Technology Assessment of Self-monitoring of Blood Glucose in Type 2 Diabetes Patients - การประเมินเทคโนโลยีการตรวจน้ำตาลในเลือดด้วยตนเองในผู้ป่วยเบาหวานชนิดที่ 2

Abstract

Currently, a blood glucometer that measures glucose concentration in finger capillary blood is a common device used in diabetes management. There are many brands available in the market, which are widely used in hospitals, clinics, and for patients’ self- monitoring. Remarkably, they were employed in the primary care units as a diagnostic tool for diabetes. The objective of this study was to assess the association between the blood glucose levels in finger capillary blood samples using five most common blood glucometers in Thailand, and fasting plasma glucose obtained from 8-hour fasting venous blood. The study design was a cross-sectional study. A total of 146 patients with type 2 diabetes from Nopparat Ratchathani and Lerdsin hospitals were included in the study. Eight-hour fasting venous blood samples were drawn from the patients, to evaluate the fasting plasma glucose (FPG). In addition, finger capillary blood samples were also obtained and analyzed by five different blood glucometers. The quality assurance and control were conducted before and during the blood collection. All five blood glucometers were approved by the International Organization for Standardization. The venous blood samples were analyzed by the standard laboratory which was regulated according to the standard method and quality control from the Association of Medical Technologists of Thailand. The results showed that the Pearson’s correlation coefficients between blood glucose levels analyzed from each blood glucose meter and laboratory venous blood glucose analysis were 0.948, 0.955, 0.956, 0.971, and 0.971 (p < 0.001), respectively. Mean percentage errors of all glucometers were 1.2, 4.2, 4.2, 5.3, and 7.4 percent, respectively. Additionally, the median percentage errors were -0.8, 1.6, 2.9, 3.0, and 6.6 mg/dl, respectively. In conclusion, blood glucose levels analyzed by the blood glucometers using capillary blood samples, and by the standard laboratory using venous blood sample were comparable. The blood glucometers are recommended for blood glucose testing in diabetes patients, testing for hypoglycemia, or patients with poor control. They have not yet recommended for diagnosis of diabetes. However, this study summarized about the precision of glucometers could not be extrapolated to either the blood sugar and hematocrit at much higher or lower levels.

Key words: blood glucose self-monitoring, diabetes mellitus type 2, glucometer