Regulatory standardisation to improve the safety of continuous glucose monitoring systems in Australia and New Zealand: joint ADS/ADEA/ADIPS/ANZSPED/NZSSD statement.

Self-monitoring of glycaemia is a cornerstone of diabetes management, particularly for people using insulin. Traditionally, glucose monitoring involved finger-pricking and measuring capillary blood glucose concentration. Continuous glucose monitors (CGMs) have revolutionised self-monitoring of glucose levels. These devices provide continuous interstitial fluid glucose measurements, including trend arrows and alarms to alert the person if glucose levels are outside predetermined ranges. The increased reliance on CGM metrics for clinical decisions to manage diabetes necessitates the consideration and implementation of minimum standards that device manufacturers should meet to demonstrate safety, precision and accuracy. This statement provides recommendations to ensure that CGM devices that are approved for the Australian and New Zealand markets meet/exceed these minimum standards of accuracy, to provide health professionals and people living with diabetes the confidence to manage their glucose levels effectively.