Optimal glycaemic control is crucial in patients with diabetes mellitus (DM) to avoid episodes of hypoglycaemia and both micro- and macrovascular complications. Diabetic control relies mainly on the evaluation of haemoglobin A1c (HbA1c), which is unfortunately unreliable in patients with haemoglobinopathies. This case report describes a patient with type 2 DM and haemoglobin J (HbJ) trait, which resulted in erratic HbA1c values throughout her follow-up. Other approaches, such as self-blood glucose monitoring, are needed to evaluate glycaemic control instead of relying on HbA1c alone to guide the management DM in these patients.
Glycated Hemoglobin ; Hemoglobinopathies

Introduction: Serum amylase and adiponectin levels have shown promise as markers of cardio-metabolic diseases. However, the levels of these markers in saliva and their association with glycaemic management in diabetes mellitus (DM) are not well documented. Therefore, we investigated the correlation of salivary amylase and adiponectin concentrations with measures of glycaemic control in type 2 diabetes mellitus (T2DM) participants. Methods: We conducted a cross-sectional study involving 80 T2DM participants of Indian and Malay ethnicity. Saliva was collected, and salivary amylase and adiponectin concentrations were analysed. Recent fasting blood sugar and HbA1c of the participants was obtained form their medical records. The correlations of salivary amylase and adiponectin with fasting blood sugar and HbA1c were calculated using Spearman’s correlation Results: There was a weak positive correlation between salivary adiponectin and HbA1c (rho = 0.221, p = 0.051). The salivary adiponectin levels was significnalty lower among participants with good glycaemic control (HbA1c ≤ 7.0%) compared to those with poor glycaemic control (HbA1c > 7.0%,) (1.13 (1.75) vs. 2.34 (3.54) ng/ml, p = 0.039). Conclusion Salivary adiponectin weakly correlated with HbA1c, while salivary amylase showed no correlation with the glycaemic parameters studied. Therefore, salivary adiponectin may warrant further investigation as a potential non-invasive biomarker of T2DM.
Diabetes Mellitus, Type 2 ; Glycated Hemoglobin

Introduction: Microalbuminuria presents significant health risks for the progression of endstage renal-failure (ESRF) among type 2 diabetes mellitus (T2DM) patients. This study aims to determine the proportion and associated factors of microalbuminuria among T2DM patients in Kuala Selangor district, Malaysia. Methods: A retrospective cross-sectional study was conducted from December 2020 to February 2021 using secondary data from the National Diabetic Registry (NDR), Malaysia, and reviewed patients’ diabetic records for the year 2020. All T2DM patients aged ≥18 years who were registered with the NDR in 2020 and fulfilled the inclusion and exclusion criteria were included in the study. Descriptive statistics and multiple logistic regression analysis were performed. Data were analysed using SPSS version 26.0. A total of 343 samples were included in this study for the determination of the proportion of microalbuminuria and its associated factors. Results: Of 343 respondents, 34.4% had microalbuminuria. HbA1c >7.0% (AdjOR 2.19, 95% CI: 1.35, 3.55, p=0.001), HDL <1.04 mmol/L (AdjOR 2.44, 95% CI: 1.323, 4.52, p=0.004), dyslipidaemia (AdjOR 1.90, 95% CI: 1.03, 3.48, p=0.039), and peripheral neuropathy (AdjOR 3.01, 95% CI: 1.02, 8.93, p=0.047) were significantly associated with microalbuminuria. Conclusion Microalbuminuria is a modifiable risk factor in preventing the progression of ESRF among T2DM patients. Therefore, identification of factors associated with microalbuminuria among this high-risk group is important to facilitate early screening and prompt treatment to prevent progression of diabetic kidney disease to ESRF.
Diabetes Mellitus, Type 2 ; Glycated Hemoglobin

High performance liquid chromatography (HPLC) is currently the mainstream technology for detecting hemoglobin. Glycated hemoglobin (HbA1c) is a gold indicator for diagnosing diabetes, however, the accuracy of HbA1c test is affected by thalassemia factor hemoglobin F (HbF)/hemoglobin A2 (HbA2) and variant hemoglobin during HPLC analysis. In this study, a new anti-interference hemoglobin analysis system of HPLC is proposed. In this system, the high-pressure three-gradient elution method was improved, and the particle size and sieve plate aperture in the high-pressure chromatography column and the structure of the double-plunger reciprocating series high-pressure pump were optimized. The system could diagnose both HbA1c and thalassemia factor HbF/HbA2 and variant hemoglobin, and the performance of the system was anti-interference and stable. It is expected to achieve industrialization. In this study, the HbA1c and thalassemia factor HbF/HbA2 detection performance was compared between this system and the world's first-line brand products such as Tosoh G8, Bio-Rad Ⅶ and D10 glycosylated hemoglobin analysis system. The results showed that the linear correlation between this system and the world-class system was good. The system is the first domestic hemoglobin analysis system by HPLC for screening of HbA1c and thalassemia factor HbF/HbA2 rapidly and accurately.
Chromatography, High Pressure Liquid ; Fetal Hemoglobin/analysis* ; Glycated Hemoglobin A/analysis* ; Hemoglobin A2/analysis* ; Hemoglobins

China ; Diabetes Mellitus ; diagnosis ; metabolism ; Glycated Hemoglobin A ; metabolism ; Humans

Objective: To compare the effects of different hemolytic diseases on the level of glycosylated hemoglobin (HbA(1c)) to further explore the relationship between HbA(1c) and laboratory indexes to disclose implications of HbA(1c) in hemolytic diseases. Methods: The distribution of 192 decreased HbA(1c) cases in 4 categories of hemolytic diseases was analyzed. Laboratory indexes related to hemolysis were tested and analyzed in each kind of disease, and relationship between laboratory indexes and HbA(1)c was statistically explored. Results: Diagnoses of decreased HbA(1c) cases mainly included erythrocyte membranopathies (88 cases), immunohemolytic anemia (72 cases), hemoglobinopathy (4 cases) and erythrocyte enzymopathy (5 cases). The distribution of HbA(2) and normal HbF subjects in immunohemolytic anemia and hemoglobinopathy was significantly different from those of HbA(2) and / or abnormal HbF subjects (41.7% vs 22.0%, χ(2)=5.574, P=0.018; 0.7% vs 7.3%, P=0.031). Compared with non-hemolytic disease patients, those who suffered from 4 categories of hemolytic diseases showed lower HbA(1c) level and higher reticulocyte percentage (Ret), indirect bilirubin (IBIL) and free hemoglobin (F-Hb). Different levels of Ret, reticulocyte hemoglobin content (Ret-He), mean corpuscular volume (MCV), IBIL and F-Hb among the 4 kinds of diseases were observed, but the causes of the differences were not the same. HbA(1c) was negatively correlated with other laboratory indexes in erythrocyte membranopathies and immunohemolytic anemia. Conclusions: Hemolytic disease resulted in false lower HbA(1c), but impact of difference on HbA1c between different diseases was not significant. HbA(1c) was closely connected to laboratory indexes related to hemolysis, which might have potential implications for hemolytic diseases such as erythrocyte membranopathies and immunohemolytic anemia.
Data Analysis ; Erythrocytes ; Glycated Hemoglobin ; Hemoglobinopathies ; Hemolysis ; Humans

To determine the types and proportion of common hemoglobin variants in Tianjin and surrounding areas, to analyze the recognition ability and the effects of hemoglobin variants on experimental results in two commonly used glycated hemoglobin systems, so as to provide data support for the consistency of HbA1c detection in Tianjin City. A case-control study was used for retrospective analysis,156 specimens with abnormal electrophoretic peaks in the detection of glycated hemoglobin were collected from more than 50 000 specimens of patients in Chu Hsien-I Memorial Hospital of Tianjin Medical University between June 2020 and December 2020. Determined their hemoglobin mutation sites by DNA sequencing, and compared the values of hemoglobin variants on glycated hemoglobin detection values by high performance liquid chromatography and capillary electrophoresis. SPSS 23 was used to calculate the blood routine results of the variant specimens, and compared with the normal reference interval. The results showed that DNA sequencing identified 21 hemoglobin variants, of which 11 were α strand variants and 10 were β strand variants. In addition, an unreported hemoglobin variant was identified, Hb Headington (HBB: c.217A>C). The HbA_1c of 11 variants including Hb G-Honolulu, Hb Queens, Hb Q-Thailand, Hb J-Broussais, Hb O-Indonesia, Hb G-Coushatta, Hb G-Taipei, Hb E, Hb Headington, Hb New York and Hb D-Los Angeles were shifted by more than 7% when measured by high-performance liquid chromatography. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. In conclusion, an unreported hemoglobin variant was found from Tianjin and neighboring areas. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. 11 of these hemoglobin variants interfered with the detection of glycated hemoglobin using high-performance liquid chromatography, resulting in inaccurate results.
Humans ; Glycated Hemoglobin ; Case-Control Studies ; Retrospective Studies ; Hospitals

To determine the types and proportion of common hemoglobin variants in Tianjin and surrounding areas, to analyze the recognition ability and the effects of hemoglobin variants on experimental results in two commonly used glycated hemoglobin systems, so as to provide data support for the consistency of HbA1c detection in Tianjin City. A case-control study was used for retrospective analysis,156 specimens with abnormal electrophoretic peaks in the detection of glycated hemoglobin were collected from more than 50 000 specimens of patients in Chu Hsien-I Memorial Hospital of Tianjin Medical University between June 2020 and December 2020. Determined their hemoglobin mutation sites by DNA sequencing, and compared the values of hemoglobin variants on glycated hemoglobin detection values by high performance liquid chromatography and capillary electrophoresis. SPSS 23 was used to calculate the blood routine results of the variant specimens, and compared with the normal reference interval. The results showed that DNA sequencing identified 21 hemoglobin variants, of which 11 were α strand variants and 10 were β strand variants. In addition, an unreported hemoglobin variant was identified, Hb Headington (HBB: c.217A>C). The HbA_1c of 11 variants including Hb G-Honolulu, Hb Queens, Hb Q-Thailand, Hb J-Broussais, Hb O-Indonesia, Hb G-Coushatta, Hb G-Taipei, Hb E, Hb Headington, Hb New York and Hb D-Los Angeles were shifted by more than 7% when measured by high-performance liquid chromatography. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. In conclusion, an unreported hemoglobin variant was found from Tianjin and neighboring areas. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. 11 of these hemoglobin variants interfered with the detection of glycated hemoglobin using high-performance liquid chromatography, resulting in inaccurate results.
Humans ; Glycated Hemoglobin ; Case-Control Studies ; Retrospective Studies ; Hospitals

Introduction: Medication adherence and metabolic control remain suboptimal among patients with diabetes mellitus in Malaysia despite the clear benefits of reduced vascular complications and mortality risk. This study examined the factors associated with medication adherence and glycaemic control in patients with type 2 diabetes mellitus in a primary care clinic. Methods: This cross-sectional study was conducted in a public health clinic in Pagoh, Johor, among 386 patients recruited via systematic random sampling. Data were obtained using a validated 7-item structured questionnaire, glycated haemoglobin (HbA1c) test and medical record review. Logistic regression analysis was performed to determine the factors associated with medication adherence. Results: The mean patient age was 60.04±10.75 years, and the mean HbA1c level was 8.3±2.0%. Approximately 60.3% of the participants were adherent to their medication, and an increasing age was significantly associated with medication nonadherence (adjusted odds ratio [OR]: 0.959; confidence interval [CI]: 0.934–0.985). Medication adherence (adjusted OR: 2.688; CI: 1.534–4.708) and use of combined oral medications (adjusted OR: 5.604; CI: 3.078–10.203), combined oral medications with insulin (adjusted OR: 23.466; CI: 8.208–67.085) and insulin only (adjusted OR: 6.528; CI: 1.876–22.717) were associated with good glycaemic control. Older age (adjusted OR: 0.954; CI: 0.923–0.986) and Malay ethnicity (adjusted OR: 0.284; CI: 0.101–0.794) were associated with poor glycaemic control. Conclusion Suboptimal medication adherence and glycaemic control are prevalent in primary care settings, especially among elderly patients. Counselling should be targeted to patients and their caretakers to improve medication adherence and optimise metabolic control.
Medication Adherence ; Diabetes Mellitus, Type 2 ; Glycemic Control ; Glycated Hemoglobin

BACKGROUNDHemoglobin A1c (HbA1c) measurement is of great value for the diagnosis and monitoring of diabetes. Many manufacturers have developed various experiments to determine the HbA1c concentration. However, the longitudinal use of these tests requires strict quality management. This study aimed to analyze the quality of HbA1c measurement systems in China using six sigma techniques to help improve their performances.

METHODSA total of 135 laboratories were involved in this investigation in 2015. Bias values and coefficients of variation were collected from an HbA1c trueness verification external quality assessment program and an internal quality control program organized by the National Center of Clinical Laboratories in China. The sigma (σ) values and the quality goal index (QGI) were used to evaluate the performances of different groups, which were divided according to principles and instruments.

RESULTSThe majority of participants (88, 65.2%) were scored as "improvement needed (σ < 3)", suggesting that the laboratories needed to improve their measurement performance. Only 8.2% (11/135) of the laboratories were scored as "world class (σ ≥ 6)". Among all the 88 laboratories whose σ values were below 3, 52 (59.1%) and 23 (26.1%) laboratories needed to improve measurement precision (QGI <8.0) and trueness (QGI >1.2), respectively; the remaining laboratories (13, 14.8%) needed to improve both measurement precision and trueness. In addition, 16.1% (5/31) and 15.0% (3/20) of the laboratories in "TOSOH" and "ARKRAY" groups, respectively, were scored as "world class", whereas none of the laboratories in "BIO-RAD" group were scored as "world class".

CONCLUSIONSThis study indicated that, although participating laboratories were laboratories with better performance in China, the performances were still unsatisfactory. Actions should be taken to improve HbA1c measurement performance before we can include HbA1c assays in diabetes diagnosis in China.