Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes
| Autor: | John H. Shin, Jennifer L. Sherr, Mark P. Christiansen, Timothy S. Bailey, Francine R. Kaufman, Ashley Sullivan, Scott W. Lee, Kevin B Kaiserman, Linda A. DiMeglio, Ronald L. Brazg, Bruce W. Bode, Robert H. Slover, Eva Tsalikian, Suiying Huang, Jeanie B. Tryggestad, Larry A. Fox |
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| Rok vydání: | 2018 |
| Předmět: |
Blood Glucose
Male Pediatrics medicine.medical_specialty endocrine system diseases Adolescent Endocrinology Diabetes and Metabolism Monitoring Ambulatory 030209 endocrinology & metabolism 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Endocrinology Diabetes mellitus Fourth generation medicine Humans Child Type 1 diabetes Continuous glucose monitoring business.industry Blood Glucose Self-Monitoring nutritional and metabolic diseases medicine.disease Medical Laboratory Technology Diabetes Mellitus Type 1 Child Preschool Female business |
| Zdroj: | Diabetes technologytherapeutics. 20(9) |
| ISSN: | 1557-8593 |
| Popis: | This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D).Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.9 years) with T1D and duration of diagnosis ≥1 year were enrolled at 11 sites in the United States and wore two Guardian Sensor 3 sensors in the abdomen and/or buttock. Sensors were connected to a transmitter paired with either a Guardian Connect system (i.e., mobile device with software application allowing display of sensor glucose [SG] values) or a Guardian Link 3 transmitter used as a Glucose Sensor Recorder (GSR). There were 145 participants who underwent a 6-h in-clinic frequent sample testing (FST) on day 1 (n = 54), day 3 (n = 48), or day 7 (n = 43) postsensor insertion. During FST, SG values were compared with a Yellow Springs Instrument (YSI) plasma reference every 5-15 min (n = 124, 7-18 years of age; n = 2, 2-6 years of age), or to a self-monitoring of blood glucose (SMBG) reference every 5-30 min (n = 19, 2-6 years of age).The overall mean absolute relative difference (ARD ± SD) between SG and reference values (YSI or SMBG) when calibrating approximately every 12 h, was 10.9% ± 10.7% (3102 paired points) for sensors communicating with the Guardian Connect system and 11.1% ± 10.6% (2624 paired points) for sensors connected to the GSR. The overall percentage of SG values within ±20% of reference values80 mg/dL or within 20 mg/dL of reference values ≤80 mg/dL was 87.8% for the Guardian Connect system and 86.7% for the GSR, respectively. There was one device-related adverse event of contact dermatitis, but no serious device-related adverse events.The Guardian CGM system demonstrated good accuracy in children and adolescents. These findings support its use in sensor-integrated insulin pump platforms, as well as a standalone technology, for managing diabetes in pediatric populations. |
| Databáze: | OpenAIRE |
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