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Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial
Julia Ware1,2, Janet M Allen1,2, Charlotte K Boughton1,3
1Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.
Hybrid closed-loop (CL) therapy improved glycemic control in very young children with type 1 diabetes (T1D) for over 18 months. This advanced system demonstrated sustained efficacy and safety in managing T1D in this age group.
Area of Science:
- Pediatric Endocrinology
- Biomedical Engineering
- Diabetes Technology
Background:
- Type 1 diabetes (T1D) management in very young children presents unique challenges.
- Hybrid closed-loop (CL) systems offer a potential solution for improved glycemic control.
- Longer-term data on CL therapy in this population are limited.
Purpose of the Study:
- To evaluate the extended safety and efficacy of hybrid CL therapy in children aged 1-7 years with T1D.
- To compare outcomes of CL therapy during an 18-month extension phase with initial sensor-augmented pump (SAP) and CL periods.
Main Methods:
- A multinational, randomized crossover trial was followed by an 18-month extension phase using CL therapy.
- Participants (n=49) aged 1-7 years with T1D continued CL therapy after a primary phase comparing CL with SAP.
- Outcomes including time in range (TIR) and HbA1c were compared between study periods.
Main Results:
- CL therapy extension phase showed significantly higher TIR (+8.4%) and lower HbA1c (-0.4%) compared to the primary SAP phase.
- Glycemic control metrics (HbA1c, TIR) remained stable and comparable between the CL extension and primary CL periods.
- Time in hypoglycemia was similar across all periods; two severe hypoglycemia events and one serious adverse device effect were reported.
Conclusions:
- The Cambridge hybrid CL system provides sustained glycemic control benefits for over 18 months in very young children with T1D.
- Hybrid CL therapy is a safe and effective option for managing T1D in preschool-aged children.
- Continued use of CL technology supports long-term improvements in diabetes management for pediatric patients.
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