se of the Hybrid Closed Loop system in people with Type 1 diabetes and impaired awareness of hypoglycaemia

Princess Margaret Hospital0 个研究点目标入组 38 人开始时间: 2016年7月8日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Aged 12 to 55 years
•2. Diagnosed with type 1 diabetes
•3. C-peptide negative (less than 0.05 nmol/L)
•4. On CSII for greater than or equal to 3 months
•5. Impaired awareness of hypoglycaemia: greater than or equal to a score of 4 on Gold’s questionnaire
•6. Understands study protocol requirements and agrees to comply with them

•1. Has adrenal insufficiency
•2. Has growth hormone insufficiency
•3. Has multiple pituitary hormone deficiency
•4. Is pregnant
•5. Chronic kidney disease (eGFR<45mL/min.1.73m2)
•6. Any non-insulin glucose lowering agent, for example metformin SGLT2 inhibitor or GLP-1 analogues within the last 3 months
•7. Oral steroid use within the last 3 months
•8. Cardiovascular disease:
•a. Uncontrolled hypertension (diastolic blood pressure >100mmHg and/or sustained systolic level (3 successive readings) > 160mmHg). Subjects taking antihypertensive medication will NOT be excluded provided they are maintained at a stable dose for 3 months prior to screening
•b. Has a history of acute myocardial infarction, heart failure, angina, transient ischemic attack (TIA), cerebrovascular accident (CVA), or thromboembolic disease.
•9. Has serious or unstable medical or psychological conditions which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.
•10. Poor visual acuity that precludes patients from using the pump technology
•11. Any additional condition(s) that in the investigator’s opinion would warrant exclusion from the study or prevent the subject from completing the study

发起方