Opiniones y recomendaciones de la Sociedad Argentina de Diabetes. Hemoglobina A1c / Opinions and recommendations of the Argentine Diabetes Society. Hemoglobin A1c

La estandarización de la hemoglobina A1c (HbA1c) permitió en algunos países su uso para el diagnóstico de la diabetes mellitus (DM) y la prediabetes, además de su empleo en el seguimiento del paciente con DM. Es importante recordar que se trata de una medida indirecta del promedio glucémico durante el tiempo de vida media del eritrocito, pudiendo verse afectada por variables no glucémicas, como también por interferencias analíticas según la metodología empleada para su determinación. A continuación, se describen las recomendaciones y consideraciones a tener en cuenta para la determinación de la HbA1c cuando se emplea como criterio diagnóstico de la DM, teniendo en cuenta que al utilizarla para tal fin es necesario que la medida se realice con métodos certificados y estandarizados al ensayo utilizado en el Diabetes Control and Complications Trial (DCCT).

The standardization of hemoglobin A1c (HbA1c) allowed in some countries its use for the diagnosis of diabetes mellitus (DM) and prediabetes, in addition to its use in the follow-up of patients with DM. It is important to highlight that it is an indirect measurement of the glycemic average during the halflife of the erythrocyte, and may be affected by non-glycemic variables, as well as by analytical interferences depending on the methodology used for its determination. The recommendations and considerations to take into account for the determination of HbA1c when it is used as a diagnostic criterion for diabetes are described below. In addition, it is important to emphasize that it is essential that the HbA1c measurement be performed with certified and standardized methods to the Diabetes Control and Complications Trial (DCCT)results.

Nivel de hemoglobina glicada de pacientes diabéticos del cantón de Pococí, Costa Rica, durante los años 2011 y 2012 / Glycated level of diabetic patients Pococí hemoglobin, Costa Rica, during the years 2011 and 2012

Justificación: Conocer el estado glicémico de los pacientes diabéticos es de vital importancia para monitorear la efectividad del tratamiento diabético implementado. Objetivo: Comparar el comportamiento de la hemoglobina glicada (HGlic) en los pacientes diabéticos de Consulta Externa del Hospital de Guápiles, mayores de edad del cantón de Pococí durante los años 2011 y 2012. Métodos: Se tomaron valores de HGlic de pacientes diabéticos adultos, de Consulta Externa de los años 2011 y 2012 de la base de datos del Laboratorio del Hospital de Guápiles. Con los valores recopilados se obtuvo el promedio de HGlic por año y por sexo y se estableció el porcentaje de valores que estaban por debajo y por encima de la meta deseada de HGlic (HGlic ≤ 7.0 %) por año, por sexo y por grupo de edad. Resultados: El porcentaje de valores para los años 2011 y 2012 por encima de la meta en hombres fue de 51.2% y de 49.5% y en las mujeres fue de 49.5% y 56.7% respectivamente. Por grupo etario hay cambios porcentuales importantes en el cumplimiento de la meta, especialmente en las mujeres en la transición del año 2011 al 2012. Conclusiones: En la transición 2011 a 2012 en los hombres hay una disminución de los valores por encima de la meta. En las mujeres, por el contrario se presentó un aumento porcentual de datos por encima de la meta. El porcentaje de incumplimiento global (valores combinados de hombres y mujeres) es mayor para el año 2012 que para el año 2011.

Justification: The monitoring of diabetic treatment effectiveness is vital for being well informed about the glycemic status of diabetic patients. Objective: To compare the glycated hemoglobin (HGlic) behavior of adult diabetic outpatients from Guápiles Hospital in “Pococí” throughout 2011 and 2012. Methods: The HGlic adult diabetic outpatient population values were obtained from the Clinical Laboratory of Guápiles Hospital database throughout years 2011 and 2012. Based on the results, the HGlic average per year and sex was obtained and established the percentage of values that were above and below the desired goal of HGlic ≤ 7.0 by year, sex, and age group. Results: The percentage of those values for 2011 and 2012 were above the goal of 51.2%, 49.5% for men and 56.7%, 49.5% for women respectively. By age group there were important percentage difference on reaching the goal, especially in women for the transition between 2011 and 2012. Conclusions: Between 2011 and 2012, the percentage for men shows a reduction in values that were above the desired goal, on the other hand, in women there was an increase of the data percentage. The global incompletion percentage (combined values for both men and women) was higher for 2012 than for 2011.

Relationship between HbA1 c and CIMT,carotid arterial stiffness of diabetic peripheral neuropathy patients / 中国糖尿病杂志

Objective To explore the relationship between HbA1 c and carotid artery intima‐media thickness (CIMT) ,carotid arterial stiffness in diabetic patients with peripheral neuropathy. Methods A total of 220 subjects were enrolled in this study and divided into three groups:T2DM group (n=60) ,DPN group (n=100) ,and healthy individuals as NC group (n=60). Serum HbA1c ,CIMT and carotid arterial stiffness were measured. Results HbA1c [(8.62 ± 2.71)% ] ,CIMT [(1.01 ± 0.11)mm] and carotid arterial stiffness [(827.6 ± 123.7)]was significantly higher in DPN group than in NC group [(4.20 ± 0.47)% ,(0.70 ± 0.07) mm ,(521.2 ± 89.3)] and T2DM group [(7.95 ± 1.98) % ,(0.81 ± 0.09) mm , (629.3 ± 113.5)] respectively (P< 0.05).The duration was significantly longer in DPN group than in T2DM group(P<0.05). CIMT [(1.11 ± 0.09)mm] and arotid arterial stiffness [(901.5 ± 241.5)] was higher in patients with HbA1 c≥10.0% than in patients with HbA1 c between 8.0% ~10.0% [(0.94 ± 0.07)mm ,(724.5 ± 159.9)] and patients with HbA1c between 7.0% ~ 8.0% [(0.73 ± 0.06)mm , (574.1 ± 145.3 )] respectively ( P< 0.05 ).Association analysis showed that HbA1 c had a positive correlation with CIMT and carotid arterial stiffness (r= 0.107 ,0.213 ,P< 0.05). Conclusion CIMT and carotid stiffness are positively correlated with HbA1 c in DPN patients.HbA1 c is a risk factor for CIM T and carotid stiffness.

Evaluación del desempeño analítico de tres métodos de cuantificación de hemoglobina A1c / Analytical performance evaluation of three methods for hemoglobin A1c quantification / Avaliação do desempenho analítico do três métodos de quantificação de hemoglobina A1c

El laboratorio debe garantizar la exactitud de los resultados de HbA1c cumpliendo con los requisitos analíticos internacionales de calidad, cada vez más estrictos y asegurar que una variación de HbA1c de 0,5 puntos porcentuales (%-NGSP) o más entre dos controles consecutivos de un paciente diabético se deba a una variación clínica y no a una variación analítica. En este trabajo se evaluó el desempeño analítico de tres métodos comerciales para HbA1c: inmunoturbidimétrico, enzimático y cromatográfico de intercambio catiónico. Para tal fin, se procesaron por cada método distintos controles comerciales de HbA1c, con trazabilidad al método de referencia IFCC, determinándose en cada caso Coeficiente de Variación Total, Bias, Error Total, Valor de Referencia del Cambio y cambio clínico significativo de HbA1c en el punto crítico 7,0%-NGSP. En las condiciones analíticas de este trabajo, solamente el método inmunoturbidimétrico tuvo un desempeño analítico aceptable, permitiendo atribuir un cambio de 0,5%-NGSP a una variación clínica significativa del paciente. Frente a las recomendaciones internacionales sobre el uso de HbA1c en el control y diagnóstico de diabetes, es indiscutible la importancia de elegir un método que satisfaga los requerimientos analíticos mínimos de calidad para asegurar la utilidad clínica del resultado de HbA1c.

The laboratory must guarantee the accuracy of HbA1c results meeting the increasingly strict international analytical quality standards and assuring that an HbA1c variation of 0.5 percentage points (%-NGSP) or more between two consecutive controls of a diabetic patient is due to a clinical variation and not to an analytical variation. In this paper, the analytical performance of three commercial methods for HbA1c: Immunoturbidimetric, Chromatographic and Enzymatic Cation Exchange, were evaluated. For this purpose, commercial controls with assigned values traceable to the IFCC reference method for HbA1c were processed. For each methodology, total Coefficient of Variation (CV%), Bias%, Total Error (TE%), Change Reference Value and Clinically Significant Change (CSC) at the critical point of HbA1c 7.0%-NGSP were determined. Within the analytical conditions of this study, only the immunoturbidimetric method had an acceptable analytical performance, allowing attribute a change in 0.5%-NGSP to a significant clinical variation. Faced with international recommendations on the use of HbA1c on control and diagnosis of diabetes, the importance of choosing a method that meets the minimum analytical quality requirements to ensure the clinical utility of HbA1c result is undeniable.

O laboratório deve garantir a precisão dos resultados da HbA1c cumprindo com os requisitos analíticos internacionais de qualidade cada vez mais exigentes e garantir que uma variação de HbA1c de 0,5 pontos percentuais (% - NGSP) ou mais entre duas verificações consecutivas de um doente diabético seja devido a uma variação clínica e não a uma variação analítica. Neste trabalho foi avaliado o desempenho analítico de três métodos comerciais para HbA1c: imunoturbidimétrico, enzimático e cromatográfico de intercâmbio catiônico. Para esse fim, foram processados diversos controles comerciais de HbA1c por cada método, com rastreabilidade ao método de referência IFCC, determinando em cada caso Quociente de Variação Total, Bias, Erro Total, Valor de Referência da Alteração e Alteração Clinicamente Significativa de HbA1c no ponto crítico 7,0%-NGSP. Nas condições de análise deste estudo, apenas o método imunoturbidimétrico teve um desempenho analítico aceitável, permitindo atribuir uma alteração de 0,5%-NGSP a uma variação clínica significativa do paciente. Perante as recomendações internacionais sobre o uso da HbA1c no controle e diagnóstico da diabetes, é inegável a importância de escolher um método que atenda os requisitos analíticos mínimos de qualidade de análise para garantir a utilidade clínica do resultado HbA1c.

Use of hemoglobin A1C to detect Haitian-Americans with undiagnosed Type 2 diabetes / Utilização de hemoglobina A1C no rastreamento de haitianos americanos com diabetes tipo 2 não diagnosticado

OBJECTIVE: To evaluate the validity of hemoglobin A1C (A1C) as a diagnostic tool for type 2 diabetes and to determine the most appropriate A1C cutoff point for diagnosis in a sample of Haitian-Americans. SUBJECTS AND METHODS: Subjects (n = 128) were recruited from Miami-Dade and Broward counties, FL. Receiver operating characteristics (ROC) analysis was run in order to measure sensitivity and specificity of A1C for detecting diabetes at different cutoff points. RESULTS: The area under the ROC curve was 0.86 using fasting plasma glucose ≥ 7.0 mmol/L as the gold standard. An A1C cutoff point of 6.26% had sensitivity of 80% and specificity of 74%, whereas an A1C cutoff point of 6.50% (recommended by the American Diabetes Association - ADA) had sensitivity of 73% and specificity of 89%. CONCLUSIONS: A1C is a reliable alternative to fasting plasma glucose in detecting diabetes in this sample of Haitian-Americans. A cutoff point of 6.26% was the optimum value to detect type 2 diabetes.

OBJETIVO: Avaliar a validade da hemoglobina A1C (A1C) como ferramenta para o diagnóstico de diabetes tipo 2 e determinar o ponto de corte mais apropriado para a A1C no diagnóstico de uma amostra de haitianos americanos. SUJEITOS E MÉTODOS: Os sujeitos (n = 128) foram recrutados dos condados de Miami-Dade e Broward na Flórida. A análise ROC (Receiver operating characteristics) foi feita de forma a medir a sensibilidade e especificidade de A1C para a detecção do diabetes em diferentes pontos de corte. RESULTADOS: A área sob a curva ROC foi 0,86 usando a glicemia de jejum ≥ 7,0 mmol/L como padrão-ouro. O ponto de corte de 6,26% para a A1C apresentou sensibilidade de 80% e especificidade de 74%, enquanto o ponto de corte de 6,50% (recomendado pela American Diabetes Association - ADA) apresentou uma sensibilidade de 73% e especificidade de 89%. CONCLUSÕES: A A1C foi uma alternativa confiável para a glicemia de jejum na detecção do diabetes nesta amostra de haitianos americanos. Um ponto de corte de 6,26% foi o valor ótimo para a detecção do diabetes tipo 2.

Condición periodontal y pérdida dental en pacientes diabéticos del Hospital Universitario San Vicente de Paúl / Periodontal condition and tooth loss in diabetic patients

Introducción. La diabetes es una enfermedad sistémica que afecta el metabolismo de la glucosa y se ha relacionado con el desarrollo de enfermedad periodontal. Objetivo. El objetivo de este estudio fue determinar la condición periodontal y la pérdida dental de un grupo de pacientes diabéticos del Hospital Universitario San Vicente de Paúl. Materiales y métodos. A 117 sujetos con diabetes de tipo 1 y 2 se les practicó un examen periodontal completo, determinación de valores de la hemoglobina A1C (glycosilated hemoglobin) y radiografías periapicales, y se les indagó sobre hábitos de higiene oral e historia de diabetes. Los datos se analizaron de forma descriptiva y comparativa entre los parámetros clínicos, pérdida dental y tipo de diabetes. Resultados. La prevalencia de gingivitis fue de 27,4 % y la de periodontitis de 72,6 %. La complicación sistémica más frecuente fue la hipertensión arterial (51,3 %). Los dientes más frecuentemente perdidos fueron los molares y, en promedio, los sujetos habían perdido siete dientes. El control de placa bacteriana fue pobre (55,4 %). No hubo diferencias en los parámetros clínicos entre pacientes diabéticos de tipo 1 y de tipo 2. El promedio de profundidad con sonda fue 2,62 mm, siendo los molares los dientes más afectados. El promedio de pérdida de inserción fue de 3,03 mm. Los dientes 17, 16, 27, 37 y 47 presentaron los valores más altos de pérdida de inserción. Conclusiones. En conclusión, la condición periodontal en pacientes diabéticos fue mala, y presentaban periodontitis en la mayoría de los casos. Esto puede ser una causa importante de pérdida dental en sujetos diabéticos y requiere de especial atención por parte de los odontólogos y médicos.

Introduction. Diabetes is a systemic disease which affects the metabolism of glucose,and it has been associated with the development of periodontal disease. Objective. The periodontal condition and tooth loss was evaluated in diabetic subjects. Materials and methods. At the San Vicente de Paúl Hospital (Medellín, Colombia), 117 subjects with type 1 and 2 diabetes mellitus were examined. Patients underwent a comprehensive periodontal evaluation, glycosylated hemoglobin analysis, oral hygiene habits and history of diabetes. A descriptive and comparative analysis between the clinical parameters, tooth loss and type of diabetes was performed. Results. The prevalence of gingivitis was 27.4% and periodontitis 72.6%. The most frequent systemic complication was hypertension (51.3%). The most frequently lost teeth were molars and in general, the subjects had lost an average of 7 teeth and had a poor plaque control (55.4%). No differences were seen in clinical parameters between type 1 and 2 diabetes patients. The mean probing depth was 2.6 mm. The first and second upper and lower molars showed the highest values of PD. The mean clinical attachment loss was 3.3 mm . Maxillary teeth 17, 16, and mandibular 37, 47 showed the highest values of clinical attachment loss. Conclusions. In conclusion, the periodontal condition in diabetic patients was poor, presenting periodontitis in most cases. This can be a major cause of tooth loss in diabetic subjects and requires special attention by clinicians.

Relationship of glycosylated hemoglobin A1C and postprandial blood glucose with urinary albumin excretion ratein patients with type 2 diabetes mellitus / 临床检验杂志

Objective To investigate the relationship of glycosylated hemoglobin A1C(HBA1c) and 2 hour postprandial blood glucose(2hPBG) with 12-hour urinary albumin excretion rate(UAE).Methods One hundred and thirteen patients with type 2 diabetes mellitus(T2DM),whose fast blood glucose(FBG) levels after treatment were less than 7.0 mmol/L,and 54 healthy subjects were the control group in this study.The level of HBA1c was detected by high performance liquid chromatography(HPLC).The level of 2hPBG was measured by glucose oxidase assay and the level of UAE was detected by radioimmunoassay.According to the level of HBA1c and 2hPBG,the patients were divided into 4 groups: group A(HBA1c7% and PBG