OBJECTIVE To determine if temporal glucose profiles differed between 1) women who were randomized to real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG), 2) women who used insulin pumps or multiple daily insulin injections (MDIs), and 3) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT). RESEARCH DESIGN AND METHODS Standard summary metrics and functional data analysis (FDA) were applied to CGM data from the CONCEPTT trial (RT-CGM, n = 100; SMBG, n = 100) taken at baseline and at 24- and 34-weeks' gestation. Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups. RESULTS FDA revealed that women using RT-CGM had significantly lower glucose (0.4-0.8 mmol/L [7-14 mg/dL]) for 7 h/day (0800 h to 1200 h and 1600 h to 1900 h) compared with those with SMBG. Women using pumps had significantly higher glucose (0.4-0.9 mmol/L [7-16 mg/dL]) for 12 h/day (0300 h to 0600 h, 1300 h to 1800 h, and 2030 h to 0030 h) at 24 weeks with no difference at 34 weeks compared with MDI. Women who had an LGA infant ran a significantly higher glucose by 0.4-0.7 mmol/L (7-13 mg/dL) for 4.5 h/day at baseline, by 0.4-0.9 mmol/L (7-16 mg/dL) for 16 h/day at 24 weeks, and by 0.4-0.7 mmol/L (7-13 mg/dL) for 14 h/day at 34 weeks. CONCLUSIONS FDA of temporal glucose profiles gives important information about differences in glucose control and its timing, which are undetectable by standard summary metrics. Women using RT-CGM were able to achieve better daytime glucose control, reducing fetal exposure to maternal glucose.

中文翻译：

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妊娠期间连续血糖监测：分析时间特征以了解临床结果的重要性。

目的要确定时间葡萄糖谱在1）随机接受实时连续血糖监测（RT-CGM）或自我监测血糖（SMBG）的女性之间是否存在差异，2）使用胰岛素泵或每日多次注射胰岛素的女性（ MDIs），以及3）通过评估从妊娠1型糖尿病妇女的连续血糖监测（CONCEPTT）中获得的CGM数据，评估其婴儿的出生年龄是否大于胎龄（LGA）。研究设计与方法将标准摘要指标和功能数据分析（FDA）应用到CONCEPTT试验（RT-CGM，n = 100； SMBG，n = 100）的基线，第24周和第34周的CGM数据中妊娠。多变量回归分析确定了三组中各组之间在24小时血糖分布图上是否存在时间差异。结果FDA揭示，与那些女性相比，使用RT-CGM的女性在7 h /天（0800 h至1200 h和1600 h至1900 h）中的葡萄糖含量（0.4-0.8 mmol / L [7-14 mg / dL]）明显降低。与SMBG。使用抽水机的女性在24小时的12小时/天（0300小时至0600小时，1300小时至1800小时以及2030小时至0030小时）的葡萄糖水平（0.4-0.9 mmol / L [7-16 mg / dL]）显着升高与MDI相比，第34周没有差异。基线时4.5 h /天，有LGA婴儿的妇女的葡萄糖显着升高0.4-0.7 mmol / L（7-13 mg / dL），而基线时升高0.4-0.9 mmol / L（7-16 mg / dL）。在24周时每天16小时，在34周时以0.4-0.7 mmol / L（7-13 mg / dL）每天14小时。结论FDA的时态葡萄糖曲线提供了有关葡萄糖控制及其时间差异的重要信息，而这些信息是标准汇总指标无法检测到的。