Automated insulin delivery to optimse current care for Maori and Pacific peoples living with type 1 diabetes: Investigating the impact on glycaemic control

niversity of Otago0 个研究点目标入组 20 人开始时间: 2024年2月29日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•1.Adults of Maori or Pacific ethnicity, any gender, aged 16 – 65 years inclusive on day of consent.
•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 8.0% (64 mmol/mol).
•4.Minimum daily insulin requirement (total daily dose [TDD]) of greater than or equal to 8 units.
•5.Willing and able to adhere to the study protocol.
•6.Access to the internet and a computer system that meets requirements for uploading the study pump.

•1.Previous use of automated insulin delivery technology prior to baseline visit.
•2.Previous significant adverse event at investigator discretion that precludes the participant safely using advanced diabetes technology/sensors e.g., unable to wear glucose sensors due to prior cutaneous adverse events.
•3.Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
•4.Current use of Metformin, SGLT-2 or GLP-1 medications.
•5.History or current evidence of severe psychiatric disorder, uncontrolled seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), or severe visual impairment that in the opinion of the Investigator would limit study involvement or be a safety issue.
•6.Known moderate to severe diabetic retinopathy.
•7.If participant is of child-bearing potential, 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 pre-existing medical 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.

发起方