Statistical analysis
diabetes
DIABETES MELLITUS TYPE 1, DIABETES
Statistical analyses were computed with SAS Version 9.4 (SAS Institute Inc., Cary, USA). Four analysis populations were defined for this study: the safety population which was composed of all patients having used the investigational device; the intent-to-treat (ITT) population composed of all included and randomized patients having used the investigational device; the modified ITT (mITT) population composed of all ITT patients excluding patients who ended the study because of the COVID-19; the per protocol (PP) population composed of all ITT patients with no major protocol deviation. Continuous and categorical variables were summarized using usual statistics. Non-inferiority analysis was made by an analysis of covariance in the PP population with the medical device as an explanatory variable and adjusted on the baseline A1C estimation. Then non-inferiority was demonstrated if the difference (LSmeans) between treatments did not overlap the non-inferiority margin (0.4%). Superiority was tested and demonstrated in the presence of a difference of 0.3% in favor of the new pump. A sensitivity analysis was performed on mITT population with imputation using the median values in case of missing data. In addition, univariate analyses were performed on age in class (according to the median value), gender, diabetes mellitus type, center, and duration of diabetes. Variables with a p-value less than 0.05 were included in the multivariate model. All other comparisons between groups were performed using Student’s t-test, a chi-squared test or a Fisher exact test.The study was approved by an independent ethic committee and was registered in the French and European database of clinical studies (ID-RCB: 2019-A02566-51) and in the ClinicalTrials.gov protocol register under NCT04223973 (study start date: January 29, 2020; primary completion date: March 1, 2021; study completion date: June 1, 2021).The study was performed in compliance with the General Data Protection Regulation (GDPR) and with the Data Privacy Committee CNIL MR001. The study was carried out in accordance with the Declaration of Helsinki. All patients were carefully informed about the study and gave written informed consent to participate.