Highlights from the Consensus Conference on Glucose Monitoring
by Varun Iyengar and Adam Brown
Twitter Summary: Meeting underscores inadequate meter surveillance; Novel program to identify subpar BGMs; Medicare coverage of CGM gaining momentum?
Short Summary: The Consensus Conference on Glucose Monitoring took place in Washington D.C. to discuss quality and safety of glucose monitoring. Discussion topics included the need for greater post-market surveillance, the DTS Surveillance Program, the FDA, and two CGM Medicare bills currently in Congress.
On September 28 and 29, we had the opportunity to attend the Consensus Conference on Glucose Monitoring in Washington D.C. The meeting brought together some of the brightest minds in industry, government, and academia to discuss the quality and safety of blood glucose monitors and continuous glucose monitors (CGMs).
The discussion largely focused on the need for greater quality surveillance of blood glucose meters after they are approved by the FDA. We heard widespread concern that a significant proportion of meters on today’s market (~50%) do not actually meet current accuracy standards – these are usually meters made by obscure manufacturers. Part of the problem is that once manufacturers receive clearance for a device, there are no quality assurance mechanisms in place. The burden is on manufacturers – not the FDA – to make sure strip quality and accuracy remain high. Manufacturers who cut corners are often not identified and, of more concern, their products remain on the market.
We also heard a promising update on the status of the Diabetes Technology Society’s (DTS) Surveillance Program for Cleared Blood Glucose Meters. This program has plans to test the accuracy of off-the-shelf, FDA-cleared meters in order to identify inaccurate products. The data would be made publicly available, allowing patients, insurance companies, and healthcare providers know which products are of high or low quality. Though DTS cannot force companies to stop manufacturing poorly performing meters, there is hope that identifying them will force a regulatory body, such as the FDA, to take action. The program is still in need of funding, though DTS representative Dr. David Klonoff said that the plan is to begin testing meters by mid-2015.
The FDA’s patient-centered spirit was a welcome sign at the meeting. The Agency’s Dr. Courtney Lias – who leads the diabetes device division – expressed a clear understanding of the daily challenges patients face, and also shared a strong desire to get devices like the artificial pancreas into patients’ hand sooner. On the glucose monitoring front, she emphasized that it is very challenging for the FDA to “un-approve” a device, making it difficult for the FDA to remove inaccurate meters from the market. In addition, the agency is pressed for resources and cannot conduct factory inspections abroad as often as it would like. The data from DTS’ program could empower the FDA to seek out and investigate those manufacturers with sub-standard products.
Last, we heard increasing momentum for two bills – now in the House and Senate – that seek to establish Medicare coverage of CGM. It was widely acknowledged that this technology should not be taken away from patients turning 65, especially given its ability to significantly reduce hypoglycemia. Our fingers are crossed that we see movement on this front.