Chicago, Illinois - While continuous glucose monitoring (CGM) systems-devices that use subcutaneous glucose sensors to automatically track blood glucose levels 24 hours a day, offer a wealth of information and potential benefit to people with diabetes, challenges in standardization and understanding have left them underutilized.
Acknowledging the potential benefit of CGM technology for people with diabetes and the need for standardized recommendations on how health care professionals, CGM manufacturers, regulatory authorities, policymakers and consumers can best ensure effective and appropriate use of CGM systems, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a team of experts to produce a joint scientific statement, “Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations,” to be published in the November 2017 issue of Diabetes Care, and online on October 25, 2017. It will be simultaneously published in Diabetologia by the European Association for the Study of Diabetes.
CGM systems alert users to changes in blood glucose levels, which assists them in making informed decisions about nutrition, physical activity and medication. While this technology has been available for more than 15 years, the percentage of people with diabetes who use CGM devices compared to those using conventional blood glucose measuring systems is still low in most parts of the world. This is, in part, due to issues of cost, measurement reliability (particularly with earlier-generation systems), user factors, lack of a standardized format for displaying results and uncertainty on how using CGM data to make therapeutic decisions.
The joint scientific statement includes specific recommendations for the stakeholders in CGM technology, including: regulatory agencies; manufacturing companies; researchers and academics; research funding bodies; patient groups, health professionals and medical associations; and consumers.
“Continuous glucose monitoring devices, by providing such in-depth information on daily glycemic profiles, can serve a vital role in improving health outcomes and quality of life for people with diabetes,” said William T. Cefalu, MD, chief scientific, medical and mission officer of the ADA. “As research, scientific and clinical knowledge continue to evolve rapidly in this area, the guidelines set forth by this scientific statement will greatly inform providers and further advance the standardization, accuracy and safety of CGM systems. This will ultimately assist patients, clinicians, researchers and manufacturers by increasing and improving the utilization of CGM technology.”
The statement is based upon an extensive review of more than 50 pieces of literature, and includes information from recent clinical trials, research abstracts, regulatory authorities (including their databases), manufacturing companies, and the team’s own clinical experience. The specific suggestions include: more systematic and structured premarketing evaluation of the performance of CGM systems; greater investment in trials to provide evidence of CGM value and reliability for all patient groups; standardization of CGM-measured glucose data reporting from clinical trials; improved consistency and accessibility of safety reports to regulatory authorities after market approval; and increased communication and cooperation across stakeholder groups.
“Continuous glucose monitoring is what those without diabetes are doing all the time, deep inside their biological control systems. That’s how energy is supplied reliably to every part of our bodies. With diabetes we lose this natural ability – but it can be replaced with technological solutions,” said David R. Matthews, MD, EASD/EFSD executive committee board member and chair of the EASD Committee on Clinical Affairs. “Such solutions – or devices – need to work well and be quality assured so that they are safe and reliable. This joint statement from the EASD and ADA outlines a clear direction of travel for further use and development of this important technology.”