Cureus. 2025 Sep;17(9): e91864
BACKGROUND: Children and adolescents with type 1 diabetes (T1D) often have poor glycemic control and low satisfaction with management tools, increasing risks of complications. This study evaluated the clinical efficacy and user satisfaction of a novel real-time continuous glucose monitoring (CGM) system, Linx™ (Microtech Medical (Hangzhou) Co., Ltd., Zhejiang, China), over three months in adolescents with poorly controlled T1D.
METHODS: In this single-center, single-arm, observational study, 75 children and adolescents using multiple daily injections were enrolled. Clinical outcomes (HbA1c, insulin dose, and hypoglycemia) and CGM metrics (time in range, glucose variability, and calculated Glycemia Risk Index) were assessed at baseline, 28, and 90 days. Patient satisfaction was measured at three months using the validated 44-item CGM Satisfaction (CGM-SAT) questionnaire.
RESULTS: After three months of continuous Linx™ CGM use, median HbA1c significantly decreased from 9.5% to 8.1% (absolute reduction of 1.4 percentage points; p<0.001). Time in range (%TIR70-180) increased by 10.2 percentage points, rising from 49.8% at 28 days to 60.0% at three months (p<0.001). The frequency of hypoglycemic events dropped dramatically (p<0.001). Glucose variability improved significantly, with the coefficient of variation decreasing by 2.2%, and the composite Glycemia Risk Index declined by 11.3 points (p<0.01). Patient-reported satisfaction was high, with an overall CGM-SAT score averaging 4.8 out of 5, indicating substantial perceived benefits (mean=4.9) and low reported hassles (mean=4.6).
CONCLUSIONS: The Linx™ 15-day CGM system led to marked improvements in glycemic control and safety, along with high satisfaction, in children and adolescents with poorly controlled T1D. These results support the value of factory-calibrated CGM devices in optimizing diabetes management and quality of life in this vulnerable group.
Keywords: glycemia risk index; glycemic assessment; glycemic variability; patient satisfaction; type 1 diabetes