Division of Endocrinology and Metabolism, Department of Internal Medicine, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, South Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
BMC Med Inform Decis Mak. 2020 Jul 10;20(1):156. doi: 10.1186/s12911-020-01179-x.
Despite the numerous healthcare smartphone applications for self-management of diabetes, patients often fail to use these applications consistently due to various limitations, including difficulty in inputting dietary information by text search and inconvenient and non-persistent self-glucose measurement by home glucometer. We plan to apply a digital integrated healthcare platform using an artificial intelligence (AI)-based dietary management solution and a continuous glucose monitoring system (CGMS) to overcome those limitations. Furthermore, medical staff will be performing monitoring and intervention to encourage continuous use of the program. The aim of this trial is to examine the efficacy of the program in patients with type 2 diabetes mellitus (T2DM) who have HbA1c 53-69 mmol/mol (7.0-8.5%) and body mass index (BMI) ≥ 23 mg/m.
This is a 48-week, open-label, randomized, multicenter trial consisting of patients with type 2 diabetes. The patients will be randomly assigned to three groups: control group A will receive routine diabetes care; experimental group B will use the digital integrated healthcare platform by themselves without feedback; and experimental group C will use the digital integrated healthcare platform with continuous glucose monitoring and feedback from medical staff. There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48. The primary end point is change in HbA1c from baseline to six months after the intervention.
This trial will verify the effectiveness of a digital integrated healthcare platform with an AI-driven dietary solution and a real-time CGMS in patients with T2DM.
Clinicaltrials.gov NCT04161170, registered on 08 November 2019. https://clinicaltrials.gov/ct2/show/NCT04161170?term=NCT04161170&draw=2&rank=1.
尽管有许多用于糖尿病自我管理的医疗保健智能手机应用程序，但由于各种限制，患者往往无法持续使用这些应用程序，包括通过文本搜索输入饮食信息的困难以及使用家用血糖仪进行不方便和非持续的自我血糖测量。我们计划应用一种基于人工智能 (AI) 的饮食管理解决方案和连续血糖监测系统 (CGMS) 的数字化综合医疗保健平台来克服这些限制。此外，医务人员将进行监测和干预，以鼓励患者持续使用该程序。本试验旨在研究该方案在糖化血红蛋白 53-69mmol/mol（7.0-8.5%）和体重指数（BMI）≥23mg/m 的 2 型糖尿病（T2DM）患者中的疗效。
这是一项为期 48 周、开放标签、随机、多中心试验，包括 2 型糖尿病患者。患者将被随机分为三组：对照组 A 将接受常规糖尿病护理；实验组 B 将自行使用数字化综合医疗保健平台，但没有反馈；实验组 C 将使用数字化综合医疗保健平台并接受医务人员的连续血糖监测和反馈。有五项随访措施：基线和干预后 12、24、36 和 48 周。主要终点是从基线到干预后六个月的糖化血红蛋白变化。
本试验将验证基于人工智能的饮食解决方案和实时 CGMS 的数字化综合医疗保健平台在 T2DM 患者中的有效性。
Clinicaltrials.gov NCT04161170，于 2019 年 11 月 8 日注册。https://clinicaltrials.gov/ct2/show/NCT04161170?term=NCT04161170&draw=2&rank=1。
