300 STAT Plus glucose analyzer. The quality of reference measurements is ensured through both internal and external quality control procedures that are part of Profil's ISO-certified quality assurance system.