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Nemaura Medical完成sugarBEAT®24小时佩戴100名患者的研究并报告中期结果

Nemaura Medical Completes 100 Patient Study for sugarBEAT® 24-hour Wear and Reports Interim Results

globenewswire 等信源发布 2023-09-11 21:00

可切换为仅中文


LOUGHBOROUGH, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing non-invasive wearable sensors and supporting personalized diabetes management and metabolic health programs, today announced it has recently completed a 100-patient study across 4 cohorts of 25 diabetic patients for sugarBEAT® and provided interim results.

LOUGHBOROUGH,2023年9月11日(GLOBE NEWSWIRE)-Nemaura Medical,Inc。(纳斯达克股票代码:NMRD)(“Nemaura”或“公司”),一家医疗技术公司,专注于开发和商业化非侵入式可穿戴式传感器并支持个性化的糖尿病管理和代谢健康计划,今天宣布,它最近完成了一项针对sugarBEAT®的4组25名糖尿病患者的100名患者研究,并提供了中期结果。

The Company has previously received CE approval in Europe, and SFDA (Saudi Food and Drug Authority) approval for its sugarBEAT® glucose sensor for a wear period of 14 hours. This study was designed to evaluate several factors, including the possibility of increasing the wear period to up to 24 hours, evaluating the possibility of auto-calibration, and different methods of application of the device to the skin.

该公司之前已在欧洲获得CE批准,SFDA(沙特食品和药物管理局)批准其sugarBEAT®葡萄糖传感器,磨损时间为14小时。本研究旨在评估几个因素,包括将磨损时间延长至24小时的可能性,评估自动校准的可能性,以及将设备应用于皮肤的不同方法。

The new sensors have been designed to improve the user experience by reducing the number of steps involved in the application of the sensor to the skin to a peel and place method. The study was conducted in the Middle East on 100 adult patients aged 18 to 75 comprising 20 persons with Type 1 diabetes and 80 persons with Type 2 diabetes, with an approximately equal split between male and female.

新传感器被设计为通过减少将传感器应用于皮肤以剥离和放置方法所涉及的步骤的数量来改善用户体验。该研究在中东对100名18至75岁的成年患者进行,其中包括20名1型糖尿病患者和80名2型糖尿病患者,男女之间的比例大致相等。

The Company reports interim data from a first cohort comprising 25 patients, on a single day sensor wear. Over a 12-hour period using a retrospectively applied algorithm, the results indicated an overall mean absolute relative difference (“MARD”) of 9.8% with 86% of the paired points within 20/20 of the reference value based on 1,037 paired points and two calibrations, (the proportion of the CGM system values that are within ±20% of relative difference of reference value at glucose levels >80 mg/dL and ±20 mg/dL of absolute difference a.

该公司报告了第一批包括25名患者的临时数据,一天传感器磨损。在使用回顾性算法的12小时内,结果表明,基于1037个配对点和两次校准,总体平均绝对相对差异(“MARD”)为9.8%,其中86%的配对点在参考值的20/20之内,(在葡萄糖水平>80 mg/dL和绝对差值±20 mg/dL时,CGM系统值在参考值相对差值±20%以内的比例。