Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial

Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial
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DOI:
10.2196/mhealth.9512
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发表时间:
2018-03-20
影响因子:
5
通讯作者:
Tarassenko, Lionel
Tarassenko, Lionel
中科院分区:
医学2区
文献类型:
--
作者:
Mackillop, Lucy;Hirst, Jane Elizabeth;Tarassenko, Lionel

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背景资料:妊娠期糖尿病(GDM)妇女的高血糖治疗与改善孕产妇和新生儿结局相关,需要加强临床投入。目前,这是通过每2 - 4周一次的医院门诊就诊来实现的,在这些就诊之间进行干预的机会有限。目的:我们进行了一项随机对照试验,以确定使用基于移动的手机的实时血糖管理系统远程管理GDM女性是否与通过门诊就诊的标准护理一样有效地控制血糖。在妊娠34周前口服葡萄糖耐量试验异常的妇女被单独随机分配到基于移动的手机的血糖管理解决方案(GDm-health,干预)或常规诊所护理。主要结果是平均血糖的变化,在每个组从招聘到交付,计算与调整血糖测量的数量,比例的餐前和餐后读数,基线特征,在study.Results的时间长度。98名干预组和85名对照组妇女的血糖数据可用。血糖变化率无显著差异(干预组为-0.16 mmol/L,对照组为-0.14 mmol/L,每28天,P= 0.78)。使用干预措施的妇女对护理的满意度更高(P= 0.049)。早产在干预组中不太常见(5/101,5.0% vs 13/102,12.7%; OR 0.36,95% CI 0.12-1.01)。与阴道分娩相比,干预组的剖宫产率更低(27/101,26.7% vs 47/102,46.1%,P= 0.005)。两组的其他血糖、母体和新生儿结局相似。从招募到分娩的中位时间相似(干预组:54天;对照组:49天; P= 0.23)。然而,干预组的血糖读数明显更多(干预组和对照组每天的平均血糖读数分别为3.80 [SD 1.80]和2.63 [SD 1.71]; P
Background: Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits.Objective: We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance.Methods: Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study.Results: A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (-0.16 mmol/L in the intervention and -0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean 2.63 [SD 1.71] readings per day in the intervention and control groups, respectively; P