Tamborlane William V, Beck Roy W, Bode Bruce W, Buckingham Bruce, Chase H Peter, Clemons Robert, Fiallo-Scharer Rosanna, Fox Larry A, Gilliam Lisa K, Hirsch Irl B, Huang Elbert S, Kollman Craig, Kowalski Aaron J, Laffel Lori, Lawrence Jean M, Lee Joyce, Mauras Nelly, O'Grady Michael, Ruedy Katrina J, Tansey Michael, Tsalikian Eva, Weinzimer Stuart, Wilson Darrell M, Wolpert Howard, Wysocki Tim, Xing Dongyuan
N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined.
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.
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.
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.)
连续血糖监测在1型糖尿病管理中的价值尚未确定。
在一项多中心临床试验中，我们将322名已接受1型糖尿病强化治疗的成人和儿童随机分为连续血糖监测组或使用血糖仪进行家庭监测的对照组。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%。主要结局是26周时糖化血红蛋白水平的变化。
两个研究组糖化血红蛋白水平的变化根据年龄组有显著差异（P = 0.003），25岁及以上患者中存在显著差异，连续监测组更具优势（变化的平均差异为-0.53%；95%置信区间[CI]，-0.71至-0.35；P < 0.001）。15至24岁患者组间差异不显著（平均差异为0.08；95% CI，-0.17至0.33；P = 0.52），8至14岁患者组间差异也不显著（平均差异为-0.13；95% CI，-0.38至0.11；P = 0.29）。在最年长和最年轻的患者中，连续监测组的次要糖化血红蛋白结局优于对照组，但15至24岁患者并非如此。25岁及以上患者中83%、15至24岁患者中30%、8至14岁患者中50%每周平均使用连续血糖监测6.0天或更多天。严重低血糖发生率较低，两个研究组之间无差异；然而，该试验的检验效能不足以检测出这种差异。
连续血糖监测可能与1型糖尿病成人患者血糖控制改善相关。需要进一步开展工作以确定儿童和青少年连续监测有效性的障碍。（ClinicalTrials.gov编号，NCT００４０６１３３。）
