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Abbott的FreeStyle Libre CGM系统现已获准在成像过程中使用

Abbott’s FreeStyle Libre CGM Systems Now Cleared for Use During Imaging Procedures

HIT 等信源发布 2024-10-30 19:58

可切换为仅中文


What You Should Know:

您应该知道:

– Abbott  announced that its FreeStyle Libre 2 and 3 continuous glucose monitoring (CGM) systems have received FDA clearance for use during common imaging procedures, including X-rays, CT scans, and MRIs.

–雅培宣布,其FreeStyle Libre 2和3连续血糖监测(CGM)系统已获得FDA批准,可用于常规成像程序,包括X射线、CT扫描和MRI。

– The development makes Abbott’s systems the first and only patient-applied CGM sensors approved for use during these screenings, offering greater convenience and potential cost savings for people with diabetes.

–这项开发使雅培的系统成为第一个也是唯一一个被批准在这些筛查过程中使用的患者应用CGM传感器,为糖尿病患者提供了更大的便利和潜在的成本节约。

Improving Diabetes Management

改进糖尿病管理

Individuals with diabetes rely on CGM systems to continuously monitor their glucose levels, enabling them to make informed decisions about their care, such as adjusting insulin doses. Previously, users had to remove and discard their CGM sensors before undergoing imaging procedures, leading to interruptions in monitoring and potential inconvenience..

糖尿病患者依靠CGM系统持续监测血糖水平,使他们能够对自己的护理做出明智的决定,例如调整胰岛素剂量。此前,用户必须在进行成像程序之前移除并丢弃其CGM传感器,从而导致监测中断和潜在的不便。。

With this new clearance, users of FreeStyle Libre 2 and 3 systems can now wear their sensors during these procedures without any impact on the sensor’s performance or accuracy. This eliminates the need for sensor removal and replacement, providing a more seamless and convenient experience for individuals managing their diabetes..

有了这个新的许可,FreeStyle Libre 2和3系统的用户现在可以在这些过程中佩戴传感器,而不会对传感器的性能或准确性产生任何影响。这消除了传感器拆卸和更换的需要,为管理糖尿病的个人提供了更加无缝和方便的体验。。

Addressing the Needs of People with Diabetes

满足糖尿病患者的需求

Diabetes can lead to various complications that often require imaging procedures for diagnosis and monitoring. X-rays, CT scans, and MRIs are commonly used to assess conditions such as:

糖尿病可导致各种并发症,通常需要成像程序进行诊断和监测。X射线、CT扫描和MRI通常用于评估以下情况:

Bone injuriesKidney stonesBlood clotsBrain injuriesIschemic heart diseaseFatty liver disease

骨损伤肾结石血凝块脑损伤缺血性心脏病脂肪肝

By allowing patients to wear their FreeStyle Libre 2 and 3 sensors during these procedures, Abbott is improving the overall diabetes management experience.

通过允许患者在这些过程中佩戴FreeStyle Libre 2和3传感器,雅培正在改善整体糖尿病管理体验。

Rigorous Testing and Validation

严格的测试和验证

Abbott conducted extensive testing to ensure the safety and efficacy of its FreeStyle Libre 2 and 3 sensors during imaging procedures. This rigorous testing led the FDA to clear the removal of the contraindication, providing reassurance to users and healthcare providers.

雅培进行了广泛的测试,以确保其FreeStyle Libre 2和3传感器在成像过程中的安全性和有效性。这项严格的测试导致FDA取消了禁忌症,为用户和医疗保健提供者提供了保证。

“For people with diabetes, especially those using insulin, removing a CGM sensor for long periods can be problematic,” said Carol Wysham, M.D., clinical professor of medicine at the University of Washington School of Medicine and section head of the department of diabetes and endocrinology at Rockwood Clinic in Spokane.

华盛顿大学医学院临床医学教授、斯波坎洛克伍德诊所糖尿病与内分泌科科长卡罗尔·维沙姆(CarolWysham)医学博士说:“对于糖尿病患者,尤其是使用胰岛素的患者,长时间移除CGM传感器可能会产生问题。”。

“Previously, patients had to remove their sensors during these procedures, resulting in several hours without critical data, especially if they didn’t have a replacement sensor. The removal of the imaging contraindication from Abbott’s FreeStyle Libre 2 and 3 systems is a big win for patients, allowing them to keep their sensors on and avoid lost data.”.

“以前,患者必须在这些过程中移除传感器,导致几个小时没有关键数据,特别是如果他们没有替代传感器的话。从雅培的FreeStyle Libre 2和3系统中移除成像禁忌症对患者来说是一个巨大的胜利,使他们能够保持传感器工作并避免数据丢失。”。