Diabetes Mellitus, Type 1 DiabetesNCT07889388
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
A study testing RIGHTEST iFree 2 Continuous Glucose Monitoring System in people with Diabetes Mellitus, Type 1 Diabetes and Diabetes Mellitus, Type 2, run by Bionime Corporation at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2, Diabetes, Gestational
- What is being tested?
- RIGHTEST iFree 2 Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jun 2026to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at enrollment.
- Diagnosis of type 1 diabetes mellitus, type 2 diabetes mellitus, or gestational diabetes mellitus.
- Gestational age of at least 12 weeks.
- Singleton pregnancy.
- Willing to wear one sensor on each upper arm simultaneously.
- Able to follow study-site instructions and complete all protocol-required tasks.
- Willing and able to provide signed written informed consent.
- Able to speak, read, and write German or Mandarin.
Who cannot join
- Known allergy to, or inability to tolerate, medical-grade adhesive tape.
- Extensive unresolved skin changes or diseases at sensor wear sites that prevent sensor placement, including extensive psoriasis, recent burns or severe sunburn, extensive eczema, scarring, tattoos, or dermatitis herpetiformis.
- Hematocrit below 30%.
- Hemoglobin below 11.0 g/dL in the first or third trimester, or below 10.5 g/dL in the second trimester, at screening.
- Body weight below 55 kg at screening.
- Inadequate venous access in the arms.
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- Stage 3 or higher renal insufficiency (eGFR below 60 mL/min/1.73 m²), current dialysis, or planned dialysis during sensor wear.
- Prescribed medication for preterm labor or high-risk complications in the current pregnancy, including:
- Use of tocolytics, such as atosiban, nifedipine, terbutaline, ritodrine, or magnesium sulfate.
- Use of progesterone for preterm birth prevention, including 17-hydroxyprogesterone caproate or vaginal progesterone.
- Placenta previa, placental abruption, preterm premature rupture of membranes, cervical insufficiency or short cervix, preeclampsia/eclampsia, or fetal growth restriction with abnormal Doppler flow.
- History of preterm birth before 34 weeks, or any condition that places the participant or fetus at undue risk in the Investigator's judgment.
- Implanted pacemaker or implantable cardioverter-defibrillator.
- Preeclampsia or eclampsia, including HELLP syndrome; severe cardiovascular disease; malignancy; severe liver dysfunction, including intrahepatic cholestasis of pregnancy or acute hepatic steatosis; known coagulation disorders; uncontrolled thyroid dysfunction; severe neurological disorders; or severe psychiatric disorders.
- Critical illness or a medical or psychiatric history that, in the Investigator's opinion, poses a participation risk or interferes with study compliance.
- Any condition that interferes with participation or poses excessive risk to study staff, including active illegal substance use or an active psychiatric disorder.
- Infectious disease, including AIDS, HIV, hepatitis B, or hepatitis C infection.
- A condition requiring or likely to require MRI, CT, positron emission tomography, angiography, X-ray, phototherapy, or diathermy during the study.
- Participation in another clinical trial within 2 weeks before screening, or planned participation in another clinical trial during this study.
- Any other reason making participation unsuitable in the Investigator's judgment, including acute febrile infection or acute exacerbation of a chronic disease.
- Severe hypoglycemia associated with seizure or loss of consciousness within 6 months before screening.
- Hypoglycemia unawareness within 6 months before screening, defined as inability to perceive or recognize symptoms of low blood glucose.
- Inability to independently read the product Instructions for Use or required user training materials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081
Manuela Link, +49 731 509900, diabetes@ifdt-ulm.de
About this study
Official title: Evaluation of the Effectiveness and Safety of the RIGHTEST™ iFree 2 Continuous Glucose Monitoring System in Pregnant Women With Diabetes Mellitus
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.
Read the detailed description
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.
- Being tested
- RIGHTEST iFree 2 Continuous Glucose Monitoring System
- Keywords
- Pregnancy, Continuous Glucose Monitoring, RIGHTEST iFree 2, Interstitial Glucose, Sensor Accuracy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIGHTEST iFree 2 Continuous Glucose Monitoring SystemDevice
The RIGHTEST iFree 2 Continuous Glucose Monitoring System (Bionime Corporation) measures interstitial glucose continuously for up to 15 days.
| Study group | Role | What they receive |
|---|---|---|
| RIGHTEST iFree 2 CGM System | Experimental | 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. Receives: Device: RIGHTEST iFree 2 Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During one sampling session of up to 6 hours on Day 1, Day 5 ±1, Day 10 ±1, or Day 15 of sensor wear.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From sensor insertion through the safety follow-up, within 7 days after sensor removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start9 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionime Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889388
- Sponsor's protocol ID
- UNI-510-M01
- Other IDs
- CIV-25-12-055655
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No