ACTRN12615000137594已完成未知
Evaluation of the Impact of Exercise on the Performance of an Artificial Pancreas in Adults with Type 1 Diabetes.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 12
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 o limit(—)
- 性别
- All
入选标准
- •Age > 18 years
- •-Type 1 Diabetes (confirmed by fasting C-peptide level < 50 pmol/L)
- •-Insulin pump therapy for at least 6 months
- •-HbA1c < 9.0%
- •-Experience with a glucose sensor
- •-Established insulin pump therapy parameters
- •-Ability to insert/change sensor
- •-Ability to undertake exercise as per protocol
排除标准
- •-Requiring > 150 units of insulin/day
- •-Diabetic ketoacidosis within the past 4 weeks
- •-Hypoglycaemic unawareness (Gold score >4) while on Sensor Augmented Pump Therapy (SAPT) or > 2 severe hypoglycaemic episodes within the last 12 months
- •-Pregnancy
- •-Renal impairment (eGFR < 60ml/min/1.73m2)
- •-Current or recent (<4 weeks) oral or inhaled steroid therapy
- •-Dermatological conditions involving the region of device insertion
- •-Ischaemic heart disease or peripheral vascular disease precluding exercise
- •-Physical limitations (e.g. impaired vision) that would compromise operation of the Closed Loop system
研究者
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