E14
Conditions
Interventions
Group 1: This is a prospective, open-label, global, multicenter, randomized, single-arm pivotal study without control groups.
Study population: Up to 104 pregnant women (52 in Germany and 52 in Taiw
Sponsors
Bionime Corporation
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Subject must be 18 years and older at time of enrollment. - Subject must have a diagnosis of type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) or gestational diabetes mellitus (GDM). - Subject must be at = 12 weeks of gestation. - Subject must be singleton pregnancy. - Subject must be willing to wear 1 Sensor on each upper arm simultaneously. - Subject must be able to follow the instructions provided to her by the study site and perform all study tasks as specified by the protocol. - Subject must be willing and able to provide signed written consent. - Subject must be able to speak, read and write in German.
Exclusion criteria
Exclusion criteria: - Known allergy or inability to tolerate to medical grade tape adhesive. - Presence and unresolved of extensive skin changes/diseases at Sensor wear site(s) that preclude wearing the Sensor(s) on skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, or dermatitis herpetiformis). - A hematocrit level is less than 30%. - Hemoglobin of < 11.0 g/dl in the 1st and 3rd trimester or < 10.5 g/dl in the 2nd trimester at screening. - Body weight < 55 kg at screening - Inadequate venous conditions for intravenous (IV) access on arms - Renal insufficiency Stage 3 or higher (eGFR < 60 mL/min/1.73m²2) or currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period. - Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy. o Use of tocolytics (e.g., atosiban, nifedipine, terbutaline, ritodrine, magnesium sulfate). o Use of progesterone for preterm birth prevention (e.g., 17-hydroxyprogesterone caproate [17-OHPC], vaginal progesterone). o High-risk obstetric complications, including any of: placenta previa, placental abruption, PPROM (preterm premature rupture of membranes), cervical insufficiency/short cervix, preeclampsia/eclampsia, fetal growth restriction (IUGR) with abnormal Doppler flow. o History of moderately preterm birth (<34 weeks), or any condition that, in the Investigator’s judgment, places the participant or fetus at undue risk. - Implanted pacemaker or Implantable Cardioverter Defibrillator. - Preeclampsia or eclampsia including HELLP syndrome (hemolysis, elevated liver enzymes, low platelets), severe cardiovascular diseases (e.g., disorders of cardiac pump function, cardiac arrhythmias), malignant diseases, sever liver dysfunction (e.g. ICP (intrahepatic cholestasis of pregnancy), acute hepatic steatosis), known coagulation disorders, uncontrolled thyroid dysfunction, severe neurological disorders (e.g. known epilepsy), severe psychiatric disorders (e.g. known schizophrenia) - Critically ill, as defined that subject having any history of medical or psychiatric conditions that in the opinion of the Investigator, would pose a risk for participation or interfere with compliance in this study. - Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose excessive risk to study staff. Some examples of conditions that Investigators may consider exclusionary are active illegal substance use; or active psychiatric disorder. - Subjects with infectious diseases are excluded from the study, including but not limited to Acquired Immune Deficiency Syndrome (AIDS). - Subject with HIV, Hepatitis B or Hepatitis C infection are excluded from the study. - A condition requiring or likely to requiring magnetic resonance imaging (MRI), computerized tomography (CT), Positron Emission Tomography, Angiography, X-ray, Phototherapy or diathermy scheduled during the study. - Participated in another clinical trial within 2 weeks prior to screening or are intending to participate in another clinical trial during the study. - Unsuitable for participation due to any other cause as determined by the Investigator e.g. acute febrile infection, acute exacerbation of a chronic disease (e.g. rheumatoid arthritis, Morbus Crohn, Colitis ulcerosa, systemic lupus erythematosus) - History of severe hypoglycemia within 6 mo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The analysis of primary endpoint with regards to system accuracy is based on all raw CGM-Reference matched pairs collected from RIGHTEST™ iFree 2 CGM during all study visits. The CGM system raw readings as provided by the primary sensor are compared with reference measurements (performed using the YSI 2300 Analyzer) within the claimed measurement range of 40 to 500 mg/dL. Accuracy: The accuracy of the CGM system depends on raw CGM-Reference matched pairs that are obtained during the in-clinic visit (on Day 1, 5, 10 or 15). The percentage of the CGM system raw readings within ±20% of paired reference measurements across the device measuring range overall are evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints evaluating accuracy, precision, stability, and performance in hypoglycemia and hyperglycemia event alerts will be assessed based on CGM system readings at different glucose rates of change and across various glucose ranges. The safety of the CGM system will be examined through the number and percentage of subjects experiencing adverse events and examined through symptoms related to the Sensor insertion site. | — |
Countries
Germany, Taiwan
Contacts
Public ContactManuela Link
Institut für Diabetes-Technologie Ulm GmbH
Outcome results
None listed