可穿戴无创血糖仪测量空腹血糖的准确性及影响因素研究

doi:10.12114/j.issn.1007-9572.2025.0526

中国全科医学 ›› 2026, Vol. 29 ›› Issue (25): 3624-3630.DOI: 10.12114/j.issn.1007-9572.2025.0526

可穿戴无创血糖仪测量空腹血糖的准确性及影响因素研究

谢文涵¹^,², 王金麒¹^,², 刘浩¹, 陈硕³, 吕世云¹^,², 韩玉梅³, 张国红³, 郭秀花¹^,²^,⁴^,^*()

1．100069　北京市，首都医科大学公共卫生学院
2．100069　北京市，环境与衰老北京市重点实验室
3．100050　北京市体检中心
4．100069　北京市，首都医科大学健康医疗大数据国家研究院

收稿日期:2025-11-10 修回日期:2026-03-20 出版日期:2026-09-05 发布日期:2026-08-11
通讯作者: 郭秀花
作者贡献：
谢文涵进行统计学处理，图、表的绘制与展示，撰写论文；王金麒进行论文的修订；刘浩、陈硕进行数据整理；吕世云进行论文的修订；韩玉梅进行数据的收集；张国红进行现场的调查与管理；郭秀花提出主要研究目标，负责研究的构思与设计，负责文章的质量控制与审查，对文章整体负责，监督管理。
基金资助:
首都卫生发展科研专项项目(首发2024-1G-4261)

Evaluation of the Accuracy of Fasting Blood Glucose Measurement Using Wearable Non-invasive Glucose Meters and Their Influencing Factors

XIE Wenhan¹^,², WANG Jinqi¹^,², LIU Hao¹, CHEN Shuo³, LYU Shiyun¹^,², HAN Yumei³, ZHANG Guohong³, GUO Xiuhua¹^,²^,⁴^,^*()

1. School of Public Health, Capital Medical University, Beijing 100069, China
2. Beijing Key Laboratory of Environment and Aging, Beijing 100069, China
3. Beijing Physical Examination Centre, Beijing 100050, China
4. National Research Institute of Healthcare Big Data, Capital Medical University, Beijing 100069, China

Received:2025-11-10 Revised:2026-03-20 Published:2026-09-05 Online:2026-08-11
Contact: GUO Xiuhua

摘要/Abstract

摘要： 背景血糖监测是血糖管理的核心环节，传统有创检测会引起疼痛和感染风险，无创血糖监测技术迅速发展，其检测性能有待评估。目的探讨可穿戴无创血糖仪测量空腹血糖的准确性、佩戴舒适度及影响因素，明确其应用可行性。方法 2025-01-13—05-11共招募北京市体检中心3个分部的103名受试者，同时分别使用可穿戴无创血糖仪、罗氏卓越金采型血糖仪、静脉采血测量受试者空腹血糖，以指尖和静脉血糖为参考。通过平均绝对相对误差（MARD）、误差栅格分析等评价准确性；通过问卷调查设备佩戴舒适度；采用最小绝对收缩和选择算子回归、Logistic回归分析探讨可穿戴无创血糖仪准确性的影响因素。结果共纳入103名受试者，其中男33名（32.04%）、女70名（67.96%），年龄范围为22~70岁。以指尖和静脉血糖为参考时，可穿戴无创血糖仪的MARD分别为19.79%、23.99%，测量点均位于Clarke误差栅格的A+B区，分别有97.09%、95.14%的测量点位于共识误差栅格的A+B区。Logistic回归分析显示以指尖血糖为参考时，准确性与低密度脂蛋白胆固醇（OR=0.80，95%CI=0.70~0.91，P<0.001）有关；以静脉血糖为参考时，准确性与中性粒细胞计数（OR=0.89，95%CI=0.81~0.97，P=0.010）、血小板体积分布宽度（OR=1.05，95%CI=1.01~1.09，P=0.048）有关。89.32%（92例）受试者认为可穿戴无创血糖仪舒适，设备佩戴不舒适者的平均血红蛋白水平较高（OR=1.04，95%CI=1.03~1.04，P<0.001）。结论该可穿戴无创血糖仪在真实世界体检人群的应用上表现出一定的测量准确性及较高的佩戴舒适度；准确性主要受低密度脂蛋白胆固醇、中性粒细胞计数及血小板体积分布宽度影响，舒适度与平均血红蛋白浓度有关，继续提升准确性后有望为血糖管理提供参考。

关键词: 空腹血糖, 准确性评价, 无创血糖仪, 可穿戴设备, 舒适度

Abstract:

Background

Blood glucose monitoring is a core component of glycaemic management. Traditional invasive testing carries risks of pain and infection, while non-invasive blood glucose monitoring technologies have advanced rapidly, with their associated performance metrics awaiting evaluation.

Objective

To investigate the accuracy, wearability, and influencing factors of non-invasive wearable glucose monitors in measuring fasting blood glucose levels, thereby determining their practical applicability.

Methods

Between 13 January and 11 May 2025, a total of 103 participants were recruited from three branches of the Beijing Physical Examination Centre. Fasting blood glucose values were measured simultaneously using wearable non-invasive glucose meters, Roche Accu-Chek Performa, and venous blood sampling, with fingerstick and venous glucose values serving as reference standards. Accuracy was assessed using mean absolute relative error (MARD) and error grid analyses. Device wear comfort was evaluated via questionnaire survey. Least absolute shrinkage and selection operator regression and Logistic regression analyses were used to explore the potential factors influencing the accuracy of wearable non-invasive glucose meters.

Results

The study included 103 participants, 33 males (32.04%) and 70 females (67.96%), aged between 22 and 70 years. When using fingerstick and venous blood glucose as reference standards, the MARD values were 19.79% and 23.99%, respectively. All measurement points fell within the Clarke error grid's A+B zone, with 97.09% and 95.14% of measurement points respectively located in the consensus error grid's A+B zone. Logistic regression analyses showed that accuracy was associated with low-density lipoprotein cholesterol when fingertip glucose was used as the reference (OR=0.80, 95%CI=0.70-0.91, P<0.001), and neutrophil count (OR=0.89, 95%CI=0.81-0.97, P=0.010), platelet volume distribution width (OR=1.05, 95%CI=1.01-1.09, P=0.048). 89.32% (92 subjects) of participants found the wearable non-invasive glucose meter comfortable; those reporting the device uncomfortable had higher mean haemoglobin concentrations (OR=1.04, 95%CI=1.03-1.04, P<0.001).

Conclusion

The wearable non-invasive blood glucose monitor demonstrated moderate measurement accuracy and high wearing comfort in real-world physical examination populations. The accuracy was primarily influenced by low-density lipoprotein cholesterol, neutrophil count, and platelet distribution width, while comfort was associated with MCHC. With further improvements in accuracy, this device holds promise for providing a valuable reference for blood glucose management.

Key words: Fasting blood glucose, Accuracy evaluation, Non-invasive glucose meter, Wearable devices, Comfort

谢文涵,王金麒,刘浩,等. 可穿戴无创血糖仪测量空腹血糖的准确性及影响因素研究[J]. 中国全科医学, 2026, 29(25): 3624-3630. DOI: 10.12114/j.issn.1007-9572.2025.0526.
XIE Wenhan,WANG Jinqi,LIU Hao, et al. Evaluation of the Accuracy of Fasting Blood Glucose Measurement Using Wearable Non-invasive Glucose Meters and Their Influencing Factors[J]. Chinese General Practice, 2026, 29(25): 3624-3630. DOI: 10.12114/j.issn.1007-9572.2025.0526.

图/表 5

表1 研究对象基本资料（n=103）

Table 1 Descriptive statistics of study participants

基本资料	数据
年龄[M（QR），岁]	26（21）
性别（男/女）	33/70
糖尿病患病[名（%）]	8（7.77）
糖尿病前期[名（%）]	16（15.53）
空腹血糖
静脉血糖[M（QR），mmol/L]	4.86（0.49）
指尖血糖[M（QR），mmol/L]	5.20（0.80）
无创血糖[M（QR），mmol/L]	5.26（1.43）
BMI[M（QR），kg/m²]	22.30（4.40）
腰臀比[M（QR）]	0.81（0.10）
中性粒细胞计数[M（QR），×10⁹/L]	3.27（1.23）
血小板体积分布宽度[M（QR），%]	10.80（2.30）
总胆固醇[M（QR），mmol/L]	4.56（0.94）
甘油三酯[M（QR），mmol/L]	0.94（0.65）
低密度脂蛋白胆固醇[M（QR），mmol/L]	2.63（0.70）
高密度脂蛋白胆固醇[M（QR），mmol/L]	1.45（0.34）
糖化血红蛋白[M（QR），%]	5.40（0.45）

图1 创血糖与指尖血糖、静脉血糖一致性比较的改良Bland-Altman图注：A为无创血糖与指尖血糖的一致性比较，B为无创血糖与静脉血糖的一致性比较。

Figure 1 Modified Bland-Altman ploto f agreement among continuous glucose monitoring, fingerstick blood glucose, and venous blood glucose

图2 以指尖血糖和静脉血糖为参考的误差栅格分析结果注：a为Clarke误差栅格分析（以指尖血糖为参考），b为Clarke误差栅格分析（以静脉血糖为参考），c为共识误差栅格分析（以指尖血糖为参考），d为共识误差栅格分析（以静脉血糖为参考）；误差栅格的A~E区代表不同临床风险等级，A+B区可视为临床可接受风险区。

Figure 2 Error grid analysis results using fingerstick blood glucose and venous blood glucose as references

表2 可穿戴无创血糖仪准确性影响因素分析

Table 2 Multivariate analysis results for accuracy of wearable non-invasive glucose meters

变量	b	SE	OR（95%CI）	t值	P值
以指尖血糖为参考
低密度脂蛋白胆固醇	-0.226	0.066	0.80（0.70~0.91）	-3.429	<0.001
以静脉血糖为参考
中性粒细胞计数	-0.118	0.045	0.89（0.81~0.97）	-2.635	0.010
血小板体积分布宽度	0.045	0.013	1.05（1.01~1.09）	2.001	0.048
腰臀比	0.814	0.585	2.26（0.71~7.21）	1.391	0.167

图3 基于LASSO回归的指尖与静脉血糖预测模型变量筛选结果注：A为系数路径图（指尖血糖为参考），B为交叉验证图（指尖血糖为参考），C为系数路径图（静脉血糖为参考），D交叉验证图（静脉血糖为参考）。

Figure 3 Variable selection results for fingerstick and venous blood glucose prediction models based on LASSO regression

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可穿戴无创血糖仪测量空腹血糖的准确性及影响因素研究

Evaluation of the Accuracy of Fasting Blood Glucose Measurement Using Wearable Non-invasive Glucose Meters and Their Influencing Factors

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