No abstract available.
Aged ; Diabetes Mellitus, Type 2/pathology ; *Electrophoresis, Capillary ; Hemoglobin A, Glycosylated/*analysis ; Hemoglobins, Abnormal/*analysis ; Humans ; Male

BACKGROUND: The purpose of this study was to evaluate the performance and agreement among HbA(1c) values measured using selected analyzers certified by the National Glycohemoglobin Standardization Program (NGSP) and standardized by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). METHODS: HbA(1c) determined using D-10 (Bio-Rad, USA), Variant II Turbo (Turbo; Bio-Rad, USA), Cobas Integra 800 (Integra; Roche, Switzerland) and Afinion AS100 (Afinion; Axis-Shield, Norway) were compared with each other. Precision and method comparisons with Deming regression were evaluated according to CLSI recommendations. We also compared the HbA(1c) values obtained with each analyzer using either IFCC or NGSP methods by correlation analysis and kappa statistics. RESULTS: The repeatability and method/device precisions of D-10 and Afinion were acceptable. The correlation coefficients of HbA(1c) were 0.986 for D-10 vs. Afinion, 0.997 for D-10 vs. Turbo, 0.988 for D-10 vs. Integra, and 0.991 for Integra vs. Afinion. The average biases of HbA(1c) Afinion (IFCC) and HbA(1c) Integra (IFCC) against HbA(1c) D-10 (NGSP) were -1.90% and -1.79%, respectively. Kappa agreement statistics for the three diabetic control group HbA(1c) values of "less than 6.5%," "6.5%-7.5%," and "greater than 7.5%" for D-10 vs. Turbo, D-10 vs. Integra, and D-10 vs. Afinion were 0.872, 0.836, and 0.833, respectively. CONCLUSIONS: The strong correlations and good clinical agreements of HbA(1c) between each analyzer expressed in terms of either NGSP or IFCC-derived NGSP indicate that these analyzers can be used interchangeably.
Blood Chemical Analysis/instrumentation/methods/standards ; Diabetes Mellitus/therapy ; Hemoglobin A, Glycosylated/*analysis/standards ; Humans ; Reproducibility of Results

After the relationship between glycemic control and the HbA1c concentration was demonstrated, many tests have been developed to determine the HbA1c concentration. The test results are standardized to the International Federation of Clinical Chemistry (IFCC) Reference Measurement Procedure (RMP) in harmony with the efforts of the National Glycohemoglobin Standardization Program (NGSP). The longitudinal use of the test requires strict quality management including accreditation of the laboratory, a dedicated internal control design, participation in an external quality assessment (EQA) program (proficiency test), and careful consideration of pre- and post-analytical aspects of the test. Performance goals for optimizing determination of the HbA1c concentration have been described. As an index of long-term glycemic control and a risk predictor, the HbA1c concentration is an indispensable part of routine management of diabetes. Because of the improving quality of the test, the HbA1c concentration is being increasingly applied in the diagnosis of diabetes. There are, however, concerns of this application in point-of-care settings. The HbA1c concentration is also used to achieve stringent control in pregnant diabetic patients. Strict standardization enables the definition of universal reference values and clinical decision limits. This review describes the present status of analytical and clinical aspects of determining the HbA1c concentration and highlights the challenges involved.
Diabetes Mellitus/blood/diagnosis ; Hemoglobin A, Glycosylated/*analysis/standards ; Humans ; Immunoassay/standards ; Point-of-Care Systems ; Quality Control

OBJECTIVE: This study examined whether glycated hemoglobin (HbA1c) and glycated albumin (GA) are well correlated with the Ankylosing Spondylitis Disease Activity Score (ASDAS)-erythrocyte sedimentation rate (ESR), and ASDAS-C-reactive protein (CRP) in AS patients without medical conditions affecting the glycated protein levels. METHODS: The data of 76 patients with AS were analyzed. Univariate and multivariate analyses of the variables associated with ASDAS-ESR and ASDAS-CRP were performed using a linear regression test. The patients were divided into active and inactive AS groups based on an ASDAS-CRP of 2.1, and the variables between the two groups were compared. RESULTS: ASDAS-ESR did not correlated with either HbA1c or GA. ASDAS-CRP was positively correlated with HbA1c (r=0.315, p=0.006) and the white blood cell (r=0.288, p=0.012), and inversely correlated with hemoglobin (r=−0.241, p=0.036) and serum albumin (r=−0.262, p=0.022), but not GA. Multivariate analysis revealed HbA1c and white blood cell to be significantly correlated with ASDAS-CRP (β=0.234, p=0.033 and β=0.265, p=0.017). The mean HbA1c, not GA, of the active group was significantly higher than that of the inactive group (p=0.020). In addition, the optimal cut-off value of HbA1c was set to 5.6, and the patients with HbA1c ≥5.6 were found to have a 3.3 times higher risk of active AS than those without. CONCLUSION: HbA1c was significantly correlated with ASDAS-CRP, and could be a useful marker to reflect ASDAS-CRP in AS patients without medical conditions affecting the glycated protein levels.
Hemoglobin A, Glycosylated ; Humans ; Leukocytes ; Linear Models ; Multivariate Analysis ; Serum Albumin ; Spondylitis, Ankylosing*

BACKGROUND: The aim of this study was to observe clinical outcomes of the mother and her infant who were possibly exposed to high blood glucose at least 2-3 months in the early and midterm pregnancy by checking gestational weeks (GW) and the first HbA1c level at initial diagnosis of gestational diabetes (GDM). METHODS: A total of 107 GDM patients and their newborns were subject of this study. GDM patients were newly diagnosed at the Holy Family Hospital of Catholic University from January 2003 until December 2007 and continuously managed in the diabetes center. Patients medical records were retrospectively reviewed to evaluate GW and HbA1c level at the time of diagnosis, and clinical outcomes of mother and newborn baby. RESULTS: The proportion of subjects who had been diagnosed of having GDM according to GW was 7.5%, in less than 24th week of pregnancy; 55.1% in the 24-28th week; 28.0% in the 29-32nd week; and 9.4% 33rd week or more. There were 39 out of 107 subjects (36.4%) with HbA1c levels > or =6.5% and 26 out of 39 subjects (24.3%) with HbA1c levels > or =7.0%. In clinical outcomes of newborn by HbA1c levels, the frequency of delivery of large for gestational age (LGA) infant was higher in mothers diagnosed with GDM after 29th week of pregnancy or with HbA1c levels 7.0% or more (P<0.001). CONCLUSIONS: If the screening test for gestational DM was delayed, HbA1c level and the risk for LGA seemed to be higher, so it may be necessary to screen GDM no later than 24th week of pregnancy.
Adult ; Diabetes, Gestational/*diagnosis ; Female ; Gestational Age ; Hemoglobin A, Glycosylated/*analysis ; Humans ; Infant, Newborn ; Mass Screening ; Pregnancy ; Retrospective Studies ; Time Factors

Hemoglobin (Hb) Yamagata is a rare Hb variant, which has been reported only twice-one case each in Japan and Korea. This variant arises from a Lys --> Asn substitution due to a mutation of AAA to AAC or AAT at codon 133 of the beta-globin gene. This study reports the third case of a patient detected with Hb Yamagata [HBB: c.399A>T; p.Lys133Asn] and discusses the effect of this variant on HbA1c measurement. This variant was detected in a 70-yr-old Korean man with diabetes mellitus during a routine follow-up. The HbA1c concentration determined using Variant ll Turbo (Bio-Rad, USA) was abnormally high at 47.9%. It was impossible to measure the HbA1c level accurately using Variant ll Thalassemia Mode (Bio-Rad, USA). However, the HbA1c levels analyzed by HLC-723 G7 (Tosoh, Japan), Cobas Integra (Roche, Switzerland) and NycoCard (Axis-Shield, Norway) were 5.0%, 8.0%, and 7.9%, respectively. This study shows that Hb Yamagata interferes with the accurate measurement of HbA1c levels in a diabetic patient. Taking these findings into consideration, we think that an immunoassay or affinity chromatography can be used as an alternate method for measuring the HbA1c level in a patient with this variant. In conclusion, a patient can be inferred to have an Hb variant if the HbA1c concentration is abnormally high or low or if there is a discrepancy between the results obtained using different methods, and if the clinical status of the patient suggests the presence of abnormal Hb. Subsequently, the HbA1c values can be determined by methods based on different principles.
Aged ; Amino Acid Substitution ; Diabetes Mellitus/diagnosis ; Electrophoresis, Capillary ; Hemoglobin A, Glycosylated/*analysis ; Hemoglobins, Abnormal/*analysis ; Humans ; Male ; Reagent Kits, Diagnostic ; Sequence Analysis, DNA ; beta-Globins/genetics

BACKGROUND: Iron deficiency anemia is the most common form of anemia in India. Hemoglobin A1c (HbA1c) is used in diabetic patients as an index of glycemic control reflecting glucose levels of the previous 3 months. Like blood sugar levels, HbA1c levels are also affected by the presence of variant hemoglobins, hemolytic anemias, nutritional anemias, uremia, pregnancy, and acute blood loss. However, reports on the effects of iron deficiency anemia on HbA1c levels are inconsistent. We conducted a study to analyze the effects of iron deficiency anemia on HbA1c levels and to assess whether treatment of iron deficiency anemia affects HbA1c levels. METHODS: Fifty patients confirmed to have iron deficiency anemia were enrolled in this study. HbA1c and absolute HbA1c levels were measured both at baseline and at 2 months after treatment, and these values were compared with those in the control population. RESULTS: The mean baseline HbA1c level in anemic patients (4.6%) was significantly lower than that in the control group (5.5%, p<0.05). A significant increase was observed in the patients' absolute HbA1c levels at 2 months after treatment (0.29 g/dL vs. 0.73 g/dL, p<0.01). There was a significant difference between the baseline values of patients and controls (0.29 g/dL vs. 0.74 g/dL, p<0.01). CONCLUSIONS: In contrast to the observations of previous studies, ours showed that HbA1c levels and absolute HbA1c levels increased with treatment of iron deficiency anemia. This could be attributable to nutritional deficiency and/or certain unknown variables. Further studies are warranted.
Adolescent ; Adult ; Anemia, Iron-Deficiency/*blood/drug therapy ; Child ; Female ; Ferritins/blood ; Hemoglobin A, Glycosylated/*analysis ; Hemoglobins/analysis ; Humans ; Iron/therapeutic use ; Male ; Time Factors

PURPOSE: The purpose of the study was to investigate the effects of an integrated self-management program on self-management, glycemic control, and maternal identity in women with gestational diabetes mellitus (GDM). METHODS: A non-equivalent control group non-synchronized quasi-experimental design was used. A total of 55 women with GDM were recruited from Cheil General Hospital, Seoul, Korea and were assigned to an experimental (n=28) or control group (n=27). The participants were 24-30 weeks pregnant women who had been diagnosed with GDM as of July 30, 2010. The program was conducted as a 1 hour small group meeting 3 out of 5 times and by telephone-counseling 2 out of 5 times. The integrated self-management program was verified by an expert panel. RESULTS: Although there was no significant reduction in HbA1c (U= -1.17, p=.238), there were statistically significant increases in self-management (U= -3.80, p<.001) and maternal identity (U= -4.48, p<.001), and decreased 2-h postprandial glucose levels (U= -2.43, p<.015) in the experimental group compared to the control group. CONCLUSION: These findings suggest that an integrated self-management program for women with GDM improves self-management, maternal identity, and glycemic control. Further studies are needed to identify the effects of an integrated self-management program on pregnancy and neonatal outcomes.
Adaptation, Psychological ; Adult ; Blood Glucose/analysis ; Counseling ; Diabetes, Gestational/*psychology ; Female ; Gestational Age ; Hemoglobin A, Glycosylated/analysis ; Humans ; Pregnancy ; Program Evaluation ; *Self Care ; Women/*psychology

BACKGROUND/AIMS: Patients with diabetes are prone to coronary artery disease (CAD); however, the majority of diabetic patients show normal coronary arteries. We examined differences in the clinical aspects of diabetic patients with insignificant and with significant stenosis of the coronary artery. METHODS: A total of 418 consecutive diabetic patients with stable angina who had undergone coronary angiography from January 2004 to March 2007 were included in this study. Patients were subdivided into control and CAD groups and then clinical characteristics and CAD-associated factors were evaluated. RESULTS: A total of 92 (22%) patients were assigned to the control group and 326 (78%) patients were assigned to the CAD group. Using univariate regression analysis, we found that patients with CAD were significantly older (control vs. CAD; 59+/-21 vs. 64.7+/-33.7, years, p<0.001), had a longer duration of diabetes (8.2+/-21.8 vs. 10.2+/-29.8, years, p=0.027), higher titers of high sensitivity C-reactive protein (hsCRP; 0.3+/-6.79 vs. 0.9+/-12.6, mg/dL, p=0.015), and increased hemoglobin A1c (HbA1c) levels (7.1+/-3.8 vs. 7.5+/-4.8, %, p=0.007) compared to control patients. Multivariate regression analysis showed that only differences in age, hsCRP, and HbA1c were statistically significant. When patients were subdivided into groups based on hsCRP levels (208 patients in the low group [49.8%], 210 patients in the high group [50.2%]), we found that patients with higher hsCRP levels showed more frequent multivessel disease. CONCLUSIONS: In diabetic patients, age, hsCRP, and HbA1c were associated with stable CAD. Among these factors, hsCRP levels were significantly correlated with multivessel involvement in diabetic CAD. Therefore, high hsCRP levels may be a strong predictor for atherosclerotic progression of the coronary arteries in diabetic patients, suggesting that regular screening tests should be performed.
Adult ; Aged ; Biological Markers ; C-Reactive Protein/*analysis ; Coronary Artery Disease/*blood ; Diabetes Complications/*blood ; Female ; Hemoglobin A, Glycosylated/analysis ; Humans ; Logistic Models ; Male ; Middle Aged

The metabolic syndrome (MetS) is the clustering of cardiovascular risk factors and known as a powerful predictor of diabetes and cardiovascular disease. Glycated hemoglobin (HbA1c) is used as one of the diagnostic criteria for diabetes and category of increased risk for diabetes. We examined the usefulness of HbA1c as a diagnostic tool for MetS and to determine the cut-off value of HbA1c as a criterion for MetS, in non-diabetic Korean subjects. We analyzed 7,307 participants (male: 4,181, 57%) in a medical check-up program, and applied the newly recommended guidelines of the International Diabetes Federation for diagnosis of MetS. The mean HbA1c was 5.54% in all subjects and showed no significant difference between genders. Using receiver-operating characteristic curve, HbA1c value corresponding to the fasting plasma glucose value of 100 mg/dL was 5.65% (sensitivity 52.3%, specificity 76.7%). The prevalence of MetS was 8.5% according to the IDF guideline and 10.9% according to HbA1c value of 5.7%, showing 69.5% agreement rate. The detection rate of MetS increased to 25.7% using the HbA1c criterion of 5.7% instead of fasting hyperglycemia. This study suggests that HbA1c might be used as a diagnostic criterion for MetS and the appropriate cut-off value of HbA1c may be 5.65% in this Korean population.
Adult ; Blood Glucose/analysis ; Chromatography, High Pressure Liquid ; Female ; Hemoglobin A, Glycosylated/*analysis ; Humans ; Male ; Metabolic Syndrome X/*diagnosis/epidemiology ; Middle Aged ; Prevalence ; ROC Curve ; Risk Factors