72-LB: Clinical Evaluation of a Long-Term Optical Continuous Glucose Monitoring (CGM) System: Lumee Glucose

Profusa is developing a CGM System which tracks glucose concentrations in interstitial fluid for several months. It consists of a small hydrogel sensor (2.5 x 0.4 x 0.3 mm) that is permanently inserted by subcutaneous injection, and a wireless optical reader that is placed over the skin to measure the sensor's fluorescent signal, which changes proportionally with glucose. We evaluated the sensor signal response compared to reference capillary blood glucose (BG) taken from a commercial glucose meter in seven subjects with type 1 and type 2 diabetes. Each subject received two sensor injections in the upper arm during the first visit, followed by multiple 6-hour ambulatory monitoring visits over a three-month period. Of the 14 sensors injected, 13 tracked glucose excursions during every monitoring visit up to 88 days. Applying retrospective calibration analysis to 106 sensor traces showed that 84% of the sensor traces had strong correlation with BG reference values, defined by r2 > 0.5. Parkes Error Grid Analysis revealed that of the paired sensor-reference values, 88.9% fell in zone A, 10.9% in zone B, and 0.2% in zone C (Figure 1). The Lumee Glucose System demonstrates glucose tracking functionality for a minimum of 3 months in subjects with type 1 and type 2 diabetes. Additional studies are ongoing to establish prospective calibration algorithms and to assess measurement timepoints beyond three months.