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 (−0.5%), weight (−2.9 kg), and daily insulin (−8.5%) were achieved after 12 months. The greatest reduction in HbA1c was obtained in individuals with baseline HbA1c >8% (−0.7% [64 mmol/mol]). The most weight loss was observed in subjects with BMI >27 kg/m2 (−3.5 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 (−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 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.

中文翻译：

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SGLT2 抑制剂作为 1 型糖尿病成人辅助治疗的有效性和安全性的真实世界证据：欧洲两中心经验

目的 评估钠-葡萄糖协同转运蛋白 2 抑制剂 (SGLT2i) 与胰岛素联合用于 1 型糖尿病患者的真实疗效和安全性。研究设计和方法 我们进行了一项回顾性队列欧洲两中心研究。收集了 199 名 1 型糖尿病成人患者的人口统计学、HbA1c、体重、胰岛素使用、肾功能和不良事件的数据，这些成人开始使用 SGLT2i 辅助胰岛素。进行亚组分析以确定谁受益最多，谁更容易发生不良事件。结果 总体而言，12 个月后平均 HbA1c (-0.5%)、体重 (-2.9 kg) 和每日胰岛素 (-8.5%) 显着降低。HbA1c 降低幅度最大的是基线 HbA1c > 8% (-0.7% [64 mmol/mol]) 的个体。在 BMI > 27 kg/m2 (-3.5 kg) 的受试者中观察到体重减轻最多。基线估计肾小球滤过率 (eGFR) <90 mL/min/1.73 m2 的个体显示 eGFR 增加 (4.5 mL/min/1.73 m2)，而尿白蛋白与肌酐比 (UACR) >15 的个体mg/g 显示 UACR 降低（-16.6 mg/g）。57 人 (28.6%) 报告了不良事件：45 人生殖器感染 (22.6%)、5 人酮症发作 (2.5%) 和 7 人糖尿病酮症酸中毒 (DKA) (3.5%)。没有报告严重的低血糖事件。结论 我们关于 SGLT2i 的真实数据显示，在降低 1 型糖尿病患者的 HbA1c、体重和胰岛素需求方面取得了可喜的结果。在基线 HbA1c 和 BMI 较高的个体中获益更为明显。尽管采取了教育措施，但 DKA 仍然是一个主要问题。