饮食调整的妊娠糖尿病中 4 点与 7 点自我监测血糖：马来西亚单一三级中心的随机临床试验。
4 vs 7 points self-monitoring blood glucose in gestational diabetes mellitus on diet modification: randomised clinical trial in a single tertiary centre in Malaysia.
机构信息
Department of Obstetrics and Gynaecology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Hospital Canselor Tuanku Muhriz, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, 56000, Kuala Lumpur, Malaysia.
Department of Obstetrics and Gynaecology, Hospital Canselor Tuanku Muhriz, Cheras, 56000, Kuala Lumpur, Malaysia.
出版信息
Arch Gynecol Obstet. 2024 Oct;310(4):1959-1965. doi: 10.1007/s00404-024-07661-5. Epub 2024 Aug 7.
PURPOSE
There is no standardized best method on monitoring of patients with gestational diabetes on diet modification in the country. This study aims to investigate the optimum method of self-monitoring blood glucose.
METHODS
This is a randomized clinical trial in a single tertiary centre involving patients with gestational diabetes mellitus (GDM) diagnosed based on NICE guideline on diet modification. The patients are randomized in 1:1 ratio to 4 or 7 points self-monitoring blood glucose. The monitoring was required to be done monthly with ultrasound for fetal growth. Blood was taken at recruitment for measurement of serum HbA and fructosamine.
RESULTS
A total of 200 patients were recruited. There were significantly more Malay patients in the 7 points group (88.9% vs 78.2%, p = 0.033). Multiparous patients were significantly more in the 4 points group (82.2% vs 68.7%, p = 0.033). Both groups were similar in clinical characteristics. There was no statistical difference in the neonatal outcome particularly fetal macrosomia and admission to neonatal intensive care unit.
CONCLUSIONS
In patients with GDM on diet modification, self-blood glucose monitoring using either 4 or 7 points resulted in similar maternal and perinatal outcomes. The research was registered under ClinicalTrials.gov (NCT04101396) on 17/9/2019 ( https://register.
CLINICALTRIALS
gov/prs/app/action/SelectProtocol?sid=S00098EN&selectaction=Edit&uid=U0004RD4&ts=2&cx=-qlk1w2 ).
目的
在我国，针对接受饮食调整的妊娠糖尿病患者，尚无监测的标准化最佳方法。本研究旨在探索自我血糖监测的最佳方法。
方法
这是一项在单一三级中心进行的随机临床试验，涉及基于 NICE 饮食调整指南诊断的妊娠糖尿病患者。患者以 1:1 的比例随机分为 4 点或 7 点自我血糖监测组。每月需进行监测，并进行超声检查以评估胎儿生长情况。招募时采集血液以测量血清 HbA 和果糖胺。
结果
共招募了 200 名患者。7 点组的马来裔患者明显更多（88.9%比 78.2%，p=0.033）。多产妇在 4 点组中明显更多（82.2%比 68.7%，p=0.033）。两组的临床特征相似。两组新生儿结局，特别是胎儿巨大儿和入住新生儿重症监护病房的比例，无统计学差异。
结论
在接受饮食调整的妊娠糖尿病患者中，使用 4 点或 7 点自我血糖监测的方法，其母婴和围产期结局相似。该研究于 2019 年 9 月 17 日在 ClinicalTrials.gov 注册（NCT04101396）（https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098EN&selectaction=Edit&uid=U0004RD4&ts=2&cx=-qlk1w2）。
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