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Abstract
Objective 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.
Methods 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.
Results 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.
Conclusions 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.
- mother
- newborn
- remote monitoring
- vital signs
- wireless sensors
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Footnotes
Contributors PKM, PT and BA conceived and designed the testing programme. PKM, PT, SB, SR, MW, SA, AT, SCN, HR and BA designed the protocol. SB, SR, AT and SCN oversaw the implementation of the programme. MW and SA managed the day-to-day operations of the programme. HR provided technological support. PKM drafted the manuscript. All the authors edited and revised the draft and approved the final version. PKM and BA are the guarantors.
Funding This work was supported by an intramural research grant from the St John’s Medical College Research Society, Bangalore, India, and a development grant from the Robert Bosch Centre for Cyber Physical Systems, Indian Institute of Science, Bangalore, India.
Competing interests PKM, PT, SB, SR, MW, SA, AT and SCN are employed at an academic medical centre (St John’s National Academy of Health Sciences, Bangalore, India) that receives public sector research funding, as well as revenue through private-sector fee-for-service medical transactions. BA and HR are employed at a public-sector science research centre (Indian Institute of Science).
Patient consent Obtained.
Ethics approval Ethics approval for the study was obtained from the St John’s Institutional Ethics Review Board (IERB #59/2011 dated 15 March 2011 and #125/2014 dated 16 August 2014). The clinical trial was registered with the Clinical Trials Registry of India (CTRI/2015/05/005779).
Provenance and peer review Not commissioned; externally peer reviewed.