一项随机对照试验，旨在评估基于智能手机应用的生活方式指导方案对妊娠期糖尿病女性的体重增长、血糖控制以及母婴结局的影响：SMART-GDM 研究。
A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study.
机构信息
Department of Medicine, National University Hospital, Singapore
Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
出版信息
Diabetes Care. 2021 Feb;44(2):456-463. doi: 10.2337/dc20-1216. Epub 2020 Nov 12.
OBJECTIVE
SMART-GDM examined whether Habits-GDM, a smartphone application (app) coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control and maternal and neonatal outcomes in gestational diabetes mellitus (GDM).
RESEARCH DESIGN AND METHODS
In this randomized controlled trial, women diagnosed with GDM between 12 and 30 weeks were randomly assigned to usual care (control) or to additional support from Habits-GDM that integrated dietary, physical activity, weight, and glucose monitoring (intervention). The primary outcome was the proportion of participants with EGWG. Secondary outcomes included absolute gestational weight gain (GWG), glycemic control, and maternal, delivery, and neonatal outcomes.
RESULTS
In total, 340 women were randomized (170 intervention, 170 control; mean ± SD age 32.0 ± 4.2 years; mean BMI 25.6 ± 5.6 kg/m). There were no statistically significant differences in the proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes between experimental groups. Average glucose readings were lower in the intervention group (mean difference -0.15 mmol/L [95% CI -0.26; -0.03], = 0.011) as were the proportions of glucose above targets (premeal: 17.9% vs. 23.3%, odds ratio 0.68 [95% CI 0.53; 0.87], = 0.003; 2-h postmeal: 19.9% vs. 50%, 0.54 [0.42; 0.70], < 0.001). When regarded as a composite (although not prespecified), the overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, and perinatal death) were significantly lower in the intervention group (38.1% vs. 53.7%, 0.53 [0.34; 0.84], = 0.006).
CONCLUSIONS
When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (nonprespecified) but did not reduce EGWG among women with GDM.
目的
SMART-GDM 研究了智能手机应用程序（app）辅导项目“习惯-GDM”是否可以预防妊娠期体重过度增加（EGWG），并改善妊娠期糖尿病（GDM）患者的血糖控制以及母婴和新生儿结局。
研究设计和方法
在这项随机对照试验中，12 至 30 周期间被诊断为 GDM 的女性被随机分配至接受常规护理（对照组）或接受 Habits-GDM 的额外支持，该应用程序整合了饮食、身体活动、体重和血糖监测（干预组）。主要结局是 EGWG 参与者的比例。次要结局包括绝对妊娠期体重增加（GWG）、血糖控制以及母婴、分娩和新生儿结局。
结果
共有 340 名女性被随机分配（干预组 170 名，对照组 170 名；平均年龄±标准差为 32.0±4.2 岁；平均 BMI 为 25.6±5.6kg/m2）。实验组之间在 EGWG、绝对 GWG 或母婴和分娩结局的比例方面没有统计学差异。干预组的平均血糖读数较低（平均差值-0.15mmol/L[95%CI-0.26；-0.03]，=0.011），血糖高于目标的比例也较低（餐前：17.9% vs.23.3%，比值比 0.68[95%CI 0.53；0.87]，=0.003；餐后 2 小时：19.9% vs.50%，0.54[0.42；0.70]，<0.001）。当作为一个综合指标（尽管不是预先指定的）时，干预组的新生儿并发症（包括出生创伤、新生儿低血糖、高胆红素血症、呼吸窘迫、新生儿重症监护病房入院和围产期死亡）总体发生率显著较低（38.1% vs.53.7%，0.53[0.34；0.84]，=0.006）。
结论
与常规护理相比，Habits-GDM 可改善母婴血糖控制和复合新生儿结局（非指定），但不能减少 GDM 女性的 EGWG。
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