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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 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 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: September 15, 2014 – Diabetes Technology Society (DTS) is pleased to announce that it will hold a public meeting regarding payer liability for funding inaccurate blood glucose monitors. This meeting, which is free to attend, is an extension of the DTS Surveillance Program for Cleared Blood Glucose Monitors, which was launched on May 20, 2014. The event will be held on November 5, 2014 in Bethesda, Maryland, at the Residence Inn Downtown Bethesda.

After a product has been cleared by the Food and Drug Administration (FDA), there is currently no systematic post-market surveillance program available to monitor ongoing product quality. As a result, some patients diagnosed with diabetes are using blood glucose meters that do not perform to the standard of their FDA clearance. These devices can interfere with the patient’s ability to accurately monitor their blood glucose levels, which can lead to incorrect decisions about treatment and therefore adverse health effects.

The surveillance program will provide an independent assessment of the performance of cleared blood glucose monitors and generate information that can assist patients, payers, and healthcare providers in making informed product selections. The meeting on November 5, 2014will cover the outcomes and consequences for payers and patients who use products that have not maintained their performance level since being cleared by the FDA. The meeting will include perspectives from payers, clinicians, attorneys, scientists, the FDA, patients, and other members of the diabetes community.

Admission to the meeting on November 5, 2014 is free; however, registration will be necessary to attend the event as space is limited. To register, please visit: www.diabetestechnology.org/surveillancepayersmeeting.