2.6 Sample size and Statistical methods To determine the sample size and obtain a clinical and statistical significant result in the primary variable (difference >14.5mg/dL on glycemic variability), it was used MAGE (mean amplitude of glycemic excursion). As MAGE is glycemic amplitude measured in mg/dL, it was arbitrarily set a difference of ≥ 14.5, which may be clinically important for the patient as judged by the study center team and its expert consultants. There is not a good study of T2DM patients that establishes which MAGE difference or improvement could be significant to prevent diabetes complications.