ACTRN12619001452189进行中（未招募）未知
The Use of an Advanced Hybrid Closed Loop System in the Management of Individuals with Type 1 Diabetes and Sub-optimal Glycaemic Control
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 46
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 25 Years（—）
- 性别
- All
入选标准
- •1. Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus, diagnosed at least 1 year ago)
- •2. Fasting C peptide <0.1nmol/L (in the absence of hypoglycaemia)
- •3. Pump therapy for at least 6 months
- •4. Age 12 to 25 years
- •5. Recent HbA1c above 8.5% in the last 3 months
- •6. Mean HbA1c above 8.5% for 6 months
- •7. Willing to follow study instructions
- •8. Willing to perform at least 3 finger stick blood glucose measurements daily
- •9. Willing to perform required sensor calibrations
- •10. Capable of reading and understand instructions in English
- •11. Living in an area with internet and cellular phone coverage
- •12. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
排除标准
- •1. Severe DKA in the 6 months prior to the screening visit
- •2. Use of any non-insulin glucose-lowering agent within the past 3 months
- •3. Commenced CGM in the 3 months prior to the screening visit
- •4. Pregnancy or planned pregnancy within the study period
- •5. Uncontrolled coeliac disease (not following a gluten free diet), or other untreated malabsorption
- •6. Uncontrolled thyroid disease
- •7. Clinically-significant gastroparesis
- •8. Poor visual acuity precluding use of the investigational technology
- •9. Inability or unwillingness to meet protocol requirements
研究者
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