Clinical Performance Evaluation of the SiJoy GS1 Continuous Glucose Monitor during Oral Glucose Tolerance Testing in Healthy Adults

Wanyi Zhao¹Dongmei Zheng²Xianbao Shi³Feng Xu²Lin Chen²Xingmei Liu²Jin Xiaolong²Qingbo Guan²Chao Xu^2*

• ¹Shandong University, Jinan, Shandong Province, China
• ²Shandong Provincial Hospital, Jinan, China
• ³Shenzhen Sibionics Co.Ltd., Shenzhen, China

ObjectiveThis study evaluated the performance of the SiJoy GS1 Continuous Glucose Monitor (CGM) system by analyzing the time lag between plasma glucose (PG) and CGM measurements during an Oral Glucose Tolerance Test (OGTT) in healthy adults. This investigation would elucidate the implications of physiological delay time and optimize technical delays in populations.Research design and methodsA total of 129 participants wore SiJoy GS1 sensors on their posterior upper arms for at least 48 hours before undergoing an OGTT.ResultsTo minimize the Mean Absolute Relative Difference (MARD), two approaches were tested: MARD minimization and minimum deviation match. The demographic characteristics of the participants included a mean age of 37.62 (±11.21) years, height of 169.84 (±7.81) cm, and weight of 71.86 (±18.0) kg. Among them 69.0% were healthy. SiJoy GS1 sensors exhibit an excellent performance of consistency with 96.6% at 20/20% and MARD of 8.01(±4.9) % at the fasting phase. The consensus error grid results showed 89.22% of all values fell within Zone A, and 100% of values were in Zone A+B collectively. In terms of minimizing Mean Absolute Relative Difference (MARD), at 30 minutes of OGTT, the first method suggested a 15-minute delay while the second proposed a 10-minute average delay time. The latter approach was more suitable due to the less variability in the timing of glucose peaks during the OGTT.ConclusionsIn the study, the SiJoy GS1 sensor exhibited consistent performance. Its accuracy was unaffected by subject characteristics. The application of the minimum deviation match method proved advantageous in reducing the CGM delay time.