[The RECORD project. continuous blood glucose monitoring among high risk subjects for developing diabetes in Spanish primary health care].

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.