A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II
| العنوان: | A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II |
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| المؤلفون: | David K. Lam, Douglas S Denham, Anna R Chang, Ronald L. Brazg, Timothy S. Bailey, Steven J Walters, Bruce W. Bode, George Atiee, Leslie J. Klaff, Mark P. Christiansen, Lynne Kelley, Carol J. Levy |
| المصدر: | Diabetes Technology & Therapeutics |
| بيانات النشر: | Mary Ann Liebert Inc, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Grid analysis, Longevity, 030209 endocrinology & metabolism, Type 2 diabetes, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Diabetes mellitus, Clinical endpoint, Humans, Hypoglycemic Agents, Insulin, Medicine, 030212 general & internal medicine, Adverse effect, Continuous glucose monitoring, Accuracy, Type 1 diabetes, business.industry, Blood Glucose Self-Monitoring, Reproducibility of Results, nutritional and metabolic diseases, Equipment Design, Original Articles, Middle Aged, medicine.disease, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Multicenter study, Anesthesia, Female, Implantable, business |
| الوصف: | Background: Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods: PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion. Results: Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%–9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P |
| تدمد: | 1557-8593 1520-9156 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4635d7c13701f6fab1050d5d3d9a9d4fTest https://doi.org/10.1089/dia.2017.0142Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4635d7c13701f6fab1050d5d3d9a9d4f |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15578593 15209156 |
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