An interventional study of RIGHTEST iFree 2 Continuous Glucose Monitoring System in Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2 and Diabetes, Gestational, sponsored by Bionime Corporation. Recruiting at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Bionime Corporation · Not applicable, Interventional, and Other
This study will evaluate the accuracy and safety of the RIGHTEST iFree 2 Continuous Glucose Monitoring (CGM) System in pregnant women with type 1 diabetes, type 2 diabetes, or gestational diabetes. The system uses a small sensor placed under the skin to measure glucose levels in the fluid between cells.
Approximately 104 women will participate at study sites in Germany and Taiwan. Each participant will wear two sensors, one on each upper arm, for up to 15 days. During one clinic visit lasting up to six hours, blood samples will be collected every 15 minutes. Sensor readings will be compared with laboratory blood glucose measurements to assess accuracy.
Participants will also be assessed for side effects, including skin reactions at the sensor sites, and will receive a safety follow-up after sensor removal. No procedures will be used to deliberately raise or lower blood glucose levels.
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 104 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Bionime Corporation is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Pregnant women with type 1 diabetes, type 2 diabetes, or gestational diabetes will wear two RIGHTEST iFree 2 CGM sensors, one on each upper arm, for up to 15 days. Each participant will undergo one frequent blood sampling visit lasting up to six hours to assess sensor accuracy against reference blood glucose measurements.
Device: RIGHTEST iFree 2 Continuous Glucose Monitoring System
The RIGHTEST iFree 2 Continuous Glucose Monitoring System (Bionime Corporation) measures interstitial glucose continuously for up to 15 days.
Percentage of CGM Readings Within ±20% of Reference Blood Glucose Measurements
Percentage of raw CGM readings from the designated primary sensor within ±20% of paired venous blood glucose measurements obtained using the YSI 2300 analyzer, across the device measuring range. CGM and reference measurements are paired within a maximum time difference of 5 minutes.
Time frame: During one sampling session of up to 6 hours on Day 1, Day 5 ±1, Day 10 ±1, or Day 15 of sensor wear.
CGM Accuracy
Accuracy of primary-sensor CGM readings against paired YSI 2300 blood glucose measurements, including agreement within ±20% after user calibration; 15/15%, 20/20%, and 40/40% agreement overall and by glucose range; glucose-range concurrence; mean absolute relative difference (MARD) by glucose range; reference values corresponding to LOW/HIGH readings; Clarke and Consensus Error Grid zone distributions; and glucose rate-of-change concurrence. Glucose ranges include \<54, 54-69, 70-180, 181-250, and \>250 mg/dL. Raw and user-calibrated readings are analyzed separately.
Time frame: During one sampling session of up to 6 hours on Day 1, Day 5 ±1, Day 10 ±1, or Day 15 of sensor wear.
Between-Sensor Precision
Precision assessed using mean paired absolute relative difference (PARD) and coefficient of variation (CV) between two sensors worn simultaneously by each participant. Readings are paired within ±30 seconds. Raw and user-calibrated readings are analyzed separately.
Time frame: Throughout the sensor wear period, up to 15 days.
Performance Across the Sensor Wear Period
Primary-sensor accuracy assessed by 15/15%, 20/20%, and 40/40% agreement and MARD at Day 1, Day 5 ±1, Day 10 ±1, and Day 15, with each participant contributing one assigned sampling visit. Raw and user-calibrated readings are analyzed separately. Sensor survival and reading provision rates are assessed throughout wear using both primary and secondary sensors.
Time frame: Throughout sensor wear, up to 15 days; reference sampling on one assigned day: Day 1, Day 5 ±1, Day 10 ±1, or Day 15.
Hypoglycemia and Hyperglycemia Alert Performance
True alert, false alert, correct detection, and missed detection rates for primary-sensor hypoglycemia and hyperglycemia alerts. Alerts are compared with reference blood glucose measurements using a ±15-minute matching window around device alerts or reference glucose events.
Time frame: During one sampling session of up to 6 hours on Day 1, Day 5 ±1, Day 10 ±1, or Day 15 of sensor wear.
Safety of the CGM System
Number and percentage of participants experiencing adverse events, serious adverse events, adverse device effects, serious adverse device effects, or unanticipated problems, characterized by severity and relationship to the device or study procedures. Assessments include reactions at sensor insertion sites.
Time frame: From sensor insertion through the safety follow-up, within 7 days after sensor removal.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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