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Eighteen-month hybrid closed-loop use in very young children with type 1 diabetes: a single-arm multicenter trial

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posted on 2024-10-17, 19:04 authored by Julia Ware, Janet M Allen, Charlotte K Boughton, Malgorzata E Wilinska, Sara Hartnell, Ajay Thankamony, Carine de Beaufort, Fiona M Campbell, Elke Fröhlich-Reiterer, Maria Fritsch, Sabine E Hofer, Thomas M Kapellen, Birgit Rami-Merhar, Martin Tauschmann, Roman Hovorka

Objective We aimed to evaluate the longer-term safety and efficacy of hybrid closed‑loop therapy in very young children with type 1 diabetes (T1D). Research Design and Methods Following a 16-week multi-national, randomized crossover trial comparing hybrid closed-loop (CL) with sensor-augmented pump (SAP) therapy in 74 very young children aged 1-7 years with T1D, participants were invited to an extension phase using CL for a further 18 months. Outcomes were compared to the primary phase SAP period and primary phase CL period. Results After the primary study phase, 60 participants were eligible to enroll in the extension. Of these, 49 consented (mean±SD age 6.6±1.5 years) to continue use of CL for 18 months. Percentage time in range (TIR) 3.9‑10.0mmol/L was 8.4 percentage points (95% CI 6.7 to 10.1; p<0.001) higher, while HbA1c was 0.4% ([5.0mmol/mol], 95% CI 0.3 to 0.6 [3.7 to 6.2]; p<0.001) lower during the CL extension phase compared to primary phase SAP period. At 18 months mean HbA1c was 6.7±0.5% and TIR 70±7%, compared to 6.7±0.5% and 71±6% in the primary phase CL period. Time in hypoglycemia (<3.9mmol/L) was similar between CL extension phase and both primary phase SAP and CL periods (p=0.31 and p=0.70 respectively). There were two severe hypoglycemia events and one other serious adverse event during the extension phase. One unexpected serious adverse device effect occurred. Conclusions Use of the Cambridge hybrid closed-loop system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D.

Funding

This primary study phase was funded by the European Commission within the Horizon 2020 Framework Programme under the grant agreement number 731560. Additional support for the artificial pancreas work from JDRF (22-2013-266 and 2-RSC-2019-828-M-N). This research was supported by the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre (NIHR203312*). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Dexcom supplied discounted continuous glucose monitoring devices. The views expressed are those of the author(s) and not necessarily those of the funders.

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