The American Diabetes Association has issued a statement on improving the clinical value and use of continuous glucose monitoring systems.

Professor John Petrie, Professor of Diabetic Medicine at the Institute of Cardiovascular and Medical Sciences, was the lead and corresponding author on the statement, which included a team of medical and research experts from the American Diabetes Association (Association) and the European Association for the Study of Diabetes (EASD), who convened to evaluate CGM and related technologies.

The group aimed to consider and make recommendations on how health care professionals, CGM manufacturers, regulatory authorities, policymakers and consumers can best ensure effective and appropriate use of CGM as the technology continues to develop.

Continuous Glucose Monitoring (CGM) devices use subcutaneous glucose sensors to automatically track blood glucose levels 24 hours a day. The systems alert users to changes in blood glucose levels, therefore assisting them in making informed decisions about nutrition, physical activity and medication. While CGM systems have been available for over 15 years, the percentage of people with diabetes who use CGM, compared to conventional blood glucose measuring systems, is still low in most parts of the world, including Scotland, where the standard of care is finger prick blood glucose testing which is painful and hard to do more than three or four times a day. 

In the UK (including Scotland), CGM devices, which avoid the need for regular finger pricking, are much less frequently used than in other developed countries as most patients have to self-fund the devices and consumables.

Prof Petrie said: “This joint statement by the world’s two largest diabetes scientific societies sets out a roadmap of the steps required to be taken by industry, regulators, funding bodies, health professionals, consumers and professional associations for much wider global uptake (and reimbursement) of non-invasive glucose-sensing technologies. 

"These devices can give people with diabetes, particularly those with type 1, much more flexibility in their daily lives – and freedom from the drudgery and pain of frequent finger-pricking. I am delighted that the University of Glasgow has been able to take a leading role in driving this forward.”

The comprehensive suggestions are featured in the article, “Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations, A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group,” to be published in the November 2017 issue of Diabetes Care, and online on October 25, 2017. The article is being simultaneously published in Diabetes Care by the American Diabetes Association and in Diabetologia by the European Association for the Study of Diabetes.

The statement is based upon an extensive review of over 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 recommendations note that while CGM devices have been studied primarily for the use of people with type 1 diabetes, there is limited evidence to support the use of CGM in people with type 2 diabetes. Additionally, insufficient proof of clinical utility and reliability, along with lack of consistent reimbursement are both cited as contributing factors to the limited use of CGM across large populations of people with diabetes. Furthermore, the authors note that CGM is critically important technology for the future outlook of automated insulin delivery systems, which combine CGM devices with insulin pumps.

The guidelines set forth in the statement urge regulators and manufacturing companies to work 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.

The specific suggestions are categorized to 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.

 

 

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Enquiries: ali.howard@glasgow.ac.uk or elizabeth.mcmeekin@glasgow.ac.uk // 0141 330 6557 or 0141 330 4831

First published: 27 October 2017