妊娠期糖尿病与血糖监测频率：一项随机对照试验
Gestational Diabetes Mellitus and Frequency of Blood Glucose Monitoring: A Randomized Controlled Trial.
作者信息
Mendez-Figueroa Hector, Schuster Meike, Maggio Lindsay, Pedroza Claudia, Chauhan Suneet P, Paglia Michael J
机构信息
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and the University of Texas Health Science Center at Houston-McGovern Medical School, Houston, Texas; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Geisinger Medical Center, Danville, Pennsylvania; and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Morsani College of Medicine, University of South Florida, Tampa, Florida.
出版信息
Obstet Gynecol. 2017 Jul;130(1):163-170. doi: 10.1097/AOG.0000000000002101.
OBJECTIVE
To assess whether testing blood glucose four times daily compared with four times every other day would lead to similar birth weights among patients with gestational diabetes mellitus (GDM).
METHODS
This noninferiority randomized controlled trial was conducted at five centers. After receiving a diagnosis of GDM, women tested their blood glucose every day for 7 days. After that period, compliant women without hyperglycemia requiring treatment were randomized to either blood glucose testing four times a day or every other day. Noninferiority would be declared if the mean birth weight in the every-other-day group was no higher than 165 g (5% difference assuming an average birth weight of 3,296 g) compared with the four times a day group. A total sample size of 286 women allowed noninferiority to be tested (one-sided .05 level of significance).
RESULTS
From May 2013 to May 2016, of the 293 women with GDM who were randomized, 149 (51%) were tested four times a day and 144 (49%) were tested every other day. Between the two groups, there were no significant differences with regard to need for medical treatment, induction, gestational age at delivery, mode of delivery, rate of preeclampsia, or shoulder dystocia. Birth weight was similar between both groups and the upper bound of the 90% confidence interval (CI) was less than 165 g, establishing noninferiority with a mean difference of -41 g (90% CI -137 to 54 g). Rate of compliance with blood glucose testing was higher in the every-other-day group (89% compared with 92%, P<.01). The differences in rates of macrosomia and birth weight greater than the 95th percentile were not clinically significant. Neonatal outcomes including neonatal hypoglycemia were similar.
CONCLUSION
Among patients with well-controlled GDM, testing blood glucose values every other day did not increase birth weight, although it did increase compliance with testing when compared with women who tested every day.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT01818557.
目的
评估与每隔一天测四次血糖相比，每天测四次血糖是否会使妊娠期糖尿病（GDM）患者的出生体重相似。
方法
这项非劣效性随机对照试验在五个中心进行。确诊为GDM后，女性连续7天每天测血糖。在此期间后，无高血糖且无需治疗的依从性好的女性被随机分为每天测四次血糖组或每隔一天测四次血糖组。如果与每天测四次血糖组相比，每隔一天测一次血糖组的平均出生体重不高于165克（假设平均出生体重为3296克时差异为5%），则判定为非劣效。286名女性的总样本量允许进行非劣效性检验（单侧显著性水平为0.05）。
结果
2013年5月至2016年5月，293名随机分组的GDM女性中，149名（51%）每天测四次血糖, 144名（49%）每隔一天测四次血糖。两组之间，在医疗需求、引产、分娩孕周、分娩方式、子痫前期发生率或肩难产方面无显著差异。两组出生体重相似，90%置信区间（CI）的上限小于165克，平均差异为-41克（90%CI -137至54克），确定为非劣效。每隔一天测血糖组的血糖检测依从率更高（89%比92%，P<0.01）。巨大儿发生率和出生体重高于第95百分位数的差异无临床意义。包括新生儿低血糖在内的新生儿结局相似。
结论
在血糖控制良好的GDM患者中，与每天测血糖的女性相比，每隔一天测血糖虽能提高检测依从性，但不会增加出生体重。
临床试验注册
ClinicalTrials.gov，NCT01818557
Zotero 插件