News & Statements


Stay up-to-date on this issue by reading the latest news coverage and statements from diabetes patients and organizations:
 
In the News

VIDEO: Experts call for tighter regulation of glucose monitoring devices
Clinical Endocrinology News
October 24, 2014
Congress should back better regulation of glucose-monitoring technologies and expanded access to continuous glucose monitoring for patients with either type 1 or insulin-dependent type 2 diabetes, according to two endocrinology organizations.

AACE Takes Glucose Monitoring Concerns to the Hill
MedPage Today
September 26, 2014
Members of the American Association of Clinical Endocrinologists will be meeting in Washington, D.C., this weekend to hash out their concerns and priorities when it comes to blood glucose monitoring.
AACE is bringing key diabetes stakeholders -- divided into four groups: science and medicine, industry, regulators and insurers, and patients -- to call attention to some of the biggest challenges in blood sugar monitoring at the moment.

AACE/ACE to Host Conference on Glucose Monitoring Based on Senior Patients Health Care Concerns
Diabetes News Journal
September 24, 2014
The end of patient coverage for the cost for continuous glucose monitors by Medicare at the age of 65 may be compromising the healthcare of older patients suffering from diabetes, according to the American Association of Clinical Endocrinologists (AACE)

Diabetes Technology Society to Monitor Glucose Meter Accuracy
Medscape
May 23, 2014
A new surveillance program will monitor blood glucose testing equipment that is currently on the market in the United States. Spearheaded by the nonprofit educational organization the Diabetes Technology Society (DTS), the DTS Surveillance Program for Cleared Blood Glucose Monitors is intended to provide independent assessment of the performance of blood glucose monitors cleared by the Food and Drug Administration (FDA) according to accepted standards.

Medicare's Diabetes Testing Supply Program Found Lacking* 
Medscape
January 29, 2014
A new survey from the American Association of Diabetes Educators (AADE) suggests that Medicare's recently introduced national mail-order program for diabetic testing supplies is limiting beneficiaries' access to the brands that work best for them.

Survey Finds Competitive Bidding Restricts Access to Diabetes Products 
The Gray Sheet
January 27, 2014
Due to poor CMS oversight, the competitive bidding system for mail ordered diabetes testing systems has reduced patient access to the products, the chief advocacy officer of the American Association of Diabetes Educators said Jan. 23, citing a recent survey put out by the association.

Retail Pharmacies Campaign against Medicare Bidding Program For Diabetic Supplies
Inside CMS
January 23, 2014
Diabetic advocates and retail pharmacists are ramping up another campaign against the Medicare bidding program for diabetes supplies, which they say hurts senior by leaving them with poor-quality products.

Blood Glucose Meters 2014 
Diabetes Forecast
January 2014
Accuracy. It’s the No. 1 thing readers shopping for a meter ask about. The fact is, home-use meters aren’t perfect, but they’re much more accurate than they used to be.

Poor performance of blood glucose monitors prompts call to action 
Endocrine Today
October 2021
The battle for better accuracy for blood glucose monitoring systems began years ago with a demand for stricter premarket standards. Emerging research and new regulatory and reimbursement issues, however, have cast the problem in a new light.

Diabetes Tech Society Gets FDA Buy-In For Glucose Monitor Surveillance Program 
The Gray Sheet 
September 13, 2021
The proposed surveillance program would test marketed blood glucose monitor systems to ensure they are performing at same the level expected as when they were cleared. It was met with support from FDA, device companies, academics and patient advocates.

Experts Debate Surveillance Program for Glucose Monitors* 
Medscape 
September 12, 2021
An ambitious new plan for postmarket surveillance of glucose testing equipment in the US aims to ameliorate recently identified accuracy problems, but attendees at a meeting earlier this week admitted that quite a few details still need to be ironed out.

Glucose Test Accuracy Concerns Prompting FDA Action* 
Medscape 
August 22, 2021
The US Food and Drug Administration (FDA) is poised to address both old and new concerns about the accuracy of home blood glucose testing.

Competitive Bidding Puts Diabetes Patients at Risk 
Roll Call
July 8, 2021
On July 1, Medicare implemented the national rollout of a new competitive bidding program for durable medical project that is intended to reduce health care costs without scarifying quality. 

The true face of competitive bidding 
The Congress Blog - The Hill
June 28, 2021
Under the Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) program, medical product manufacturers submit bids to supply products to Medicare beneficiaries. Lower costs win the war. There is a fatal flaw with this approach – it assumes all products are created equal.
 
Blood Glucose Meter Accuracy Problems Acknowledge by FDA, Industry and Clinicians 
The Gray Sheet
May 27, 2021
The Diabetes Technology Society sponsored a meeting last week entitled, “Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?” The resounding answer from participants: no.

Accuracy of Blood Glucose Meters Draws Scrutiny 
Kaiser Health News
May 21, 2021
Blood glucose meters, which millions of diabetics rely upon to regulate their blood sugar, have become less costly and easier and less painful to use. But they haven’t become more accurate, a top Food and Drug Administration official said Tuesday at a meeting of researchers analyzing studies that show wide variation in the performance of the machines used to measure blood glucose levels.

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Press Releases and Statements


AADE Analysis on Draft Guidance for Blood Glucose Monitoring Systems
American Association of Diabetes Educators
November 2014
The American Association of Diabetes Educators (AADE) was commissioned to conduct an analysis of the recent comments and feedback provided to the FDA on draft guidance for blood glucose monitoring systems. “Draft Guidance for Industry and FDA Staff – Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.”

American Association of Clinical Endocrinologists (AACE) Calls On Congress To Take Action To Improve Diabetes Patient Care
American Association of Clinical Endocrinologists (AACE)
October 24, 2014
The American Association of Clinical Endocrinologists (AACE) is calling on Congressional officials to enact crucial measures that will help ensure the safety of the nation’s patients with diabetes. 

American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) Rally Public, Private Stakeholders to Advocate for Improved Regulatory Oversight, Enhanced Patient Access to Diabetes Technologies
American Association of Clinical Endocrinologists (AACE)
September 30, 2014
Representatives from scientific and medical societies, patient advocacy groups, government entities, the insurance industry, the health products industry and more all agree that the time has come for regulatory improvements that will ensure the availability, safety and reliability of diabetes care technologies.

Diabetes Technology Society Outlines Potential Post-clearance Surveillance Program To Address Inaccuracy Of Blood Glucose Monitors
Diabetes Technology Society (DTS)
September 13, 2014
Diabetes experts met this week in Bethesda, Md., to identify new measures to ensure the safety of patients using potentially inaccurate self-monitoring blood glucose (SMBG) systems. This meeting comes on the heels of recent evidence demonstrating that some monitors fail to consistently meet accuracy standards post-FDA clearance.

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration
January 7, 2014
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document describes studies and criteria FDA recommends for blood glucose monitoring test systems (BGMSs) which are for prescription point-of-care use.

Diabetes Patients Face Unintended Consequences with New Competitive Bidding Program [AADE Survey] 
National Diabetes Volunteer Leadership Council (NDVLC)
January 2014
Dear Member of Congress, as you may recall, last July, Medicare rolled out a new competitive bidding program for durable medical products that was intended to reduce health care costs. While a good idea in theory, significant issues have surfaced in reality – especially when it comes to diabetes care.
 
Research Highlights the Need to Ensure Accuracy and Patient Choice of Diabetes Testing Supplies 
American Association of Diabetes Educators (AADE)
January 21, 2014
Two new surveys conducted by the American Association of Diabetes Educators demonstrate once again the need for the healthcare, insurance, and diabetes educator communities to ensure that people with diabetes are using meters that are appropriate for their individual needs – and are accurate.

Diabetes Hands Foundation Commends the Diabetes Technology Society (DTS), Food and Drug Administration (FDA) for First Steps to Protect Diabetes Patients 
Diabetes Hands Foundation (DHF)
September 10, 2021
The Diabetes Hands Foundation commends the Diabetes Technology Society (DTS) for its proposed plan to develop a post-market surveillance system to ensure the accuracy and quality of self-monitoring of blood glucose (SMBG) systems.

National Diabetes Volunteer Leadership Council (NDVLC) Urges FDA to Enforce Stringent Accuracy Standards for Blood Glucose Monitoring Systems 
National Diabetes Volunteer Leadership Council (NDVLC)
September 9, 2021
Today, representatives from the U.S. Food and Drug Administration (FDA), industry and the diabetes advocacy community will convene at a Diabetes Technology Society meeting in Bethesda, Md., to discuss possible solutions for verifying the accuracy of self-monitoring blood glucose (SMBG) systems.

Diabetes Hands Foundation Advocate To Speak At Diabetes Safety Meeting To Address Blood Glucose Monitoring 
Diabetes Hands Foundation (DHF)
September 6, 2021
The Diabetes Hands Foundation announced today that it will send diabetes advocate Bennet Dunlap to participate on a panel September 9, 2021 aiming to address the growing concerns around blood glucose test strip accuracy.

Statement by the American Diabetes Association on the Need for Food and Drug Administration’s Regulation of Blood Glucose Test Strips 
American Diabetes Association (ADA)
July 31, 2021
The evolution of portable glucose meters and test strips over the past few decades has revolutionized diabetes management. By being able to test their blood glucose as frequently as needed, patients have been able to simultaneously improve their diabetes self-management and gain greater freedom in their daily schedules for meals and physical activity.

Experts Agree: Inaccurate Blood Glucose Monitors on the Market May be Putting Patients at Risk 
Diabetes Technology Society (DTS)
May 28, 2021
Diabetes experts met and determined that some self-monitoring blood glucose (SMBG) systems, despite meeting accuracy standards at the time of U.S. Food and Drug Administration (FDA) clearance, fail to consistently meet accuracy standards once on the market, potentially putting patient health at risk.

Medical Devices in Diabetes Care: A statement on behalf of the European Association for the Study of Diabetes 
European Association for the Study of Diabetes (EASD)
March 14, 2021
The European Association for the Study of Diabetes is calling for an urgent overhaul of the current CE Marking procedure for the evaluation and approval of medical devices in Europe. As it currently stands, this system could result in situations that may seriously threaten the lives of people with diabetes because of its inadequacies. 

 

 

Did You Know?

The U.S. spends approximately $245 billion annually on diabetes care with $176 billion in direct medical costs, and $69 billion in indirect costs due to disability, work loss and premature mortality.4