Independent Analysis of Clinical Trial Data: GS1 Continuous Glucose Monitoring System (CGMS) in Pediatric Diabetes Management

Background: Diabetes mellitus poses significant challenges in pediatric populations, necessitating advanced glycemic monitoring technologies. This study presents an independent analysis of the GS1 Continuous Glucose Monitoring System (CGMS), originally developed by Shenzhen SiSensing Co., Ltd., and provided by its Turkish partner, BMED Pharmaceuticals. The analysis evaluates the efficacy, safety, and usability of the GS1 CGMS in pediatric patients aged 3 to under 18 years with diabetes mellitus. Methods: This multicenter, prospective trial included 81 pediatric participants across three clinical centers in China: Beijing Children’s Hospital, Capital Medical University (Center 01); Shenzhen Children’s Hospital (Center 02); and Fujian Medical University Union Hospital (Center 03). Participants underwent 14 days of CGMS monitoring, with venous blood glucose measurements as reference. Key metrics included concordance rates within the 20/20% error range, Clarke and Consensus Error Grid analyses, and Mean Absolute Relative Difference (MARD%). Safety and usability were assessed through adverse event monitoring and participant feedback. Results: A total of 79 participants completed the trial, achieving a 97.5% completion rate. Concordance rates were 93.9% across all glycemic ranges, surpassing predefined thresholds. Sensitivity and specificity for hypoglycemia detection were 97.6% and 87.3%, respectively, while hyperglycemia detection achieved 89.8% sensitivity and 97.0% specificity. The MARD% was 8.7%, consistently below the target of 18%. Usability scores averaged 95.3 ± 7.59, reflecting high satisfaction. Device-related adverse events, such as mild skin irritation, were self-limiting, and no serious adverse events were reported. Conclusion: This independent analysis demonstrated that the GS1 CGMS offers high accuracy, safety, and usability in pediatric glycemic monitoring. These findings support its broader application in routine pediatric diabetes care. Future studies should explore long-term efficacy and comparative evaluations with other CGMS technologies. Keywords Independent analysis, Continuous Glucose Monitoring (CGM), GS1 CGMS, Pediatric diabetes patients