Statement: CGM Trials Need Standards, Safety Reports Must Be Transparent

Clinical trials for continuous glucose monitoring (CGM) systems would benefit from common standards to allow comparisons and meta-analyses, and regulatory safety reports must be transparent to win the confidence of payers and consumers alike, says a new scientific statement on CGM from the leading advocacy groups in the United States and Europe.

The statement, from the Diabetes Technology Working Group of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) finds that, while CGM technology has vastly improved over the past decade, it has not reached its potential for a variety reasons, including lack of reimbursement, especially among those with type 2 diabetes (T2D). Advocate Kelly Close of Close Concerns offered comments on the statement from a consumer perspective.

With CGM systems poised to become smaller, cheaper, and more user-friendly, the potential for the technology to penetrate the vastly larger T2D population—roughly 29 million in the United States—could fall short if payers refuse to cover it. The statement released Thursday in Diabetes Care serves as a primer on what steps manufacturers might take to avoid that fate.

The statement notes the contrast between the limited data needed for regulatory approval and the larger, longer-duration trials typically performed to win over payers, whose results may be based on devices that lag behind whatever new model is hitting the market. In the United States, this has played out over the past year as some payers have balked at covering the Medtronic MiniMed 670G, the first technology to earn the FDA designation of “artificial pancreas,” after years of anticipation among those with type 1 diabetes (T1D).

The authors made 31 specific recommendations, which covered 5 broad areas:

• Manufacturers should make more “systematic and structured premarketing evaluation” of CGM systems before seeking approval and bringing them to market.
• More “investment” is needed in CGM trials to show reliability and safety; in other words, trials should be larger and longer.
• Data reporting from clinical trials must be standardized. The statement noted that, while there have been some data summaries, there have been diverse conclusions, in part because of the way original data were reported.
• Post-marketing safety reports to regulatory authorities need more “consistency and accessibility.”
• The statement called for “improved communication and cooperation across all stakeholder groups.”

While CGM is considered the standard of care in T1D, and Medicare has approved the Dexcom G5 for both T1D and those with T2D on intensive insulin therapy, the authors noted that studies funded by industry put CGM systems in a more favorable light than did those funded by payers.

Lack of education on how to use CGM data, for both patients and clinicians, is also a problem. Most education is funded by manufacturers, and patients who use CGM may not have meaningful discussions with primary care physicians about trends revealed in the data. The paperwork alone is a deterrent for patients who might benefit from CGM, the authors write.

“Insufficient evidence of clinical utility and reliability and the lack of consistent reimbursement contribute to limited use of CGM across large populations of people with diabetes who could potentially benefit,” the authors conclude.

“We call upon regulators and manufacturing companies to work urgently with health professionals and people with diabetes to create an environment with much greater standardization of outcome measures, a high level of attention to safety issues, and full transparency of adverse event reporting.”

Reference

Petrie JR, Peters AL, Bergenstal RM, Holl RW, Fleming GA, Heinemann L. Improving the clinical value and utility of CGM systems: issues and recommendations [published online October 25, 2017]. Diabetes Care. 2017; https://doi.org/10.2337/dci17-0043.