RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study

A vizsgálat adatai

Ki végzi

Bionime Corporation

Azonosító

NCT07889388

A regiszteradat frissítve

2026. november 2.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: Prescribed medication for preterm labor or high-risk complications in the current pregnancy, including:; Participation in another clinical trial within 2 weeks before screening, or planned participation in another clinical trial during this study; Severe hypoglycemia associated with seizure or loss of consciousness within 6 months before screening; 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; 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; 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; Any other reason making participation unsuitable in the Investigator's judgment, including acute febrile infection or acute exacerbation of a chronic disease; Hemoglobin below 11.0 g/dL in the first or third trimester, or below 10.5 g/dL in the second trimester, at screening; Stage 3 or higher renal insufficiency (eGFR below 60 mL/min/1.73 m²), current dialysis, or planned dialysis during sensor wear; Use of tocolytics, such as atosiban, nifedipine, terbutaline, ritodrine, or magnesium sulfate; Hypoglycemia unawareness within 6 months before screening, defined as inability to perceive or recognize symptoms of low blood glucose; Hematocrit below 30%; Body weight below 55 kg at screening; Inadequate venous access in the arms; Use of progesterone for preterm birth prevention, including 17-hydroxyprogesterone caproate or vaginal progesterone; Implanted pacemaker or implantable cardioverter-defibrillator; Inability to independently read the product Instructions for Use or required user training materials.

ClinicalTrials.gov NCT07889388