ACTRN12622000889752尚未招募未知
Efficacy and Safety of Glucose Control with a Next Generation Hybrid Closed Loop (HCL) System in Adults with Diabetes and Advanced Renal Disease
St Vincent's Hospital Mebourne0 个研究点目标入组 40 人开始时间: 2022年6月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Age 18-70 years
- •Type 1 Diabetes of at least 1-year duration or insulin requiring Type 2 Diabetes
- •Managed with multiple daily insulin injections or insulin pump therapy
- •HbA1c <10.5%
- •Renal function falls into one of the following 3 groups:
- •·Group A: Stage 3B and Stage 4 renal failure (eGFR <45 and >15mL/min/1.73m2)
- •·Group B: ESRD requiring peritoneal dialysis
- •·Group C: ESRD requiring haemodialysis
- •Total daily dose of insulin <200 units
- •Participant (and carer where applicable) is fluent in English reading and writing
- •Willing to learn how to carbohydrate count and to apply this knowledge
- •Have a computer with internet access
- •Have access to Smart device with data plan
排除标准
- •Already using a hybrid closed loop system
- •On sulphonylureas or SGLT2 inhibitors
- •For Group A patients – on metformin or GLP1 analogues outside of regulatory guidelines
- •For Group B and C patients – on any non-insulin glucose lowering therapies
- •History of diabetic ketoacidosis
- •Systemic steroid therapy within past four weeks
- •Moderate to severe cognitive impairment precluding the use of insulin pump therapy
- •Major allergy to tape or adhesives
- •Women who are pregnant or planning pregnancy during the study period
- •Major life-threatening illness limiting the participant’s life expectancy to <6 months
- •Major psychiatric history
- •On peritoneal dialysis using icodextrin
研究者
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