YpsoPump Home-Use Study YP-HUS - IDT-1365-YL, YP-HUS, YPU101

Ypsomed AG0 个研究点目标入组 35 人开始时间: 2017年5月2日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Signed and dated informed consent
•- Adult (=18 years old when signing informed consent)
•- At least 1 year of personal experience with insulin pump therapy using insulin analogue
•- Willing to continue insulin pump therapy with the YpsoPump system during study
•- Willing to perform self-monitoring of BG at least four times per day

•- Severe late complications of diabetes mellitus, e.g. severe macro- and/or micro-angiopathy (as determined by the investigator)
•- Pregnancy or lactation period or active child wish (women only)
•- Unstable chronic disease other than diabetes (e.g. coronary artery disease, hypertension, renal disease) or any known life-threatening disease
•- Occurrence of self-reported severe hypoglycemic event requiring third party or health care assistance within the last 12 months prior to study start
•- Occurrence of self-reported diabetic ketoacidosis (severe, with hospitalization) within the last 6 months prior to study start
•- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation e.g. with required documentation
•- Current addiction to alcohol or substances of abuse as determined by the investigator
•- Known hypoglycemia unawareness
•- Any other condition that the investigator feels would interfere with trial participation or evaluation of results

发起方