妊娠期糖尿病患者每日监测血糖与隔日监测血糖相比的新生儿出生体重:随机对照试验。

IF 8.3 2区 材料科学 Q1 MATERIALS SCIENCE, MULTIDISCIPLINARY
ACS Applied Materials & Interfaces Pub Date : 2024-11-01 Epub Date: 2024-02-08 DOI:10.1097/AOG.0000000000005528
Kristina Martimucci Feldman, Arielle Coughlin, Jasmin Feliciano, Guillaume Stoffels, Kelly Z Wang, Tirtza Spiegel Strauss, Olivia Grubman, Zainab Al-Ibraheemi, David Cole, Graham Ashmead, Farrah Hussain, Sophia Scarpelli Shchur, Deborah Lee, Lois Brustman
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引用次数: 0

摘要

目的评估妊娠期糖尿病(GDM)患者普遍使用隔日血糖监测与传统的每日血糖监测相比,是否会导致相似的出生体重和用药情况,以及患者是否更喜欢使用隔日血糖监测:这是一项非劣效性随机对照试验,于 2021 年 4 月至 2022 年 5 月在纽约市一家医院进行。单胎妊娠患者在妊娠 20 周后被诊断为 GDM,且之前至少进行过 7 天的每日血糖检测,这些患者被随机分配到每日或隔日检测血糖值。主要结果是新生儿出生体重。我们计算了测试非劣效性所需的总样本量为 196 人,假设每隔一天测试组的平均出生体重与每天测试组相比不高于预先设定的 200 克非劣效差值(80% 的功率和 0.05 的单侧α)。随机化后的特征,包括血糖值、用药开始和用药时间均有记录。使用经过验证的牛津孕产妇糖尿病治疗满意度问卷对治疗组进行满意度评估:共有 197 名患者接受了随机治疗:98 名患者为每日治疗组,99 名患者为隔日治疗组。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 3,090±418 克,隔日组新生儿的平均出生体重为 3,181±482 克)。就主要结果而言,隔日分娩组的结果不劣于每日分娩组,平均出生体重的平均差异置信上限为197克,低于200克的非劣效区间距(P=0.046)。随机分组后,需要用药的患者人数、开始用药的胎龄或用药类型均无显著差异。两组患者的空腹血糖和餐后血糖平均值相似。随机接受隔日血糖检测的患者对治疗组的依从性有所提高,但患者满意度没有差异:结论:对于 GDM 患者,隔天检测血糖值与每天检测血糖值一样有效,对出生体重、用药或血糖控制没有明显影响。降低血糖监测频率可能有助于减轻 GDM 患者的精神、身体和经济负担:临床试验注册:ClinicalTrials.gov,NCT04857073。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Neonatal Birth Weight With Daily Compared With Every-Other-Day Glucose Monitoring in Gestational Diabetes Mellitus: A Randomized Controlled Trial.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Clinical trial registration: ClinicalTrials.gov , NCT04857073.

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来源期刊
ACS Applied Materials & Interfaces
ACS Applied Materials & Interfaces 工程技术-材料科学:综合
CiteScore
16.00
自引率
6.30%
发文量
4978
审稿时长
1.8 months
期刊介绍: ACS Applied Materials & Interfaces is a leading interdisciplinary journal that brings together chemists, engineers, physicists, and biologists to explore the development and utilization of newly-discovered materials and interfacial processes for specific applications. Our journal has experienced remarkable growth since its establishment in 2009, both in terms of the number of articles published and the impact of the research showcased. We are proud to foster a truly global community, with the majority of published articles originating from outside the United States, reflecting the rapid growth of applied research worldwide.
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