Continuous glucose monitoring and intensive treatment of type 1 diabetes
Continuous glucose monitoring and intensive treatment of type 1 diabetes
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DOI：
10.1056/nejmoa0805017
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发表时间：
2008-10-02
影响因子：
158.5
通讯作者：
Xing, Dongyuan
中科院分区：
文献类型：
--
作者：
Tamborlane, William V.;Beck, Roy W.;Xing, Dongyuan
背景动态血糖监测在1型糖尿病管理中的价值尚未确定。方法在一项多中心临床试验中，我们将322名已经接受1型糖尿病强化治疗的成人和儿童随机分配到一组进行动态血糖监测或对照组使用血糖仪进行家庭监测。所有患者根据年龄分为三组，糖化血红蛋白水平为7.0%至10.0%。主要观察指标为26周时糖化血红蛋白水平的变化。结果两个研究组糖化血红蛋白水平的变化在不同年龄组之间有显著差异（P = 0.003），25岁或以上患者之间存在显著差异，有利于连续监测组（变化的平均差异，-0.53%; 95%置信区间[ CI]，-0.71至-0.35; P< 0.001）。在15至24岁的受试者（平均差异，0.08; 95% CI，-0.17至0.33; P = 0.52）或8至14岁的受试者（平均差异，-0.13; 95% CI，-0.38至0.11; P = 0.29）中，组间差异不显著。在年龄最大和最小的患者中，连续监测组的次要糖化血红蛋白结局优于对照组，但在15至24岁的患者中并非如此。83%的25岁或以上患者、30%的15 - 24岁患者和50%的8 - 14岁患者平均每周使用6.0天或以上的动态血糖监测。严重低血糖的发生率很低，两个研究组之间没有差异;然而，该试验没有动力检测到这样的差异。结论：在1型糖尿病成人患者中，连续血糖监测可以改善血糖控制。需要进一步开展工作，以确定对儿童和青少年进行有效持续监测的障碍。（临床试验。政府编号，NCT 00406133）。
Background The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined.Methods In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks.Results The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group ( P = 0.003), with a significant difference among patients 25 years of age or older that favored the continuous- monitoring group ( mean difference in change, - 0.53%; 95% confidence interval [ CI], - 0.71 to - 0.35; P< 0.001). The between- group difference was not significant among those who were 15 to 24 years of age ( mean difference, 0.08; 95% CI, - 0.17 to 0.33; P = 0.52) or among those who were 8 to 14 years of age ( mean difference, - 0.13; 95% CI, - 0.38 to 0.11; P = 0.29). Secondary glycated hemoglobin outcomes were better in the continuous- monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference.Conclusions Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. ( ClinicalTrials. gov number, NCT00406133.).