Malin S F, Ruchti T L, Blank T B, Thennadil S N, Monfre S L
Instrumentation Metrics, Incorporated, 2085 Technology Circle, Suite 302, Tempe, AR 85284, USA.
Clin Chem. 1999 Sep;45(9):1651-8.
Self-monitoring of blood glucose by diabetics is crucial in the reduction of complications related to diabetes. Current monitoring techniques are invasive and painful, and discourage regular use. The aim of this study was to demonstrate the use of near-infrared (NIR) diffuse reflectance over the 1050-2450 nm wavelength range for noninvasive monitoring of blood glucose.
Two approaches were used to develop calibration models for predicting the concentration of blood glucose. In the first approach, seven diabetic subjects were studied over a 35-day period with random collection of NIR spectra. Corresponding blood samples were collected for analyte analysis during the collection of each NIR spectrum. The second approach involved three nondiabetic subjects and the use of oral glucose tolerance tests (OGTTs) over multiple days to cause fluctuations in blood glucose concentrations. Twenty NIR spectra were collected over the 3.5-h test, with 16 corresponding blood specimens taken for analyte analysis.
Statistically valid calibration models were developed on three of the seven diabetic subjects. The mean standard error of prediction through cross-validation was 1.41 mmol/L (25 mg/dL). The results from the OGTT testing of three nondiabetic subjects yielded a mean standard error of calibration of 1.1 mmol/L (20 mg/dL). Validation of the calibration model with an independent test set produced a mean standard error of prediction equivalent to 1.03 mmol/L (19 mg/dL).
These data provide preliminary evidence and allow cautious optimism that NIR diffuse reflectance spectroscopy using the 1050-2450 nm wavelength range can be used to predict blood glucose concentrations noninvasively. Substantial research is still required to validate whether this technology is a viable tool for long-term home diagnostic use by diabetics.
糖尿病患者自我监测血糖对于减少糖尿病相关并发症至关重要。目前的监测技术具有侵入性且会带来疼痛,不利于患者定期使用。本研究的目的是证明在1050 - 2450纳米波长范围内使用近红外(NIR)漫反射进行血糖的无创监测。
采用两种方法建立预测血糖浓度的校准模型。第一种方法是在35天内对7名糖尿病患者进行研究,随机采集近红外光谱。在每次采集近红外光谱期间,采集相应的血样进行分析物分析。第二种方法涉及3名非糖尿病患者,并在多天内进行口服葡萄糖耐量试验(OGTT)以引起血糖浓度波动。在3.5小时的测试过程中采集了20个近红外光谱,并采集了16份相应的血样进行分析物分析。
在7名糖尿病患者中的3名患者身上建立了具有统计学有效性的校准模型。通过交叉验证得到的预测平均标准误差为1.41毫摩尔/升(25毫克/分升)。3名非糖尿病患者的OGTT测试结果得出校准平均标准误差为1.1毫摩尔/升(20毫克/分升)。使用独立测试集对校准模型进行验证,得出的预测平均标准误差相当于1.03毫摩尔/升(19毫克/分升)。
这些数据提供了初步证据,并让人谨慎乐观地认为,使用1050 - 2450纳米波长范围的近红外漫反射光谱可用于无创预测血糖浓度。仍需要大量研究来验证该技术是否是糖尿病患者长期家庭诊断的可行工具。