Evaluation of the effectiveness and safety of the RIGHTEST™ iFree 2 continuous glucose monitoring system in pregnant women with diabetes mellitus

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.