Randomized cross over trial comparing advanced hybrid closed loop mode with sensor augmented pump therapy in type 1 diabetes.

Medtronic Inc0 个研究点目标入组 59 人开始时间: 2019年1月8日最近更新: 2020年1月6日

适应症

试验速览

暂无简介。

•Male or female aged 7 – 80 years inclusive.
•Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
•On insulin pump therapy for at least 6 months prior to study Day 1.
•Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
•Willing and able to adhere to the study protocol.
•Access to the internet and a computer system that meets requirements for uploading the study pump.

•1.Mean HbA1c of more than 10.0% (86 mmol/mol), within 6 months prior to Study Day 1 (minimum of one test).
•2.Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
•3.Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
•4.Current use of SGLT-2 or GLP-1 medications.
•4.History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
•5.History of severe visual impairment, in the opinion of the Investigator.
•6.If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at screening is exclusionary.
•7.Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

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