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基于智能手机的日常反馈系统对妊娠期糖尿病女性的依从性、血糖控制、满意度和妊娠结局的影响:一项随机对照试验。

The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Israel; Department of Pediatric Endocrinology and Diabetes Unit, Edith Wolfson Medical Center, Holon, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Am J Obstet Gynecol. 2018 Apr;218(4):453.e1-453.e7. doi: 10.1016/j.ajog.2018.01.044. Epub 2018 Feb 7.

DOI:10.1016/j.ajog.2018.01.044
PMID:29425836
Abstract

BACKGROUND

Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients.

OBJECTIVE

We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction.

STUDY DESIGN

This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements.

RESULTS

A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P < .001); lower mean blood glucose (105.1 ± 8.6 mg/dL vs 112.6 ± 7.4 mg/dL, P < .001); lower rates of off-target measurements both fasting (4.7 ± 0.4% vs 8.4 ± 0.6%, P < .001) and 1-hour postprandial (7.7 ± 0.8% vs 14.3 ± 0.8%, P < .001); and a lower rate of pregnancies requiring insulin treatment (13.3% vs 30.0%, P = .044). The rates of macrosomia, neonatal hypoglycemia, shoulder dystocia, and other delivery and neonatal complications did not differ between the groups. Patients in the smartphone group reported excellent satisfaction from the use of the application and from their overall prenatal care.

CONCLUSION

Introduction of a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and glycemic control, and lowered the rate of insulin treatment.

摘要

背景

患者依从性和严格的血糖控制已被证明可以改善妊娠合并糖尿病患者的结局。在医学的各个领域,使用先进的技术工具,包括基于智能手机的平台,来改善医疗保健和结果已经得到了证明,但只有少数几项针对妊娠糖尿病患者的小型研究。

目的

我们旨在研究引入基于智能手机的日常反馈和医患沟通平台对患者依从性、血糖控制、妊娠结局和患者满意度的影响。

研究设计

这是一项前瞻性、单中心、随机对照试验。新诊断的妊娠糖尿病患者在我们的多学科妊娠糖尿病诊所就诊,被随机分为:(1)常规每两周一次的产前诊所护理(对照组);或(2)通过安装在他们智能手机上的应用程序,由诊所团队每天提供关于他们依从性和血糖控制的详细反馈(智能手机组)。主要结局是患者依从性,定义为实际血糖测量数/医嘱测量数×100。次要结局包括糖尿病控制参数、妊娠和新生儿结局。根据初步阶段的研究,该研究有足够的能力检测到患者依从性提高 20%的差异,该阶段研究表明,基线时的葡萄糖测量依从性为 70%。

结果

共分析了 120 例新诊断的妊娠糖尿病患者。两组在年龄、产次、教育程度、体重指数、家族史、母体合并症、口服葡萄糖耐量试验值和随机分组时的糖化血红蛋白水平方面无差异。智能手机组的依从性更高(84±0.16% vs 66±0.28%,P<.001);平均血糖水平更低(105.1±8.6mg/dL vs 112.6±7.4mg/dL,P<.001);空腹(4.7±0.4% vs 8.4±0.6%,P<.001)和餐后 1 小时(7.7±0.8% vs 14.3±0.8%,P<.001)时靶标测量值不达标的发生率更低;需要胰岛素治疗的妊娠比例也更低(13.3% vs 30.0%,P=.044)。两组的巨大儿、新生儿低血糖、肩难产以及其他分娩和新生儿并发症发生率无差异。智能手机组的患者对应用程序的使用和整体产前护理非常满意。

结论

在妊娠糖尿病患者和多学科妊娠糖尿病诊所团队之间引入基于智能手机的日常反馈和沟通平台,提高了患者的依从性和血糖控制水平,并降低了胰岛素治疗的发生率。

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