Title
Regulatory standardisation to improve the safety of continuous glucose monitoring systems in Australia and New Zealand: joint ADS/ADEA/ADIPS/ANZSPED/NZSSD statement
Link to article in PubMed
Author(s)
Andrikopoulos, Sofianos
Raven, Lisa M
Ajjan, Ramzi
Lomax, Kate
Whelan, Tara
Fenton, Brett
Bartlett, Amanda
Joseph, Shantha
Abraham, Mary
Crocket, Hamish
Wilkinson, Tom
McClintock, Joanna
Wheeler, Benjamin
Ross, Glynis
Abstract
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.
Publication information
Intern Med J. 2026 Jul 29. doi: 10.1111/imj.70586. Online ahead of print.
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Regulatory standardisation to improve the safety of continuous glucose monitoring systems.pdf
Description
Re-used under a Creative Commons Attribution License: https://creativecommons.org/licenses/by-nc-nd/4.0/
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737.07 KB
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Date Issued
2026-07-29
Type
Journal Article
Journal Title
Internal medicine journal
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