Accuracy and Safety of the LinX Continuous Glucose Monitoring System in Adults With Diabetes: A Prospective Multicentre Open-Label Clinical Performance Study.

Background

Accurate continuous glucose monitoring (CGM) is essential for diabetes management. This study evaluated the accuracy and safety of the LinX CGM system over 15 days in adults with diabetes.

Methods

In this prospective, multicentre, open-label clinical performance study, 87 adults who wore two LinX sensors were enrolled. Reference glucose was measured using a Biosen analyser. Primary endpoints were the proportions of readings within ±15%/±40% of reference values and mean absolute relative difference (MARD).

Results

Overall MARD was 8.66% (95% CI: 8.27%-9.05%). For glucose concentrations in the range of 3.9-10.0 mmol/L (70-180 mg/dL), 87.2% of readings were within ±15%; for concentrations ≥ 10.0 mmol/L (≥ 180 mg/dL), 90.2% were within ±15%. Within ±40%, agreement rates were 99.8% and 100.0%, respectively. Sensor survival at 15 days was 96.0%. No serious adverse events occurred.

Conclusion

The LinX CGM system demonstrated good analytical accuracy and favourable short-term safety over a 15-day wear period in adults with diabetes. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR2200064004.