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Accuracy and Reliability of the Sinocare Continuous Glucose Monitoring System
Anuj Bhargava1, Kristy S McKeating2, Alvin Lin3
1Iowa Diabetes Research, West Des Moines, IA, USA.
Summary
The Sinocare iCan i3 Continuous Glucose Monitoring (CGM) system demonstrated 17.2% MARD in a real-world setting. Most sensors lasted 15 days, showing good accuracy against blood glucose meter references.
Area of Science:
- Endocrinology
- Medical Devices
- Diabetes Technology
Background:
- The Sinocare iCan i3 Continuous Glucose Monitoring (CGM) system is available in China and select European markets.
- Real-world performance data for this CGM system is limited.
Purpose of the Study:
- To evaluate the performance of the Sinocare iCan i3 CGM system in a free-living environment.
- Assess the accuracy and reliability of the CGM system compared to a blood glucose meter (BGM).
Main Methods:
- 36 participants with type 1 or type 2 diabetes wore the iCan i3 CGM for up to 15 days.
- CGM data was compared against capillary fingerstick BGM tests performed up to 8 times daily.
- Sensor performance was evaluated for analytical accuracy, clinical accuracy, and sensor survival rate.
Main Results:
- The mean absolute relative difference (MARD) was 17.2%.
- 69.5% of CGM readings were within 20 mg/dL or 20% of BGM reference values.
- 77.1% of sensors achieved the full 15-day wear duration.
Conclusions:
- The Sinocare iCan i3 CGM system demonstrated acceptable accuracy and reliability in a real-world setting.
- Sensor survival rate indicates potential for sustained glucose monitoring over 15 days.
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