Division of Maternal-Fetal Medicine, Obstetrics, Gynecology and Reproductive Medicine, Mount Sinai West, Obstetrics, Gynecology and Reproductive Medicine, Mount Sinai West, and the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.
Obstet Gynecol. 2024 Nov 1;144(5):707-714. doi: 10.1097/AOG.0000000000005528. Epub 2024 Feb 8.
To assess whether universal use of every-other-day glucose monitoring in patients with gestational diabetes mellitus (GDM) resulted in similar birth weights and medication use and was preferred by the patient compared with traditional daily glucose monitoring.
This was a noninferiority randomized controlled trial conducted at a single New York City hospital between April 2021 and May 2022. Patients with singleton pregnancies who were diagnosed with GDM after 20 weeks of gestation and had a minimum of 7 days of previous daily blood glucose testing were randomly assigned to test blood glucose values daily or every other day. The primary outcome was neonatal birth weight. We calculated a total sample size of 196 participants needed for noninferiority to be tested, assuming the mean birth weight in the every-other-day group, compared with the daily group, was no higher than the predefined noninferiority margin of 200 g (80% power and one-sided alpha of 0.05). Postrandomization characteristics, including blood glucose values and medication initiation and timing, were recorded. Satisfaction with treatment group was assessed using the validated Oxford Maternity Diabetes Treatment Satisfaction Questionnaire.
A total of 197 patients were randomized: 98 in the daily group and 99 in the every-other-day group. Baseline characteristics were similar between groups. The mean neonatal birth weight was similar between groups (mean±SD 3,090±418 g among newborns in the daily group compared with 3,181±482 g among newborns in the every-other-day group). For the primary outcome, the every-other-day group was found to be noninferior to the daily group with an upper confidence limit for the mean difference in mean birth weight of 197 g, which was below the noninferiority margin of 200 g ( P =.046). Postrandomization, there were no significant differences in the number of patients who required medication, the gestational age at which medication was started, or the type of medication used. Average fasting and postprandial glucose values were similar between groups. There was an increase in adherence to treatment group in those randomized to every-other-day blood sugars, but no difference in patient satisfaction.
In patients with GDM, testing blood glucose values every other day was as effective as testing daily, without apparent effects on birth weight, medication initiation, or glucose control. Reduced frequency of blood glucose monitoring might help decrease the emotional, physical, and financial burden experienced by patients with GDM.
ClinicalTrials.gov , NCT04857073.
评估在患有妊娠期糖尿病(GDM)的患者中是否普遍使用隔天血糖监测与传统的每日血糖监测相比,是否在出生体重和药物使用方面具有相似的效果,以及患者是否更倾向于使用这种方法。
这是一项非劣效性随机对照试验,于 2021 年 4 月至 2022 年 5 月在纽约市的一家医院进行。入选单胎妊娠且在妊娠 20 周后被诊断为 GDM 且至少有 7 天的日常血糖检测史的患者,随机分为每日组或隔天组进行血糖值检测。主要结局为新生儿出生体重。我们假设隔天组的平均出生体重与每日组相比,不高于预先设定的非劣效性边界 200g(80%的效能和单侧 alpha 值为 0.05),计算得出需要 196 名参与者的总样本量来进行非劣效性检验。记录随机分组后的特征,包括血糖值和药物起始及时间。使用经过验证的牛津妊娠糖尿病治疗满意度问卷评估对治疗组的满意度。
共有 197 名患者被随机分配到每日组(98 名)和隔天组(99 名)。两组的基线特征相似。两组新生儿的平均出生体重相似(每日组新生儿的平均出生体重为 3090±418g,隔天组新生儿的平均出生体重为 3181±482g)。对于主要结局,隔天组与每日组相比被证明是非劣效的,平均出生体重的均值差值的上限置信区间为 197g,低于 200g 的非劣效性边界(P=0.046)。随机分组后,需要药物治疗的患者数量、开始药物治疗的孕龄或使用的药物类型均无显著差异。两组间的空腹和餐后血糖值相似。与每日组相比,随机分配到隔天组的患者对治疗组的依从性增加,但患者满意度没有差异。
在患有 GDM 的患者中,隔天检测血糖值与每日检测一样有效,且对出生体重、药物起始或血糖控制无明显影响。减少血糖监测的频率可能有助于减轻 GDM 患者的情绪、身体和经济负担。
ClinicalTrials.gov,NCT04857073。