Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes
Authors' conclusion
The system showed a good performance compared to capillary BG measurements. This level of accuracy could be shown over the entire measurement range, especially in the low glycemic range, and the whole wear time of the sensors. The results of this study are supporting a non-adjunctive use of the device.
Study context
- Population
- Adults with diabetes139 sensors analysed
- Participants
- 48 adults
- Comparison
- Novel continuous glucose monitoring (CGM) system vs capillary blood glucose (BG)
- Outcome
- 20/20 agreement rate: % of CGM readings within ±20 mg/dL (BG <100 mg/dL) or ±20% (BG ≥100 mg/dL) of the comparator
Methodological detailsmulticentre
- Multicentre
Performance
As reported in the abstract
20/20 AR vs capillary BG (in-clinic sessions) · up to 14 days
20/20 agreement rate (AR) during in-clinic sessions
90.5%
Further findings
Mean absolute relative difference (MARD) (in-clinic sessions)
- MARD during in-clinic sessions
- 9.2%
20/20 AR by BG range
- BG <70 mg/dL
- 94.3%
- BG 70-180 mg/dL
- 89.0%
- BG >180 mg/dL
- 92.5%
20/20 AR across sensor wear time
- Beginning of wear time
- 92.8%
- Middle of wear time
- 91.5%
- End of wear time
- 85.9%
Sensor survival · up to 14 days
- 14-day survival probability
- 82.4%
Safety
- Pain and bleeding after sensor insertion were within the expected range; use of the device regarded as safe
Original publication
Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes. J Diabetes Sci Technol. Published 19 August 2024. doi:10.
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