anzCGM Libre Evidence
Libre CGM sensors* meet the anzCGM Minimum Performance Standards, an independent framework developed by leading diabetes organisations in Australia and New Zealand to define what good CGM accuracy, precision and performance should look like. These standards help people living with diabetes understand what they can expect from a high‑quality glucose sensor in both everyday use and clinical settings. In Australia, only some CGMs currently meet anzCGM standards.84
As demonstrated by the below table, Libre CGMs* meet the anzCGM Minimum Performance Standards. By choosing Libre, you can feel confident your readings are accurate, consistent and ready to support your daily decisions. If you’re unsure whether your current CGM meets the anzCGM Minimum Performance Standards, speak with your healthcare professional.
Proposed/Recommended Minimum Standards for anzCGM Devices in Australia and New Zealand
(Source: https://www.diabetessociety.com.au/wp-content/uploads/2026/04/Ads-Adea-Adips-Anzsped-Nzssd-anzCGM-Minimum-Standards-April-2026.pdf. Accessed 21 April 2026).
| Testing requirements | Evidence: | ||
|---|---|---|---|
| At least 100 subjects are required in performance studies. |
U.S. Food and Drug Administration (FDA). 510(k) K222447. 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf. Accessed 21 April 2026.^
|
||
| A minimum of 4,000 paired data points in children and 12,000 pairs for adults | |||
| Glucose Range | Performance against reference reading | Lower one-sided 95% confidence bound must exceed requirement | Evidence: |
| Hypoglycaemia | |||
| < 3.9mmol/L | within +/-0.83 mmol/L | > 85% of readings | U.S. Food and Drug Administration (FDA). 510(k) K222447. 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf. Accessed 21 April 2026.^ |
| < 3.9 mmol/L | Within ± 2.22 mmol/L | >98% of readings | U.S. Food and Drug Administration (FDA). 510(k) K222447. 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf. Accessed 21 April 2026. |
| Normoglycaemia | |||
| 3.9-10.0 mmol/L | Within ± 15% | >70% of readings |
U.S. Food and Drug Administration (FDA). 510(k) K222447. 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf. Accessed 21 April 2026.
|
| 3.9-10.0 mmol/L | Within ± 40% | >99% of readings | |
| Hyperglycaemia | |||
| >10.0 mmol/L | Within ± 15% | >80% of readings |
U.S. Food and Drug Administration (FDA). 510(k) K222447. 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf. Accessed 21 April 2026.
|
| >10.0 mmol/L | Within ± 40% | >99% of readings | |
| Other Measures | |||
| Across reportable range | Within ± 20% | >87% of readings |
U.S. Food and Drug Administration (FDA). 510(k) K222447. 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf. Accessed 21 April 2026.
|
| Overall, across all glucose measuring ranges | Within ± 20% | >87% of readings | |
| CGM < 3.9 mmol/L when reference > 10.0 mmol/L | 0 readings | ||
| CGM > 10.0 mmol/L when reference < 3.9 mmol/L | 0 readings | ||
| CGM ROC > 0.055 mmol/L/min when corresponding true negative ROC < -0.111 mmol/L/min | ≤1% of readings | ||
| CGM ROC < -0.055 mmol/L/min when corresponding true positive ROC > 0.111 mmol/L/min | ≤1% of readings | ||
CGM – continuous glucose monitor; ROC – rate of change
*Current on-market Libre brand sensors in Australia and New Zealand. As of Apr 2026.
^Data demonstrates similar accuracy and rate of change performance in the pediatric population as compared to that in the adult population.
ADC-2689523 V1.0