Ketoacidosis with SGLT2 inhibitors in routine clinical practice of type 2 diabetes: Scandinavian cohort and nested case–control study
Authors' conclusion
Ketoacidosis risk with SGLT2 inhibitors varies greatly by patient characteristics and is not confined to early in treatment.
Study context
- Population
- Patients with T2D aged ≥18 years with SGLT2i treatment episodes, Sweden, Denmark and Norway, 2013–2021/2022; mean age 63 years, 36.1% women
- Participants
- 282,282 patients322,597 treatment episodes
- Outcome
- Ketoacidosis incidence during SGLT2i treatment
- Follow-up
- Median 1.3 (IQR 0.7-2.8) years
Methodological detailsnationwide registers, three Scandinavian countries, nested case-control matched on age, sex, region of birth, calendar time and time since treatment initiation
- Nationwide registers
- Three Scandinavian countries
- Nested case-control matched on age, sex, region of birth, calendar time and time since treatment initiation
Main finding
As reported in the abstract
Ketoacidosis incidence · median follow-up 1.3 years
Ketoacidosis events
1452
Incidence
2.43 per 1000 person-years
Observational data: associations, not effects.
Further findings
| Outcome | Ketoacidosis cases | Controls | OR (95% CI) | |
|---|---|---|---|---|
| Infection as precipitating or co-occurring event | 31.8% | 6.1% | 7.60 (6.62–8.71) | |
| 0.10.31310Odds ratio (log scale) |
- Infection as precipitating or co-occurring event: 454 of 1428 cases; 862 of 14 233 controls
Risk factors for ketoacidosis (nested case-control)
- HbA1c ≥83 vs ≤52 mmol/mol, OR
- 15.37 (11.50-20.53) (95% CI)
- Malnutrition, OR
- 10.54 (7.32-15.18)
- Previous ketoacidosis, OR
- 10.40 (7.09-15.24)
- BMI <20 vs 20 to <25 kg/m², OR
- 9.98 (5.68-17.53)
- Recent hypoglycaemia, OR
- 5.22 (2.60-10.49)
- Matched nested case-control
Infection as precipitating or co-occurring event
- Strongest associations: alcohol intoxication, acute renal events, acute abdomen, stroke, major surgery; some transient exposures may be overestimated (under-registration among controls)
- Exploratory: associations largely general to T2D rather than specific to SGLT2i
Diabetes medication after ketoacidosis · 1 year after ketoacidosis
- Remained on SGLT2i
- 211 (25.1%) of 842
- Insulin use before → after
- 269 (31.9%) → 615 (73.0%) of 842
Original publication
Ketoacidosis with SGLT2 inhibitors in routine clinical practice of type 2 diabetes: Scandinavian cohort and nested case–control study. Lancet Diabetes Endocrinol. Published 1 September 2026. doi:10.
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