De Ridder Francesca, Braspenning Rie, Ordonez Juan S, Klarenbeek Gijs, Lauwers Patrick, Ledeganck Kristien J, Delbeke Danaë, De Block Christophe
Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, Antwerp, Belgium.
Faculty of Medicine & Health Science, Laboratory of Experimental Medicine and Pediatrics, University of Antwerp, Antwerp, Belgium.
PLoS One. 2024 May 3;19(5):e0301041. doi: 10.1371/journal.pone.0301041. eCollection 2024.
To evaluate the safety and performance of an implantable near-infrared (NIR) spectroscopy sensor for multi-metabolite monitoring of glucose, ketones, lactate, and ethanol.
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.
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.
The first implantable multi-biomarker sensor was shown to be well tolerated and produce accurate measurements of glucose, ketones, lactate, and ethanol.
Clinical trial identifier: NCT04782934.
评估用于葡萄糖、酮体、乳酸和乙醇多代谢物监测的植入式近红外（NIR）光谱传感器的安全性和性能。
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）患者，3名健康志愿者），他们植入了YANG近红外光谱传感器（Indigo）28天。采用代谢挑战来改变葡萄糖水平（40 - 400 mg/dL，2.2 - 22.2 mmol/L）和/或诱导酮体（酮体饮料，最高3.5 mM）、乳酸（健身自行车运动，最高13 mM）和乙醇（4 - 8杯酒精饮料，40 - 80克）增加。将通过偏最小二乘回归分析的葡萄糖、酮体、乳酸和乙醇水平的近红外光谱与葡萄糖（Biosen EKF）、酮体和乳酸（GlucoMen LX Plus）的血液值以及呼气乙醇水平（ACE II呼气酒精含量测定仪）进行比较。在T1D参与者中研究了潜在混杂因素对葡萄糖测量的影响（对乙酰氨基酚、阿斯巴甜、乙酰水杨酸、布洛芬、山梨醇、咖啡因、果糖、维生素C）。
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。7个传感器中有6个在整个研究期间保持完全运行。葡萄糖测量足够准确（总体平均绝对（相对）差异MARD为7.4%，平均绝对偏差MAD为8.8 mg/dl），且不受混杂因素的显著影响。酮体的MAD值为0.12 mM，乳酸为0.16 mM，乙醇为0.18 mM。
首个植入式多生物标志物传感器显示出良好的耐受性，并且能够准确测量葡萄糖、酮体、乳酸和乙醇。
临床试验标识符：NCT04782934。
