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.
Abstract
摘要
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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。
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