Safety monitoring & adverse events
poisoning, ketoacidosis, hypoglycaemia
ADVERSE EVENTS, KETOACIDOSIS, HYPOGLYCAEMIA
Of the completers, two participants reported ketone levels >0.6 mmol/L during the intervention period but did not require medical treatment: one participant was unwell due to suspected food poisoning, and the other participant had ketones ~3.0 mmol/L in the context of normal blood glucose levels with no negative symptoms. No episodes of severe hypoglycaemia requiring hospitalisation or other adverse events were reported during the intervention period. One participant who dropped out of the study was hospitalised for ketoacidosis during the control period prior to making any diet or insulin changes.