Hence, there is a need for guidance document to assist clinicians in using this novel insulin regimen with unique pharmacological properties in real-life clinical practice in terms of dose timing relative to meal(s), daily dosage, treatment intensification or switching from previous antidiabetic therapy as well as different patient populations (adult, children, T1D, T2D, pregnant, elderly, hospitalized). This evidence concerns the gene INS and type 2 diabetes mellitus.