Real-world Evidence of Efficacy and Safety of Sodium–Glucose Cotransporter 2 Inhibitors as Adjunctive Therapy in Adults With Type 1 Diabetes: A European Two-Center Experience

Abstract

<b>Objective:</b> To evaluate real-world efficacy and safety of SGLT2 inhibitor (SGLT2i) use in combination with insulin in people with type 1 diabetes. <p><b>Research design and methods:</b> We conducted a retrospective cohort European two-center study. Data on demographics, HbA1c, weight, insulin use, renal function, and adverse events were collected from 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.</p> <p><b>Results:</b> Overall, significant reductions in HbA1c (-0.5%), weight (-2.9 kg), and mean daily insulin (-8.5%) were achieved after 12 months. The highest reduction in HbA1c was obtained in individuals with baseline HbA1c >8% (-0.7%) [64mmol/mol]. The largest weight loss was observed in subjects with BMI >27 kg/m<sup>2 </sup>(-3.5 kg). Individuals with baseline eGFR <90 showed an increase in eGFR (4.5 ml/min/1.73m<sup>2</sup>), whereas those with UACR >15 mg/g showed a decrease in UACR (-16.6 mg/g). Fifty-seven individuals (28.6%) reported adverse events: 45 genital infections (22.6%), 5 ketosis episodes (2.5%), and 7 cases of diabetic ketoacidosis (DKA) (3.5%). No severe hypoglycemia events were reported.</p> <p><b>Conclusions: </b>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 to evaluate SGLT2i longer-term effects and their impact on reno-cardiovascular outcomes.</p>