Real-world evidence on ketoacidosis risk associated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) remains limited. A cohort and nested case-control study across three Scandinavian countries evaluated the incidence, risk factors, and prognosis of ketoacidosis during SGLT2i treatment in patients with type 2 diabetes (T2D). The study analyzed 322,597 treatment episodes involving 282,282 patients with T2D (mean age, 63 years). Over a median follow-up of 1.3 years, 1,452 ketoacidosis events occurred.

Although ketoacidosis risk peaked soon after treatment initiation, it remained elevated throughout the follow-up period. Strong risk factors for ketoacidosis included high HbA1c (≥83 vs ≤52 mmol/mol, odds ratio [OR] 15.37), malnutrition (OR 10.54), previous ketoacidosis (OR 10.40), low BMI (<20 vs 20 to <25 kg/m², OR 9.98), and recent hypoglycemia (OR 5.22). Infection was the most…