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
- PMID: 30974987
- PMCID: PMC6501534
- DOI: 10.1177/1932296819843398
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
Keywords: FDA; accuracy; blood glucose monitor; clinical trial; surveillance.
Conflict of interest statement
Comment on
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Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478).J Diabetes Sci Technol. 2019 May;13(3):498-506. doi: 10.1177/1932296819841585. Epub 2019 Apr 11. J Diabetes Sci Technol. 2019. PMID: 30974986 Free PMC article. Clinical Trial.
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Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.J Diabetes Sci Technol. 2019 May;13(3):514-521. doi: 10.1177/1932296819841357. Epub 2019 Apr 11. J Diabetes Sci Technol. 2019. PMID: 30974988 Free PMC article.
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