Mony Prem K, Thankachan Prashanth, Bhat Swarnarekha, Rao Suman, Washington Maryann, Antony Sumi, Thomas Annamma, Nagarajarao Sheela C, Rao Hiteshwar, Amrutur Bharadwaj
Division of Epidemiology & Population Health, St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, Karnataka, India.
Department of Neonatology, St John's Medical College Hospital, St John's National Academy of Health Sciences, Bangalore, Karnataka, India.
BMJ Innov. 2018 Apr;4(2):60-67. doi: 10.1136/bmjinnov-2016-000153. Epub 2018 Feb 14.
Newer technologies such as wearables, sensors, mobile telephony and computing offer opportunities to monitor vital physiological parameters and tackle healthcare problems, thereby improving access and quality of care. We describe the design, development and testing of a wearable sensor device for remote biomonitoring of body temperatures in mothers and newborns in southern India.
Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of 'social innovation' design. The device underwent multiple iterations in product design and engineering based on user feedback, and then following preclinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care teaching hospital in Bangalore, India. Clinical trial phases I and IIa for evaluation of safety and efficacy were undertaken in the following sequence: 7 healthy adult volunteers; 18 healthy mothers; 3 healthy babies; 10 stable babies in the neonatal care intensive unit and 1 baby with morbidities. Time-stamped skin temperature readings obtained at 5 min intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice.
Devices were comfortably secured on to adults and neonates, and data were efficiently transmitted via the gateway device for secure storage and retrieval for analysis. The mean skin temperatures in mothers were lower than the axillary temperatures by 2°C; and in newborns, there was a precision of -0.5°C relative to axillary measurements. While occasional minimal adverse events were noted in healthy volunteers, no adverse events were noted in mothers or neonates.
This proof-of-concept study shows that this device is promising in terms of feasibility, safety and accuracy (with appropriate calibration) with potential for further refinements in device accuracy and pursuit of further phases of clinical research for improved maternal and neonatal health.
可穿戴设备、传感器、移动电话和计算等新技术为监测重要生理参数和解决医疗保健问题提供了机会，从而改善了医疗服务的可及性和质量。我们描述了一种用于印度南部母亲和新生儿体温远程生物监测的可穿戴传感器设备的设计、开发和测试。
根据客户需求和技术要求，采用“社会创新”设计原则设计并开发了一种可穿戴传感器设备。该设备根据用户反馈在产品设计和工程方面进行了多次迭代，然后在印度班加罗尔的一家三级护理教学医院进行了临床前测试、技术可行性研究和临床试验。按照以下顺序进行了评估安全性和有效性的临床试验I期和IIa期：7名健康成年志愿者；18名健康母亲；3名健康婴儿；新生儿重症监护病房的10名稳定婴儿和1名患病婴儿。将在1小时内每隔5分钟从固定在母亲上臂和新生儿腹部的设备上获得的带时间戳的皮肤温度读数与临床实践中常规使用的温度计读数进行比较。
设备舒适地固定在成人和新生儿身上，数据通过网关设备有效传输，以便安全存储和检索进行分析。母亲的平均皮肤温度比腋窝温度低2°C；在新生儿中，相对于腋窝测量的精度为-0.5°C。虽然在健康志愿者中偶尔注意到轻微的不良事件，但在母亲或新生儿中未发现不良事件。
这项概念验证研究表明，该设备在可行性、安全性和准确性（经过适当校准）方面很有前景，有可能进一步提高设备精度，并开展进一步阶段的临床研究以改善母婴健康。
