Abstract
Objetivo
Evaluar la determinación ambulatoria de glucohemoglobina (HbA1c) comparada con la de laboratorio, midiendo control metabólico, calidad de vida y episodios de hipoglucemia, en adultos con diabetes mellitus tipo 1 o 2.
Diseño
Revisión sistemática.
Fuente de datos
MEDLINE (1966-agosto 2006), EMBASE (2000-agosto 2006), bases mantenidas por el Center for Reviews and Dissemination (DARE, INAHTA, NHSEED), Cochrane Library (número 3, 2006), Agencia Europea del Medicamento, Food and Drug Administration y Red Europea de Tecnologías Emergentes. Se realizó una búsqueda manual en Point of Care y en el registro de ensayos ClinicalTrials.gov.
Métodos
Los criterios de inclusión fueron estudios con adultos diabéticos de tipo 1 o 2, que utilizaran dispositivos ambulatorios portátiles y se compararan con referencias de laboratorio. Se excluyeron aquellos con menores de edad, con otro tipo de diabetes, sin dispositivo portátil o si el comparador no incluía métodos de referencia. Se recuperaron completos los que, a priori, cumplían los criterios. Se realizó análisis de la calidad según los criterios del programa CASPe y se extrajeron los datos con un formulario específico. Se realizó una síntesis cualitativa al no poder realizar un metaanálisis.
Resultados
Se seleccionaron 20 publicaciones. La mayoría de los dispositivos mostraron buena correlación entre valores (R2 = 0,85 y R2 = 0,059, p < 0,001). Algunos estudios describían que aumentaba el control glucémico, con descenso de HbA1c de 0,1-1,5% (p < 0,01); se intensificaba el control terapéutico (intervalo de confianza del 95% de la odds ratio, 0,95-1,52) y disminuían las visitas médicas.
Conclusiones
Son técnicas rápidas y cómodas, que aumentan el control metabólico de los pacientes, pero poseen ciertas limitaciones.
Palabras clave: Diabetes mellitus, Glucohemoglobina, Diagnóstico, Cabecera del paciente, Evaluación de tecnología sanitaria
Abstract
Objective
To compare out-patient determination of HbA1c with lab figures, by measuring metabolic control, quality of life and hypoglycaemia episodes, in adults with type-1 or -2 Diabetes mellitus.
Design
Systematic review.
Data sources
MEDLINE (1966-August 2006), EMBASE (2000-August 2006), bases held by the Center for Reviews and Dissemination (DARE, INAHTA, NHSEED), Cochrane Library (number 3, 2006), European Medication Agency, Food and Drug Administration and the European Network of Emerging Technologies. A manual search was made in Point of Care and in the register of trials, ClinicalTrials.gov.
Methods
Inclusion criteria were studies with type-1 or -2 diabetics who used portable out-patient devices and with comparison with lab references. Studies of minors, of any other kind of Diabetes, of patients without a portable device and where the comparator did not include reference methods were excluded. Those that a priori met the criteria were recovered fully. A quality analysis was run according to the CASPe programme criteria and data were extracted with specific formulae. As meta-analysis was not possible, a qualitative synthesis was made.
Results
Twenty publications were selected. The values of most devices correlated well (R2=0.85 and R2=0.059; P<.001). Some studies described increase in glycaemia control, with drop in HbA1c of 0.1-1.5% (P<.01); therapy control was more intense (OR: 0.95-1.52; CI 95%) and visits to the doctor decreased.
Conclusions
Out-patient evaluations are rapid and comfortable, increasing patients’ metabolic control. However, they possess certain limitations.
Key words: Diabetes mellitus, Glycosylated haemoglobin, Diagnosis, Point of care, Health technology assessment
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