Lumen Biosensing has moved its needle-free continuous glucose monitor into final-stage accuracy trials, a milestone the company hopes will support a regulatory submission within the next year.
Unlike current CGM systems, which require a subcutaneous filament replaced every one to two weeks, Lumen’s device uses a wrist-worn optical sensor that measures glucose through interstitial fluid spectroscopy, with no skin penetration required.
Early-stage data presented earlier this year showed a mean absolute relative difference within range of existing filament-based CGMs, though the company has acknowledged accuracy during rapid glucose swings — such as immediately after a meal — remains an area of active refinement.
If successful, the trials would position Lumen’s sensor as a direct alternative for the large population of CGM users who cite skin irritation or sensor cost as barriers to continuous use.