TY -的盟Agarwal Payal盟——Mukerji Geetha盟——Desveaux劳拉盟——iver诺亚M AU - Bhattacharyya Onil AU - Hensel,詹妮弗·米非盟-肖,詹姆斯盟——Bouck Zachary AU -吞云吐雾,特盟——Onabajo耐克AU -库珀,玛德琳盟——Marani侯赛因盟,杰夫斯丽芬妮AU - Bhatia, R萨夏PY - 2019 DA - 2019/01/10 TI -移动应用对改善2型糖尿病患者的自我管理:多中心实用随机对照试验JO - JMIR Mhealth Uhealth SP - e10321 VL - 7is - 1kw -移动应用程序KW - 2型糖尿病KW -自我管理KW -血糖自我监测KW -随机对照试验KW -实用临床试验AB -由于2型糖尿病的日益流行给卫生系统带来了适当管理这些患者的压力，因此设计用于改善糖尿病自我管理的移动应用程序越来越多。其中一款名为蓝星(BlueStar)的应用程序在小型研究中被证明可以显著降低血红蛋白A1c (HbA1c)水平，是美国第一个获得食品和药物管理局(Food and Drug Administration)批准的移动处方疗法应用程序。然而，该应用程序在不同临床站点和卫生系统中对现实世界人口的影响尚不清楚。目的:本研究的主要目的是对蓝星移动应用程序进行一项实用的随机对照试验，以确定应用程序的使用是否会改善现实临床环境中不同参与者的HbA1c水平。我们假设与对照组相比，这个移动应用程序可以改善自我管理和HbA1c水平。方法:采用多中心实用随机对照试验。总体而言，随机分配到立即治疗组(ITG)的110名参与者接受了为期6个月的干预，随机分配到等候名单对照组(WLC)的113名参与者接受了前3个月的常规护理，然后接受了3个月的干预。主要终点是3个月时通过HbA1c水平测量的血糖控制。 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 HbA1c levels did not show evidence of intervention impact on HbA1c 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 HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants’ 3-month HbA1c 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 HbA1c 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. Trial Registration: Clinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343) SN - 2291-5222 UR - https://mhealth.www.mybigtv.com/2019/1/e10321/ UR - https://doi.org/10.2196/10321 UR - http://www.ncbi.nlm.nih.gov/pubmed/30632972 DO - 10.2196/10321 ID - info:doi/10.2196/10321 ER -