Safety of a continuous glucose monitoring device during hyperbaric exposure

Abstract

Hyperbaric oxygen therapy has been demonstrated to lower blood glucose levels in patients with diabetes. Continuous glucose monitoring (CGM) allows glucose monitoring in real time. Battery-operated CGM transmitters have yet to be formally tested and given safety approval for use in a hyperbaric environment. We evaluated and tested commercially available Dexcom® G6 CGM transmitters under hyperbaric conditions. Each transmitter contains a 3V, 130-mAh (0.39 Wh) lithium manganese dioxide battery (IEC CR1632) and circuit board that are fully encapsulated in epoxy. Each transmitter is pressurized to 90 pounds per square inch (psi) in an autoclave at 40°C for up to 72 hours during manufacturing to ensure that all enclosed air spaces are eliminated from the epoxy. We compared the CGM components against section 14.2.9.3.17.5 of the 2018 National Fire Protection Association 99 (NFPA 99) Health Care Facilities Code requirements. Six CGM transmitters attached to estimated glucose value generators (EGVGs) underwent 11 pressurization cycles to 45 feet of seawater (fsw). All transmitters were returned to the manufacturer to assess post-exposure structural integrity. G6 sensors, which contain no electrical components or compressible air spaces, do not pose a risk in the hyperbaric environment. There was no observed change in preset EGVG readings during hyperbaric exposures. Post-exposure testing revealed no structural compromise after repeated hyperbaric exposures. The CGM transmitter meets section 14.2.9.3.17.5 of the 2018 NFPA 99 requirements for battery-operated devices allowed for use in a hyperbaric environment. This analysis revealed no significant safety concerns with subjecting Dexcom G6 CGM transmitters to hyperbaric environments.