Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor
| Autor: | Bruce W. Bode, Mark P. Christiansen, Robert H. Slover, Ashley Sullivan, Suiying Huang, Ronald L. Brazg, Francine R. Kaufman, Scott W. Lee, John H. Shin, Timothy S. Bailey, Satish K. Garg |
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| Rok vydání: | 2017 |
| Předmět: |
Insulin pump
Adult Blood Glucose Male medicine.medical_specialty Adolescent Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism Type 2 diabetes 03 medical and health sciences Young Adult 0302 clinical medicine Endocrinology Subcutaneous glucose sensor Insulin Infusion Systems Reference Values Diabetes mellitus Commentaries medicine Fourth generation Humans 030212 general & internal medicine Aged business.industry Blood Glucose Self-Monitoring Reproducibility of Results Middle Aged medicine.disease Surgery Medical Laboratory Technology Diabetes Mellitus Type 2 Reference values Anesthesia Calibration Female business |
| Zdroj: | Diabetes technologytherapeutics. 19(8) |
| ISSN: | 1557-8593 |
| Popis: | This study evaluated the accuracy and performance of a fourth-generation subcutaneous glucose sensor (GuardianEighty-eight subjects (14-75 years of age, mean ± standard deviation [SD] of 42.0 ± 19.1 years) with type 1 or type 2 diabetes participated in the study. Subjects wore two sensors in the abdomen that were paired with either a MiniMedThe overall mean absolute relative difference (MARD ± SD) between abdomen sensor glucose (SG) and YSI reference values was 9.6% ± 9.0% and 9.4% ± 9.8% for the MiniMed 640G insulin pump and Guardian Connect system, respectively; and 8.7% ± 8.0% between arm SG and YSI reference values. The percentage of SG values within 20% agreement of the YSI reference value (for YSI80 mg/dL) was 90.7% with the MiniMed 640G insulin pump, 91.8% with the Guardian Connect system, and 93.1% for GSR-connected arm sensors. Mean functional sensor life, when calibrating 3-4 times/day, was 145.9 ± 39.3 h for sensors paired with the MiniMed 640G insulin pump, 146.1 ± 41.6 h for sensors paired with the Guardian Connect system, and 147.6 ± 40.4 h for sensors connected to the GSR. Responses to survey questions regarding sensor comfort and ease of use were favorable.The Guardian Sensor 3 glucose sensor, whether located in abdomen or the arm, provided accurate glucose readings when compared with the YSI reference and demonstrated functional life commensurate with the intended 7-day use. ClinicalTrials.gov : NCT02246582. |
| Databáze: | OpenAIRE |
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