DRKS00031941招募中Unknown
CYCLUS. CYcle-tracking in Closed and open Loop Users for estimation of cycle- dependent variations in insulin Sensitivity. -A pilot study - CYCLUS
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 30
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
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 13 Years 至 30 Years（—）
- 性别
- All
入选标准
- •Age between 13 and 30 years (inclusive)
- •T1D for at least 12 months
- •Willing to use Auto mode or SmartGuard mode with target glucose of 100 mg/dl if available
- •Willing to use an insulin pump with continuous glucose monitoring (commercially available open loop system or hybrid closed loop system) or a smart insulin pen
- •Willing to use isCGM/ rtCGM
- •Willing to download pump and isCGM/ rtCGM data at periodic intervals
- •Willing to perform ovulation prediction test for female participants without contraceptive method
- •Willing to perform a pregnancy test once a month
- •Menarche occurred at least 2 years ago for female participants
- •Sufficient language skills
- •Sexual maturity rating 5 (TANNER stadium) for male participants
- •In regular medical care at the Medical University Vienna or the Clinic Hietzing during the study periods
- •Treated with faster-rapid acting insulin or rapid- acting insulin analogue
排除标准
- •Breastfeeding
- •Treatment with steroids/ immunosuppressant
- •Severe psychiatric disorder
- •Type 2 diabetes, type 3 diabetes or monogenic diabetes
- •Progestin- only pills or levonorgestrel releasing intrauterine device as contraceptive method
研究者
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