Accuracy of a 15-day Factory-Calibrated Continuous Glucose Monitoring System With Improved Sensor Design
Authors' conclusion
The Libre 2 Plus and Libre 3 Plus Systems provide accurate glucose results across the dynamic range during the 15-day sensor wear period.
Study context
- Population
- Participants aged ≥2 years with paired continuous glucose monitoring (CGM) and comparator data, 7 US sitesenrolled
- Participants
- 332 participants
- Comparison
- 15-day CGM sensor vs YSI comparator glucose
- Adultsn = 149
- Pediatric (6-17 years)n = 124
- Pediatric (2 to 5 years)n = 12
- Outcome
- Proportion of CGM values within ±20%/±20 mg/dL of comparator glucose values and MARD between CGM and comparator values
- Follow-up
- 15-day sensor wear period
Methodological detailsmulticentre, factory-calibrated, supervised glycemic manipulation (≥11 years)
- Multicentre
- Factory-calibrated
- Supervised glycemic manipulation (≥11 years)
Performance
As reported in the abstract
Accuracy vs YSI comparator
| Outcome | Adults | Pediatric (6-17 years) |
|---|---|---|
| Within ±20 mg/dL/20% | 94.2% | 94.0% |
| MARD | 8.2% | 8.1% |
Further findings
| Outcome | Adults | Pediatric (6-17 years) |
|---|---|---|
| Hypoglycemic range: results within ±15 mg/dL of YSI comparator | 97.1% | 98.0% |
- Accuracy vs self-monitoring of blood glucose (SMBG) comparator, ages 2 to 5 years: Pediatric (2-5 years) within ±20 mg/dL/20% 86.6% · mean absolute relative difference (MARD) 11.2%
Original publication
Accuracy of a 15-day Factory-Calibrated Continuous Glucose Monitoring System With Improved Sensor Design. J Diabetes Sci Technol. Published 4 April 2025. doi:10.
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