EASD, ADA Recommendations Aimed at Improving Safety, Efficacy of CGM

As the use of continuous glucose monitoring (CGM) devices becomes more prevalent worldwide, several professional medical organizations have banded together to examine barriers to use, including cost, reliability, and lack of standardization. Two organizations — the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group — have penned a joint statement, published in Diabetologia, examining the most efficacious ways to create systemic improvement, increase clinical use, and standardize device regulations.

“Growing evidence supports the benefits of using CGM,” noted John R. Petrie, MD, of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow in the United Kingdom, and colleagues. “[T]he studies and clinical trials reviewed … suggest that adults with type 1 diabetes who wear a CGM device … can improve glycemic control.”

Dr Petrie and colleagues continued, “Our goal was to assess current clinical and regulatory aspects of CGM within this rapidly evolving landscape in order to encourage cycles of improvement in device performance, clinical outcomes, and utilization.”

Following a meta-analysis of current studies examining CGM use in diabetes, the researchers were able to organize their recommendations according to the following themes:

• Increased structured and systemic premarket performance evaluations of CGM systems
• Greater investment in clinical trials providing evidence of the value and reliability of CGM in multiple patient groups
• Standardized glucose data reporting from clinical trials
• Consistent, accessible safety reports provided to regulatory authorities following device approval
• Increased cooperation and communication among all stakeholder groups

Investigators concluded their position statement by calling on both regulators and manufacturing companies to “work urgently with health professionals and people with diabetes” to create an environment conducive to the use of CGM devices.

A full list of the published recommendations can be viewed here.

Reference

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