FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 935
- 试验地点
- 10
- 主要终点
- Safety of the FreeStyle Libre Flash Glucose Monitoring System
研究概览
简要总结
This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in people with diabetes.
详细描述
Up to 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects who complete the final visit. Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age.
- •Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
- •Subject is currently using SMBG for managing their diabetes.
- •Subject must be able to read and understand English
- •In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- •Subject must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
- •Subject must be willing and able to provide written signed and dated informed consent.
排除标准
- •Subject is a member of the Site Staff.
- •Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes
- •Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- •Subject is pregnant or is attempting to become pregnant at the time of enrollment.
- •Subject is on dialysis at the time of enrollment.
- •Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
- •Subject currently is participating in another clinical trial.
- •Subject is unsuitable for participation due to any other cause as determined by the Investigator.
结局指标
主要结局
Safety of the FreeStyle Libre Flash Glucose Monitoring System
时间窗: Approximately one year per subject.
The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the intended study population.
次要结局
未报告次要终点