Study design and patients
DIABETES MELLITUS
This was a multicenter, randomized, open-label comparative study. The study was conducted between February 2020 and February 2021 in 8 hospital centers in France that recruited patients. The randomization was done in two parallel groups (1:1), with a stratified randomization by center with randomized blocks of 4. Randomization lists were produced by the CRO statistician with SAS Version 9.4. The randomization list was implemented in the Ennov Clinical eCRF.To be enrolled in the study, patients had to fulfil the following inclusion criteria: type 1 or 2 diabetes mellitus, at least 18 years old, already using an Omnipod