Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial
Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial
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DOI：
10.2196/10321
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发表时间：
2019-01-10
影响因子：
5
通讯作者：
Bhatia, R. Sacha
中科院分区：
文献类型：
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作者：
Agarwal, Payal;Mukerji, Geetha;Bhatia, R. Sacha
背景资料：随着2型糖尿病患病率的增加，卫生系统面临着适当管理这些患者的压力，越来越多的移动的应用程序旨在改善糖尿病的自我管理。其中一款应用程序BlueStar在小型研究中被证明可以显著降低血红蛋白A（1c）（HbA（1c））水平，并且是美国第一款获得食品和药物管理局批准作为移动的处方治疗的应用程序。然而，在不同的临床站点和卫生systems.Objective：本研究的主要目的是进行一项务实的随机对照试验的蓝星移动的应用程序，以确定应用程序的使用是否会导致不同的参与者在现实生活中的临床环境中的HbA（1c）水平的改善。我们假设，这个移动的应用程序将提高自我管理和HbA（1c）水平相比，controls.Methods：该研究包括一个多中心的务实的随机对照试验。总体而言，随机分配到立即治疗组（ITG）的110名参与者接受了6个月的干预，随机分配到等待列表对照组（WLC）的113名参与者在前3个月接受常规护理，然后接受3个月的干预。主要结局是3个月时通过HbA（1c）水平测量的血糖控制。次要结果评估了干预对患者自我管理、护理经验和自我报告的健康利用的影响，使用经验证的量表，包括糖尿病问题领域、糖尿病自我护理活动总结和EuroQol-5D。结果：控制基线HbA（1c）水平的协方差分析结果未显示干预对3个月时HbA（1c）水平的影响（平均差异[ITG-WLC]-0.42，95%CI-1.05至0.21; P= 0.19）。同样，对测量糖尿病自我效能、生活质量和卫生保健利用行为的次要结局没有干预作用。一项针对57名ITG参与者的探索性分析调查了应用程序使用对HbA（1c）水平的影响，结果显示，应用程序使用每增加一天，参与者3个月的HbA（1c）水平就会下降0.016个点（95% CI -0.03至-0.003）。应用程序的使用情况因网站而异，因为来自1个网站的参与者在14周内登录应用程序的平均时间为36天（四分位数间距[IQR] 10.5-124）;在另一个网站使用该应用程序的人明显较少（中位数9; IQR 6-51）。结果显示，干预组和对照组之间通过HbA（1c）水平测量的血糖控制的主要临床结局无差异。虽然参与者对应用程序的使用率很低，但结果表明，上下文因素，特别是网站，对整体使用率产生了重大影响。需要进一步研究增加应用程序利用率的患者和特定地点因素。
Background: As the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A(1c) (HbA(1c)) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear.Objective: The primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA(1c) levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA(1c) levels compared with controls.Methods: The study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA(1c) levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app.Results: The results of an analysis of covariance controlling for baseline HbA(1c) levels did not show evidence of intervention impact on HbA(1c) levels at 3 months (mean difference [ITG-WLC] -0.42, 95% CI -1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA(1c) levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants' 3-month HbA(1c) levels (95% CI -0.03 to -0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51).Conclusions: The results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA(1c) levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed.