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Regulatory standardisation to improve the safety of continuous glucose monitoring systems in Australia and New Zealand: joint ADS/ADEA/ADIPS/ANZSPED/NZSSD statement
Journal article   Open access   Peer reviewed

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

Sofianos Andrikopoulos, Lisa M Raven, Ramzi Ajjan, Kate Lomax, Tara Whelan, Brett Fenton, Amanda Bartlett, Shantha Joseph, Matthew Hare, Mary B Abraham, …
Internal medicine journal
29/07/2026
Handle:
https://hdl.handle.net/10523/52008

Abstract

CGM type 1 diabetes continuous glucose monitor diabetes
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.
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Internal Medicine Journal - 2026 - Andrikopoulos - Regulatory standardisation to improve the safety of continuous glucose737.96 kBDownloadView
Published (Version of record) Open Access CC BY-NC-ND V4.0
url
https://doi.org/10.1111/imj.70586View
Published (Version of record) Open CC BY-NC-ND V4.0

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