Accuracy and Safety of the 15-Day CareSens Air Continuous Glucose Monitoring System
Authors' conclusion
The CareSens Air demonstrated accurate performance across the wide glycemic range and was well tolerated during the 15-day sensor use period.
Study context
- Population
- Adults with T1D or T2D requiring intensive insulin therapy, 4 sites in South Korea
- Participants
- 83 adults10,029 CGM-YSI pairs
- Comparison
- CareSens Air continuous glucose monitoring (CGM) vs YSI reference
- CareSens Airn = 83
- Outcome
- Accuracy: proportion of CGM values within 15% of YSI values ≥100 mg/dL or within 15 mg/dL of YSI values <100 mg/dL (%15/15), with %20/20, %30/30, %40/40 agreement rates; MARD vs YSI
- Follow-up
- 15 days
Methodological detailsmulticentre, single-group, Four 8-h clinic sessions on Day 1, 5 ± 1, 10 ± 1, and 15
- Multicentre
- Single-group
- Four 8-h clinic sessions on Day 1, 5 ± 1, 10 ± 1, and 15
Performance
As reported in the abstract
Overall accuracy vs YSI (10,029 CGM-YSI matched pairs)
- Overall mean absolute relative difference (MARD)
- 10.42%
- Overall %15/15 accuracy
- 78.55%
- Overall %20/20 accuracy
- 89.04%
- Overall %30/30 accuracy
- 96.47%
- Overall %40/40 accuracy
- 98.87%
Further findings
Consensus error grid analysis
- CGM values in Zone A or B
- 99.92%
- Zone A
- 89.83%
- Zone B
- 10.09%
%20/20 accuracy by day
- Day 1
- 88.11%
- Day 3-5
- 90.11%
- Day 8-10
- 92.09%
- Day 15
- 85.63%
Safety
- Serious adverse events
- 0
Original publication
Accuracy and Safety of the 15-Day CareSens Air Continuous Glucose Monitoring System. Diabetes Technol Ther. Published 13 February 2024. doi:10.
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