Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies

Background: Continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use in diabetes management is increasing. Cutaneous complications associated with these devices were reported. We conducted a systematic review to provide an overview of cutaneous complications with CGM/FGM use. Methods: We identified observational studies and intervention trials that report on cutaneous complications with CGM/FGM use up to January 14, 2019. Studies were identified through Medline, Embase, and PubMed, or with hand searching of the previous publications. Screening was duplicated and data extracted to consider four main themes: incidence rate and severity, participant perspectives of cutaneous complications, potential solutions, and future directions in diabetic technology relevant to reducing cutaneous complications. Results: A total of 54 eligible studies were identified. The overall event rate of cutaneous complications reported from 19 trials was one event per eight weeks of sensor wear-time of which 1.5% were considered severe. The most common cutaneous complications were wear-related erythema, itching, and induration. Although skin irritations were the most common cause of CGM/FGM discontinuation, most users experienced less pain or discomfort with CGM/FGM than capillary blood glucose testing. Future technological advances may reduce, but not eliminate cutaneous complications. Conclusion: The incidence rate of reported cutaneous complications with CGM/FGM use from the available literature is low, with one event per eight weeks of sensor wear-time. Reported complication severity was also low, leading to low rates of CGM/FGM discontinuation. However, there appear to be discrepancies between reporting in trial and observational data. Greater constancy in reporting is necessary to understand the frequency of this issue.