| Autor: |
Dulanjalee Kariyawasam, MD, Carole Morin, MD, Kristina Casteels, ProfMD, Claire Le Tallec, MD, Annie Sfez, MD, Cécile Godot, MD, Erik Huneker, MSc, Nathalie Garrec, MD, Pierre-Yves Benhamou, ProfMD, Michel Polak, ProfMD, Guillaume Charpentier, MD, Sylvia Franc, MD, Jacques Beltrand, ProfMD |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
The Lancet: Digital Health, Vol 4, Iss 3, Pp e158-e168 (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2589-7500 |
| DOI: |
10.1016/S2589-7500(21)00271-5 |
| Popis: |
Summary: Background: Time in range (TIR) goals are rarely met in children with type 1 diabetes, except at the cost of increased hypoglycaemia episodes. Our objective was to evaluate the safety and efficiency of the Diabeloop DBL4K (Diabeloop, Grenoble, France) hybrid closed-loop system in prepubescent children. Methods: We did a multicentre, open-label, randomised, controlled, non-inferiority, two-session crossover study in the paediatric endocrinology departments of three university hospitals in France and Belgium. Eligible participants were aged 6–12 years with type 1 diabetes for at least 1 year, glycated haemoglobin A1C 9% (75 mmol/mol) or less, and insulin pump treatment for at least 3 months. Participants were randomly assigned (1:1) to a closed-loop device or sensor-augmented pump (open loop) therapy. Randomisation was by a permuted block randomisation scheme, using an interactive web-based response system, and was stratified on centre (block size 6). The assessed closed-loop device, the Diabeloop for Kids DBL4K hybrid closed-loop system, is an automated blood glucose regulation system composed of a handset, insulin pump, and continuous glucose monitor. The open-loop system is defined as a sensor-augmented pump therapy composed of the usual insulin pump used by the patient and a continuous glucose monitor. A 72-h in-patient period was followed by a 6-week home phase. After a 1-week washout period, the participants crossed over to the other device. The primary outcome, assessed in the intention-to-treat population, was the mean proportion of time spent in hypoglycaemia (3·9 mmol/L [ |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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