Kim Gyuri, Bae Ji Cheol, Yi Byoung Kee, Hur Kyu Yeon, Chang Dong Kyung, Lee Moon-Kyu, Kim Jae Hyeon, Jin Sang-Man
Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 135-710, Republic of Korea.
Division of Endocrinology and Metabolism, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.
BMC Med Inform Decis Mak. 2017 Jul 18;17(1):109. doi: 10.1186/s12911-017-0507-4.
A Personal Health Record (PHR) is an online application that allows patients to access, manage, and share their health data. PHRs not only enhance shared decision making with healthcare providers, but also enable remote monitoring and at-home-collection of detailed data. The benefits of PHRs can be maximized in insulin dose adjustment for patients starting or intensifying insulin regimens, as frequent self-monitoring of glucose, self-adjustment of insulin dose, and precise at-home data collection during the visit-to-visit period are important for glycemic control. The aim of this study is to examine the efficacy and safety of insulin dose adjustment based on a smartphone PHR application in patients with diabetes mellitus (DM) and to confirm the validity and stability of an information and communication technology (ICT)-based centralized clinical trial monitoring system.
This is a 24-week, open-label, randomized, multi-center trial. There are three follow-up measures: baseline, post-intervention at week 12, and at week 24. Subjects diagnosed with type 1 DM, type 2 DM, and/or post-transplant DM who initiate basal insulin or intensify their insulin regimen to a basal-bolus regimen are included. After education on insulin dose titration and prevention for hypoglycemia and a 1-week acclimation period, subjects are randomized in a 1:1 ratio to either an ICT-based intervention group or a conventional intervention group. Subjects in the conventional intervention group will save and send their health information to the server via a PHR application, whereas those in ICT-based intervention group will receive additional algorithm-based feedback messages. The health information includes level of blood glucose, insulin dose, details on hypoglycemia, food diary, and step count. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of study enrollment, without severe hypoglycemia or unscheduled clinic visits.
This clinical trial will reveal whether insulin dose adjustment based on a smartphone PHR application can facilitate the optimization of insulin doses in patients with DM. In addition, the process evaluation will provide information about the validity and stability of the ICT-based centralized clinical trial monitoring system in this research field.
Clinicaltrials.gov NCT 03112343 . Registered on 12 April 2017.
个人健康记录（PHR）是一种在线应用程序，允许患者访问、管理和共享他们的健康数据。PHR不仅能加强与医疗服务提供者的共同决策，还能实现远程监测和在家收集详细数据。对于开始或强化胰岛素治疗方案的患者，在胰岛素剂量调整中可以最大限度地发挥PHR的益处，因为在每次就诊期间频繁的自我血糖监测、胰岛素剂量自我调整以及精确的在家数据收集对于血糖控制很重要。本研究的目的是检验基于智能手机PHR应用程序的胰岛素剂量调整在糖尿病（DM）患者中的疗效和安全性，并确认基于信息通信技术（ICT）的集中式临床试验监测系统的有效性和稳定性。
这是一项为期24周的开放标签、随机、多中心试验。有三项随访措施：基线、第12周干预后和第24周。纳入开始基础胰岛素治疗或强化胰岛素治疗方案至基础-餐时胰岛素治疗方案的1型糖尿病、2型糖尿病和/或移植后糖尿病患者。在接受胰岛素剂量滴定和低血糖预防教育以及1周适应期后，受试者按1:1比例随机分为基于ICT的干预组或传统干预组。传统干预组的受试者将通过PHR应用程序保存并将其健康信息发送到服务器，而基于ICT的干预组的受试者将收到额外的基于算法的反馈信息。健康信息包括血糖水平、胰岛素剂量、低血糖细节、饮食日记和步数。主要结局将是在研究入组12周内达到最佳胰岛素剂量且无严重低血糖或非计划门诊就诊的患者比例。
这项临床试验将揭示基于智能手机PHR应用程序的胰岛素剂量调整是否能促进糖尿病患者胰岛素剂量的优化。此外，过程评估将提供有关该研究领域基于ICT的集中式临床试验监测系统的有效性和稳定性的信息。
Clinicaltrials.gov NCT 03112343。于2017年4月12日注册。
