DRKS00034645尚未招募不适用
Prospective cohort study on the use of automated insulin delivery systems during a two-week summer camp for children with type 1 diabetes: an exploratory pilot study - AID@Camp
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
- Observational
入排标准
- 年龄范围
- 8 Years 至 12 Years（—）
- 性别
- All
入选标准
- •1) Diagnosed with type 1 diabetes
- •2) Signed consent form by a parent or legal guardian
- •3) Participation in the summer camp
- •4) Children aged 8-12 years
- •5) Use of an automated insulin delivery system or an insulin pump with CGM sensor without automation (sensor-augmented pump therapy, SAP) for at least one month at the start of the study.
排除标准
- •Concurrent participation in another study.
- •2) Receipt of an investigational product within one week prior to screening in this study.
- •3) HbA1c > 11% (96 mmol/mol)
- •4) Any chronic (metabolic) disorder or serious illness other than type 1 diabetes that, in the opinion of the investigator, could jeopardize the safety of the participant or compliance with the protocol.
- •5) Participants with intellectual disabilities or language barriers, including inadequate understanding or cooperation, or those who, according to their primary care physician or the investigator, should not participate in the study.
- •6) Any condition that, in the opinion of the investigator, would impair the participant's ability to participate in the study or the evaluation of results.
研究者
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