Effect of advanced hybrid closed loop/artificial pancreas on glycaemic control in youth with type 1 diabetes using conventional injection therapy and high-risk glycaemic control

niversity of Otago0 个研究点目标入组 20 人开始时间: 2021年5月12日最近更新: 2024年4月1日

适应症

试验速览

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•1. Male or female aged 13 – 25 years inclusive.
•2. Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
•3. Current HbA1c level of greater than or equal to 8.5% (69mmol/mol).
•4. Not on insulin pump therapy prior to trial.
•5. Minimum daily insulin requirement of greater than or equal to 0.5 units of insulin/kg/day.
•6. Willing and able to adhere to the study protocol.
•7. Access to the internet and a computer system that meets requirements for uploading the study pump.

•1. Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
•2. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
•3. Current use of SGLT-2 or GLP-1 medications.
•4. Use of Hydroxyurea.
•5. History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
•6. History of severe visual impairment, in the opinion of the Investigator.
•7. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
•8. 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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