RT Journal Article
SR Electronic
T1 Remote biomonitoring of temperatures in mothers and newborns: design, development and testing of a wearable sensor device in a tertiary-care hospital in southern India
JF BMJ Innovations
JO BMJ Innov
FD All India Institute of Medical Sciences
SP 60
OP 67
DO 10.1136/bmjinnov-2016-000153
VO 4
IS 2
A1 Prem K Mony
A1 Prashanth Thankachan
A1 Swarnarekha Bhat
A1 Suman Rao
A1 Maryann Washington
A1 Sumi Antony
A1 Annamma Thomas
A1 Sheela C Nagarajarao
A1 Hiteshwar Rao
A1 Bharadwaj Amrutur
YR 2018
UL http://innovations.bmj.com/content/4/2/60.abstract
AB 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.