Introduction and Objective: A novel fully autonomous microneedle array sensor providing semi-quantitative real-time glucose ranges expressed as three colors (Fig 1), activity and sleep data (Biolinq Incorporated, San Diego, CA) was developed to improve adherence in users with low numeracy burdened by CGM for safety and accuracy.Methods: A trial was conducted at 6 US sites in subjects with DM ages 22-82. The trial consisted of a 5-day wear period with two,10-hr clinic days where glucose was manipulated. The sensor used a calibration-free, prospective algorithm to compare to the YSI 2300, SMBG, CGM, and Fitbit.Results: 190 T1 and T2 DM subjects wore sensors on the forearm. Race/ethnicity matched the US Type 2 DM population, 87% were intensive insulin users, and 50% had obesity. Sensor lifetime was 85% with a median 5-min display rate of 98%. Mean and Median ARD vs YSI were 14.8% and 12.1%, respectively. MRD was -0.7% and within 20mg/dL/20% agreement was 75% vs YSI. More than 30% of sensors had <10% MARD. For glucose measurements 40-70 mg/dL, MARD was 11.1% and 88% of values were within 15 mg/dL of YSI. There was no meaningful performance difference across glucose levels, wear day, DM type, skin tone, BMI and age. Activity and sleep metrics strongly correlated with Fitbit and diary. Individual adverse events were <1%.Conclusion: This novel biosensor is safe and effective. The unique, user-friendly color-coded display could facilitate engagement and adherence in people not using insulin.
T. Bailey: Advisory Panel; Current; Abbott Diabetes. Research Support; Current; Abbott Diabetes, Biolinq, Dexcom, Inc., Senseonics, Medtronic. Consultant; Current; i-SENS, Inc., Sanofi, Roche Diabetes Care. Research Support; Current; Roche Diabetes Care, Eli Lilly and Company, vTv Therapeutics. F.E. Broyles: None. D.R. Liljenquist: None. B.W. Bode: None. M. Kipnes: None. J.Y. Stone: None. S.M. Marks: None. M.T. Saint: None. A. Cardeno: Employee; Current; Biolinq. Stock/Shareholder; Current; AtaCor Medical, Inc.
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