Ponzani Paola, Berra Cesare, Di Lelio Alessandra, Del Sindaco Paola, Di Loreto Chiara, Reggiani Francesco, Lucisano Giuseppe, Rossi Maria Chiara
SSD Endocrinologia, Diabetologia e Malattie Metaboliche, ASL3 Genovese, Genoa, Italy.
Humanitas Research Institute, Rozzano, MI, Italy.
Diabetes Ther. 2020 Jan;11(1):97-105. doi: 10.1007/s13300-019-00722-y. Epub 2019 Nov 9.
Real-world evidence on the effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. We have therefore evaluated the effectiveness and safety of IDeg, including impact on metabolic control, glycemic variability, weight gain and hypoglycemia, in patients with type 1 diabetes under routine clinical practice conditions.
This was an observational longitudinal multicenter study. A retrospective chart review of all patients with type 1 diabetes who were switched from basal insulin to IDeg was performed, and temporal trends in clinical outcomes were assessed.
Data obtained from 195 patients, with a median age of 42.8 [interquartile range (IQR) 24.6-56.4] years and a median diabetes duration of 16 (IQR 10.0-28) years, were analyzed. Median follow-up was 9.5 (IQR 7.7-11.3) months. Improvements were found in glycated hemoglobin (- 0.34%; p < 0.0001), fasting blood glucose (- 24.82 mg/dL; p < 0.0001), post-prandial glucose (- 17.23 mg/dL; p = 0.0009), glycemic variability as indicated by standard deviation of blood glucose (- 5.67 mg/dL; p < 0.0001) and high blood glucose index (- 3.77; p < 0.0001). Body weight and body mass index remained substantially stable during the follow-up (- 0.18 kg; p = 0.56 and - 0.12; p = 0.42, respectively). Risk of nocturnal hypoglycemia decreased by 52% [incidence rate ratio 0.48; 95% confidence interval (CI) 0.29-0.77] and risk of total hypoglycemic episodes by 41% (incidence ratio 0.59; 95% CI 0.45-0.83). Basal and short-acting insulin doses decreased by - 1.4 and - 3.1 IU, respectively.
Switching patients with type 1 diabetes to IDeg from other basal insulins was associated with relevant improvements in metabolic control and glycemic variability without weight gain; the risk of hypoglycemic episodes also significantly declined.
Novo Nordisk S.p.A. unconditional grant.
关于德谷胰岛素（IDeg）在糖尿病患者中的有效性和安全性的真实世界证据是当务之急。因此，我们评估了在常规临床实践条件下，IDeg对1型糖尿病患者的有效性和安全性，包括对代谢控制、血糖变异性、体重增加和低血糖的影响。
这是一项观察性纵向多中心研究。对所有从基础胰岛素转换为IDeg的1型糖尿病患者进行回顾性病历审查，并评估临床结局的时间趋势。
分析了195例患者的数据，患者中位年龄为42.8岁[四分位间距（IQR）24.6 - 56.4岁]，糖尿病病程中位数为16年（IQR 10.0 - 28年）。中位随访时间为9.5个月（IQR 7.7 - 11.3个月）。糖化血红蛋白（-0.34%；p < 0.0001）、空腹血糖（-24.82mg/dL；p < 0.0001）、餐后血糖（-17.23mg/dL；p = 0.0009）、以血糖标准差表示的血糖变异性（-5.67mg/dL；p < 0.0001）和高血糖指数（-3.77；p < 0.0001）均有改善。随访期间体重和体重指数基本保持稳定（分别为-0.18kg；p = 0.56和-0.12；p = 0.42）。夜间低血糖风险降低了52%[发病率比0.48；95%置信区间（CI）0.29 - 0.77]，总低血糖事件风险降低了41%（发病率比0.59；95%CI 0.45 - 0.83）。基础胰岛素和短效胰岛素剂量分别减少了-1.4和-3.1IU。
将1型糖尿病患者从其他基础胰岛素转换为IDeg与代谢控制和血糖变异性的相关改善有关，且无体重增加；低血糖事件的风险也显著下降。
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