Background/AimsInformation regarding the use of wearable devices in clinical research, including disease areas, intervention techniques, trends in device types, and sample size targets, remains elusive. Therefore, we conducted a comprehensive review of clinical research trends related to wristband wearable devices in research planning and examined their applications in clinical investigations.MethodsAs this study identified trends in the adoption of wearable devices during the planning phase of clinical research, including specific disease areas and targeted number of intervention cases, we searched ClinicalTrials.gov—a prominent platform for registering and disseminating clinical research. Since wrist-worn devices represent a large share of the market, we focused on wrist-worn devices and selected the most representative models among them. The main analysis focused on major wearable devices to facilitate data analysis and interpretation, but other wearables were also surveyed for reference. We searched ClinicalTrials.gov with the keywords “ActiGraph,”“Apple Watch,”“Empatica,”“Fitbit,”“Garmin,” and “wearable devices” to obtain studies published up to 21 August 2022. This initial search yielded 3214 studies. After excluding duplicate National Clinical Trial studies (the overlap was permissible among different device types except for wearable devices), our analysis focused on 2930 studies, including simple, time-series, and type-specific assessments of various variables.ResultsOverall, an increasing number of clinical studies have incorporated wearable devices since 2012. While ActiGraph and Fitbit initially dominated this landscape, the use of other devices has steadily increased, constituting approximately 10% of the total after 2015. Observational studies outnumbered intervention studies, with behavioral and device-based interventions being particularly prevalent. Regarding disease types, cancer and cardiovascular diseases accounted for approximately 20% of the total. Notably, 114 studies adopted multiple devices simultaneously within the context of their clinical investigations.ConclusionsOur findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3 years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention therapy utilizing apps is becoming more extensive, and we expect to see more examples that will lead to their approval as programmed medical devices in the future.

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评估可穿戴设备在临床研究中的使用现状

背景/目标有关在临床研究中使用可穿戴设备的信息，包括疾病领域、干预技术、设备类型趋势和样本量目标，仍然难以捉摸。因此，我们对研究规划中与腕带可穿戴设备相关的临床研究趋势进行了全面回顾，并考察了其在临床研究中的应用。方法本研究确定了临床研究规划阶段可穿戴设备采用的趋势，包括特定疾病领域和目标干预案例数量，我们搜索了 ClinicalTrials.gov——一个注册和传播临床研究的重要平台。由于腕戴式设备占据了很大的市场份额，因此我们重点关注腕戴式设备，并选择了其中最具代表性的型号。主要分析集中于主要可穿戴设备，以方便数据分析和解释，但也调查了其他可穿戴设备以供参考。我们使用关键字“ActiGraph”、“Apple Watch”、“Empatica”、“Fitbit”、“Garmin”和“可穿戴设备”搜索了 ClinicalTrials.gov，以获取截至 2022 年 8 月 21 日发表的研究。初步搜索产生了 3214 项研究。在排除重复的国家临床试验研究（除可穿戴设备外，不同设备类型之间允许重叠）后，我们的分析集中于 2930 项研究，包括对各种变量的简单、时间序列和特定类型的评估。结果总体而言，数量不断增加自 2012 年以来，已有大量临床研究纳入可穿戴设备。虽然 ActiGraph 和 Fitbit 最初在这一领域占据主导地位，但其他设备的使用量稳步增加，2015 年之后约占总数的 10%。观察性研究的数量超过了干预研究，其中基于行为和设备的研究干预措施尤为普遍。从疾病类型来看，癌症和心血管疾病约占总数的20%。值得注意的是，有 114 项研究在临床研究的背景下同时采用了多种设备。结论我们的研究结果表明，自 2012 年以来，可穿戴设备在各种疾病领域进行数据收集和行为干预的使用不断增加。研究数量的增加过去3年尤为显着，表明这一趋势未来还将继续加速。经过彻底验证、确认其准确性并遵守既定法律法规的设备及其评估方法可能会在评估中发挥关键作用，从而允许进行远程临床试验。此外，利用应用程序进行行为干预治疗正变得越来越广泛，我们期望看到更多的例子，从而使它们在未来被批准为编程医疗设备。