Outcome Measures: |
Primary: Difference in A1c Levels, A1c using high performance liquid chromatography measured in percentage, baseline and 24 weeks|Number of Hypoglycemic Events, Hypoglycemia was defined by capillary glycemia\< 70 mg/dL (3.9 mmol/L), even if it was not accompanied by typical symptoms. Otherwise, hypoglycemia was classified as "severe" with SMBG below 50 mg/dL (2.8 mmol/L) or when it resulted in stupor, seizure, or unconsciousness that precluded self-treatment, thus requiring the assistance of another individual. Nocturnal events were defined as SMBG \< 70mg/dL occurring after midnight and before wake-up in the morning (before 7:00am)12., between 1rst and 24 weeks of each treatment arm | Other: Glycemic Variability, In order to observe variability in interstitial glucose levels related to the therapy in use, participants wore a blinded CGM for 3 days. Changes in glycemic patterns were expressed by the average daily time spent in hypoglycemia (≤70 mg/dL or \<3.9 mmol/L), hyperglycemia (\>180 mg/dL or \>10 mmol/L) and euglycemia (70-180 mg/dL or 3.9-10 mmol/L)., 24 week|Total Daily Insulin Dose, Daily total insulin dose at baseline compared to dose at week 24., baseline and 24 weeks|Body Mass Index (BMI), The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres., baseline and 24 weeks|Serum Creatinine, Creatinine is measured in milligrams per deciliter of blood (mg/dL, baseline and 24 weeks|Estimated Glomerular Filtration Rate (eGFR) Calculated by CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is one of the most widely used IDMS traceable equations for estimating GFR in patients age 18 and over. CKD-EPI equation includes variables for age, gender, and race, which may allow providers to observe that CKD is present despite a serum creatinine concentration that appears to fall within or just above the normal reference interval. CKD-EPI equation expressed as a single equation: GFR = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 \[if female\] × 1.159 \[if black\] where: Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males,min indicates the minimum of Scr /κ or 1, and max indicates the maximum of Scr /κ or 1., baseline and 24 weeks
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