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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.

Diabetes Care
|October 17, 2024
PubMed

Insights

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.
Abstract

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