Statistical analysis
hypoglycemia
HYPOGLYCEMIA
To be able to detect a difference in percentage of time with SG <3.9 mmol/L of 2.3%-points (approximately 30 minutes) with 90% power, a 5% significance level, and a presumed 3.0%-points standard deviation (10), it was established that 20 participants were to be included in the study (2-sided test). Categorical variables were reported as frequencies (percentage), whereas continuous variables were reported as mean (SD) or median (interquartile range [IQR]). Continuous data was assessed for normality using Shapiro-Wilk test. For normally distributed variables, paired student’s t-test was used to conduct pairwise comparisons between the two groups. For skewedly distributed variables despite log-transformation, the non-parametric Wilcoxon signed-rank test was used. Missing glucose data were estimated using linear interpolation. We used McNemar’s test to assess the significance of the difference in the incidence of level 2 hypoglycemia between the two study arms. Analyses were performed on an intention-to-treat basis. Statistical analyses were performed using RStudio version 1.4.