The analysis of the studies indicates that the insulin‐only configuration of the iLet BP was shown to be effective in reducing HbA1c and improving CGM metrics of mean glucose, hyperglycaemia, and TIR compared with prospectively collected data for the study participants who participated in the SC control group during the immediately preceding 13‐week period, without increasing CGM‐measured hypoglycaemia. This evidence concerns the gene INS and Hypoglycemia.