How to Demonstrate the Glucose Specificity of a Non-Invasive CGM: A Case Study of the SKAMo-2 Clinical Trial and Neoglyâ¢
Abstract
Abstract Background: Every non-invasive continuous glucose monitoring (NI-CGM) technology introduced into the landscape faces the same skeptical question, from regulators, clinicians, and competing developers alike: is the candidate signal actually specific to glucose, or does an apparently reasonable accuracy figure simply reflect a model fitting to motion, temperature, calibration offset, or trial-duration artifact? Existing evaluation practice does not answer this question directly. NI-CGM performance is instead reported almost exclusively with metrics inherited from minimally invasive, subcutaneous CGM, the Mean Absolute Relative Difference (MARD), Clarke/Parkes error grids, and ISO 15197-style agreement rates, which were designed for sensors whose glucose specificity is already chemically established and which therefore take specificity as a premise rather than treating it as a result to be demonstrated. Methods: We present a methodology for demonstrating NI-CGM technology glucose specificity during the algorithm-development phase, and illustrate it with a case study based on a quantum-cascade-laser (QCL) photoacoustic NI-CGM device (Neogly) evaluated in the SKAMo-2 free-living clinical trial (eight participants with type 1 diabetes). The methodology combines a white-noise control, a constant-glycemia control, a sensor-ablation control that removes the candidate physical signal while retaining auxiliary covariates, and explicit reporting of the train/test generalization…
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