Statistical analyses
The primary outcome was the change(s) in HbA1c across timepoints (pre-control, post-control, and post-intervention). Based on a clinically relevant difference in HbA1c of 0.7% (absolute), with a standard deviation of 1.0, to achieve 80% power with alpha <0.05, a sample size of n = 16 was determined using a paired t-test of comparisons [