ACTRN12614000035628招募中未知
The impact of the overnight Closed loop system on glycemia, subsequent day-time metabolic control, insulin delivery, counter regulatory hormones, sleep quality, cognition and satisfaction with treatment, compared to Open loop system (Sensor Augmented Pump Therapy) in both the clinical trial centre (CTC) and in the home setting in adults with Type 1 Diabetes.
niversity of Melbourne0 个研究点目标入组 24 人开始时间: 2014年1月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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
- 14 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults aged greater than 14 years able to provide informed consent.
- •- T1 Diabetes for a minimum of 6 months (fasting C-peptide levels less than 50 pmol/L).
- •- HbA1c less than 8.5%.
- •- Experience with a continuous glucose sensor with established basal insulin infusion patterns, insulin to carbohydrate ratios, regular use of the insulin bolus calculator, can insert/ change sensor by themselves, can recharge transmitter, and has experience in reading real time continuous glucose monitoring (RT-CGM) data.
- •- Accurate carbohydrate counting.
- •- Experience in uploading pump information to web.
- •- Residing in Melbourne or Perth.
- •- Willing to comply with the study protocol requirements inclusive of those requirements related to participant safety.
排除标准
- •- Requiring greater than 150 units of insulin/day.
- •- Diabetic ketoacidosis (DKA) within the past 4 weeks.
- •- Hypoglycaemic unawareness (Gold score = 4) while on SAPT
- •- More than 2 severe hypoglycaemic episodes within the last 12 months
- •- Pregnant or planning pregnancy within study period.
- •- Renal impairment (eGFR less than 60ml/min).
- •- Current or recent (less than 4 weeks) inhaled or oral steroid therapy.
- •- Dermatological conditions (eg psoriasis) involving the region of glucose sensor/ insulin delivery cannula insertion.
- •- Subject has physical limitations (eg impaired vision) that would compromise operation of the closed loop system.
- •- Currently involved in another investigational study.
研究者
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