The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System
By T. Bailey, B. Bode, Mark P. Christiansen, L. Klaff, S. Alva. Diabetes Technology & Therapeutics, 2015
670 citations recorded by the source corpus.
Introduction: The purpose of the study was to evaluate the performance and usability of the FreeStyle® Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) for interstitial glucose results compared with capillary blood glucose results. Materials and Methods: Seventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S. clinical sites. A sensor was inserted on the back of each upper arm for up to 14 days. Three factory-only calibrated sensor lots were used in the study. Sensor glucose measurements were compared with capillary blood glucose (BG) results (approximately eight per day) obtained using the BG meter built into the reader (BG reference) and with the YSI analyzer (Yellow Springs Instrument, Yellow Springs, OH) reference tests at three clinic visits (32 samples per visit). Sensor readings were masked to the participants. Results: The accuracy of the results was demonstrated against capillary BG reference values, with 86.7% of sensor results within Consensus Error Grid Zone A. The percentage of readings within Consensus Error Grid Zone A on Days 2, 7, and 14 was 88.4%, 89.2%, and 85.2%, respectively. The overall mean absolute relative difference was 11.4%. The mean lag time between sensor and YSI reference values was 4.5±4.8 min. Sensor accuracy was not affected by factors such as body mass index, age, type of diabetes, clinical site, insulin administration, or hemoglobin A1c. Conclusions: Interstitial glucose measurements with the FreeStyle Libre system were found to be accurate compared with capillary BG reference values, with accuracy remaining stable over 14 days of wear and unaffected by patient characteristics.
Subfields: Biophysics, Endocrinology, Diabetes and Metabolism
View Paper: https://www.semanticscholar.org/paper/e44234224318e4f61cd170ff7559030dcdc75601
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In Biophysics
In Endocrinology, Diabetes and Metabolism
Citations in the corpus
- Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities (2016, methodology): “One can expect that user acceptance will continue to improve as sensor lifetime increases and ease of sensor insertion improves.(3) Calibration Calibration using capillary blood glucose meters and reagent strips involves cost, discomfort, and inconvenience, increases the number of devices and comple”
- Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment (2017, background): “4% [42] 14-day lifetime, trend arrows, communication with a smart device To read glucose values the sensor needs to be scanned with the receiver or the smartphone, not FDA approved yet”
- Ten-hour time-restricted eating reduces weight, blood pressure, and atherogenic lipids in patients with metabolic syndrome (2019, methodology): “Continuous Glucose Monitors (CGMs)—We used the Abbott Freestyle Libre Pro CGM which has been validated for 14 days of continuous use with factory calibration (Bailey et al., 2015).”