Clinical trials of a non-invasive glucometer in China. Standards and requirements for blood glucose monitoring systems. Non-invasive blood glucose measurement.

According to the evaluation criteria in the “Chinese Guideline on the Clinical Application of Blood Glucose Monitoring” (2021 edition), the accuracy requirements are as follows: at blood glucose concentration < 5.5 mmol/L, at least 95% of the difference in test results should be within the deviation of ± 0.83 mmol/L; at blood glucose concentration ≥ 0.5 mmol/L, at least 95% of the difference in test results should be within the deviation of ± 0.83 mmol/L. At 5.5 mmol/L, at least 95% of the difference in test results must be within a ± 15% deviation.

There is some debate over what constitutes good technical accuracy when comparing glucose meters against a laboratory method. Standards organizations and professional societies differ on accuracy acceptability criteria (Table 1). The ADA has recommended that glucose meters agree to within ±15% of the laboratory method at all concentrations, with a future performance goal of ±5% agreement at all glucose concentration.Since meter performance can change across the range of the glucose concentrations, some performance criteria differ between the hypoglycemic range and the hyperglycemic range. For instance, the International Organization for Standardization and the U.S. Food and Drug Administration has set accuracy criteria to ±20 mg/dl (1.11 mmol/liter) for levels <100 mg/dl (5.6 mmol/liter) or ±20% for glucose levels >100mg/dl (5.6 mmol/liter) for at least 95% of results.13,23 There is thus no single standard to assess the accuracy of a glucose meter, so the determination of accuracy will vary by country and recommendation utilized for the judgment.

All medical devices that are sold in Europe must be CE marked. CE marking is not a quality mark. It is required for various medical devices, including glucometers. In the Netherlands, the NEN (Dutch Standard) represents the Dutch position on the interaction between patients, medical device manufacturers and doctors. The standard for measuring equipment is set out in NEN-EN-ISO 15197. “In vitro diagnostic systems – Requirements for blood glucose monitoring systems for self-testing for the management of diabetes mellitus”. This standard was last amended in 2015. At that time, it was determined that the allowable measurement deviation should be reduced from 20% to 15%.

The Company commissioned Chongqing Red Cross Hospital (Jiangbei County People's Hospital) to conduct a clinical trial of a non-invasive watch for monitoring blood glucose levels. Under the guidance of Prof. Liang, a number of professional medical personnel conducted medical examinations of a sufficient number of type 2 diabetes patients, and analyzed and summarized the collected data of non-invasive blood glucose test, fingertip blood glucose test and venous plasma glucose test. The clinical validation accuracy of the non-invasive blood glucose watch reaches 95.37%.

Chongqing Red Cross Hospital (Jiangbei County People's Hospital) is a national second class “A” general hospital integrating medical care, teaching and research. It is a western medical center in the northern part of New Town. The hospital adheres to the concept of people-oriented comprehensive development, reform and quality-based survival. It has been rated as “Provincial Advanced Health System Team”, “Provincial Civilized Hospital”, “Municipal Civilized Unit” and “Trustworthy Hospital of Chongqing” many times.

Clinical trials of our non-invasive watch in China.

Local measurement tolerances.

Requirements of international standards.

Restrictions.

Research and Findings.

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