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J Diabetes Sci Technol. 2016 May 3;10(3):697-707. doi: 10.1177/1932296815614587. Print 2016 May.

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

Author information

1
Mills-Peninsula Health Services, San Mateo, CA, USA dklonoff@diabetestechnology.org.
2
US Food and Drug Administration, Silver Spring, MD, USA.
3
Joan Lee Parkes Consulting Inc, Bristol, IN, USA.
4
University of Virginia, Center for Diabetes Technology, Charlottesville, VA, USA.
5
Walter Reed National Military Medical Center, Bethesda, MD, USA.
6
National Institutes of Health, Bethesda, MD, USA.
7
Albert Einstein College of Medicine, Bronx, NY, USA.
8
JDRF, New York, NY, USA.
9
University of Missouri, School of Medicine, Columbia, MO, USA.
10
Vanderbilt University, School of Medicine, Nashville, TN, USA.
11
American Diabetes Association, Alexandria, VA, USA.
12
Sampson Consulting Inc, Washington, DC.
13
Abbott Diabetes Care, Alameda, CA, USA.
14
New York-Presbyterian Hospital/Weill Cornell Medical College, New York, NY, USA.
15
Isala, Zwolle, the Netherlands.
16
Centers for Disease Control and Prevention, Atlanta, GA, USA.

Abstract

BACKGROUND:

Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs.

METHODS:

The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations.

RESULTS:

A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material.

CONCLUSION:

This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market.

KEYWORDS:

FDA; accuracy; blood glucose monitor; meter; protocol; surveillance

PMID:
26481642
PMCID:
PMC5038526
DOI:
10.1177/1932296815614587
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DCK has served on advisory panels for Insuline, Lifecare, Novartis, Roche, Sanofi, Tempramed and Voluntis, has received research support from Eli Lilly, Halozyme, Janssen, and Novo Nordisk, and owns stocks/shares in Tempramed. JLP is an independent consultant and president of Joan Lee Parkes Consulting Inc. She has consulted for Diabetes Technology Society and Lifescan in 2014 and 2015. BPK served as an advisor to Astra Zeneca, Becton, Dickinson, and Company and Sanofi-Aventis and has received research support from Animas Inc, BD, Dexcom, Insulet, Roche Diagnostics, Sanofi-Aventis, and Tandem Diabetes Care. Stock ownership: Inspark Technologies, Inc, and TypeZero Technologies. RAV was a consultant for Sanofi, Medtronic, and Bayer at the time of the development of this program. He received an Investigator Initiated Research Grant from Dexcom. Currently, he has no disclosures except that he is an employee of Medtronic. RDB is on the Board of Diabetes Technology Society. JN has received honoraria and travel expenses from IL, BioRad, Fujiribio, Radiometer and Becton Dickinson over the past year related to scientific presentations and professional consulting. SS is an employee of Abbott Diabetes Care. JJS attended an advisory board meeting for Bayer Diabetes Care on April 25, 2015. CL, SB, GAR, AK, RL, MP, KR, DS, ES, RS, and HWV have no relevant disclosures.

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