Difference Analysis of System Accuracy Criteria between Self-Monitoring Blood Glucose Test System and Point-of-Care Blood Glucose Monitoring Systems / 中国医疗器械杂志

According to users and places, blood glucose monitoring systems(BGMSs) can be divided into self-monitoring blood glucose test systems(SMBGs) and Point-of-Care Blood Glucose monitoring systems(POC-BGMSs). The Food and Drug Administration(FDA) believes that standards for SMBGs and POC-BGMSs should be different because of different operators, different use environments, different intendance uses and different applicable populations. Now the international standards for evaluating BGMSs include ISO 15197:2013 issued by International Organization for Standardization(ISO), two guidelines on blood glucose monitoring systems issued by FDA, and POCT12-A3 guidelines issued by the American Association for Clinical and Laboratory Standardization(CLSI), ISO standard and FDA guideline-OTC are applicable in SMBGs, CLSI guideline and FDA guideline-POCTI2-A3 are suitable for POC-BGMSs. By analyzing the accuracy evaluation processes of BGMSs based on four standard documents, it is found that the accuracy evaluation of medical BGMSs is more stringent. It is proposed that SMBGs and POC-BGMSs should be supervised separately.

Comparison of Blood Glucose Measurements Using Samples Obtained from the Forearm, Finger Skin Puncture, and Venous Serum / 대한진단검사의학회지

BACKGROUND: Blood glucose testing (BGT) at the forearm minimizes the pain experienced during sampling of capillary blood. We compared the BGT results for forearm sampling with those for standard finger skin puncture and venous serum to evaluate the clinical validity of forearm BGT. METHODS: BGT was performed on the finger (G(F)) and forearm (G(A)) with a portable glucometer in 555 subjects, including 61 diabetic patients, under fasting conditions. BGT with venous serum (G(V)) was followed within an hour in 514 subjects. Simple linear regression, intraclass correlation, and Passing-Bablok regression analyses were performed using the G(A)-G(F) and G(A)-G(V) data. RESULTS: G(A) showed an excellent linear relationship with both G(F) and G(V) with a Pearson correlation coefficient (r) of 0.97 (P<0.0001) in the patient group, which was similar to the findings in the normal group except for the lower r values. The mean bias between G(A) and G(F) and between G(A) and G(V) were within +/- 10 mg/dL in both groups. The intraclass correlation coefficients were slightly smaller than the corresponding r values, but they showed the same tendency in both groups. In the Passing-Bablok analyses, the 95% confidence intervals of the slope and intercept parameters were <+/-20% of unity and <+/-20 mg/dL, respectively, which were within the acceptable ranges. All 3 statistical analyses supported the satisfactory agreement of G(A) with G(F) or G(V). CONCLUSIONS: BGT at the forearm was highly consistent with the standard BGT, thereby confirming its applicability in clinical practice for self-testing under steady fasting conditions.

Variaciones de la presión arterial sistólica durante el periódo posprandial / Variations of systolic blood pressure during postprandial time

OBJETIVO. Evaluar las variaciones de la presión arterial sistólica (PAS) en el periodo posprandial en sujetos hiperten-sos y sus controles. MATERIALES Y MÉTODOS. Se estudió a 27 adultos hipertensos esenciales de entre 40 y 60 años y sus 27 controles pareados por sexo, edad e IMC. Se les realizó el test de tolerancia a la glucosa (TTG) junto a la medición de presión arterial basal, a los 30, 60 y 120 minutos. Se consideró variación anormal a un descenso o aumento de más de 20 mm Hg en el promedio de las la glucosa y la insulina a los 30, 60, 120 minutos de la prueba. RESULTADOS. El 65 por ciento de los pacientes hipertensos pre-sentó variaciones anormales de la PAS frente al 8 por ciento de los controles. La anormalidad más frecuente de PAS en el estado posprandial fue la hipotensión (88 por ciento), la que estuvo en relación al antecedente de hipertensión arterial. Se observó un mayor valor de glicemia a las 2 horas-posprandial en los que presentaron variaciones anormales en relación a los que no lo hicieron (120 mg/dL vs. 102 mg/dL, p menor que 0,05). El grupo que presentó hipotensión posprandial presentó valores de triglicéridos menores en relación a los que presentaron hipertensión posprandial (114 mg/dL vs. 176 mg/dL, p menor que 0,05) y se observó triglicéridos en ayunas altos en los sujetos que presentaron hipertensión posprandial y los valores más bajos en aquellos con hipotensión posprandial. Los niveles de insulina no presentaron diferencias en ambos grupos. CONCLUSIÓN. La variación posprandial más frecuente posterior a una sobrecarga de carbohidratos fue la hipotensión arterial sistólica, la que se presentó principalmente en los sujetos hipertensos. Todas las variaciones anormales de la presión arterial sistólica posprandial estuvieron asociadas a mayores niveles de la glucosa a las 2 horas-posprandial.

OBJECTIVE. To assess variations in systolic blood pressure dur-ing the postprandial time in hypertensive subjects and controls. MATERIAL AND METHODS. It was studied 27 adults patients with essential hypertension between 40 and 60 and their 27 controls matched by sex, age and BMI. All of them underwent to the glu-cose tolerance test (GTT) and insulin, lipids and blood pressure were measured at baseline, 30, 60 and 120 minutes. Abnormal variation was considered a decrease or increase over 20 mmHg in mean systolic pressures after ingestion with respect to base-line. RESULTS. Sixty five per cent of hypertensive patients showed abnormal variations in blood pressure compared with 8 per cent per cetn of controls. The most common abnormality in the postprandial state was hypotension (88 per cent), mainly in hypertensive patients. There was an increased in the mean blood glucose at 2 hours post-prandial in those with abnormal variations of systolic blood pressure in contrast with those who did not (120 mg/dL vs. 102 mg/dL, p minor that 0,05). The group that showed postprandial hypo-tension had less levels of triglycerides than patients with post-prandial hypertension (114 mg/dL vs. 176 mg/dL, p minor that 0,05). Insulin levels did not differ in both groups. CONCLUSION. The most frequent variation in blood pressure after a glucose load-ing was systolic arterial hypotension, mainly in hypertensive patients. All the variations of postprandial systolic blood pres-sure were associated to higher levels of postprandial glycemia.

Clinical Implications of the Glucose Test Strip Method for Early Detection of Pulmonary Aspiration in Nasogastric Tube- Fed Patients / 간호학회지

PURPOSE: This study was performed to test the clinical usefulness of the glucose test strip method for early detection of pulmonary aspiration in tube fed patients. METHOD: The subjects for the study were 36 patients who were receiving enteral feedings and 39 patients who were not given enteral feedings. For the analysis, the tube fed patients were divided into two groups (clinically significant aspiration and no aspiration) according to criteria. RESULT: The mean glucose concentration of tracheal secretions from non enteral fed patients was 26.35mg/dl and were lower than those concentrations found in tube fed patients (32.75mg/dl). The mean glucose concentration of the aspiration group was 45.60mg/dl and the glucose concentration of the non aspiration group was 19.93mg/dl. The difference was statistically significant (t=2.163, p=. 038). More subjects in the no aspiration group (73%) than the aspiration group (56%) had glucose concentrations below 20mg/dl. After deleting the cases that had samples containing blood, glucose concentrations of tracheal aspirates were lower in both groups. CONCLUSION: The glucose level of the aspiration group was significantly lower than the no aspiration group and more subjects in the aspiration group had a glucose level higher than 101mg/dl. Therefore, the glucose test of tracheal secretions in tube fed patients could be a desirable test for screening for tracheal aspiration. Especially the patient who is showing repeatedly high glucose levels should not be given feedings until reassessment is completed.

Tests to Differentiate Cerebrospinal Fluid from Local Anesthetics during Epidural Anesthesia / 대한마취과학회지

BACKGROUND: One of the most serious risks of epidural anesthesia is total spinal blockade from unintentional dural puncture. We evaluated the glucose test and the thiopental precipitation test to differentiate cerebrospinal fluid (CSF) from local anesthetics (LA). METHODS: (1) Experiment 1: CSF from twenty patients was serially diluted with 2% lidocaine or 0.5% bupivacaine. The ratio of CSF to LA-CSF mixture (CSF/(LA+CSF)) was from 0 to 1.0 at an interval of 0.1. We measured the glucose level of each sample with blood sugar meter. (2) Experiment 2: CSF from a hydrocephalus patient was serially diluted and its glucose level of each sample was measured in the same way as Experiment 1. We performed a urine stick test with each sample. Ten anesthetists blinded to the nature of the sample were asked to identify the results of the tests. (3) Experiment 3: Two milimeters of 2.5% thiopental was respectively mixed with local anesthetics, the amount of which was from 0.1 to 1.0 ml at an interval of 0.1 ml. Sixteen anesthetists blinded to the nature of sample were asked to identify the results of the tests. RESULTS: (1) Experiment 1: We can measure glucose level at CSF/(LA +CSF) of 0.5 in 2% lidocaine group and 0.6 in 0.5% bupivacaine group. (2) Experiment 2: We can detect glucose at lower level of CSF/(LA +CSF) by glucose meter than urine stick test (p<0.05). (3) At least 0.35 ml of 2% lidocaine and 0.29 ml of 0.5% bupivacaine was needed respectively to detect precipitation. CONCLUSION: We suggest that blood glucose meter be used instead of glucose test strip. For thiopental precipitation test, we have to adjust the amount of thiopental depending on the amount of test fluid.

Tests to Differentiate Cerebrospinal Fluid from Local Anesthetics during Epidural Anesthesia / 대한마취과학회지

BACKGROUND: One of the most serious risks of epidural anesthesia is total spinal blockade from unintentional dural puncture. We evaluated the glucose test and the thiopental precipitation test to differentiate cerebrospinal fluid (CSF) from local anesthetics (LA). METHODS: (1) Experiment 1: CSF from twenty patients was serially diluted with 2% lidocaine or 0.5% bupivacaine. The ratio of CSF to LA-CSF mixture (CSF/(LA+CSF)) was from 0 to 1.0 at an interval of 0.1. We measured the glucose level of each sample with blood sugar meter. (2) Experiment 2: CSF from a hydrocephalus patient was serially diluted and its glucose level of each sample was measured in the same way as Experiment 1. We performed a urine stick test with each sample. Ten anesthetists blinded to the nature of the sample were asked to identify the results of the tests. (3) Experiment 3: Two milimeters of 2.5% thiopental was respectively mixed with local anesthetics, the amount of which was from 0.1 to 1.0 ml at an interval of 0.1 ml. Sixteen anesthetists blinded to the nature of sample were asked to identify the results of the tests. RESULTS: (1) Experiment 1: We can measure glucose level at CSF/(LA +CSF) of 0.5 in 2% lidocaine group and 0.6 in 0.5% bupivacaine group. (2) Experiment 2: We can detect glucose at lower level of CSF/(LA +CSF) by glucose meter than urine stick test (p<0.05). (3) At least 0.35 ml of 2% lidocaine and 0.29 ml of 0.5% bupivacaine was needed respectively to detect precipitation. CONCLUSION: We suggest that blood glucose meter be used instead of glucose test strip. For thiopental precipitation test, we have to adjust the amount of thiopental depending on the amount of test fluid.