Diabetes, obesity & metabolism · 2025
Safety and efficacy of hybrid closed-loop insulin pump therapy in adolescents and adults with type 1 diabetes in China.
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Shen Jing, Zeng Tianshu, Li Xia, Zheng Chao, Li Yufeng, Wu Xiaohong, Yao Hui, Chen Linqi, Liu Yang, Zhu Weiwei, Fu Junfen, Zhao Weigang, Mu Yiming
Аннотация
AIMS: To evaluate the effectiveness and safety of a hybrid closed-loop (HCL) insulin infusion system in treating adult and adolescent patients with type 1 diabetes (T1D).
MATERIALS AND METHODS: A total of 126 participants (22 adolescents and 104 adults) underwent a 2-week initial treatment phase followed by a 2-week run-in phase with the Equil® S HCL insulin pump system MTM-Z in Manual Mode with calibration-free continuous glucose monitoring (CGM) System G7, followed by a 12-week study phase with HCL Auto Mode enabled. The primary outcome was the overall mean change in CGM time in range (TIR; 70-180 mg/dL). Safety endpoints included rates of severe hypoglycaemia, hyperglycaemia and diabetic ketoacidosis (DKA).
RESULTS: Compared with the baseline run-in, Auto Mode increased TIR from 69.11% to 76.72% (p < 0.001) and reduced time below range (<70 mg/dL) from 3.92% to 2.73% (p < 0.001). The mean sensor glucose (SG) decreased from 151 ± 28 to 144 ± 19 mg/dL. The proportion of achieving TIR of >70% increased from 56.03% to 77.59%. The standard deviation (SD: -5.90 mg/dL) and coefficient of variation (CV: -2.49%) reduced significantly. The greatest change in TIR (mean 20.55%), mean SG (estimated treatment difference [ETD]: -30.13, 95% confidence interval [CI]: -41.84, -18.41; p = 0.001) and SD of SG (ETD: -14.21, 95% CI: -21.17, -6.71; p = 0.004) was observed in participants with a baseline glycosylated haemoglobin A1c (HbA1c) value of >8.0%. The percentage of achieving combined recommendations for time at SG ranges increased from 25.86% to 56.90%. No severe hypoglycaemia, DKA or adverse events were observed.
CONCLUSIONS: HCL therapy is safe in Chinese adolescent and adult patients with T1D. The 12-week application of the Equil® S HCL insulin pump system MTM-Z with Auto Mode increased TIR and reduced HbA1c, hyperglycaemia and hypoglycaemia.
MATERIALS AND METHODS: A total of 126 participants (22 adolescents and 104 adults) underwent a 2-week initial treatment phase followed by a 2-week run-in phase with the Equil® S HCL insulin pump system MTM-Z in Manual Mode with calibration-free continuous glucose monitoring (CGM) System G7, followed by a 12-week study phase with HCL Auto Mode enabled. The primary outcome was the overall mean change in CGM time in range (TIR; 70-180 mg/dL). Safety endpoints included rates of severe hypoglycaemia, hyperglycaemia and diabetic ketoacidosis (DKA).
RESULTS: Compared with the baseline run-in, Auto Mode increased TIR from 69.11% to 76.72% (p < 0.001) and reduced time below range (<70 mg/dL) from 3.92% to 2.73% (p < 0.001). The mean sensor glucose (SG) decreased from 151 ± 28 to 144 ± 19 mg/dL. The proportion of achieving TIR of >70% increased from 56.03% to 77.59%. The standard deviation (SD: -5.90 mg/dL) and coefficient of variation (CV: -2.49%) reduced significantly. The greatest change in TIR (mean 20.55%), mean SG (estimated treatment difference [ETD]: -30.13, 95% confidence interval [CI]: -41.84, -18.41; p = 0.001) and SD of SG (ETD: -14.21, 95% CI: -21.17, -6.71; p = 0.004) was observed in participants with a baseline glycosylated haemoglobin A1c (HbA1c) value of >8.0%. The percentage of achieving combined recommendations for time at SG ranges increased from 25.86% to 56.90%. No severe hypoglycaemia, DKA or adverse events were observed.
CONCLUSIONS: HCL therapy is safe in Chinese adolescent and adult patients with T1D. The 12-week application of the Equil® S HCL insulin pump system MTM-Z with Auto Mode increased TIR and reduced HbA1c, hyperglycaemia and hypoglycaemia.