Statistical analysis and data management
DKA
HYPOGLYCEMIA, RECRUITMENT, DIABETIC KETOACIDOSIS
As described in our published methodology, a sample size of 88 (44 participants in each group) was estimated to provide 80% power to detect a difference in changes in HbA1c of 7 mmol/mol (0.75%) between the intervention and control groups using standard deviation (SD) of 15 mmol/mol and correlation of 0.7 between repeated observations on the same person and a two-sided test at the 0.05 level.The primary analysis followed intention to-treat principles with all participants analyzed in the group to which they were randomized, regardless of actual sensor wear. Additional analyses included standard glycemic metrics, glucose monitoring frequency and adherence, episodes of severe hypoglycemia, episodes of diabetic ketoacidosis (DKA), and psychosocial variables. Mean differences and Recruitment was from July 1, 2021, to June 1, 2022, with all subjects completing the 12-week RCT by September 1, 2022.