Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites: the Abdomen and Upper Thigh Compared to the Upper Arm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Mean Absolute Relative Difference
研究概览
简要总结
On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes convention. Making this the only way to receive the device in Belgium. Since then, many type 1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper arm too visible. Abbott does not recommend to place the sensor on a different place of the body than the back of the upper arm, because no tests were done yet (besides on the upper arm) to make an accuracy claim. With this study, we want to evaluate the accuracy and the precision of the Freestyle Libre FGM by using three FGM sensors simultaneously on different places of the body and perform regular self-monitoring of blood glucose (SMBG) tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients with a diagnosis of T1D for more than 6 months
- •Adult patients ≥ 18 years
- •Signed informed consent form
排除标准
- •Pregnancy
- •Patients with severe cognitive dysfunction or other disease which makes FGM use difficult.
- •History of allergic reaction to any of the FGMs materials or adhesives when in contact with the skin.
- •History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
- •Abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- •Presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR < 45 ml/min).
研究组 & 干预措施
Intervention
Using 3 Abbott FreeStyle Libre Flash Glucose Monitoring sensors in parallel and measure 7 times a day BG by capillary finger stick testing.
干预措施: Abbott FreeStyle Libre Flash Glucose Monitoring sensors (Device)
结局指标
主要结局
Mean Absolute Relative Difference
时间窗: 14 days
Mean Absolute Relative Difference (MARD) between FGM measurements for the three insertion sites and paired SMBG measurements.
次要结局
- Precision Absolute Relative Deviation(14 days)
研究者
prof dr Pieter Gillard
Professor Doctor Pieter Gillard
Universitaire Ziekenhuizen KU Leuven