Literature DB >> 30974987

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.

David C Klonoff1.   

Abstract

Entities:  

Keywords:  FDA; accuracy; blood glucose monitor; clinical trial; surveillance

Mesh：

Substances：

Year:  2019        PMID： 30974987      PMCID： PMC6501534          DOI： 10.1177/1932296819843398

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN： 1932-2968


× No keyword cloud information.
  11 in total

1.  The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2019-03-06

2.  Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.

Authors:  Filiz Demircik; Valeria Kirsch; Sanja Ramljak; Mario Vogg; Anke H Pfützner; Andreas Pfützner
Journal:  J Diabetes Sci Technol       Date:  2019-04-11

Review 3.  A Review of Blood Glucose Monitor Accuracy.

Authors:  Fraya King; David Ahn; Victoria Hsiao; Travis Porco; David C Klonoff
Journal:  Diabetes Technol Ther       Date:  2018-10-29       Impact factor: 6.118

Review 4.  Performance of Cleared Blood Glucose Monitors.

Authors:  David C Klonoff; Priya Prahalad
Journal:  J Diabetes Sci Technol       Date:  2015-06-08

5.  Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478).

Authors:  Athena Philis-Tsimikas; Irene Stratton; Lone Nørgård Troelsen; Britta Anker Bak; Lawrence A Leiter
Journal:  J Diabetes Sci Technol       Date:  2019-04-11

6.  System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials.

Authors:  Andreas Pfützner; Filiz Demircik; Valeria Kirsch; Johannes Pfützner; Stephanie Strobl; Mina Hanna; Jan Spatz; Anke H Pfützner
Journal:  J Diabetes Sci Technol       Date:  2019-04-11

7.  Successful Performance of Laboratory Investigations with Blood Glucose Meters Employing a Dynamic Electrochemistry-Based Correction Algorithm Is Dependent on Careful Sample Handling.

Authors:  Filiz Demircik; David Klonoff; Petra B Musholt; Sanja Ramljak; Andreas Pfützner
Journal:  Diabetes Technol Ther       Date:  2016-10       Impact factor: 6.118

8.  Proof of Concept Study to Assess the Influence of Oxygen Partial Pressure in Capillary Blood on SMBG Measurements.

Authors:  Annette Baumstark; Stefan Pleus; Nina Jendrike; Christina Liebing; Rolf Hinzmann; Cornelia Haug; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2019-03-06

9.  Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors.

Authors:  David C Klonoff; Joan Lee Parkes; Boris P Kovatchev; David Kerr; Wendy C Bevier; Ronald L Brazg; Mark Christiansen; Timothy S Bailey; James H Nichols; Michael A Kohn
Journal:  Diabetes Care       Date:  2018-06-13       Impact factor: 19.112

10.  Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

Authors:  David C Klonoff; Courtney Lias; Stayce Beck; Joan Lee Parkes; Boris Kovatchev; Robert A Vigersky; Guillermo Arreaza-Rubin; Robert D Burk; Aaron Kowalski; Randie Little; James Nichols; Matt Petersen; Kelly Rawlings; David B Sacks; Eric Sampson; Steve Scott; Jane Jeffrie Seley; Robbert Slingerland; Hubert W Vesper
Journal:  J Diabetes Sci Technol       Date:  2016-05-03
View more
  2 in total

1.  How conclusive is the CONCLUDE trial?

Authors:  Stefano Del Prato
Journal:  Diabetologia       Date:  2020-01-16       Impact factor: 10.122

2.  Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.

Authors:  Takeyuki Moriuchi; Yuto Otaki; Hiroya Satou; Fumihiko Chai; Yuma Hayashida; Ryokei Aikawa; Takayuki Sugiyama; Koji Sode
Journal:  J Diabetes Sci Technol       Date:  2021-12-10
  2 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.