Statistics
Diabetes, diabetes
REGRESSION, DIABETES, DIABETES
A statistical plan was drafted a priori and approved by the ethics committee. A sample size of 58 (29 per group) had 80% power to detect a 0.6% difference in HbA1c (above the minimum clinically important difference of 0.5%) between groups. This accounted for 20% drop-out or loss to follow-up. All analyses followed the intention-to-treat principle and significance was taken at the 5% level. The statistician was blinded to treatment allocation until the last participant had completed follow-up. Patient characteristics were summarised as mean and standard deviation and/or median and interquartile range for each treatment arm and compared between arms using Wilcoxon rank-sum or Kruskal-Wallis tests.Multivariable linear regression models were used to test for a difference in key outcomes between treatment arms while controlling for minimisation variables (centre, BMI (≤42 and >42 kg/mA multivariable logistic regression model following the same principle as the linear models was used to test for a difference in diabetes resolution between treatment arms. Diabetes resolution is defined as the patient achieving an HbA1c of <48 mmol/mol and off all diabetes medications.