Quality analysis and comparison of portable blood glucose meters in Zhejiang Province
10.3760/cma.j.cn114452-20240806-00459
- VernacularTitle:浙江省便携式血糖仪的质量分析与比较
- Author:
Hongrui ZHANG
1
;
Xiongwei YE
1
;
Lu CHENG
1
;
Xiaochen WAN
1
;
Yueshuang SHEN
1
;
Meng LI
1
Author Information
1. 浙江医院医学检验科，杭州 310013
- Publication Type:Journal Article
- Keywords:
Diabetes;
Blood sugar;
POCT;
Portable blood glucose meter;
Quality analysis
- From:
Chinese Journal of Laboratory Medicine
2025;48(3):402-408
- CountryChina
- Language:Chinese
-
Abstract:
Objective:We conducted a quality analysis and a survey of current situation of portable blood glucose meters from hospitals and patient sources in Zhejiang Province..Methods:The study is a retrospective cross-sectional study that included 252 portable blood glucose meters, of which 35 portable blood glucose meters (4 in provincial hospitals, 29 in municipal hospitals, and 2 in county-level hospitals) selected for the "Zhejiang Province Portable Blood Glucose Meter Flight Quality Control Inspection" project in April 2023, 126 portable blood glucose meters collected for the "Zhejiang Hospital Portable Blood Glucose Meter Whole Hospital Comparison" project in January 2024, and 91 portable blood glucose meters collected from patients in the "Zhejiang Hospital Home Portable Blood Glucose Meter Convenience Service" project from 2021 to 2023. By comparing the blood glucose results with the reference analyzer, evaluate the qualification rate of portable blood glucose meters between hospitals and patients, imported and domestic brands, and analyze the distribution of blood glucose concentration intervals for unqualified portable blood glucose meters. Conduct a survey questionnaire on the use of portable blood glucose meters by patients to analyze their trust in the results, quality control execution rate, comparison awareness rate, and comparison execution rate.Results:The overall qualification rate of portable blood glucose meters in hospitals (95.7%) was higher than that of portable blood glucose meters use by patients (70.3%), and the difference was statistically significant ( χ 2=31.94 , P<0.001). Among the unqualified blood glucose meters, the unqualified blood glucose concentration is mainly concentrated in the high concentration range (65.9%). Among imported brands, the qualification rate of blood glucose meters from hospitals(99.3%) is higher than that from patients(74.0%), and the difference is statistically significant ( χ 2=36.97, P<0.001). Meanwhile, 75% of patients fully trust the detection results of the blood glucose meter, but its instrument qualification rate is 69%. The awareness rate of patients regarding the comparison of portable blood glucose meters is 73%, but the execution rate of quality control and standard comparison of portable blood glucose meters by patients is 0. Conclusion:The quality of portable blood glucose meters in Zhejiang Province is uneven, with the highest pass rate for portable blood glucose meters from hospitals. Patients have weak awareness of quality control and comparison of portable blood glucose meters.
