Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers’ Fear of Hypoglycemia and Improves Their Well-being
Year: 2022
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVE: To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers' well-being, fear of hypoglycemia, and sleepiness. RESEARCH DESIGN AND METHODS: We conducted a multinational, open-label, randomized crossover study. Children (age 1-7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization-Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires. RESULTS: Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09). CONCLUSIONS: Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.
Source: Diabetes Care
DOI: 10.2337/dc22-0693
Authors: Carine de Beaufort, Ulrike Schierloh, Ajay Thankamony, Julia Ware, Malgorzata E. Wilinska, Elke Fröhlich-Reiterer, Thomas M. Kapellen, Birgit Rami-Merhar, Sabine E. Hofer, Fiona M. Campbell, James Yong, Laura E. Bocchino, Judy Sibayan, Julia Lawton, Stephane Roze, Maria Fritsch, Alena Thiele, Janet M. Allen, Charlotte Boughton, Julia K. Mader, Craig Kollman, Roman Hovorka, Ineke M. Pit-ten Cate, 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, Carine de Beaufort, Ulrike Schierloh, Muriel Fichelle, Dominique Schaeffer, Elke Fröhlich-Reiterer, 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
Institutions: Centre Hospitalier de Luxembourg, University of Luxembourg, Universitair Ziekenhuis Brussel, University of Cambridge, Wellcome/MRC Institute of Metabolic Science, Medical University of Graz, Leipzig University, Medical University of Vienna, Innsbruck Medical University, Universität Innsbruck, Leeds Teaching Hospitals NHS Trust, Jaeb Center for Health Research, University of Edinburgh, University Hospital Leipzig
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Juvenile Diabetes Research Foundation United States of America, Wellcome Trust, Insulet Corporation, Dexcom, Tandem Diabetes Care, National Institute for Health and Care Research, European Commission, Novo Nordisk, Servier, Roche Diabetes Care, Horizon 2020 Framework Programme, Abbott Diabetes Care, NIHR Cambridge Biomedical Research Centre
OpenAlex ID: W4301187538