NCT07356089招募中不适用
Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
Deka Research and Development0 个研究点目标入组 1,875 人开始时间: 2025年12月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,875
研究概览
简要总结
The goal of this surveillance study is to collect real-world data on adults and youth with type 1 diabetes (T1D) using twiist(TM) for insulin delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent (or a parent or other legally authorized representative)
- •Age ≥ 6 years old
- •Diagnosis of T1D
- •Currently using twiist AID system, with initiation of twiist within 90 days of enrollment
- •Willing to only use an insulin approved for the pump
- •Residing in United States
- •Willing to use twiist in accordance with the user manual
- •Willing to have the study use the twiist data and any information that has been provided to Sequel Medtech, LLC or customer support since twiist was started
- •Willing to complete surveys at the beginning of the study and then monthly for 12 months
- •Willing to be contacted if clarification or further information is needed for any events reported on a survey or to customer support
- •Willing to provide medical records or sign a record release for any hospitalizations
- •Has cell service or if not, will have access to WIFI at least once a week
- •For females, not pregnant or planning pregnancy in the next 12 months
- •Able to speak and read English
- •Able to obtain documentation of HbA1c result obtained within 6 months prior to twiist initiation
排除标准
- •Any form of diabetes other than T1D
- •Receiving dialysis for end-stage renal disease
研究者
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