NCT07739342尚未招募不适用
Evaluating the Occurrence of DKA in People With Type 1 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 试验地点
- 7
- 主要终点
- Primary Objective
研究概览
简要总结
This study will evaluate the occurrences of Diabetes-related Ketoacidosis (DKA) in adult and pediatric individuals living with Type I diabetes while managing diabetes with Abbott's Continuous Monitoring Systems.
详细描述
The purpose of this study is to understand the occurrence of DKA in people with type 1 diabetes which will subsequently inform the benefit of continuous glucose and ketone monitoring in this population.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 2 years old at the time of study enrollment.
- •Diagnosis of type 1 diabetes with at least 12 months of diabetes medical history.
- •In the investigator's opinion, the participant is willing to wear the sensor, follow study specific instructions, and perform all study tasks.
- •Willing and able to provide written signed and dated informed consent (adults) or participant's parent/legal guardian must be willing and able to provide written signed and dated informed consent along with assent form completed by the participant for those mature enough to make their own decisions per investigator assessment (those less than 16 years of age).
排除标准
- •In the investigator's opinion, the participant has a known (or suspected) allergy to medical grade adhesives at enrollment that would interfere with participant completing study required activities.
- •In the investigator's opinion, the participant has concomitant medical condition(s) which could interfere with the study or present a risk to the safety or welfare of the participant or study staff.
- •Participant is currently in another clinical study which may affect glucose or ketone management (or does so during the study).
- •Participant is unsuitable for participation due to any other cause as determined by the investigator.
- •Participant has implanted medical devices such as pacemakers or requires dialysis or is critically ill.
结局指标
主要结局
Primary Objective
时间窗: 12 months
Occurrence of Diabetes-related Ketoacidosis (DKA) in adult and pediatric individuals living with type 1 diabetes while managing diabetes with the Abbott's Continuous Dual Glucose Ketone Monitoring System.
次要结局
未报告次要终点
研究者
研究点 (7)
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