66-LB: System Performance of an Integrated Blood Glucose Monitoring Device Developed to Reduce Common Barriers to Checking Glucose

Abstract

The POGO Automatic® Blood Glucose Monitoring System miniaturizes individual items required to perform a blood glucose test (lancet, lancing device, test strip, etc.) and integrates those components into a multi-test cartridge that pairs to a handheld device, addressing many perceived checking barriers. This device allows the user to place and hold a finger on the device while the blood sample is acquired and moved to the reagent pad automatically for quantitation. Performance testing was conducted on the device to assess accuracy, precision, and tolerance to hematocrit and interfering substances. Fingerstick capillary blood was collected from 285 untrained subjects with either type 1 or type 2 diabetes at two sites (age 21-95, mean 58.1; 50.2% female, 84.9% Caucasian) and run on a YSI 2300 analyzer while the subject used the system as designed to obtain a glucose result. When compared against the YSI reference result, 264/277 (95.3%) results were within ± 15 mg/dL or 15% of the reference reading, and 275/277 (99.3%) results were within ± 15 mg/dL or 20% of the reference reading. Precision testing was conducted by running 300 tests using venous blood at each of five glucose levels across the dynamic range, achieving CVs ranging from 2.3%-3.4%. Hematocrit tolerance was evaluated using venous whole blood manipulated into a matrix of seven hematocrit levels (20%-60%) ; each hematocrit was tested across the dynamic range. No mean bias versus YSI at any test condition exceeded 7.5%, and at least 95% of all tests at each condition were within 15% of the YSI reference value. Twenty-three substances, including acetaminophen, ascorbic acid, and maltose, were tested at both therapeutic and toxic concentrations to determine potential interference with measurement accuracy. For all substances tested, the entire 95% confidence interval for interferent bias was within ± 15%, and the average bias was within ± 10% of results from the control sample. Disclosure M. Tomasco: Employee; Intuity Medical, Inc. J. M. Davis: None. P. D. Reynolds: Employee; Intuity Medical, Inc. R. Escutia: Employee; Intuity Medical, Inc. J. N. Perry: Employee; Intuity Medical, Inc. T. O’donnell: Employee; Intuity Medical, Inc. R. P. Hesley: Employee; Intuity Medical, Inc.