| Outcome Measures: |
Primary: Change in blood glucose variability, Mean change from baseline to 12 months in glucose variability. Glucose variability is estimated as standard deviation (SD) of serial glycemic values, and is based on 3 daily glucose profiles (each with at least 5 self-measurements of blood glucose)., baseline to 12 months. | Secondary: Number of patients with episodes of hypoglycemia., Hypoglycemic episodes: an event accompanied or not accompanied by typical symptoms but with a measured plasma glucose concentration ≤70 mg/dl (3.9 mmol/l)., baseline, 1, 6, 12 months.|Change in body weight., Weight will be measured in Kg. An increase in body weight ≥2 kg gain in one week will be considered a marker of fluid congestion., baseline, 1, 6, 12 months.|Change in plasma concentration of a natriuretic peptide, BNP or NT-proBNP concentrations will be measured as ng/L of plasma., baseline, 1, 6, 12 months.|Changes in urinary albumin excretion, Urinary albumin concentration will be expressed as the urinary albumin-to-creatinine ratio (UACR), measured in milligrams per grams of creatinine, with a limit of detection of 1.5 mg/g., baseline, 1, 6, 12 months.|Change in New York Heart Association (NYHA) class, Any change in NYHA class. The New York Heart Association (NYHA) Functional Classification places patients in one of four categories (I through IV) based on heart failure symptoms and functional limitations. Higher NYHA classes indicate a greater heart failure severity and poorer outcome.", baseline, 1, 6, 12 months.|All-cause hospitalizations, Number of patients admitted to hospital for any cause., baseline to 12 months|Hospitalizations for worsening of HF., Number of patients admitted to hospital for worsening of HF., baseline to 12 months|All-cause mortality, Number of patients who died for cardiovascular and non-cardiovascular causes., baseline to 12 months|Number of patients with episodes of ketoacidosis as evaluation of safety., Ketoacidosis is defined as the presence of at least two of the following factors: a) elevated plasma glucose (\>250 mg/dL), b) ketones in serum or urine and c) acidosis (serum bicarbonate \<18 mEq/L and/or pH \<7.30)., baseline to 12 months|Number of patients with episodes of lactic acidosis as evaluation of safety., Lactic acidosis is characterized by persistently increased blood lactate levels (usually \>5 mmol/L) in association with metabolic acidosis., baseline to 12 months|Changes in left ventricular ejection fraction (LVEF)., LVEF will be calculated from left ventricular volume in diastole and systole estimated by echocardiography. LVEF will be measured as percentage. A decrease in LVEF will be taken as a marker of worsening of cardiac function., baseline, 1, 6, 12 months.|Changes in E/e'., E/e' ratio will be calculated from echo-Doppler recordings. As a ratio it will not have a unit of measure., baseline, 1, 6, 12 months.|Changes in Hemoglobin A1c (HbA1c)., HbA1c will be measured as percentage of total hemoglobin concentration., baseline, 1, 6, 12 months.
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| Locations: |
Ospedale Bolognini di Seriate, Seriate, BG, 24068, Italy|Ospedale Treviglio, Treviglio, BG, 24047, Italy|Ospedale di Passirana, Passirana, MI, 20017, Italy
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