FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Safety of the SMBG devices. The safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in a pediatric patient population will be characterized: Serious Adverse events
研究概览
简要总结
This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.
详细描述
Approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. 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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 4 - 17 years of age.
- •Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
- •Subject is currently using SMBG for managing their diabetes.
- •Subject and/or caregiver must be able to read and understand English.
- •In the investigator's opinion, the subject and/or caregiver 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 and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.
排除标准
- •Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
- •Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- •Subject is known to be 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 SMBG devices. The safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in a pediatric patient population will be characterized: Serious Adverse events
时间窗: six months
Rate of Serious Adverse events associated with Hypoglycemia and Hyper glycaemia will be determined. (e.g severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person \[e.g. as a result of confusion, coma, or seizure\] during the study.
次要结局
未报告次要终点