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Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices.为保障受试者安全以及准确判定糖尿病药物和器械临床试验的有效性，需要对血糖监测系统进行上市后监测。
J Diabetes Sci Technol. 2019 May;13(3):419-423. doi: 10.1177/1932296819843398. Epub 2019 Apr 11.
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Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.糖尿病技术协会血糖监测系统监测方案的制定。
J Diabetes Sci Technol. 2016 May 3;10(3):697-707. doi: 10.1177/1932296815614587. Print 2016 May.
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Diabetes Technology Meeting 2022.2022 年糖尿病技术会议。
J Diabetes Sci Technol. 2023 Jul;17(4):1085-1120. doi: 10.1177/19322968221148743. Epub 2023 Jan 26.
2
Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management.血糖监测系统准确性对糖尿病管理临床决策的影响。
J Diabetes Sci Technol. 2023 May;17(3):683-689. doi: 10.1177/19322968221080916. Epub 2022 Feb 28.
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Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.临床研究使用创新光学传输吸收系统的高精度绿色设计血糖仪。
J Diabetes Sci Technol. 2022 Sep;16(5):1069-1075. doi: 10.1177/19322968211060865. Epub 2021 Dec 10.
4
Post-Market Surveillance of a Blood Glucose Test Strip Demonstrates No Evidence of Interference on Clinical Accuracy in a Large Cohort of People with Type 1 or Type 2 Diabetes.一项血糖仪的上市后监测研究在 1 型或 2 型糖尿病患者的大样本中并未发现对临床准确性有干扰的证据。
J Diabetes Sci Technol. 2023 Jan;17(1):141-151. doi: 10.1177/19322968211042352. Epub 2021 Sep 4.
5
Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance.改进算法增强产品性能的血糖仪临床准确性的上市后监测评估
J Diabetes Sci Technol. 2023 Jan;17(1):133-140. doi: 10.1177/19322968211039465. Epub 2021 Aug 31.
6
How conclusive is the CONCLUDE trial?CONCLUDE 试验的结论性如何？
Diabetologia. 2020 Apr;63(4):692-697. doi: 10.1007/s00125-020-05086-8. Epub 2020 Jan 16.

本文引用的文献

1
Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.使用联网血糖仪对线性、重复性和血细胞比容干扰进行实验室评估。
J Diabetes Sci Technol. 2019 May;13(3):514-521. doi: 10.1177/1932296819841357. Epub 2019 Apr 11.
2
Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478).德谷胰岛素与甘精胰岛素300单位/毫升相比在有胰岛素治疗经验的2型糖尿病患者中的疗效和安全性：试验方案修正案（NCT03078478）
J Diabetes Sci Technol. 2019 May;13(3):498-506. doi: 10.1177/1932296819841585. Epub 2019 Apr 11.
3
System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials.一项具有无线互联网接入功能的血糖仪在临床试验中的系统准确性评估，该试验与异常低血糖模式相关。
J Diabetes Sci Technol. 2019 May;13(3):507-513. doi: 10.1177/1932296819841353. Epub 2019 Apr 11.
4
Proof of Concept Study to Assess the Influence of Oxygen Partial Pressure in Capillary Blood on SMBG Measurements.评估毛细血管血中氧分压对自我血糖监测测量影响的概念验证研究
J Diabetes Sci Technol. 2019 Nov;13(6):1105-1111. doi: 10.1177/1932296819833369. Epub 2019 Mar 6.
5
The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.真实世界证据试验在医疗保健决策中的作用不断扩大。
J Diabetes Sci Technol. 2020 Jan;14(1):174-179. doi: 10.1177/1932296819832653. Epub 2019 Mar 6.
6
A Review of Blood Glucose Monitor Accuracy.血糖仪准确性评估综述。
Diabetes Technol Ther. 2018 Dec;20(12):843-856. doi: 10.1089/dia.2018.0232. Epub 2018 Oct 29.
7
Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors.18 种市售血糖仪准确性的调查。
Diabetes Care. 2018 Aug;41(8):1681-1688. doi: 10.2337/dc17-1960. Epub 2018 Jun 13.
8
Why the New FDA Glucose Meter POCT Guidance Is Disappointing.为何美国食品药品监督管理局（FDA）新的血糖仪即时检验指南令人失望。
J Diabetes Sci Technol. 2017 Nov;11(6):1274. doi: 10.1177/1932296816682763. Epub 2016 Dec 5.
9
Successful Performance of Laboratory Investigations with Blood Glucose Meters Employing a Dynamic Electrochemistry-Based Correction Algorithm Is Dependent on Careful Sample Handling.采用基于动态电化学校正算法的血糖仪进行实验室检测时，成功与否取决于对样本的仔细处理。
Diabetes Technol Ther. 2016 Oct;18(10):650-656. doi: 10.1089/dia.2016.0202.
10
Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.糖尿病技术协会血糖监测系统监测方案的制定。
J Diabetes Sci Technol. 2016 May 3;10(3):697-707. doi: 10.1177/1932296815614587. Print 2016 May.

Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices.

作者信息

Klonoff David C

机构信息

1 Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.

出版信息

J Diabetes Sci Technol. 2019 May;13(3):419-423. doi: 10.1177/1932296819843398. Epub 2019 Apr 11.

DOI:10.1177/1932296819843398
PMID:30974987
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6501534/
Abstract
摘要