Diabetes, obesity & metabolism · 2026
Real-World Effectiveness and Safety of a Tubeless Automated Insulin Delivery System With an Adaptive Control Algorithm (APGO) in Children and Adolescents With Type 1 Diabetes: A Multicentre Observational Study.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Zanfardino Angela, Iafusco Dario, Ippolito Giorgia, Del Giudice Emanuele Miraglia, Rollato Assunta Serena, Chianese Antonietta, Figuccia Adele, Toni Sonia, Ferlito Annalisa Giulia, Piccini Barbara
Аннотация
AIM: Automated insulin delivery (AID) systems improve glycaemic outcomes in Type 1 diabetes; however, paediatric real-world data on newly introduced tubeless AID systems remain limited. We aimed to provide the first clinical evaluation of the A8 TouchCare Nano AID system with the APGO algorithm in children and adolescents with Type 1 diabetes.
MATERIALS AND METHODS: In this prospective observational study, children and adolescents initiating TouchCare Nano AID therapy were followed for 6 months. Continuous glucose monitoring metrics were assessed at baseline and 1, 3 and 6 months. The primary outcome was change in time in range (TIR, 70-180 mg/dL). Secondary outcomes included time in tight range (TiTR, 70-140 mg/dL), time above and below range, glucose variability, insulin dose, achievement of ISPAD glycaemic targets and safety. HbA1c was measured at baseline, 3 and 6 months.
RESULTS: Seventy-six participants (mean age 13.3 ± 3.2 years) completed follow-up. Mean TIR increased from 59.0% ± 15.6% at baseline to 74.2% ± 8.9% at 1 month and remained significantly higher at 3 and 6 months (all p < 0.05). TiTR significantly improved, whilst time above range decreased and time below range remained stable. More than half of participants achieved the ISPAD target of TIR > 70% at 6 months. Mean sensor glucose and glucose variability declined, and HbA1c decreased from 7.4% ± 0.8% to 6.9% ± 0.7% at 3 and 6 months (all p < 0.05). No episodes of severe hypoglycaemia or diabetic ketoacidosis were observed.
CONCLUSIONS: In routine paediatric care, use of this tubeless AID system was associated with rapid and sustained improvements in glycaemic control without increased hypoglycaemia.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT07425912.
MATERIALS AND METHODS: In this prospective observational study, children and adolescents initiating TouchCare Nano AID therapy were followed for 6 months. Continuous glucose monitoring metrics were assessed at baseline and 1, 3 and 6 months. The primary outcome was change in time in range (TIR, 70-180 mg/dL). Secondary outcomes included time in tight range (TiTR, 70-140 mg/dL), time above and below range, glucose variability, insulin dose, achievement of ISPAD glycaemic targets and safety. HbA1c was measured at baseline, 3 and 6 months.
RESULTS: Seventy-six participants (mean age 13.3 ± 3.2 years) completed follow-up. Mean TIR increased from 59.0% ± 15.6% at baseline to 74.2% ± 8.9% at 1 month and remained significantly higher at 3 and 6 months (all p < 0.05). TiTR significantly improved, whilst time above range decreased and time below range remained stable. More than half of participants achieved the ISPAD target of TIR > 70% at 6 months. Mean sensor glucose and glucose variability declined, and HbA1c decreased from 7.4% ± 0.8% to 6.9% ± 0.7% at 3 and 6 months (all p < 0.05). No episodes of severe hypoglycaemia or diabetic ketoacidosis were observed.
CONCLUSIONS: In routine paediatric care, use of this tubeless AID system was associated with rapid and sustained improvements in glycaemic control without increased hypoglycaemia.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT07425912.