The importance of glucose meter accuracy

Accurate blood glucose meter measurements enable patients with diabetes to make appropriate clinical decisions (e.g., amount of insulin to be injected). These meters are also referred to as Self Monitoring Blood Glucose (SMBG) meters or Home Monitoring Blood Glucose meters. 
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 on the market has come into fierce debate after reports of failing blood glucose meters and test strips. The European Association for the Study of Diabetes (EASD) and the Diabetes Technology Society (DTS) have published calls to action, advocating the need for surveillance programs and development of test protocols to assess ongoing 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 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. 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. In addition, we have considerable expertise in studying Continuous Glucose Monitors, which are replacing Glucose Meters more and more.

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Dr. Eric Zijlstra

Executive Project Director