Department of Pediatric Endocrinology, Diabetes and Metabolism, Faculty of Medicine, University Medical Centre-University Children’s Hospital, University of Ljubljana, Ljubljana, Slovenia.
Diabetes Care. 2011 Apr;34(4):795-800. doi: 10.2337/dc10-1989. Epub 2011 Feb 19.
To assess the impact of continuous glucose monitoring on hypoglycemia in people with type 1 diabetes.
In this randomized, controlled, multicenter study, 120 children and adults on intensive therapy for type 1 diabetes and a screening level of glycated hemoglobin A(1c) (HbA(1c)) <7.5% were randomly assigned to a control group performing conventional home monitoring with a blood glucose meter and wearing a masked continuous glucose monitor every second week for five days or to a group with real-time continuous glucose monitoring. The primary outcome was the time spent in hypoglycemia (interstitial glucose concentration <63 mg/dL) over a period of 26 weeks. Analysis was by intention to treat for all randomized patients.
The time per day spent in hypoglycemia was significantly shorter in the continuous monitoring group than in the control group (mean ± SD 0.48 ± 0.57 and 0.97 ± 1.55 h/day, respectively; ratio of means 0.49; 95% CI 0.26-0.76; P = 0.03). HbA(1c) at 26 weeks was lower in the continuous monitoring group than in the control group (difference -0.27%; 95% CI -0.47 to -0.07; P = 0.008). Time spent in 70 to 180 mg/dL normoglycemia was significantly longer in the continuous glucose monitoring group compared with the control group (mean hours per day, 17.6 vs. 16.0, P = 0.009).
Continuous glucose monitoring was associated with reduced time spent in hypoglycemia and a concomitant decrease in HbA(1c) in children and adults with type 1 diabetes.
评估连续血糖监测对 1 型糖尿病患者低血糖的影响。
在这项随机、对照、多中心研究中，120 名接受强化治疗的 1 型糖尿病儿童和成人，糖化血红蛋白（HbA1c）筛查水平<7.5%，随机分为对照组和实时连续血糖监测组。对照组采用血糖仪进行常规家庭监测，每两周佩戴一个掩蔽式连续血糖监测仪 5 天；实时连续血糖监测组则佩戴实时连续血糖监测仪。主要结局为 26 周内低血糖（间质葡萄糖浓度<63mg/dL）的时间。所有随机患者均进行意向治疗分析。
连续监测组每天低血糖时间明显短于对照组（平均±标准差分别为 0.48±0.57 和 0.97±1.55h/天；均值比为 0.49；95%可信区间为 0.26-0.76；P=0.03）。26 周时，连续监测组的 HbA1c 低于对照组（差值-0.27%；95%可信区间为-0.47 至-0.07；P=0.008）。连续血糖监测组的 70-180mg/dL 正常血糖时间明显长于对照组（平均每天小时数，17.6 比 16.0，P=0.009）。
连续血糖监测可减少 1 型糖尿病儿童和成人的低血糖时间，并使 HbA1c 相应降低。
