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Rockley Photonics在开发无创葡萄糖传感器方面遥遥领先

Rockley Photonics plows ahead in developing noninvasive glucose sensor

Biotech Today 等信源发布 2023-12-12 17:00

可切换为仅中文


Hot on the heels of study data showing its cuffless blood pressure monitor is well on its way to reaching desired accuracy levels, Rockley Photonics is boasting similar progress in the development of another of its biosensor technologies—this one to monitor blood sugar levels for people with diabetes..

紧随着研究数据显示其无袖带血压监测仪正在达到预期的准确度水平,Rockley Photonics在开发另一种生物传感器技术方面取得了类似的进展,这种技术用于监测糖尿病患者的血糖水平。。

The company documented that progress in a pair of studies spanning both simulated benchtop testing and an actual in-human assessment, per a Tuesday announcement.

根据周二的公告,该公司记录了一对研究的进展,这些研究跨越了模拟台式测试和实际的人体评估。

Taken together, the studies describe what could one day become a completely noninvasive option for glucose monitoring. That approach integrates Rockley’s short-wave infrared (SWIR) spectroscopy technology into its miniaturized photonic integrated circuit (PIC) chips, with the resulting mechanism embedded into a smartwatch-style wearable device to replace the current standard of adhesive, skin-puncturing continuous glucose monitors and fingerstick-taking blood glucose monitors..

综上所述,这些研究描述了有一天可能成为血糖监测的完全无创选择。该方法将罗克利的短波红外(SWIR)光谱技术集成到其小型光子集成电路(PIC)芯片中,产生的机制嵌入到智能手表式可穿戴设备中,以取代当前的粘合剂、皮肤穿刺连续血糖监测仪和手指血糖监测仪标准。。

In the benchtop study, researchers put the PIC technology to the test in a simulated tissue model. According to Rockley, those measurements showed that its biosensor could measure glucose levels with an accuracy of 5 mg/dL.

在台式研究中,研究人员在模拟组织模型中对PIC技术进行了测试。根据Rockley的说法,这些测量结果表明,其生物传感器可以测量葡萄糖水平,准确度为5 mg/dL。

For comparison, current ISO standards require that more than 95% of an integrated CGM’s readings be within 15 mg/dL of actual blood sugar levels, while the FDA mandates that at least 87% of a device’s readings fall within 20% of a reference measurement—which translates to an allowed difference of roughly 20 mg/dL from the recommended blood sugar levels for people with diabetes, which should ideally land between 80 mg/dL and 130 mg/dL before a meal..

为了进行比较,目前的ISO标准要求综合CGM读数的95%以上在实际血糖水平的15 mg/dL以内,而FDA要求至少87%的设备读数在参考测量值的20%以内,这意味着允许与糖尿病患者推荐的血糖水平相差约20 mg/dL,理想情况下,餐前应在80毫克/分升至130毫克/分升之间。。

The other study, meanwhile, recruited 40 people with either Type 1 or Type 2 diabetes and lasted a total of 10 weeks. Though Rockley didn’t provide details about the content of the study, it reported that the results “demonstrated significant progress towards the development of a noninvasive wearable glucose monitor.”.

与此同时,另一项研究招募了40名1型或2型糖尿病患者,共持续了10周。虽然Rockley没有提供有关研究内容的详细信息,但据报道,研究结果“证明了无创可穿戴血糖监测仪的开发取得了重大进展”。

CEO Andrew Rickman, Ph.D., doubled down on that conclusion in the release, saying of both studies: “The results confirm that Rockley’s integrated silicon photonic technology and novel processing of the SWIR signal offers a unique opportunity to realize the goal of a wearable, noninvasive glucose sensor for a host of medical applications.”.

首席执行官安德鲁·里克曼(AndrewRickman)博士(Ph.D.)在新闻稿中对这一结论做出了双重评价,他在谈到这两项研究时表示:“研究结果证实,罗克利的集成硅光子技术和SWIR信号的新型处理为实现可穿戴、无创葡萄糖传感器的目标提供了独特的机会,可用于多种医疗应用。”。

Neither study’s results have yet been published, and Rockley didn’t immediately respond to a request to view the data.

这两项研究的结果都尚未公布,罗克利也没有立即回应查看数据的请求。

Just last month, fresh out of six months of bankruptcy proceedings, Rockley described the results of another pair of studies, this time focusing on applying the SWIR biosensing technology to blood pressure monitoring with an aim of replacing traditional inflating cuffs.

就在上个月,刚刚结束了六个月的破产程序,罗克利描述了另一对研究的结果,这次研究的重点是将SWIR生物传感技术应用于血压监测,旨在取代传统的充气袖带。

The first analysis was a clear success: After calibration using only one reference data point, Rockley’s sensor was able to track changes in 30 participants’ blood pressure levels with accuracy levels well within the bounds of two FDA-recognized standards when compared to readings from a “gold-standard” intra-arterial pressure transducer, or A-line..

第一次分析取得了明显的成功:在仅使用一个参考数据点进行校准后,Rockley的传感器能够跟踪30名参与者血压水平的变化,与“金标准”动脉内压力传感器或a线的读数相比,准确度水平在两个FDA认可的标准范围内。。

The second study, however, showed the technology still has room to grow. While the first study took place in a single clinic visit, this one followed participants for about a month after the initial calibration. During that time, the biosensor fell short of the accuracy targets but was “within sight of meeting” the standards—and also maintained about the same error level over time, rather than increasingly diverging from the A-line’s results, per Rockley..

然而,第二项研究表明,该技术仍有发展空间。虽然第一项研究是在一次诊所就诊中进行的,但这项研究在初始校准后跟踪参与者大约一个月。在这段时间里,生物传感器没有达到准确度目标,但“有望达到”标准,并且随着时间的推移也保持了大致相同的误差水平,而不是越来越偏离A线的结果。。