Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population.
Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population.
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试验方案将基于智能手机的血糖管理系统与妊娠糖尿病人群中标准诊所护理的功效进行比较。
DOI：
10.1136/bmjopen-2015-009702
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发表时间：
2016-03-17
期刊：
影响因子：
2.9
通讯作者：
Hirst JE
中科院分区：
文献类型：
--
作者：
Mackillop LH;Bartlett K;Birks J;Farmer AJ;Gibson OJ;Kevat DA;Kenworthy Y;Levy JC;Loerup L;Tarassenko L;Velardo C;Hirst JE
妊娠期糖尿病（GDM）的患病率在英国正在上升。良好的贫血控制可改善孕产妇和新生儿结局。由于妊娠期生理变化迅速，其过程不可预测，因此需要医疗保健专业人员对GDM患者进行频繁的临床审查。与传统的面对面或基于电话的咨询相比，允许家庭血糖（BG）监测并将结果真实的传输给医疗保健专业人员的新技术有可能更方便地向女性提供高质量的医疗保健，并且对患者和医疗保健提供者来说成本更低。我们已经开发了一个综合的GDM健康管理系统，旨在测试使用该系统对孕产妇贫血控制，成本，患者满意度和孕产妇和新生儿的结果相比，在一个大型的公共资助（国民保健服务（NHS））产科单位的标准诊所护理的影响。在当前妊娠中确诊妊娠期糖尿病的妇女被单独随机分配到GDm卫生系统和一半的正常诊所就诊或正常诊所护理。主要结局是计算每组从招募到分娩的平均BG，并对BG测量次数、餐前和餐后读数比例以及研究时间长度进行调整，并进行组间比较。次要目的是比较两组对分配的血糖监测方案的依从性、孕产妇和新生儿结局、使用糖化血红蛋白（HbA 1c）和其他血糖指标进行的血糖控制以及使用问卷和资源使用评估的患者对护理的态度。两组的治疗、饮食建议和临床管理原则相同。研究结果将发表在一份同行评审的期刊上，并以电子和印刷形式传播。NCT 01916694;预结果。
The prevalence of gestational diabetes mellitus (GDM) is rising in the UK. Good glycaemic control improves maternal and neonatal outcomes. Frequent clinical review of patients with GDM by healthcare professionals is required owing to the rapidly changing physiology of pregnancy and its unpredictable course. Novel technologies that allow home blood glucose (BG) monitoring with results transmitted in real time to a healthcare professional have the potential to deliver good-quality healthcare to women more conveniently and at a lower cost to the patient and the healthcare provider compared to the conventional face-to-face or telephone-based consultation. We have developed an integrated GDm-health management system and aim to test the impact of using this system on maternal glycaemic control, costs, patient satisfaction and maternal and neonatal outcomes compared to standard clinic care in a single large publicly funded (National Health Service (NHS)) maternity unit. Women with confirmed gestational diabetes in a current pregnancy are individually randomised to either the GDm-health system and half the normal clinic visits or normal clinic care. Primary outcome is mean BG in each group from recruitment to delivery calculated, with adjustments made for number of BG measurements, proportion of preprandial and postprandial readings and length of time in study, and compared between the groups. The secondary objective will be to compare the two groups for compliance to the allocated BG monitoring regime, maternal and neonatal outcomes, glycaemic control using glycated haemoglobin (HbA1c) and other BG metrics, and patient attitudes to care assessed using a questionnaire and resource use. Thresholds for treatment, dietary advice and clinical management are the same in both groups. The results of the study will be published in a peer-reviewed journal and disseminated electronically and in print. NCT01916694; Pre-results.