RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study

This prospective, multicenter, single-arm clinical performance study will evaluate the RIGHTEST iFree 2 CGM System over its intended 15-day wear period. Planned enrollment is 52 participants in Germany and 52 in Taiwan. The primary assessment will compare factory-calibrated readings from the designated primary sensor with paired reference blood glucose measurements. Additional assessments will evaluate accuracy across glucose ranges, glucose trend accuracy, agreement between the two sensors, performance throughout the wear period, sensor survival, data availability, and low- and high-glucose alert performance. Safety assessments will include adverse events and examination of sensor insertion sites.