RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• 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.

• 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.