Li Feng-Fei, Zhang Ying, Zhang Wen-Li, Liu Xiao-Mei, Chen Mao-Yuan, Sun Yi-Xuan, Su Xiao-Fei, Wu Jin-Dan, Ye Lei, Ma Jian-Hua
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore, Singapore.
Diabetes Ther. 2018 Oct;9(5):1969-1977. doi: 10.1007/s13300-018-0492-3. Epub 2018 Aug 22.
To explore whether there was a gender difference in the risk of hypoglycemia during intensive insulin therapy in patients with longstanding type 2 diabetes (T2D). This was a post hoc analysis of a single-center, open-label and prospective trial.
All subjects were admitted as inpatients, underwent a standard bread meal test at baseline and received a 7-day continuous subcutaneous insulin infusion (CSII) therapy for achieving glycemic control. Patients then were randomized 1:1 to two groups receiving (1) 4 days of Novo Mix 30 followed by 2 days of Humalog Mix 50; (2) 4 days of Humalog Mix 50 followed by 2 days of Novo Mix 30. All patients were subjected to 4-day retrospective continuous glucose monitoring (CGM) during the last 4 days in this study. The primary outcome was the incidences of hypoglycemia monitored by CGM at the end point.
A total of 102 patients met the inclusion criteria and completed the study. Our data revealed that 29 patients (28%) experienced hypoglycemia as detected by CGM at the end point. Binary logistic stepwise regression analysis showed that only gender significantly correlated with hypoglycemia (B = 1.17, p = 0.017). Importantly, male patients had a significantly higher incidence of hypoglycemia than female patients (male = 20/52, female = 9/50, p = 0.022), although male patients required significantly lower insulin doses to maintain glycemic control than female patient (p = 0.00).
Male patients with longstanding T2D had a higher incidence of hypoglycemia than female patients during intensive insulin therapy.
ClinicalTrials.gov identifier, ChiCTR-IPR-15007340.
探讨长期2型糖尿病（T2D）患者强化胰岛素治疗期间低血糖风险是否存在性别差异。这是一项单中心、开放标签的前瞻性试验的事后分析。
所有受试者均作为住院患者入院，在基线时进行标准餐试验，并接受为期7天的持续皮下胰岛素输注（CSII）治疗以实现血糖控制。然后患者按1:1随机分为两组，分别接受：（1）4天诺和锐30，随后2天优泌乐50；（2）4天优泌乐50，随后2天诺和锐30。在本研究的最后4天，所有患者均接受为期4天的回顾性动态血糖监测（CGM）。主要结局是终点时通过CGM监测的低血糖发生率。
共有102例患者符合纳入标准并完成研究。我们的数据显示，终点时CGM检测到29例患者（28%）发生低血糖。二元逻辑逐步回归分析表明，只有性别与低血糖显著相关（B = 1.17，p = 0.017）。重要的是，男性患者低血糖发生率显著高于女性患者（男性 = 20/52，女性 = 9/50，p = 0.022），尽管男性患者维持血糖控制所需的胰岛素剂量显著低于女性患者（p = 0.00）。
长期T2D男性患者在强化胰岛素治疗期间低血糖发生率高于女性患者。
ClinicalTrials.gov标识符，ChiCTR-IPR-15007340。
