Comparison of the Measurement Performance of POCTech CT-100B System, Dexcom G5® Mobile Continuous Glucose Monitoring System and Abbott FreeStyle® Libre System - IDT-1844-AY

Ascensia Diabetes Care Holdings AG0 个研究点目标入组 24 人开始时间: 2020年11月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Clinical diagnosis of type 1 diabetes for at least one year
•Age 18-70 years
•An understanding of and willingness to follow the protocol and sign the informed consent

•Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
•Hypoglycemia unawareness
•Results of screening of laboratory blood values are in the opinion of the investigator not acceptable and the safety of the patient or study personnel is impaired
•Female subjects: pregnancy, lactation period, lack of a negative
•pregnancy test (except in case of menopause, sterilization or hysterectomy)
•Intake of Paracetamol / Acetaminophen needed
•Known severe tape reactions or allergies
•History of frequent catheter abscesses associated with pump therapy
•BMI < 20 kg/m²
•Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
•Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug misuse
•Dependency from the sponsor or the clinical investigator

发起方