Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial
Year: 2024
Type: article
Abstract: OBJECTIVE: We aimed to evaluate the longer-term safety and efficacy of hybrid closed-loop (CL) therapy in very young children with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Following a 16-week multinational, randomized crossover trial comparing hybrid 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 with 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) 3.9-10.0 mmol/L was 8.4 percentage points (95% CI 6.7-10.1; P < 0.001) higher, while HbA1c was 0.4% ([5.0 mmol/mol], 95% CI 0.3-0.6 [3.7-6.2]; P < 0.001) lower during the CL extension phase compared with primary-phase SAP period. At 18 months, mean HbA1c was 6.7 ± 0.5% and TIR was 70 ± 7%, compared with 6.7 ± 0.5% and 71 ± 6% in the primary-phase CL period. Time in hypoglycemia (<3.9 mmol/L) was similar between CL extension phase and both primary-phase SAP (P = 0.31) and CL periods (P = 0.70). 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 CL system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D.
Source: Diabetes Care
DOI: 10.2337/dc24-1313
Authors: 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, Roman Hovorka, Carlo L Acerini, Ajay Thankamony, Charlotte K Boughton, Klemen Dovc, Julia Ware, Gianluca Musolino, Malgorzata E Wilinska, Janet M Allen, Sara Hartnell, Yue Ruan, Nicole Ashcroft, Matthew Haydock, Catherine Hill, Maria Fritsch, Hildegard Jasser-Nitsche, Julia K Mader, Kerstin Faninger, Thomas M Kapellen, Heike Bartelt, Alena Thiele, Birgit Rami-Merhar, Gabriele Berger, Nicole Blauensteiner, Renata Gellai, Katrin Nagl, Martin Tauschmann, Sarah Cvach, Sonja Katzenbeisser-Pawlik, Sabine E Hofer, Daniela Abt, Anita Malik, Barbara Lanthaler, Matthias Wenzel, Fiona Campbell, James Yong, Emily Metcalfe, Majorie Allen, Sarah Ambler, Saima Waheed, Jane Exall, Joseph Tulip, Carine de Beaufort, Ulrike Schierloh, Muriel Fichelle, Dominique Schaeffer, Julia Lawton, David Rankin, Ruth Hart, Barbara Kimbell, Stéphane Roze, Timothy Jones, Chris Patterson, Peter Adolfsson
Institutions: University of Cambridge, Wellcome/MRC Institute of Metabolic Science, Cambridge University Hospitals NHS Foundation Trust, Centre Hospitalier de Luxembourg, University of Luxembourg, Universitair Ziekenhuis Brussel, Leeds Teaching Hospitals NHS Trust, Medical University of Graz, Innsbruck Medical University, Universität Innsbruck, Leipzig University, Medical University of Vienna
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Eli Lilly and Company, Sanofi, Wellcome Trust, Insulet Corporation, Dexcom, National Institute for Health and Care Research, Department of Health and Social Care, European Commission, Novo Nordisk, Horizon 2020 Framework Programme, Abbott Diabetes Care, NIHR Cambridge Biomedical Research Centre, JDRF
OpenAlex ID: W4403509054