Trevitt Sara, Simpson Sue, Wood Annette
NIHR Horizon Scanning Research & Intelligence Centre, University of Birmingham, Birmingham, UK
NIHR Horizon Scanning Research & Intelligence Centre, University of Birmingham, Birmingham, UK.
J Diabetes Sci Technol. 2016 May 3;10(3):714-23. doi: 10.1177/1932296815617968. Print 2016 May.
Closed-loop artificial pancreas device (APD) systems are externally worn medical devices that are being developed to enable people with type 1 diabetes to regulate their blood glucose levels in a more automated way. The innovative concept of this emerging technology is that hands-free, continuous, glycemic control can be achieved by using digital communication technology and advanced computer algorithms.
A horizon scanning review of this field was conducted using online sources of intelligence to identify systems in development. The systems were classified into subtypes according to their level of automation, the hormonal and glycemic control approaches used, and their research setting.
Eighteen closed-loop APD systems were identified. All were being tested in clinical trials prior to potential commercialization. Six were being studied in the home setting, 5 in outpatient settings, and 7 in inpatient settings. It is estimated that 2 systems may become commercially available in the EU by the end of 2016, 1 during 2017, and 2 more in 2018.
There are around 18 closed-loop APD systems progressing through early stages of clinical development. Only a few of these are currently in phase 3 trials and in settings that replicate real life.
闭环人工胰腺装置(APD)系统是一种正在研发的体外佩戴式医疗设备,旨在使1型糖尿病患者能够以更自动化的方式调节血糖水平。这项新兴技术的创新理念是,通过使用数字通信技术和先进的计算机算法,可以实现免提、连续的血糖控制。
利用在线情报来源对该领域进行了前瞻性扫描综述,以识别正在研发的系统。根据系统的自动化程度、所采用的激素和血糖控制方法以及研究环境,将这些系统分为不同的亚型。
共识别出18个闭环APD系统。所有系统在潜在商业化之前均在进行临床试验。其中6个在家庭环境中进行研究,5个在门诊环境中进行研究,7个在住院环境中进行研究。据估计,到2016年底,欧盟可能有2个系统上市,2017年有1个,2018年还有2个。
约有18个闭环APD系统正处于临床开发的早期阶段。目前只有少数几个处于3期试验阶段,且试验环境模拟了现实生活。