Real-world Evidence of Efficacy and Safety of SGLT2 Inhibitors as Adjunctive Therapy in Adults With Type 1 Diabetes: A European Two-Center Experience

Abstract

OBJECTIVE To evaluate real-world efficacy and safety of sodium–glucose cotransporter 2 inhibitor (SGLT2i) use in combination with insulin in people with type 1 diabetes. RESEARCH DESIGN AND METHODS We conducted a retrospective cohort European two-center study. Data on demographics, HbA1c, weight, insulin use, renal function, and adverse events were collected for 199 adults with type 1 diabetes who initiated a SGLT2i adjunct to insulin. Subgroup analyses were performed to identify who benefited most and who was more at risk for adverse events. RESULTS Overall, significant reductions in mean HbA1c (20.5%), weight (22.9 kg), and daily insulin (28.5%) were achieved after 12 months. The greatest reduction in HbA1c was obtained in individuals with baseline HbA1c >8% (20.7% [64 mmol/mol]). The most weight loss was observed in subjects with BMI >27 kg/m2 (23.5 kg). Individuals with baseline estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 showed an increase in eGFR (4.5 mL/min/1.73 m2), whereas those with urinary albumin-to-creatinine ratio (UACR) >15 mg/g showed a decrease in UACR (216.6 mg/g). Fifty-seven individuals (28.6%) reported adverse events: 45 with genital infections (22.6%), 5 ketosis episodes (2.5%), and 7 diabetic ketoacidosis (DKA) (3.5%). No severe hypoglycemia events were reported. CONCLUSIONS Our real-world data on SGLT2i showed promising results in reductions in HbA1c, weight, and insulin requirements in type 1 diabetes. Benefits were more pronounced in individuals with higher baseline HbA1c and BMI. DKA remained a major concern, despite educational measures. Further real-life evidence is still required for evaluation of SGLT2i longer-term effects and their impact on reno-cardiovascular outcomes.