Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting

Abstract

Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.

Keywords: CGM; Clinical trials; Recommendation.