Abstract
Objetivo
Evaluar si una nueva técnica, el registro continuo de la glucemia (RCG), es viable y útil para contrastar el diagnóstico y predecir la evolución durante la prediabetes tipo 2.
Diseño
Observacional, multicéntrico, transversal (fase 1); posteriormente, longitudinal de seguimiento de cohortes (fase 2).
Emplazamiento
Atención primaria de salud (5 centros).
Participantes
Será incluido un grupo de 84 sujetos de alto riesgo libres de diabetes si una prueba actual de tolerancia oral a la glucosa (PTOG) descarta la enfermedad. Se efectuará un primer RCG mediante un biosensor calibrado por la glucemia plasmática, obteniendo un perfil glucémico continuo. Se establecen 2 cohortes de seguimiento diferenciando los sujetos con PTOG normal (n = 42) de aquellos con hiperglucemia prediabética (n = 42). A los 12 y 24 meses, se reclasificará el diagnóstico mediante sobrecarga oral seguida de un nuevo registro.
Mediciones principales
Datos demográficos, clínicos (incluidos componentes del síndrome metabólico), analíticos básicos y avanzados (marcadores de inflamación, insulinemia, péptido C). Análisis informático del RCG comparando sus períodos (basal, pre-posprandial, nocturno) y el área bajo la curva del perfil continuo con el diagnóstico convencional revisando su concordancia temporal. Estudio de su influencia sobre la incidencia de diabetes o la regresión a la normalidad glucémica. Evaluación de la satisfacción del usuario con el RCG mediante cuestionario estructurado tipo Likert.
Discusión
El proyecto es un contrapunto diagnóstico evolutivo entre PTOG estándar y RCG, más fisiológico y basado en un criterio infrautilizado, la glucemia al azar. Una técnica aún no evaluada en atención primaria puede aportar datos de indudable interés científico para el estudio de la prediabetes tipo 2.
Palabras clave: Prediabetes, Diabetes, Glucemia basal alterada, Intolerancia a la glucosa, Registro continuo de la glucemia
Abstract
Objective
To evaluate the accuracy of continuous blood glucose monitoring (CBGM) in order to asses diagnostic procedures and predict glycaemic status in type 2 prediabetes.
Design
Observational, multicenter, cross-sectional (phase 1) plus longitudinal, cohort follow-up study (phase 2).
Setting
Five primary health-care centers.
Interventions
A total of 84 high-risk subjects will be included after a non-diabetic oral glucose tolerance test (OGTT). A first CBGM using a subcutaneous microdialysis glucose sensor technique in order to obtain a continuous profile will be carried out. Two different cohorts, subjects with normal OGTT (n=42) and individuals with prediabetic hyperglycemia (n=42) will be established. Diagnoses will be revised at 12 and 24 month follow-up by means of an OGTT together with a new monitoring.
Main measurement
Demographical, clinical (including metabolic syndrome items), basic, and advanced analyses (inflammation emergent markers, insulinemia, C-peptide). CBGM computerized analysis comparing fasting, preprandial, postprandial, nocturnal period, and area under the curve of continuous profile with regular diagnoses, taking into account temporary concordance. Relationship of CBGM parameters with normal glucose tolerance or diabetes incidence. Evaluation of day-to-day quality of life of CBGM users by means of an standardized Likert questionnaire.
Discussion
This study seeks to demonstrate the effectiveness and feasibility of CBGM, more physiological than OGTT and based on an underestimated random blood glucose diagnostic criterion. This innovative system may provide interesting scientific data in the field of type 2 prediabetes.
Key words: Prediabetes, Diabetes, Impaired fasting glucose, Impaired glucose tolerance, Continuous blood glucose monitoring
Footnotes
El proyecto ha sido galardonado y cuenta para su desarrollo con la ayuda a la investigación de l’Associació Catalana de Diabetis en su convocatoria de 2004.
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