A Multicentre Clinical Investigation Plan to Investigate the Performance of the CGM-Watchâ?¢ in an Adult Population with Type 1 and 2 Diabetes Mellitus

emaura Pharma Ltd0 个研究点目标入组 140 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•a)Male or female between 18-72 years of age at screening visit
•b)Diagnosed with Type 1 or Type 2 diabetes mellitus and on stable antidiabetic treatment for at least 3 months prior to screening visit
•c)No clinically significant derangement in liver and kidney functions per investigator discretion as assessed by standard laboratory parameters
•d)No clinical significant abnormality in haematocrit (Packed Cell volume) level per investigator discretion as assessed by standard laboratory parameters
•e)Willing to provide written informed consent

•a)Has skin changes or disease that preclude wearing of the device on normal skin at the application site, e.g. psoriasis, recent burns/scalds, recent sunburn, eczema, extensive scarring, extensive tattoos, dermatitis etc.
•b)Has a known allergy to medical grade adhesives
•c)Is pregnant (confirmed by positive pregnancy test) or suspected to be pregnant or are not willing to use appropriate contraception during the clinical investigation
•d)Has participated in another investigational study within 30 days of screening
•e)Any other clinically significant condition e.g. ischaemic heart disease, peripheral vascular disease, cardiomyopathy, cerebrovascular disease, congenital heart disease, or significant arrhythmia, epilepsy, significant hypoglycaemia unawareness, chronic infectious disease or any other inter-current illness which in the judgement of the investigator will interfere with the subjectâ??s ability to participate in this Clinical Investigational Plan
•f)History of severe hypoglycemia within 6 months of screening visit
•g)History of HIV, Hepatitis B or Hepatitis C
•h)Active psychotic illness or severe cognitive impairment

发起方

emaura Pharma Ltd