PS230005 Control-IQ 1.5 Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Incidence Rates of Severe Hypoglycemia (SH)
研究概览
简要总结
This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to <6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.
详细描述
The study will recruit participants age 2 to <6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.
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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump
- •Age 2 to <6 years at time of screening
- •Using an insulin approved for use in the pump
- •Using an iCGM sensor approved for use with the pump
- •Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.
- •Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
- •Ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
- •Reside full-time in the United States.
- •Willingness to download the t:connect Mobile application to their smartphone and keep it active throughout the study if using a Tandem t:slim X2 pump. Participants who are unable to use the t:connect mobile application must be willing to manually upload their insulin pump data to Tandem Source every three months and at the completion of the study.
- •Participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).
排除标准
- •Use of any glucose-lowering therapy other than insulin.
- •A medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study.
研究组 & 干预措施
Control-IQ Technology v1.5
Real-world use of Control-IQ technology v1.5 for 12 months.
干预措施: Control-IQ Technology v1.5 (Device)
结局指标
主要结局
Incidence Rates of Severe Hypoglycemia (SH)
时间窗: 12 months
Overall incidence rate of SH events per 100 patient years during 12 months of Control-IQ use
Incidence Rates of Diabetic Ketoacidosis (DKA)
时间窗: 12 months
Overall incidence rate of DKA events per 100 patient years during 12 months of Control-IQ use
次要结局
- Percent Time in Range 70 - 180 mg/dL(12 months)
- Percent Time Greater Than 180 mg/dL(12 months)
- Percent Time Greater Than 250 mg/dL(12 months)
- Percent Time Less Than 70 mg/dL(12 months)
- Percent Time Less Than 54 mg/dL(12 months)
- Mean Glucose mg/dL(12 months)