Chair: David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
Mills-Peninsula Health Services, San Mateo, California
Guillermo Arreaza-Rubin, MD
National Institutes of Health, Bethesda, Maryland
Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM) from the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH).
Select Experience
Scientific Director, Diabetogen Biosciences, Inc., London, Ontario, Canada, 2000-2005
Senior Research Scientist, The Robarts Research Institute, Autoimmunity/ Diabetes Group, University of Western Ontario, 1998-2000
Postdoctoral Fellowship, The Robarts Research Institute, Autoimmunity/Diabetes Group, University of Western Ontario, 1994-1997
Research Fellowship, Endocrinology Research Laboratory, The Wellesley Hospital, Department of Medicine, University of Toronto, 1991-1994
Internal Medicine Specialty and Endocrinology Fellowship, University Hospital, Central University of Venezuela, 1985-1991
Current Responsibilities and Activities
Dr. Arreaza responsibilities include directing the Small Business Innovation Research/Small Business Technology Transfer Research (SBIR/STTR) program—which supports small business innovative research with potential for commercialization—in areas related to diabetes and endocrine diseases. These areas include: drug discovery and technology development for diabetes and other endocrine diseases and their complications; new technologies for islet isolation, stem cell/regeneration, and transplantation; immune modulatory agents for the primary and secondary prevention of diabetes; inflammatory aspects of type 2 diabetes, insulin resistance, and obesity; and closed-loop systems/artificial pancreas development.
Dr. Arreaza is in charge of the academic program for technologies for the diagnosis and control of diabetes and is the program director for the Clinical Islet Transplantation (CIT) Consortium and the Clinical Islet Transplantation Registry (CITR) acting as executive secretary of the CIT- Consortium Data and Safety Monitoring Board (DSMB). He also participates in the coordination of the new human islet research network (HIRN) program. He has served as co-director of the Type 1 diabetes Rapid Access to Intervention Development (T1D-RAID) program and director of the preclinical testing in animal models of diabetes program, both cooperative efforts to facilitate translation of new and promising therapies. Dr. Arreaza also represents NIH in the Artificial Pancreas Interagency Working Group and participates in several NIDDK and NIH working groups and committees for the development and testing of novel therapies and technologies.
Dr. Arreaza is the author of 46 peer reviewed publications.
Robert Burk, MD
Albert Einstein College of Medicine, Bronx, New York
He is an expert on the genomics and evolution of human papillomaviruses (HPV)—viruses best known as the primary cause of cervical cancer—Dr. Burk is chair of the Papillomavirus Working Group of the International Committee on Taxonomy of Viruses. While his main research focus has been to understand the natural history of HPV infection of the cervix and the development of cervix cancer, as a geneticist, Dr. Burk is interested in how subtle changes in the HPV genome causes cancer. His investigations also include the association of HPV and head & neck cancer; the risk factors for prostate cancer among a population isolate; the molecular basis of von Hippel-Lindau mutations and development of renal cancer; and the genetic basis of excessive sweating (hyperhidrosis); more recently his lab is studying the role of the human microbiome on disease processes, particularly the gut microbiome and diabetes. One of his papers, which appeared in the New England Journal of Medicine, demonstrated that HPV has a short duration of infection in young women, and was fundamental in changing the medical management of young women with abnormal Pap smears; it has been cited over 2,500 times. He has published more than 350 peer-reviewed papers, was the past chair of the American Cancer Society Peer Review Committee on Molecular Genetics and Oncogenes and is currently an academic editor of PLOS ONE. He completed his medical degree at the George Washington University (GWU) School of Medicine, and worked in the laboratory of Dr. Marshall Nirenberg with Dr. John Minna at NIH, while in medical school and won both local and national awards for this research. Following an internship in General Surgery at UCSF, he switched fields to be more compatible with a scientific career. He completed residency training in Pediatrics also at UCSF and then completed a fellowship in Medical Genetics at the Johns Hopkins Medical Center. He is board certified in Pediatrics and Clinical Genetics.
Boris Kovatchev, PhD
University of Virginia Center for Diabetes Technology, Charlottesville, Virginia
Expertise: Mathematical Modeling, Diabetes Technology, Continuous Glucose Monitoring, Closed-Loop Control and Artificial Pancreas.
Aaron Kowalski, PhD
Juvenile Diabetes Research Foundation, New York, New York
Aaron J. Kowalski, Ph.D., oversees JDRF-funded research aimed at accelerating the delivery and development of artificial pancreas systems.
Dr. Kowalski is an internationally recognized expert in the area of diabetes technologies and has been a leader of JDRF’s Artificial Pancreas Project, a multi-million dollar initiative that began in 2005 to accelerate the progress toward a closed-loop, automated insulin-delivery system. He has authored numerous articles in the field and was a co-author of the landmark study in The New England Journal of Medicine that revealed the effectiveness of continuous glucose monitors in T1D.
Dr. Kowalski has traveled widely across North America and abroad describing diabetes research progress, and is known for his ability to translate science into easily understandable concepts. Dr. Kowalski has been an invited speaker at many national and international conferences, including the ADA Annual Scientific Sessions, and was the keynote speaker at the 2009 Diabetes Technology Society Meeting. He has been a voice for diabetes research in the popular media, appearing on The Martha Stewart Show, dLife, Fox Business, NPR, and many other shows, and is often quoted in print media, including The New York Times, The Wall Street Journal, USA Today, and People magazine. He earned his doctorate in molecular genetics from Rutgers University and the University of Medicine and Dentistry of New Jersey.
In 1977 at the age of three, Dr. Kowalski’s brother Stephen was diagnosed with T1D and in 1984 at the age of 13 he too developed T1.
Courtney Lias, PhD
Food and Drug Administration, Silver Spring, Maryland
Randie Little, PhD
University of Missouri School of Medicine, Columbia, Missouri
James Nichols, MD
Vanderbilt University School of Medicine, Nashville, Tennessee
Representing American Association for Clinical Chemistry, Washington, DC
Joan Lee Parkes, PhD
Joan Lee Parkes Consulting Inc., Bristol, Indiana
Joan then moved from academia to industry to work on products that could improve the quality of life for persons with diabetes. At Becton Dickinson (BD) she helped develop a clinical trials department that conducted studies on less painful lancing devices and lancets and on various types of insulin delivery devices including: insulin syringes, insulin pens, jet injectors, inhaled insulin, and transdermal patches. During her stay at BD, she and colleagues conducted the research and published the highly referenced paper on the Parkes (or Consensus) Error Grid that is now part of the ISO 15197:2013 standards for blood glucose monitoring systems. Subsequently as Director of Clinical Trials and Outcomes Research for Bayer Diabetes Care, Joan developed and led an excellent team devoted to clinical research on blood glucose monitoring systems including blood glucose meters with improved accuracy and usability as well as on continuous glucose monitoring systems. Joan retired from Bayer in 2013. She now is president of her own consulting company, Joan Lee Parkes Consulting, Inc.
Throughout her career, Joan has published extensively on her research.
Joan has dedicated herself to the protection of human subjects in clinical trials and was founder and Chair of the Hudson Valley Institutional Review Board.
More recently, Joan has renewed her work with the Diabetes Technology Society (DTS) as a member of the Steering Committee for the recently published Surveillance Error Grid. She currently is a member of DTS’s Blood Glucose Meter Post Market Surveillance Steering Committee.
Matt Petersen
American Diabetes Association, Alexandria, Virginia
Mr. Petersen has broad responsibility for ensuring consistent messages about diabetes and diabetes issues throughout the organization. He also manages several education/information initiatives for consumers and healthcare professionals, and is responsible for the Association’s management and dissemination of information about statistical aspects of diabetes. He oversees the development of the Economic Costs of Diabetes Study as well as other statistical resources, including the ADA’s contribution to the National Diabetes Fact Sheet produced by the CDC.
Mr. Petersen leads the Association’s Health Information Technology Team and the Professional Engagement Team. He developed and his department maintains the Association’s professional website, DiabetesPro, and he oversees the Association’s involvement with new technologies to deliver information and education content to consumers and health professionals.
Kelly Rawlings
American Diabetes Association, Alexandria, Virginia
David B. Sacks, MB, ChB, FRCPath
National Institutes of Health, Bethesda, Maryland
Representing College of American Pathologists, Northfield, Illinois
David B. Sacks is a Senior Investigator and Chief of Clinical Chemistry at the National Institutes of Health, Clinical Professor of Pathology at George Washington University and Adjunct Professor of Medicine at Georgetown University. Dr. Sacks obtained his medical degree from the University of Cape Town, South Africa. Further training included residencies in both Internal Medicine at hospitals affiliated with Georgetown Medical School and in Clinical Pathology at Washington University School of Medicine. He spent 21 years at Harvard Medical School.
Dr. Sacks’s primary clinical focus is in diabetes mellitus, with an emphasis on the interface between the clinical laboratory and patient care. He chaired the CLSI committees for both the 2nd and 3rd editions of POCT Blood Glucose Testing (C30-A and POCT12) and served as a liaison to the ISO/TC 212 Working Group. Currently he is Chair of the National Glycohemoglobin Standardization Program (NGSP) steering committee. In addition, he serves on several other national and international committees. Dr. Sacks has authored over 175 research publications in peer-reviewed journals. He is an Associate Editor of Clinical Chemistry and is a member of a number of other editorial boards. He was elected a Fellow of the Royal College of Pathologists in 1998.
Eric Sampson, PhD
Sampson Consulting Inc., Washington, DC
In 2010, the Director, CDC, asked Dr. Sampson to serve as a Senior Advisor at the Director’s Office, Food and Drug Administration (FDA), on science and policy issues between the agencies. His work involved a number of diverse areas including: food safety, nutrition, tobacco, and counterfeit drugs. Between 2011 and 2012, he also served as Acting Director of Science, Office of Regulatory Affairs, FDA.
Over the course of his career, Dr. Sampson has authored or coauthored more than 120 publications and has been the recipient of numerous awards including: the Young Investigator Award from the American Association of Clinical Chemistry; the Department of Health and Human Services Secretary’s Award for Distinguished Service; the Association of Public Health Laboratories President’s Award for service to the public health laboratory system; the Diabetes Technology Society Leadership Award; and the William C. Watson, Jr. Medal of Excellence Award, CDC’s highest award. Dr. Sampson has testified before Congressional committees and briefed congressional staffers on numerous occasions.
Since retiring in 2013, Dr. Sampson has been a consultant and serves as the Senior Science Advisor to the CDC Foundation.
Steve Scott
Abbott Laboratories, Alameda, California
Steve joined MediSense in May 1986, as a project scientist. During the past 28 years he has held various management positions within the R&D and operations organizations, including manufacturing manager, technical operations manager, and U.K. research and development director, and was involved in several key product launches, including MediSense’s first blood glucose monitoring system, the ExacTech.
Steve continued to lead the U.K. research and development organization following Abbott’s acquisition of MediSense in 1996, overseeing product and process design, including the launch of the MediSense Precision G test strip and the first MediSense ketone test strip. The MediSense Products group was part of Abbott’s Diagnostics Division. In 2000, he was named U.S. research and development director. In this role, Mr. Scott continued to oversee U.K. test strip development as well as U.S. meter development.
Steve became divisional vice president in August 2002 and was responsible for the definition and implementation of MediSense’s R&D programs in the U.S. and the U.K., launching several new products.
After the acquisition of Therasense in 2004, Abbott Diabetes Care (ADC) was created as a separate division of Abbott. Steve led the research and development of all of ADC’s in-vitro diagnostic projects and continued to launch new products including the no calibration FreeStyle Lite system and the subsequent FreeStyle strip upgrade (Omni) to include ZipWickTM technology. Steve won Abbott’s Chairman’s Award in 2010 for his contribution to the launch of this significant upgrade. In 2010 Steve took over leading ADC’s sensor based research and development.
Steve earned a B.Sc. in chemistry from the University of Aberdeen in Scotland, and has completed executive development programs at Cornell University, NY and INSEAD, Fontainebleau, France.
Jane Seley, DNP, MPH, BC-ADM, CDE
New York-Presbyterian/Weill Cornell, New York, New York
Representing American Association of Diabetes Educators, Chicago, Illinois
Robbert Slingerland, PhD
Isala Clinics, Apeldoorn, Netherlands
Klinieken, one of the largest hospitals in the Netherlands. The Clinical Chemistry Department employs 250 people. The laboratory serves the hospital as well as family doctors. Coagulation service and a transplantation laboratory are part of the laboratory. The laboratory supports e.g. the cardiology department that serves about 1.3 million people.
His span of control includes Point-of-Care Testing, Diabetes and Cardiology investigations, Special chemistry and Quality Assurance conducted through the Isala Clinics. Also Home-Use Testing is his responsibility.
As chair of the European Reference Laboratory he is responsible for the production of the world gold standard for HbA1c (primary reference material) and secondary reference material which is made available to all manufacturers in the world. The European Reference Laboratory makes also the HbA1c-materials for EQUAS-organizers to check the quality at the user-level.
Two primary reference methods are run in his lab (HbA1c and glucose) as well as 3 secondary
reference methods for HbA1c and 3 secondary reference methods for glucose. All home-use glucose meters including new strip batches on the Dutch market are yearly tested in the Isala Clinics.
The Isala Clinics has a long tradition in Point-of-Care Testing
Hubert Vesper, PhD
Centers for Disease Control, Atlanta, Georgia
Robert Vigersky, MD, COL MC
Walter Reed National Military Medical Center, Bethesda, Maryland
Representing The Endocrine Society, Washington, DC
Diabetes Technology Society (DTS) is a nonprofit organization committed to promoting development and use of technology in the fight against diabetes. DTS was established in 2001 by David C. Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE, Medical Director of the Diabetes Research Institute at Mills Peninsula Health Services and Clinical Professor of Medicine at University of California, San Francisco.
The DTS mission is to spearhead collaborative efforts by experts in academia, clinical practice, industry, and government to accelerate development of practical technology for treating, monitoring, diagnosing, and preventing diabetes mellitus and its complications.
In pursuit of its goals, DTS works closely with many government agencies, national organizations, and universities. DTS also maintains regular communication with developers and manufacturers of pharmaceutical drugs, devices, and software for diabetes care.
DTS presents four scientific conferences each year, Diabetes Technology Meeting, Clinical Diabetes Technology Meeting, European Clinical Diabetes Technology Meeting, and International Hospital Diabetes Meeting. Several thousand scientists and researchers from more than 25 countries regularly participate in these highly successful conferences.
To disseminate the latest information on research developments and clinical trends in diabetes technology, DTS publishes Journal of Diabetes Science and Technology, which is indexed by the National Library of Medicine for MEDLINE/PubMed. This journal’s editorial board includes scientists and clinicians from ten different U.S. government agencies as well as diabetes experts from around the world.
Copyright © 2014 Diabetes Technology Society
Foster City, California: May 20, 2014—Diabetes Technology Society (DTS) is pleased to announce the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This program is intended to protect patients from inaccurate BGM products currently on the market. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers, and payers in making the right product selection.
After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post clearance. Low-quality BGM systems can negatively impact the ability of people with diabetes to reliably monitor their blood glucose levels and can lead to adverse health effects. Efforts by the FDA to improve accuracy standards for pre-market clearance would have little impact if performance was not maintained post-market, so a post-market surveillance program is critically important to ensuring the accuracy of cleared products for people with diabetes.
A Steering Committee and an Advisory Committee will be formed consisting of experts in blood glucose monitoring from academia, medical practice, clinical chemistry, government, industry, and medical organizations. Patient advocacy group(s) will be represented. A protocol to assess BGM System performance will be developed and then product testing will begin. It is expected that the information generated by this program will inform patients, payers, and regulators as to which cleared products actually perform accurately in a real world standardized environment.
FDA supports a BGM Surveillance program to protect public health. The agency has agreed with the concept of a surveillance plan and has stated that it will act on information that it receives on low-quality BGM products, including from surveillance testing. Initial funds to get the post-market surveillance program started have been committed by Abbott, the global healthcare company. The project will begin this month.
“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and Clinical Professor of Medicine at University of California, San Francisco. “Patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program. I encourage other manufacturers to come forward to join Abbott in support of this program.”
About Diabetes Technology Society
Diabetes Technology Society is a non-profit educational organization dedicated to promote development and use of technology to help people with diabetes. DTS publishesJournal of Diabetes Science and Technology, the world’s largest scientific journal devoted to new technologies in the fight against diabetes, including glucose monitoring, insulin delivery, the artificial pancreas, software, wireless health solutions, social media, and bioengineered solutions for treating obesity. DTS presents the annual Diabetes Technology Meeting, the Hospital Diabetes Meeting, the Certified Diabetes Technology Clinician certification meeting in the US and in Europe, and the Tissue Response to Implanted Active Medical Devices Meeting. DTS has developed a Personalized Medicine Diabetes Program for the US Air Force. DTS is currently spearheading development of a new error grid for defining clinical accuracy of a blood glucose monitor in cooperation with FDA, American Diabetes Association, The Endocrine Society, and Association for Advancement of Medical Instrumentation.
For additional information, contact Brett McGreevy at Diabetes Technology Society.
650-357-7140(mcgreevy@diabetestechnology.org) (www.diabetestechnology.org)
Foster City, California: June 12, 2014 - Diabetes Technology Society (DTS) is pleased to announce that the Steering Committee has been assembled for its Surveillance Program for Cleared Blood Glucose Monitors. The first Steering Committee meeting will take place next month in Washington DC.
This program is intended to identify poorly performing blood glucose monitoring products on the market. This surveillance program will provide an independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance. The program will generate information that can assist patients, healthcare providers, and payers in making informed product selections. The information will also be provided to FDA, which is the government agency that regulates these products.
After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post-clearance. Poorly performing BGM system can interfere with the ability of people with diabetes to reliably monitor their blood glucose levels, and make correct decision based upon the readings. Inaccurate readings can lead to incorrect actions and therefore to adverse outcomes. Ongoing efforts by the FDA to improve accuracy standards for pre-market clearance would be undermined if performance was not maintained post-market. Therefore, a post-market surveillance program is critically important to ensure the accuracy of cleared products for people with diabetes.
A Steering Committee has been formed consisting of world class experts in blood glucose monitoring, diabetes, and laboratory methods from academia, medical practice, government, industry, and medical organizations. Many of them have experience in establishing surveillance programs and testing verification programs for other medical tests. Patient advocacy group(s) will be represented in a future Advisory Board that will be established soon. A protocol to assess BGM System performance will be developed and then product testing will begin.
“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and a Clinical Professor of Medicine at University of California, San Francisco. “Patients will benefit by having access to information that can assist them in selecting more accurate blood glucose meter systems and manufacturers committed to delivering accurate products will have an opportunity to back up claims about quality and accuracy with verification from this independent testing program.”
About Diabetes Technology Society
Diabetes Technology Society is a non-profit educational organization dedicated to promote development and use of technology to help people with diabetes. DTS publishes Journal of Diabetes Science and Technology, the world’s largest scientific journal devoted to new technologies in the fight against diabetes, including glucose monitoring, insulin delivery, the artificial pancreas, software, wireless health solutions, social media, and bioengineered solutions for treating obesity. DTS presents the annual Diabetes Technology Meeting, the Hospital Diabetes Meeting, the Certified Diabetes Technology Clinician certification meeting in the US and in Europe, and the Tissue Response to Implanted Active Medical Devices Meeting. DTS has developed a Personalized Medicine Diabetes Program for the US Air Force. DTS is currently spearheading development of a new error grid for defining clinical accuracy of blood glucose monitors in cooperation with FDA, American Diabetes Association, The Endocrine Society, and Association for Advancement of Medical Instrumentation.
For additional information, contact Brett McGreevy at Diabetes Technology Society.
650-357-7140(mcgreevy@diabetestechnology.org) (www.diabetestechnology.org)
Foster City, California: June 12, 2014 - Diabetes Technology Society (DTS) is pleased to announce that the Steering Committee has been assembled for its Surveillance Program for Cleared Blood Glucose Monitors. The first Steering Committee meeting will take place next month in Washington DC.
This program is intended to identify poorly performing blood glucose monitoring products on the market. This surveillance program will provide an independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance. The program will generate information that can assist patients, healthcare providers, and payers in making informed product selections. The information will also be provided to FDA, which is the government agency that regulates these products.
After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post-clearance. Poorly performing BGM system can interfere with the ability of people with diabetes to reliably monitor their blood glucose levels, and make correct decision based upon the readings. Inaccurate readings can lead to incorrect actions and therefore to adverse outcomes. Ongoing efforts by the FDA to improve accuracy standards for pre-market clearance would be undermined if performance was not maintained post-market. Therefore, a post-market surveillance program is critically important to ensure the accuracy of cleared products for people with diabetes.
A Steering Committee has been formed consisting of world class experts in blood glucose monitoring, diabetes, and laboratory methods from academia, medical practice, government, industry, and medical organizations. Many of them have experience in establishing surveillance programs and testing verification programs for other medical tests. Patient advocacy group(s) will be represented in a future Advisory Board that will be established soon. A protocol to assess BGM System performance will be developed and then product testing will begin.
“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and a Clinical Professor of Medicine at University of California, San Francisco. “Patients will benefit by having access to information that can assist them in selecting more accurate blood glucose meter systems and manufacturers committed to delivering accurate products will have an opportunity to back up claims about quality and accuracy with verification from this independent testing program.”
About Diabetes Technology Society
Diabetes Technology Society is a non-profit educational organization dedicated to promote development and use of technology to help people with diabetes. DTS publishes Journal of Diabetes Science and Technology, the world’s largest scientific journal devoted to new technologies in the fight against diabetes, including glucose monitoring, insulin delivery, the artificial pancreas, software, wireless health solutions, social media, and bioengineered solutions for treating obesity. DTS presents the annual Diabetes Technology Meeting, the Hospital Diabetes Meeting, the Certified Diabetes Technology Clinician certification meeting in the US and in Europe, and the Tissue Response to Implanted Active Medical Devices Meeting. DTS has developed a Personalized Medicine Diabetes Program for the US Air Force. DTS is currently spearheading development of a new error grid for defining clinical accuracy of blood glucose monitors in cooperation with FDA, American Diabetes Association, The Endocrine Society, and Association for Advancement of Medical Instrumentation.
For additional information, contact Brett McGreevy at Diabetes Technology Society.
650-357-7140(mcgreevy@diabetestechnology.org) (www.diabetestechnology.org)