PDF(Pubmed)
Abstract：
OBJECTIVE: To evaluate the safety and performance of an implantable near-infrared (NIR) spectroscopy sensor for multi-metabolite monitoring of glucose, ketones, lactate, and ethanol.
METHODS: This is an early feasibility study (GLOW, NCT04782934) including 7 participants (4 with type 1 diabetes (T1D), 3 healthy volunteers) in whom the YANG NIR spectroscopy sensor (Indigo) was implanted for 28 days. Metabolic challenges were used to vary glucose levels (40-400 mg/dL, 2.2-22.2 mmol/L) and/or induce increases in ketones (ketone drink, up to 3.5 mM), lactate (exercise bike, up to 13 mM) and ethanol (4-8 alcoholic beverages, 40-80g). NIR spectra for glucose, ketones, lactate, and ethanol levels analyzed with partial least squares regression were compared with blood values for glucose (Biosen EKF), ketones and lactate (GlucoMen LX Plus), and breath ethanol levels (ACE II Breathalyzer). The effect of potential confounders on glucose measurements (paracetamol, aspartame, acetylsalicylic acid, ibuprofen, sorbitol, caffeine, fructose, vitamin C) was investigated in T1D participants.
RESULTS: The implanted YANG sensor was safe and well tolerated and did not cause any infectious or wound healing complications. Six out 7 sensors remained fully operational over the entire study period. Glucose measurements were sufficiently accurate (overall mean absolute (relative) difference MARD of 7.4%, MAD 8.8 mg/dl) without significant impact of confounders. MAD values were 0.12 mM for ketones, 0.16 mM for lactate, and 0.18 mM for ethanol.
CONCLUSIONS: The first implantable multi-biomarker sensor was shown to be well tolerated and produce accurate measurements of glucose, ketones, lactate, and ethanol.
BACKGROUND: Clinical trial identifier: NCT04782934.
METHODS: This is an early feasibility study (GLOW, NCT04782934) including 7 participants (4 with type 1 diabetes (T1D), 3 healthy volunteers) in whom the YANG NIR spectroscopy sensor (Indigo) was implanted for 28 days. Metabolic challenges were used to vary glucose levels (40-400 mg/dL, 2.2-22.2 mmol/L) and/or induce increases in ketones (ketone drink, up to 3.5 mM), lactate (exercise bike, up to 13 mM) and ethanol (4-8 alcoholic beverages, 40-80g). NIR spectra for glucose, ketones, lactate, and ethanol levels analyzed with partial least squares regression were compared with blood values for glucose (Biosen EKF), ketones and lactate (GlucoMen LX Plus), and breath ethanol levels (ACE II Breathalyzer). The effect of potential confounders on glucose measurements (paracetamol, aspartame, acetylsalicylic acid, ibuprofen, sorbitol, caffeine, fructose, vitamin C) was investigated in T1D participants.
RESULTS: The implanted YANG sensor was safe and well tolerated and did not cause any infectious or wound healing complications. Six out 7 sensors remained fully operational over the entire study period. Glucose measurements were sufficiently accurate (overall mean absolute (relative) difference MARD of 7.4%, MAD 8.8 mg/dl) without significant impact of confounders. MAD values were 0.12 mM for ketones, 0.16 mM for lactate, and 0.18 mM for ethanol.
CONCLUSIONS: The first implantable multi-biomarker sensor was shown to be well tolerated and produce accurate measurements of glucose, ketones, lactate, and ethanol.
BACKGROUND: Clinical trial identifier: NCT04782934.
摘要：
目的：评估用于葡萄糖多代谢物监测的可植入近红外（NIR）光谱传感器的安全性和性能，酮,乳酸，和乙醇。
方法：这是一项早期可行性研究(GLOW，NCT04782934）包括7名参与者（4名1型糖尿病（T1D），3名健康志愿者），其中YANGNIR光谱传感器（Indigo）被植入28天。代谢挑战用于改变葡萄糖水平(40-400毫克/分升，2.2-22.2mmol/L）和/或诱导酮增加（酮饮料，高达3.5mM)，乳酸(运动自行车，高达13mM)和乙醇(4-8种酒精饮料，40-80g）。葡萄糖的近红外光谱，酮,乳酸，用偏最小二乘回归分析的乙醇水平与血液葡萄糖值（BiosenEKF）进行比较，酮和乳酸（GlucoMenLXPlus），和呼气乙醇水平（ACEII呼吸分析仪）。潜在混杂因素对葡萄糖测量的影响(扑热息痛，阿斯巴甜,乙酰水杨酸,布洛芬,山梨醇,咖啡因,果糖,维生素C）在T1D参与者中进行了调查。
结果：植入的YANG传感器安全且耐受性良好，未引起任何感染或伤口愈合并发症。在整个研究期间，7个传感器中有6个保持完全运行。葡萄糖测量结果足够准确(总体平均绝对(相对)差异MARD为7.4%,MAD8.8mg/dl)，没有显著的混杂因素影响。酮的MAD值为0.12mM，乳酸为0.16mM，和0.18mM的乙醇。
结论：第一个可植入的多生物标志物传感器被证明具有良好的耐受性，并能产生准确的葡萄糖测量值，酮,乳酸，和乙醇。
背景：临床试验标识符：NCT04782934。
方法：这是一项早期可行性研究(GLOW，NCT04782934）包括7名参与者（4名1型糖尿病（T1D），3名健康志愿者），其中YANGNIR光谱传感器（Indigo）被植入28天。代谢挑战用于改变葡萄糖水平(40-400毫克/分升，2.2-22.2mmol/L）和/或诱导酮增加（酮饮料，高达3.5mM)，乳酸(运动自行车，高达13mM)和乙醇(4-8种酒精饮料，40-80g）。葡萄糖的近红外光谱，酮,乳酸，用偏最小二乘回归分析的乙醇水平与血液葡萄糖值（BiosenEKF）进行比较，酮和乳酸（GlucoMenLXPlus），和呼气乙醇水平（ACEII呼吸分析仪）。潜在混杂因素对葡萄糖测量的影响(扑热息痛，阿斯巴甜,乙酰水杨酸,布洛芬,山梨醇,咖啡因,果糖,维生素C）在T1D参与者中进行了调查。
结果：植入的YANG传感器安全且耐受性良好，未引起任何感染或伤口愈合并发症。在整个研究期间，7个传感器中有6个保持完全运行。葡萄糖测量结果足够准确(总体平均绝对(相对)差异MARD为7.4%,MAD8.8mg/dl)，没有显著的混杂因素影响。酮的MAD值为0.12mM，乳酸为0.16mM，和0.18mM的乙醇。
结论：第一个可植入的多生物标志物传感器被证明具有良好的耐受性，并能产生准确的葡萄糖测量值，酮,乳酸，和乙醇。
背景：临床试验标识符：NCT04782934。
