A Pathway to Better Clinical Value for Continuous Glucose Monitoring Systems

The global diabetes community once had high expectations for continuous glucose monitoring (CGM) systems, but the technology hasn’t caught on as quickly as anticipated. Costs, human factors, questions on how to use the data, measurement reliability, and no standards for displaying results have hindered its adoption in many areas of the world.

To improve the clinical utility of CGM systems, the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group issued a joint scientific statement that makes recommendations to all interested stakeholders including manufacturers, regulatory agencies, researchers, clinicians, and patient groups. “The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes,” the groups stated.

CGM aims to improve metabolic control by continually tracking glucose levels in the interstitial fluid. Some systems are viewed in real-time, others are blinded to the user. Implantable CGM devices are becoming available, although most are inserted into the skin and worn externally by consumers. Clinical studies and trial results generally support the advantages of CGM technology, although the clinical evidence of benefit is stronger for type 1 diabetes than type 2 diabetes. CGM devices have some design limitations and technical problems, as they cause rashes in some individuals and their sensors can malfunction. Wearing a device continually can be burdensome and there also are high costs associated with maintaining CGM.

“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 groups indicated. Improving CGM use requires a global effort from all interested parties to invest in clinical trials that would evidence the value of this technology to consumers, and to standardize CGM-measured glucose data reported from these trials, they suggested. The groups also called for structured pre-marketing evaluations of CGM system performance, making safety reports available to regulators after market approval, and fostering collaborative relationships among stakeholders.

The authors advised that:

1. Regulatory agencies establish a well-organized and independent premarketing and post-approval process to evaluate CGM system performance;
2. Manufacturers work with academia and healthcare professionals to educate people with diabetes about CGM, packaging the output data in usable formats for major electronic health record companies;
3. Researchers and academics develop improved algorithms for CGM and automated insulin delivery systems performance;
4. Research funding bodies fund larger, more comprehensive “class” studies that incorporate more than one CGM system, and large independent registry studies;
5. Patient groups, health professionals, and medical associations work with major diabetes organizations and other patient advocacy groups to broaden access to CGM to diabetics interested in using these devices on a regular basis; and
6. Consumers of CGM technology, including patients, family members, and caregivers, inform manufacturers and appropriate regulatory agencies of any device malfunctions or errors.

“For this vision to be realized without further delay, 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,” the authors summarized.