1型糖尿病患儿的持续皮下葡萄糖监测：一项单盲、随机、对照试验。

Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial.

作者信息

Lagarde William H, Barrows Frank P, Davenport Marsha L, Kang Minsun, Guess Harry A, Calikoglu Ali S

机构信息

Department of Pediatrics, The University of North Carolina at Chapel Hill, NC 27599-7039, USA.

出版信息

Pediatr Diabetes. 2006 Jun;7(3):159-64. doi: 10.1111/j.1399-543X.2006.00162.x.

DOI:10.1111/j.1399-543X.2006.00162.x

PMID:16787523

Abstract

BACKGROUND

Tight glycemic control delays the long-term complications of type 1 diabetes mellitus (T1DM) but increases the risk for hypoglycemia. The continuous glucose-monitoring system (CGMS) provides blood glucose (BG) readings every 5 min, and its accuracy and reliability has been established in adults. However, there are limited data on its efficacy and safety in children. The purpose of this study was to determine if CGMS use improves metabolic control in children with T1DM.

METHODS

Twenty-seven children (12 male) with T1DM participated in this single-blind, randomized, controlled trial. Participants (age: 11.4 +/- 3.7 (mean +/- SD) yr, range: 7-17 yr) were randomized to an intervention group (n = 18) or a control group (n = 9). Both groups wore the CGMS for 72-h periods at 0, 2, and 4 months. Adjustments in therapy for the intervention group were based on both CGMS and self-monitoring of BG (SMBG) data, while only SMBG data were used for the control group. Hemoglobin A1c (HbA1c) was determined at 0, 2, 4, and 6 months. The change in HbA1c from 0 to 6 months (HbA1c(Delta1-4)) and mean daily area under the CGMS curve for glucose <70 mg/dL area under the curve (AUC(<70)) were compared between groups.

RESULTS

At study entry, HbA1c levels were similar in the intervention and control groups (8.4 +/- 0.98 and 8.8 +/- 0.86%, respectively; p = 0.12) but were significantly lower in the intervention group compared with the control group at study completion (7.8 +/- 0.88 and 8.6 +/- 0.95%, respectively; p = 0.02). The decrease in HbA1c of 0.61 +/- 0.68% in the intervention group was statistically significant (p = 0.03), whereas the decrease in HbA1c of 0.28 +/- 0.78% in the control group was not. Nonetheless, the differences in HbA1c(Delta1-4) between groups did not reach statistical significance (p = 0.13). There was no statistically significant difference in AUC(<70) between study groups (p = 0.18).

CONCLUSION

CGMS use may improve metabolic control in children with T1DM without increasing the risk for hypoglycemia.

摘要

背景

严格的血糖控制可延缓1型糖尿病（T1DM）的长期并发症，但会增加低血糖风险。连续血糖监测系统（CGMS）每5分钟提供一次血糖（BG）读数，其准确性和可靠性已在成人中得到证实。然而，关于其在儿童中的有效性和安全性的数据有限。本研究的目的是确定使用CGMS是否能改善T1DM儿童的代谢控制。

方法

27名T1DM儿童（12名男性）参与了这项单盲、随机、对照试验。参与者（年龄：11.4±3.7（平均±标准差）岁，范围：7 - 17岁）被随机分为干预组（n = 18）或对照组（n = 9）。两组在0、2和4个月时均佩戴CGMS 72小时。干预组的治疗调整基于CGMS和自我血糖监测（SMBG）数据，而对照组仅使用SMBG数据。在0、2、4和6个月时测定糖化血红蛋白（HbA1c）。比较两组从0到6个月HbA1c的变化（HbA1c(Delta1 - 4)）以及CGMS曲线下血糖<70 mg/dL的平均每日曲线下面积（AUC(<70)）。

结果

在研究开始时，干预组和对照组的HbA1c水平相似（分别为8.4±0.98%和8.8±0.86%；p = 0.12），但在研究结束时，干预组的HbA1c水平显著低于对照组（分别为7.8±0.88%和8.6±0.95%；p = 0.02）。干预组HbA1c下降0.61±0.68%具有统计学意义（p = 0.03），而对照组HbA1c下降0.28±0.78%则无统计学意义。尽管如此，两组之间HbA1c(Delta1 - 4)的差异未达到统计学意义（p = 0.13）。研究组之间的AUC(<70)无统计学差异（p = 0.18）。