Kato Sawako, Ando Masahiko, Kondo Takaaki, Yoshida Yasuko, Honda Hiroyuki, Maruyama Shoichi
Department of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.
Nagoya J Med Sci. 2018 May;80(2):175-182. doi: 10.18999/nagjms.80.2.175.
Modification of lifestyle habits, including diet and physical activity, is essential for the prevention and control of type 2 diabetes mellitus (T2DM) in elderly patients. However, individualized treatment is more critical for the elderly than for general patients. This study aimed to determine lifestyle interventions that resulted in lowering hemoglobin A (HbA) in Japanese pre- and early diabetic elderly subjects. The BEST-LIFE trial is an ongoing, open-label, 6-month, randomized (1:1) parallel group trial. Subjects with HbA of ≥5.6%-randomly assigned to the intervention or control group -use wearable monitoring devices loaded with Internet of things (IoT) systems that aids them with self-management and obtaining monthly remote health guidance from a public health nurse. The primary outcome is changes in HbA after a 6-month intervention relative to the baseline values. The secondary outcome is the change of behavior modification stages. The background, rationale, and study design of this trial are also presented. One hundred forty-five subjects have already been enrolled in this lifestyle intervention program, which will end in 2019. The BEST-LIFE trial will provide new evidence regarding the effectiveness and safety of our program on lowering HbA in elderly subjects with T2DM. It will also investigate whether information communication technology tools and monitoring devices loaded with IoT can support health care in elderly subjects. The trial registration number is UMIN-CTR: UMIN 000023356.
改变生活方式习惯，包括饮食和体育活动，对于老年2型糖尿病（T2DM）患者的预防和控制至关重要。然而，个体化治疗对老年人比对普通患者更为关键。本研究旨在确定能使日本糖尿病前期和早期老年受试者血红蛋白A（HbA）降低的生活方式干预措施。BEST-LIFE试验是一项正在进行的、开放标签、为期6个月的随机（1:1）平行组试验。HbA≥5.6%的受试者——随机分配至干预组或对照组——使用装有物联网（IoT）系统的可穿戴监测设备，该设备可帮助他们进行自我管理，并每月从公共卫生护士处获得远程健康指导。主要结局是6个月干预后HbA相对于基线值的变化。次要结局是行为改变阶段的变化。本文还介绍了该试验的背景、基本原理和研究设计。已有145名受试者参与了这个生活方式干预项目，该项目将于2019年结束。BEST-LIFE试验将为我们的项目降低老年T2DM患者HbA的有效性和安全性提供新证据。它还将研究装有物联网的信息通信技术工具和监测设备是否能为老年受试者的医疗保健提供支持。试验注册号为UMIN-CTR：UMIN 000023356。
