Factors in Accuracy Studies Influencing Measured Continuous Glucose Monitoring system (CGM) Performance: a comparison of measured continuous glucose monitor performance using venous, arterialized-venous and capillary reference glucose samples. - FACT-CGM study

Academisch Medisch Centrum0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•* aged 18 years or above
•* diagnosed with type 1 DM at least 6 months according to the WHO definition
•* Body Mass Index (BMI) <35 kg/m²
•* willing and able to wear a CGM device for the duration of the study and undergo all study procedures
•* HbA1c <10%
•* signed informed consent form prior to study entry

•* patient is pregnant, or breast feeding during the period of the study.
•* patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration.
•* patient requires regular use of acetaminophen (paracetamol) while participating in the study due to known negative impact on CGM performance.
•* patient is actively enrolled in another clinical trial or took part in a study within 30 days.
•* known adrenal gland problem, panhypopitutarism, gastroparesis, migraine, epilepsy or ischemic heart disease or other cardiovascular event in the year previous to study participation .
•* inability of the patient to comply with all study procedures.
•* inability of the patient to understand the patient information.
•* patient donated blood in the last 3 months.
•* has severe medical or psychological condition(s) or chronic conditions/ infections that in the opinion of the investigator would compromise the patient*s safety or successful participation in the study.
•* is assessed by the investigators to have difficult intravenous (IV) access.

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