Standardized Procedure for the Assessment of new-to-market Continuous glucosE monitoring systems: an open-label study

Academic Medical Centre (Netherlands)0 个研究点目标入组 20 人开始时间: 2012年8月2日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Aged 18 years or above
•2. Diagnosed with Type 1 diabetes mellitus (DM) at least 6 months according to the WHO definition
•3. Body Mass Index (BMI) <35 kg/m²
•4. Willing and able to wear a CGM device for the duration of the study and undergo all study procedures
•5. HbA1c <10%
•6. Signed informed consent form prior to study entry

•1. Patient is pregnant or breastfeeding during the period of the study
•2. Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last 3 months and expected to remain stable for the study duration
•3. 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
•4. Patient is actively enrolled in another clinical trial or took part in a study within 30 days
•5. Known adrenal gland problem, pancreatic tumour or insulinoma
•6. Inability of the patient to comply with all study procedures
•7. Inability of the patient to understand the patient information
•8. Patient donated blood in the last 3 months

发起方

Academic Medical Centre (Netherlands)