The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 21
- 主要终点
- Rate of diabetic ketoacidosis (DKA).
研究概览
简要总结
This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.
详细描述
This post-market surveillance study is a single-arm, prospective cohort study. It is designed to:
- Demonstrate, in the post-approval setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe metabolic complications (severe hypoglycemia and/or diabetic ketoacidosis).
- Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation.
- Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life.
- Describe the real-world use of the Control-IQ System.
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
- •Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or G7 CGM sensor.
- •Age ≥ 6 years at enrollment.
- •Using an insulin approved for use in the pump.
- •Ability for patient or parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
- •Reside full-time in mainland France.
- •Have an email address and mobile phone number
- •Participant or participant's parent/guardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to :
- •use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
- •the reuse of their clinical data including HbA1c results, obtained at most 4 months prior to enrollment, and as available according to the standard of care during the next 12 months.
- •complete questionnaires per the study protocol.
排除标准
- •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.
- •Patients considered vulnerable under French law.
研究组 & 干预措施
Control-IQ System
Participants will use the Control-IQ System as per standard of care.
干预措施: t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) (Device)
结局指标
主要结局
Rate of diabetic ketoacidosis (DKA).
时间窗: 12 months
The incidence rate of diabetic ketoacidosis (DKA) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years.
Rate of severe hypoglycemia (SH)
时间窗: 12 months
The incidence rate of severe hypoglycemia (SH) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years.
次要结局
- Time in Range 70-180 mg/dL (TIR)(12 months)
- Time above 180 mg/dL(12 months)
- Time above 250 mg/dL(12 months)
- Time less than 70 mg/dL(12 months)
- Time less than 54 mg/dL(12 months)
- Treatment Satisfaction(12 months)
- System Usability(12 months)
- Quality of Life Change(12 months)
- Fear of Hypoglycemic Events Change(12 months)
- Rate of use of the system(12 months)