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

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, HbA(1c), 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 HbA(1c) (-0.5%), weight (-2.9 kg), and daily insulin (-8.5%) were achieved after 12 months. The greatest reduction in HbA(1c) was obtained in individuals with baseline HbA(1c) >8% (-0.7% [64 mmol/mol]). The most weight loss was observed in subjects with BMI >27 kg/m(2) (-3.5 kg). Individuals with baseline estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m(2) showed an increase in eGFR (4.5 mL/min/1.73 m(2)), whereas those with urinary albumin-to-creatinine ratio (UACR) >15 mg/g showed a decrease in UACR (-16.6 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 HbA(1c), weight, and insulin requirements in type 1 diabetes. Benefits were more pronounced in individuals with higher baseline HbA(1c) 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.

Automated summary

This study evaluated the real-world efficacy and safety of combining sodium-glucose cotransporter 2 inhibitor (SGLT2i) with insulin in individuals with type 1 diabetes. The results showed significant reductions in HbA(1c), weight, and insulin requirements after 12 months of treatment. The greatest improvements were observed in individuals with higher baseline HbA(1c) and BMI. Adverse events, including genital infections and diabetic ketoacidosis, were reported in a subset of participants.