NL-OMON51613尚未招募不适用
Portable Artificial Pancreas Applied for Youth and Adolescents, PAPAYA 1 - PAPAYA 1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •- Diagnosed with Type 1 Diabetes
- •- 12-18 years old
- •- Treated with insulin therapy for at least 6 months
排除标准
- •- Impaired awareness of hypoglycaemia (score >= 4) according to Gold and/or
- •Clarke questionnaire
- •- BMI >= 35 kg/m2
- •- Pregnancy and/or breastfeeding
- •- HbA1c > 97 mmol/mol (11.0%)
- •- Use of acetaminophen (paracetamol) during the open loop or closed-loop period
- •- Limited ability to see, hear or feel the alarm signals of the closed-loop
- •- Unwillingness to act in response to the alarm signals
- •- Living alone during the night during the closed-loop period
- •- Expected poor internet connectivity regarding 24/7 tele monitoring
研究者
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