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

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Titel: Eighteen-month hybrid closed-loop use in very young children with type 1 diabetes: a single-arm multicenter trial: A Single-Arm Multicenter Trial
Autoren: 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, Carlo L Acerini, Charlotte K Boughton, Klemen Dovc, Gianluca Musolino, Malgorzata E Wilinska, Janet M Allen, Yue Ruan, Nicole Ashcroft, Matthew Haydock, Catherine Hill, Hildegard Jasser-Nitsche, Julia K Mader, Kerstin Faninger, Thomas M Kapellen, Heike Bartelt, Alena Thiele, Gabriele Berger, Nicole Blauensteiner, Renata Gellai, Katrin Nagl, 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, Ulrike Schierloh, Muriel Fichelle, Dominique Schaeffer, Julia Lawton, David Rankin, Ruth Hart, Barbara Kimbell, Stéphane Roze, Timothy Jones, Chris Patterson, Peter Adolfsson
Weitere Verfasser: Clinical sciences, Faculty of Medicine and Pharmacy, DSpace at Cambridge pro (8.1)
Quelle: Diabetes Care
Verlagsinformationen: American Diabetes Association, 2024.
Publikationsjahr: 2024
Schlagwörter: Male, Blood Glucose, Cross-Over Studies, Child, preschool, Diabetes Mellitus, Type 1/drug therapy, Infant, Hypoglycemic Agents/administration & dosage, Blood Glucose/drug effects, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Child, Preschool, Humans, Hypoglycemic Agents, Insulin, Original Article, Female, Child, Insulin/administration & dosage
Beschreibung: 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
Publikationsart: Article
Other literature type
Dateibeschreibung: application/pdf
ISSN: 1935-5548
0149-5992
DOI: 10.2337/figshare.27040651
DOI: 10.2337/dc24-1313
DOI: 10.2337/figshare.27040651.v1
DOI: 10.17863/cam.114848
Zugangs-URL: https://pubmed.ncbi.nlm.nih.gov/39418532
https://biblio.vub.ac.be/vubir/(2e15341f-19ed-4deb-8702-8787767ae7f0).html
Rights: CC BY NC SA
CC BY
URL: https://www.diabetesjournals.org/journals/pages/license
Dokumentencode: edsair.doi.dedup.....97d34b0b124dd7cbc889b3c24cbb0f70
Datenbank: OpenAIRE
Beschreibung
Abstract: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
ISSN:19355548
01495992
DOI:10.2337/figshare.27040651