Evaluation of Data Processing Performance for Subcutaneous Glucose Monitoring with an Optical Investigational Device

Background and Aims: Lumee Glucose is a small soft glucose-sensitive hydrogel (5.0 x 0.75 x 0.65mm hydrated) currently in clinical development and intended for permanent subcutaneous placement by injection to continuously monitor glucose. The sensor is comprised of a hydrogel scaffold containing fluorescent molecules that produce near infrared light proportional to glucose concentration when interrogated by an optical skin reader placed over the hydrogel. The reader utilizes a set of LEDs to excite the fluorophores within the hydrogel and communicates wirelessly with a tablet. Machine learning and quality data processing algorithms are also being assessed to establish monitoring accuracy using MARD. Methods: Glucose monitoring including a carbohydrate-rich meal was conducted during 8-hour in-clinic visits in 28 subjects with insulin-treated diabetes (female, 48 yrs [20-82], BMI 26.2kg/m2 [19.7-40.3]) over a 3-month period. Frequent venous blood glucose measurements were obtained as reference (Super GL analyzer) . Sensor signals from a total of 188 monitoring traces and 3030 paired values were subjected to retrospective data processing with 3-point glucose reference calibration using machine learning and quality filters to remove potentially compromised optical signals. Results: The average MARD for all 3030 paired values during the 6 to 91-day monitoring period was 12.3%. The MARD was 11.8% when applying additional signal quality filters. Conclusions: Following injection, the hydrogel is suitable for long-term non-invasive glucose monitoring for a minimum period of three months. Projected performance parameters are within the range of currently available glucose monitoring devices. Quality signal processing algorithms revealed marginal performance improvements and should be further optimized with respect to compensating for signal perturbations resulting from motion, temperature, and ambient light changes. Disclosure J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker’s Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. K.Rebrin: Stock/Shareholder; Profusa, Inc. R.Siegl: None. A.K.Reinhard: None. J.Kopanz: None. A.Simic: None. M.Hartmann: None. S.J.Gamsey: None. S.Banerjee: None. U.Kamecke: Consultant; Profusa, Inc.