Literature DB >> 20513313

The food and drug administration is now preparing to establish tighter performance requirements for blood glucose monitors.

David C Klonoff1.   

Abstract

On March 16 and 17, 2010, the Food and Drug Administration (FDA) presented a public meeting about blood glucose monitoring at the Gaithersberg Hilton Hotel. The meeting was intended to present expert opinions and solicit input from the public about whether to develop new regulatory policies for blood glucose monitors. The meeting was divided into three sections: (1) Clinical Accuracy Requirements for Blood Glucose Monitors, (2) Interferences and Limitations of Blood Glucose Monitors, and (3) Tight Glycemic Control. Many officials from the Center for Devices and Radiologic Health and the Office of In Vitro Diagnostic Devices, which are the parts of FDA that regulate approval of blood glucose monitors, either spoke on the agenda or attended in the audience. Approximately 300 people attended; they were mostly clinicians (such as adult endocrinologists, pediatric endocrinologists, internists, clinical chemists, intensivists, surgeons, nurses, and diabetes educators) or industry officials from companies involved in glucose monitoring, pharmaceutical products, data analysis, or regulatory consulting. (c) 2010 Diabetes Technology Society.

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Year:  2010        PMID: 20513313      PMCID: PMC2901024          DOI: 10.1177/193229681000400301

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


  11 in total

1.  Seismic upgrades of healthcare facilities.

Authors:  A Yusuf
Journal:  J Healthc Resour Manag       Date:  1997-06

2.  Impact of blood glucose self-monitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study.

Authors:  Marc D Breton; Boris P Kovatchev
Journal:  J Diabetes Sci Technol       Date:  2010-05-01

Review 3.  How accurately do we measure blood glucose levels in intensive care unit (ICU) patients?

Authors:  Hans Günther Wahl
Journal:  Best Pract Res Clin Anaesthesiol       Date:  2009-12

4.  Predicted blood glucose from insulin administration based on values from miscoded glucose meters.

Authors:  Charles H Raine; Scott Pardo; Joan Lee Parkes
Journal:  J Diabetes Sci Technol       Date:  2008-07

Review 5.  Perioperative and critical illness dysglycemia--controlling the iceberg.

Authors:  Mark T Keegan; Michael E Goldberg; Marc C Torjman; Douglas B Coursin
Journal:  J Diabetes Sci Technol       Date:  2009-11-01

6.  Eliminating the blood: ongoing outbreaks of hepatitis B virus infection and the need for innovative glucose monitoring technologies.

Authors:  Nicola D Thompson; Joseph F Perz
Journal:  J Diabetes Sci Technol       Date:  2009-03-01

Review 7.  Glucose meters: a review of technical challenges to obtaining accurate results.

Authors:  Ksenia Tonyushkina; James H Nichols
Journal:  J Diabetes Sci Technol       Date:  2009-07-01

8.  Effect of adverse storage conditions on performance of glucometer test strips.

Authors:  Richard Bamberg; Kathleen Schulman; Melissa MacKenzie; Joanna Moore; Sarah Olchesky
Journal:  Clin Lab Sci       Date:  2005

Review 9.  Analytical and clinical performance of blood glucose monitors.

Authors:  Suzanne Austin Boren; William L Clarke
Journal:  J Diabetes Sci Technol       Date:  2010-01-01

Review 10.  A review of standards and statistics used to describe blood glucose monitor performance.

Authors:  Jan S Krouwer; George S Cembrowski
Journal:  J Diabetes Sci Technol       Date:  2010-01-01
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  25 in total

1.  Glucose information for tight glycemic control: different methods with different challenges.

Authors:  Christian Weber; Kurt Neeser
Journal:  J Diabetes Sci Technol       Date:  2010-09-01

Review 2.  Blood glucose measurements in critically ill patients.

Authors:  Tom Van Herpe; Dieter Mesotten
Journal:  J Diabetes Sci Technol       Date:  2012-01-01

3.  Improving the safety of blood glucose monitoring.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2011-11-01

4.  Performance evaluation and labeling comprehension of a new blood glucose monitoring system with integrated information management.

Authors:  Susan M List; Nykole Starks; John Baum; Carmine Greene; Scott Pardo; Joan L Parkes; Holly C Schachner; Robert Cuddihy
Journal:  J Diabetes Sci Technol       Date:  2011-09-01

5.  The need for clinical accuracy guidelines for blood glucose monitors.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2012-01-01

6.  Intraoperative accuracy of a point-of-care glucose meter compared with simultaneous central laboratory measurements.

Authors:  Boris Mraovic; Eric S Schwenk; Richard H Epstein
Journal:  J Diabetes Sci Technol       Date:  2012-05-01

7.  Seven-Year Surveillance of the Clinical Performance of a Blood Glucose Test Strip Product.

Authors:  Steven Setford; Mike Grady; Stuart Phillips; Lesley Miller; Stephen Mackintosh; Hilary Cameron; Krisna Corrigall
Journal:  J Diabetes Sci Technol       Date:  2017-04-13

8.  Accuracy in blood glucose measurement: what will a tightening of requirements yield?

Authors:  Lutz Heinemann; Volker Lodwig; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2012-03-01

Review 9.  Challenges of inpatient blood glucose monitoring: standards, methods, and devices to measure blood glucose.

Authors:  Kathie L Hermayer; Aundrea S Loftley; Sumana Reddy; Satya Nandana Narla; Nina A Epps; Yusheng Zhu
Journal:  Curr Diab Rep       Date:  2015-03       Impact factor: 4.810

10.  A new test strip technology platform for self-monitoring of blood glucose.

Authors:  Robert Bernstein; Joan Lee Parkes; Amy Goldy; Daniel Brown; Bern Harrison; Amy Chu; Brian K Pflug; David A Simmons; Scott Pardo; Timothy S Bailey
Journal:  J Diabetes Sci Technol       Date:  2013-09-01
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