Eli Lilly and Company, Indianapolis, Indiana, USA.
Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
We set out to study the relationship between different measures of glycemic variability and the rate of hypoglycemia in patients with type 2 diabetes.
Data were pooled from three 24-week insulin trials including patients on twice-daily (BID) insulin lispro mix 75/25 (75% insulin lispro protamine suspension, 25% insulin lispro) (n=805), daily (QD) insulin glargine (n=1,019), insulin lispro protamine suspension (n=353) (QD or BID), and insulin detemir (n=166) (QD or BID), all with continuation of prestudy oral antihyperglycemic medications. Glycemic variability measures were derived from seven-point self-monitored blood glucose profiles.
At baseline, mean (±SD) age was 56.9±9.7 years, duration of type 2 diabetes was 9.5±6.1 years, hemoglobin A1c (HbA1c) was 8.9±1.1%, and 51.9% were male. Intra-day glucose coefficient of variation (CV), fasting blood glucose, intra-day minimum glucose and inter-day glucose CV at 24 weeks, and intra-day glucose CV at baseline were significantly correlated with the rate of hypoglycemia events between Weeks 12 to 24 (P<0.05 for all measures).
Intra-day and inter-day glycemic variability is significantly associated with the risk of hypoglycemia in insulin-treated patients with type 2 diabetes, even after adjusting for mean glucose and HbA1c. The intra-day glycemic variability before starting insulin is significantly associated with the risk of hypoglycemia during insulin treatment, which points at treatment- and patient-related factors mediating this relationship.
我们旨在研究不同血糖变异性测量指标与 2 型糖尿病患者低血糖发生率之间的关系。
该研究数据来自三项为期 24 周的胰岛素试验,共纳入 805 例接受每日两次(BID)胰岛素赖脯混和 75/25(75%胰岛素赖脯精蛋白悬液,25%胰岛素赖脯)治疗、1019 例接受甘精胰岛素治疗、353 例接受胰岛素赖脯精蛋白悬液(QD 或 BID)治疗和 166 例接受地特胰岛素(QD 或 BID)治疗的患者,所有患者均继续使用研究前的口服降糖药物。血糖变异性测量指标来源于七点自我监测血糖谱。
基线时,患者的平均(±SD)年龄为 56.9±9.7 岁,2 型糖尿病病程为 9.5±6.1 年,糖化血红蛋白(HbA1c)为 8.9±1.1%,51.9%为男性。24 周时,日内血糖变异系数(CV)、空腹血糖、日内最低血糖、日间血糖 CV 以及基线时日内血糖 CV 与 12 周至 24 周之间的低血糖事件发生率显著相关(所有指标 P<0.05)。
即使在调整平均血糖和 HbA1c 后,日内和日间血糖变异性与接受胰岛素治疗的 2 型糖尿病患者低血糖风险显著相关。开始胰岛素治疗前的日内血糖变异性与胰岛素治疗期间的低血糖风险显著相关,提示与治疗和患者相关的因素介导了这种关系。